DATA AN ALYSIS, INTERPRETATION

AND PRESENTATION

Lecture - 7
W H Y D O WE A N A LY Z E DATA

The purpose of analysing data is to obtain usable and useful information. The
analysis, irrespective of whether the data is qualitative or quantitative, may:

• describe and summarise the data

• identify relationships between variables
• compare variables
• identify the difference between variables
• forecast outcomes
Summarizing data
• Tables
• Simplest way to summarize data

• Data are presented as absolute numbers or percentages

• Charts and graphs

• Visual representation of data

• Data are presented as absolute numbers or percentages

Basic guidance when summarizing data

• Ensure graphic has a title

• Label the components of your graphic

• Indicate source of data with date

• Provide number of observations (n=xx) as a reference point

• Add footnote if more information is needed

Data Analysis
• Analysis: Turning raw data into useful information

• Purpose: To provide answers to questions being asked

• Even the greatest amount and best quality of data mean nothing if data are not
properly analyzed or analyzed at all.

• Analysis is looking at the data in light of the questions you need to answer:
Descriptive Analysis

• Describes the sample/target population (demographic and clinical

characteristics)

• Does not define causality; tells you what, not why

• Example: Average number of clients seen per month

 Basic Terminology and Concepts
• Statistical terms
• Ratio
• Proportion
• Percentage
• Rate
• Mean
• Median
• Trend
Central Tendency

Measures of the location of the middle or the center of a distribution

of data

• Mean

• Median
 Mean
• The average of your dataset

• The value obtained by dividing the sum of a set of quantities by the

number of quantities in the set

• Example:

• (22+18+30+19+37+33) = 159 ÷ 6 = 26.5

• The mean is sensitive to extreme values

Median
• The middle of a distribution (when numbers are in order: that is, half of the
numbers are above the median and half are below the median)

• The median is not as sensitive to extreme values as the mean.

• Odd number of numbers, median = the middle number

• Median of 2, 4, 7 = 4

• Even number of numbers, median = mean of the two middle numbers

• Median of 2, 4, 7, 12 => (4+7) /2 = 5.5
 Trend

• A trend is a pattern of gradual change in a condition, output, or

process, or an average or general tendency of a series of data points to
move in a certain direction over time, represented by a line or curve on a
graph.

• To follow a trend you must not only be aware of what is currently

happening but also be astute enough to predict what is going to
happen in the future.
 Adults and children on antiretroviral therapy (ART), 2008–2011

200

180

160
# of people (in thousands)

140

120
# adults on ART
100
# children on ART
80

60

40

20

0
2008 2009 2010 2011
Questions to Ask Yourself When Choosing a Chart
• 1. Want to compare values?

Charts are perfect for comparing one or many value sets, and they can
easily show the low and high values in the data sets.

• Use these charts to show comparisons:

• Column/bar
• Circular area
• Line
• Scatter plot
• Bullet
2. Want to show the composition of something?

• To show how individual parts make up the whole of something (such as

the device used for mobile visitors to your website, or total sales broken
down by sales rep)

• Use these charts to show composition:

• Pie
• Stacked bar
• Stacked column
• Area
3. Want to understand the distribution of your data?

• Distribution charts help you to understand outliers, the

normal tendency, and the range of information in your values.

• Use these charts to show distribution:

• Scatter plot
• Line
• Column
• Bar
4. Interested in analyzing trends in your data set?

• If you want more information about how a data set

performed during a specific period, there are specific
chart types that do this extremely well.

• Use these charts to analyze trends:

• Line
• Dual-axis line
• Column
5. Want to better understand the relationships among value sets?

• Relationship charts are designed to show how one variable relates to

one or many different variables. You could show how
something positively affects (or has no effect, or negatively affects)
another variable.

• Use these charts to show relationships:

• Scatter plot
• Bubble
• Line
Interpreting data

• Adding meaning to information by making connections and

comparisons and exploring causes and consequences

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
Interpretation – relevance of finding

• Adding meaning to information by making connections and

comparisons and exploring causes and consequences

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
Interpretation – relevance of finding

• Does the indicator meet the target?

• How far from the target is it?

• How does it compare (to other time periods, other facilities)?

• Are there any extreme highs and lows in the data?

Interpretation – possible causes?

• Supplement with expert opinion

• Others with knowledge of the program or target population

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
Interpretation – consider other data

Use routine service data to clarify questions

Use other data sources

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
Interpretation – other data sources

• Situation analyses

• Demographic and health surveys

• Performance improvement data

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
 Interpretation – conduct further research

• Data gap

• conduct further research

• Methodology depends on questions being asked and resources available

Conduct
Relevance Reasons Consider
further
of finding for finding other data
research
 Key messages
• Use the right graph for the right data
• Tables – can display a large amount of data

• Graphs/charts – visual, easier to detect patterns

• Label the components of your graphic

• Interpreting data adds meaning by making connections and

comparisons to program

• Service data are good at tracking progress & identifying concerns – do

not show causality
 Intellectual Property
Fundamentals of Patents

Lecture - 8
What is intellectual Property?
• Property
- Ownership

- Free to use it as owner wishes

- Exclude others from so using that owned item of property

• Intellectual Property

- Types of property that results from creations

of human mind, the intellect.
WIPO Convention

“Literary artistic and scientific works; performances of

performing artists, phonograms, and broadcasts;
inventions in all fields of human endeavor; scientific
discoveries; industrial designs; trademarks, service
marks, and commercial names and designations;
protection against unfair competition; and "all other
rights resulting from intellectual activity in the industrial,
scientific, literary or artistic fields.”
Intellectual Property Rights

• Literary, artistic and scientific works e.g. books.

Protection of this property is governed by laws
concerning Copyright.

• Performances, broadcasts e.g. concerts. Protection of

this property is governed by laws concerning
Copyright's Related Rights.

• Inventions e.g. a new form of jet engine. Protection of

inventions is covered by laws concerning Patents.
Intellectual Property
• Industrial designs e.g. the shape of a soft drinks
bottle. Industrial Designs may be protected by its own
specialized laws, or those of Industrial Property or
Copyright.

• Trademarks, service marks and commercial names

and designations e.g. logos

• Names for a product with unique geographical origin,

such as Champagne are protected by Geographical
Indicators.
• Technical Designs of electronic devices are
protected by Integrated Circuits.

• New Plant varieties are protected by Plant

Varieties Protection Act.

• Confidential information not in public domain

can be protected as Trade Secret.
Why IP has become Important?

• Development of Global Technological capability

• Reverse Engineering feasible in developing

countries

• Follow-up of General Agreement on Trade and

Tariffs (GATT)

• Agreement on Trade Related Aspects of

Intellectual Property Rights (TRIPS Agreement)
WHY DO IP RIGHTS MATTER?
• Provide incentive towards various creative
endeavors of the mind by offering protections;
• Give such creators official recognition;
• Create repositories of vital information;
• Exclusive rights – high market share
• To protect your own business and inventions
from your competitors
Why do IP Rights matter?

• To avoid the risk of being exposed to assertions

of patent infringement by competitors/ third
parties

• Facilitate the growth of domestic industry and

international trade

• Monetisation - Income from licensing

• Attract Investors
 WHY IP IS IMPRTANT TO INVESTORS?

• IP is integral part of value creation in a tech-

based enterprise
• Investors are faced with considerable
uncertainty and therefore rely on patents as
signals when trying to assess
• IP is the basis for putting resources to risk
• Appropriate use of the IP system is a powerful
tool for competition, stability and mitigation of
risks on capital investments.
• Venture capitalists want to maximize returns
and minimize risks
 WHAT IS A PATENT ?

A RIGHT GRANTED TO INVENTORS TO PREVENT

UNAUTHORIZED USE OF AN INVENTION, WITHIN A
PARTICULAR TERRITORY, FOR A LIMITED TIME.
DOES NOT GUARANTEE THE FREEDOM TO
EXPLOIT THE INVENTION.
Patent-Explanation
• Negative Right
• Patents are territorial
e.g., an Indian patent has no force in other
countries , just as a foreign patent has no
force in this country.
• Limited Time: 20 years from Date of application.
• Positive right restricted by previous patents
-Freedom to operate/market/practice
All patent applications are published after 18
months
Social Contract
• Patent rights are granted in return for the
inventor’s full disclosure of the technology to
the public
• The patent holder receives the right to prevent
anyone else from practicing the invention
• In exchange, the government ensures that the
information regarding the invention is publicly
disclosed, and the invention itself is available
for anyone’s use after the expiration of the
patent.
REQUIREMENTS OF PATENTABILITY
SUBSTANTIVE REQUIREMENTS

• SUBJECT MATTER
• NOVELTY
• NON-OBVIOUSNESS
• UTILITY

PROCEDURAL REQUIREMENTS

• ENABLEMENT
• DEFINITENESS
• BEST MODE
IDEAS/CONCEPTS CANNOT BE PATENTED
 REQUIREMENTS OF PATENTABILITY
SUBJECT MATTER
• MANUFACTURE
• MACHINE
• COMPOSITION OF MATTER
• PROCESS
e.g. GENETICALLY MODIFIED BACTERIA
HUMAN ENGINEERED MICE
UTILITY
MINIMUM DEMONSTRATION
NOVELTY
NOT ANTICIPATED IN ”PRIOR ART”
“PRIOR ART”- ANYTHING PREVIOUSLY
PUBLISHED,PATENTED,KNOWN,USED,SOLD
 REQUIREMENTS OF PATENTABILITY

OBVIOUSNESS
Knowledge at the time of invention must not be obvious
to one of ordinary skill in that area

DETERMINED BY
Scope / content of prior art
As level of ordinary skill in technology increases, so
does the obviousness of advances
REQUIREMENTS OF PATENTABILITY
ENABLEMENT
Ability to use the invention without “undue
experimentation” (specification)

DEFINITENESS INQUIRY
Understanding limits of invention based on claim
language

BEST MODE
Best way known to him/her to carry out the claimed
invention. Disclosure must allow a person of
“ordinary skill in the art “to practice the invention.
Concealment of best mode results in rejection.
PATENTABILITY OF INVENTIONS
• An invention which is frivolous or which claims
anything obviously contrary to the well established
natural laws
• An invention the primary or intended use or
commercial exploitation of which would be
contrary to public order or morality or which
causes serious prejudice to human, animal or
plant life or health or to the environment, law,
morality or injurious to public health.
• The mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of
any living thing or non-living thing in nature
 PATENTABILITY OF INVENTIONS
• The mere discovery of a new property or new use for
a known substance or of the mere use of a known
process, machine or apparatus unless such known
process results in a new product or employs at least
one new reactant
• A substance obtained by a mere admixture resulting
only in the aggregation of the properties of the
components thereof or a process for producing such
substances
• The mere arrangement or rearrangement or
duplication of known devices each functioning
independently of one another in a known way
 PATENTABILITY OF INVENTIONS

• A method of agriculture or horticulture

• Any process for the medicinal, surgical, curative,

prophylactic, diagnostic, therapeutic or other
treatment of human beings or any process for a
similar treatment of an animal or plants to render
them free of disease or to increase their economic
value or that of their products
 EXCEPTIONS TO THE INVENTIONS

• Plants and animals in whole or part thereof other

than micro organism but including seeds, varieties
and species and essentially biological processes
for production or propagation of plants and animals
• A mathematical or business method or a computer
programme per se or algorithms
• A literary, dramatic, musical or artistic work or any
other aesthetic creation whatsoever including
cinematographic works and television productions
 EXCEPTIONS TO THE INVENTIONS

- A mere scheme or rule or method of performing mental

act or method of playing games
- A presentation of information
- Topography of integrated circuits
- An invention which, in effect , is traditional knowledge
or which is an aggregation or duplication of known
properties of traditionally known component or
components
 DEFINITIONS
• INVENTIONS
• “Invention” means a new product or process involving an
inventive step and capable of industrial application
• INVENTIVE STEP
• “Inventive step” means a feature that makes the inventions not
obvious to a person skilled in the art
• CAPABLE OF INDUSTRIAL APPLICATION
• In relation to an invention means that the invention is capable of
being used in an industry
(Industry here does not mean manufacturing sector alone. It is an
all encompassing definition for the purpose of utility).
PATENTABILITY UNDER US SYSTEM

Anything that involves human interference can be

patented

Plants,buisness methods,software (all technology

areas)
 Patent Claim Types
• Product claims- Apparatus/Device/ Composition
• Process/ Method claims
• Use/Application claims
• Product-by-process claims
• Biotech claims
• Software claims
• Omnibus claims
• Design claims
 Process Vs Product Patent

A+B
A+B
a B+C
e b
X
C+D d c B+D

X – Product
a, b, c, d, e - Processes
A,B,C,D – Raw materials
Important Changes In Respect Of Chemical
Process

Patents to the products capable of being used as

food, agrochemicals , drug and medicines and
those of chemical process.

Chemical processes to include biochemical,

biotechnological and microbiological processes
COMMUNICATIONS THAT COUNT
AGAINST AN INVENTOR
• PRINTED PUBLICATIONS

• MICROFILMS / DIGITAL MEDIA

• SLIDES AND DRAWINGS

• PHOTOGRAPHS

• SPEECHES AND HANDOUTS

• LIBRARY CATALOUGING (THESIS)

• GOVERNMENT RESEARCH GRANT PROPOSAL

• EMPHASIS ON `ACCESSIBILITY AND DISSEMINATION OF THE WORK’

• INVENTION ON SALE

• INVENTION AVAILABLE FOR PUBLIC USE.

• USA- ONE YEAR GRACE AFTER PUBLICATION

WHO CAN QUALIFY AS INVENTORS

• Provider of the idea/concept

• Members of team who made significant conceptual

contributions

• Every team members should have his own notebook

or document to record his contribution, dated, signed
and witnessed

• If you design an experiment for someone else to

perform enter your instructions into your notebook
R&D Alerts for Patent Protection

• Record the date of conception of an idea

• Record the date when the Conception was first
“Reduced to Practice"
• Show “Due Diligence" in reducing the invention to
practice sign and witness all entries in
• Notebook. The laboratory notebook is a legal
record. A System for lab record keeping should be
evolved.
INVENTORSHIP Vs. OWNERSHIP

• Organizational IPR policies (work for hire)

• Commercial work of non-employees

• Artistic works
• Architectural or engineering drawings
• Computer software
• Reports by consultants or subcontractors
• Sponsorships /grants – assignments / march in rights /
shop rights
Types of Patents

• Utility Patents

• Design Patents

• Plant Patents

• Innovation Patents

• Provisional Patents
 TYPES OF PATENTS

Utility Patents-are available for processes, machines, articles of

manufacture, or compositions of matter that are deemed new,
useful and non-obvious. The traditional subject matter of patents
covers tangible, technical inventions, such as improvements to
client-server systems, motors, radios, computer chips and various
technical product features
 TYPES OF PATENTS
• Patents for business methods: E.g a method for
completing a credit card transaction without the need for
the physical presence of the credit card.

• Design Patents- to protect ornamental (non-functional)

designs. Apple’s Patent D 604,305 covering the design of
its iPhone interface

• Plant Patents

• Innovation Patents

• Provisional Patents
 PROVISIONAL PATENT

• In India, the United States and some other countries, a

temporary patent application, to protect invention while
work is in progress termed as provisional application, may
be filed.
• Must be “completed” within 12 months by the filing of a
complete application.
• The legal requirements for a provisional application may
be less than those for a complete application, for
example, it is not necessary to include claims in a
provisional.
Compulsory Licensing
• In certain cases, in fact, the use of the patented
invention may be authorized to a third party either by
the competent court or by a Patent Office (depending
on the law of the country)

• Prevents the abuses which might result from the

exclusive rights conferred by a patent. This regime may
also be applied in case of non-use of the patented
invention within a prescribed period (generally four
years from the filing date of application for patent, or
three years from the issue of patent).
 FOREIGN PATENTS

- Territorial right- restricted to grant giving country

- NO CONCEPT OF WORLD PATENT or

INTERNATIONAL PATENT

- System of filing inernational patent application for the

purpose of priority date and examination exists under
the patent cooperation treaty (pct) administered by
world intellectual property organisation (wipo)
Patent Cooperation Treaty (PCT)

• Filing in a home country

• International Search (ISA)

• International Publication (WIPO)- 18 Months

• International Preliminary Examination (optional)

• National Phase (Optional in designated countries)- up till

12 months after publication
ADVANTAGES of PCT

• Simplify the process

• Single Priority date

• Gain time to make a decision

• Disseminate more effectively the technical

knowledge contained in patent documentation.

• Increased efficiency of national patent offices

European Patent System

• European patent convention

- European directives
- National laws on the subject matter

• European patent office (epo)

- Patent valid in contracting countries
• National patents (german-de) etc.
• Africa and middle east to follow similar practice
PARIS CONVENTION OF INDUSTRIAL
PROPERTY

• Oldest Convention (1883)

• The Right of Priority – Filing within 12 Months

• Concept of National Treatment

• Independence of Patents
PATENT PROSECUTION

• Examiners search

• Citation of prior art

• Normal for all claims to be rejected

• Grounds on which claims have been rejected

• Invention has to be of an earlier date than cited

prior art

• Answer to the objections/amend claims/ withdraw

Patent Protection in India – Important Milestones

• 1856 - Protection for inventions formally started

• Based on the British Patent Law of 1852

• 1911 - The Indian Patents & Designs Act

• Product patents / composition of matter patents available

• 1972 - The Indian Patents Act ( April 20, 1972)

• Only process patents in pharmaceuticals, agrochemicals
and food
• Term – 5 years from date of grant or 7 years from date of
application, whichever was earlier
Patent Protection in India – Important
Milestones

• 1994 – Indian signs GATT agreement

• 1997 – India becomes a PCT member-state
• Amendments to the 1970 Act
• 1999 - (effective Jan 1, 1995)
• 2002 (effective May 20, 2003)
• 2005 (effective Jan. 1,2005) – Reintroduction of product
patents for pharma, food and agrochem.
• Patents for other technology areas like Biotech
INDIAN IPR LAWS ARE TRIPS COMPLIANT
 Commercial exploitation of patents

• Patents to Exclude the Competition - the

Pharmaceutical Industry
• Patents for Survival - the Biotechnology Industry
• Patents as Bargaining Chips - the Electronics
Industry
• Patents as a Source of Royalty Income -
Universities
• Patents as Marketing Tools- National Labs
• Patents as Lottery Tickets - Individual Inventors
Patents : Hidden Benefits

• Advancement of Technology

• Source of Information

• Economic Indicators (R&D Investment)

• Innovation Indicators

• Delineation of technology fronts

(Useful for Technology Forecasts)

• Research and Business Planning

Ethics Consultation Process

Lecture - 9
 Morals

 An individual’s own code for acceptable

behavior
 They arise from an individual’s conscience
 They act as a guide for individual behavior
 They are Learned
 Ethics
 Ethics deals with the
“rightness” or
“wrongness” of human
behavior
 Concerned with the
motivation behind the
behavior
 Bioethics is the
application of these
principles to life-and-
death issues
Ethical Principles
 Autonomy
 Nonmaleficence
 Beneficence
 Justice
 Fidelity
 Confidentiality
 Veracity
 Accountability
 Autonomy
 The freedom to make decisions about oneself
 The right to self-determination
 Healthcare providers need to respect patient’s
rights to make choices about healthcare, even if the
healthcare providers do not agree with the patient’s
decision.
 Nonmaleficence

 Requires that no harm be caused to an

individual, either unintentionally or
deliberately
 This principle requires nurses to protect
individuals who are unable to protect
themselves
 Beneficence
 This principle means
“doing good” for others
 Nurses need to assist
clients in meeting all their
needs
◦ Biological
◦ Psychological
◦ Social
 Justice
 Every individual must be treated
equally
 This requires nurses to be
nonjudgmental
 Fidelity
 Loyalty
 The promise to fulfill all
commitments
 The basis of accountability
 Includes the professionals
faithfulness or loyalty to
agreements &
responsibilities accepted as
part of the practice of the
profession
 Confidentiality
 Anything stated to nurses or health-
care providers by patients must
remain confidential
 The only times this principle may
be violated are:
◦ If patients may indicate harm to
themselves or others
◦ If the patient gives permission for the
information to be shared
 Veracity
 This principle implies
“truthfulness”
 Nurses need to be truthful
to their clients
 Veracity is an important
component of building
trusting relationships
 Accountability
 Individuals need to be
responsible for their own
actions
 Nurses are accountable
to themselves and to
their colleagues
 Ethical Dilemmas

 Occur when a problem

exists between ethical
principles
 Deciding in favor of one
principle usually violates
another
 Both sides have
“goodness” and
“badness” associated with
them
 Why call an Ethics Consult?
 Ethics Consult can help:
◦ Discover and understand the issues
◦ Serves as a forum for sharing of concerns and
questions
◦ Identifies possible treatment alternatives
◦ Provides guidance to the staff, patient, and
family members
◦ Resolves conflicts
 Using the Nursing Process

 Assessment
 Planning
 Implementation
 Evaluation
 Approach to Ethical Dilemma
Approach

Assessment Planning Implementation Evaluation

Am I involved Determine goals Work towards Determine

of treatment a mutually whether desired
acceptable decision outcomes have been
reached

Collect Identify Use of Re-evaluate as necessary

the facts Decision-Makers discussion and
negotiation

What Values are in conflict List and

Rank the options
Ethical Decision Making Process
 Describe the problem
 Gather the facts
 Clarify values
 Note reactions
 Identify ethical Principles
 Clarify legal rules
 Explore options and alternatives
 Decide on a recommendation
 Develop an action plan
 Evaluate the plan
 Case #1
Patient is an 89 year old male admitted with
Hyperkalemia, ESRD, HTN, and Bladder Cancer.
Patient’s past medical history includes recurrent
bladder carcinoma, CVA, hernia repair and
hemodyalisis. Patient was admitted due to weakness
and 2 weeks of diarrhea for which he had refused to
be dialyzed for 7 days.
Patient lives at home with wife and daughter who
are both his healthcare surrogates. Based on
patient’s poor prognosis, oncologist had
recommended on previous admissions that patient
be made Hospice Care with comfort measures.
 Case #1 Cont.
Daughter and wife have refused Hospice care and
want patient to be dialyzed and continue
aggressive treatment to include full
resuscitation if cardiopulmonary arrest.
Daughter and wife have requested all
physicians to refrain from speaking to patient
about his prognosis.
At this time all physicians have followed
daughter and wife’s request not let patient know
that his cancer has returned, except for the
“new” attending physician.
 Is there an Ethical dilemma?

• Autonomy?
• Nonmaleficence?
• Beneficence?
• Justice?
• Fidelity?
• Confidentiality?
• Veracity?
• Accountability?
 What would you do?
 Tell “new” physician to get on board with
the rest of the healthcare providers in
following the wife and daughter’s request…
 Tell the patient that his wife and daughter
are keeping information from him…
 Do nothing…
 Call for an ethics consult?
 Ethical Decision Making Process
 Describe the problem
 Gather the facts
 Clarify values
 Note reactions
 Identify ethical Principles
 Clarify legal rules
 Explore options and alternatives
 Decide on a recommendation
 Develop an action plan
 Evaluate the plan
 Resolution
 Ethics spoke with Attending physician and plan was
to speak first with daughter and wife regarding their
role as health care surrogates.
 Attending physician, healthcare team, and ethics
would then meet with patient and inquire if he
wanted information regarding his prognosis and/or
medical care.
 After speaking with daughter, wife, and patient
individually and obtaining a clearer understanding of
the patient’s wishes, and the clarification of the
healthcare surrogates role, a family conference
would be scheduled with health care team and
family to summarize the findings…
 Resolution
 Things never go as you plan them…
 Daughter refused to have wife speak with
the team
 Daughter wanted to be part of the
conversation when attending spoke to her
father to inquire if he wanted information or
not…
 Attending agreed to let daughter be present
during the conversation (mistake)
 Case # 2
88 year old male with extensive medical history including end stage
Parkinson's disease. He was admitted due to pneumonia and was
intubated and now is in Intensive care unit. Patient’s wife was
identified as proxy since patient had never completed an Advance
Directive or had a Living Will.
2 weeks have passed and patient has been unable to be weaned from
ventilator.
Wife continues to indicate she wants to take patient home on the
ventilator…
Attending physician did not feel that wife’s request to take patient
home were realistic nor did he feel patient would have “a good
quality of life.”
His recommendations were Comfort Measure/Withdraw of life
support.
 Case # 2 Continued
Palliative Care is involved and many family
conferences have been held. Wife refuses to
make patient a Do Not Resuscitate, or sign any
type of withdrawal papers. She wants “full care”
She continues to verbalize she wants to take patient
home.
Wife had full time 24 hour care team at home
taking care of patient and she wants to take him
home.
Ethics consult is called by attending physician….
 What would you do?

 Try to convince wife that a DNR would be

the best for the patient in his condition…
 Speak to physician to find out what he
plans to do next…
 Call for an ethics consult
 Ethical Decision Making Process

 Describe the problem

 Gather the facts
 Clarify values
 Note reactions
 Identify ethical Principles
 Clarify legal rules
 Explore options and alternatives
 Decide on a recommendation
 Develop an action plan
 Evaluate the plan
 Resolution
Palliative Care and ethics consultant met with wife and
she understood that if he went home, he would have to
have a tracheotomy. Recommendations from team
was to arrange Respiratory department to show
caregivers and wife how to take care of patient once
he was at home with tracheotomy.
Wife agrees to tracheotomy and a consult is requested.
Wife was also informed of him having to go to a skilled
nursing facility first and then after he was stronger
would be able to go home.
Patient was trached and discharge to skilled nursing
facility for rehab.
 Case #3
54 year old male - history of previous subdural hematoma, HTN,
and atrial fibrillation. Patient aspirated and coded. He is in
intensive care unit on ventilator and Dopamine for
hemodynamic stability.
Attempts at weaning have been unsuccessful…wife (healthcare
surrogate) signed consent for tracheotomy in order for patient to
be weaned off ventilator as recommended by pulmonologist…
On the same day wife signed consent for tracheotomy, Primary
Care Physicians during rounds feels that his prognosis is poor,
and his recommendation for plan of care is to have patient made
CMO and eventually withdrawal of life support should be
initiated, he did not agree with pulmonologist
recommendations…
Pulmonologist does not agree with current plan to make patient
CMO and withdrawal and wants to continue therapy…”he can
improve, give him time”.
 Case #3 Cont.
Pulmonologist contacts wife regarding the scheduling of
the tracheotomy, and is surprised to find out that she
has signed papers for Comfort Measures Only &
withdrawal of ventilator…
Family is now confused with conflicting goals of
care…wife has agreed to CMO and withdrawal of
vent after speaking with attending but is still not sure
she is doing the right thing…she would like to give
time but “how long?”
Staff is torn between wife’s decision and her
verbalization of “confusion” and physician’s
recommendations and conflicting opinions by
pulmonologist and attending physician…
Pulmonologists calls for ethics consult…patient is not
withdrawn awaiting ethics recommendations…
 What would you do?
 Tell wife attending is right and she should sign
the CMO papers…
 Tell wife she should get a pulmonologists
second opinion…
 Call Risk Management because of the conflict
between the attending and pulmonary
doctor…
 Call attending and tell him wife is confused…
 Do NOTHING!
** Ethics Consult was requested by
pulmonologist…
 Ethical Decision Making Process
 Describe the problem
 Gather the facts
 Clarify values
 Note reactions
 Identify ethical Principles
 Clarify legal rules
 Explore options and alternatives
 Decide on a recommendation
 Develop an action plan
 Evaluate the plan
 Resolution
 Social Work and ethics chair spoke individually to
attending and pulmonologist to clarify goals of care and
prognosis.
 Social Work and ethics consultant spoke with patient's wife
and she verbalized her confusion but had agreed to sign
CMO and Withdrawal of life support at the time because
she didn’t really understand what that meant…
 Wife wanted to give her husband a chance to be weaned off
ventilator and she rescinded the CMO and Withdrawal of
Life Support forms
 Patient had the scheduled trache done the following day
 Patient was transferred to vent floor and was transferred to
long term care facility for rehab…
Lecture - 12
History of GMOs
•In the year 1973, biochemists Herbert Boyer and Stanley Cohen for the first time cut a
kanamycin-resistant gene from one bacterium and inserted it into a plasmid of another
bacterium transferring the kanamycin-resistant trait. This was the first genetically modified
organism developed by mankind. Soon, in 1974, they transferred a gene from a toad species,
Xenopus laevis, into a bacterium making the first GMO with genes from another kingdom.

•In 1977, GM E. coli species capable of encoding human insulin hormone was developed by
Genetech company, the first GMOs producing company. In 1978, the company announced their
GM E. coli species capable of producing insulin which they name ―Humulin‖. The US FDA
approved the use of humulin in 1982 and it became the first product from GMO to be used for
consumption.

•The first GMO in the animal kingdom was a mouse. Rudolf Jaenisch first created a transgenic
mouse in 1974, but a GM mouse with heritable characters was first developed in 1984.

•The first GM plant was an antibiotic-resistant tobacco plant, developed in 1983 by

transforming antibiotic-resistant genes through Agrobacterium spp.
•In the year 1988, a genetically modified strain of Pseudomonas syringae was
released into the environment for the first time.

•Genetically modified virus-resistant tobacco plant was the first GM crop

cultivated commercially. It was produced and cultivated by China in 1992.

•The first GM food to be approved and cultivated was a genetically modified

tomato, called the Flavr Savr, produced by an American agriculture biotechnology
and agrochemical company Monsanto.

•The first GM animal to be approved and used as food is AquAdvantage Salmon

fish. It was approved for consumption in 2015.

•Since these early developments of GMOs, a large number of plants and animals
have been genetically modified. Mainly plants have been genetically modified and
are being widely used as cash crops or food crops globally.
Application of GMOs
1.In agriculture: GM organisms as high yielding, disease and pest resistant, and more
adjusting in drastic environments crops and domestic animals
2.In medicine: Antibiotics, antibodies, hormones, enzymes, proteins, fatty-acids, amino acids,
probiotics, minerals, and vitamins producing/containing products are produced from several
GMOs.
3.In Biotechnological Companies and Research: GMOs are used in scientific research and
biotech companies as vectors, model organisms for producing certain traits or compounds, etc.
4.In recreation/decoration: GMOs are vivid and more attractive as they are genetically
modified to enhance their aesthetic value.
5.In scientific research: Several organisms are genetically manipulated and used in research,
to prove several hypotheses, to research novel therapeutics, etc.
Ethics in GMO
Ethics in GMOs revolves around the ethical considerations and concerns
associated with the development, production, and use of genetically modified
organisms in various fields, including agriculture, medicine, and environmental
conservation.

Some key ethical issues and considerations related to GMOs:

1. Environmental Concerns: One major ethical consideration is the potential

environmental impact of GMOs. This includes concerns about the unintended
effects of genetically modified crops on ecosystems, biodiversity, and the
natural environment. There are also worries about the spread of genetically
modified traits to non-GMO plants through cross-pollination, leading to
unintended consequences.
2. Food Safety: Another critical ethical issue is the safety of genetically modified
foods for human consumption. While regulatory agencies typically require
rigorous safety assessments before approving GMOs for commercialization, some
people remain concerned about the long-term health effects of consuming
genetically modified crops and foods. Labeling of GMO products is also an
ethical consideration, as some argue that consumers have the right to know if their
food contains GMOs.

3. Socio-Economic Impacts: The socio-economic impacts of GMOs are also

subject to ethical scrutiny. Some argue that GMOs have the potential to address
food security issues by increasing crop yields and reducing agricultural inputs,
benefiting farmers and consumers. However, others raise concerns about the
concentration of power and control over seeds in the hands of a few large
biotechnology companies, potential displacement of small-scale farmers, and
unequal access to GMO technologies in developing countries.
4. Animal Welfare: Ethical considerations extend to the use of genetically modified animals
in research, agriculture, and biomedicine. Questions arise about the welfare of genetically
modified animals, potential suffering or harm caused by genetic modification techniques, and
the implications of altering animal traits for human purposes.

5. Informed Consent and Transparency: Ethical principles of informed consent and

transparency are crucial in the development and deployment of GMOs. This includes ensuring
that individuals and communities affected by GMOs have access to accurate information
about the potential risks and benefits, as well as opportunities for meaningful participation in
decision-making processes.

6. Long-Term Impacts and Uncertainties: Finally, there are ethical concerns about the long-
term impacts and uncertainties associated with GMOs. Given the complexity of biological
systems and the potential for unintended consequences, ethical decision-making requires
careful consideration of the risks, uncertainties, and potential unintended consequences of
genetically modifying organisms.
 Lecture - 13

Clinical Trials
A Real-World Application of the
Scientific Method
 How do you know if the
medicines you take are safe?
◼ Did you know that all
medical drugs,
treatments, preventions
and even medical devices
have to go through a
thorough process before
they are available to you?

◼ This process is call a

Clinical Trial.
 What are Clinical Trials?

◼ Clinical Trials are medical or health-related

research studies done in human beings (or
in animals if the study is a veterinary study).
 Why are Clinical Trials
Important?
◼ In Clinical Trials, researchers take the results from
basic scientific research and translate them into
ways to prevent, treat, or diagnose disease.
◼ Without them, we would could not ensure safe,
effective treatments for diseases.
 The Scientific Method
◼ Clinical Trials are “real
world” applications of the
Scientific Method.
◼ Each time a drug, medical
device or procedure, is
tested, a question is
asked, a hypothesis is
made, an experiment is
conducted, results are
analyzed, and a
conclusion is reached.
 Think Break:

◼ What are Clinical Trials?

◼ Why are Clinical Trials important?

◼ How are Clinical Trials like the Scientific

Method?
 Types of Clinical Trials:
(as defined by the National Institutes of Health)

◼ Treatment Trials - test new treatments, new

combination of drugs or new approaches to
surgery or radiation.
◼ Prevention Trials - look for better ways to prevent
diseases.
 Types of Clinical Trials:
◼ Diagnostic Trials - determine
better tests or procedures for
diagnosing a particular disease
or condition.
◼ Screening Trials - test the best
way to detect or treat diseases.
◼ Quality of Life Trials - explore
and measure ways to improve
the comfort and quality of life of
people with a chronic illness.
 Sponsors
◼ Clinical trials are usually
sponsored or funded by
companies that make
pharmaceuticals or medical
devices.
◼ Trials can occur at sites as
varied as hospitals,
universities, doctors’ offices,
community clinics, or in the
offices of clinical-trial
contractors.
 Clinical Trials are Done in
Phases:
◼ First, a Pre-Clinical Trial must
be done before the Clinical
Trial starts.
◼ Preclinical trial – research
on a new drug or a new
medical device or procedure,
usually done on animals, to
learn about mechanisms of
action, determine how well the
treatment works, and see if it
is safe to test on humans.
 Think about it:

◼ Who sponsors Clinical Trials?

◼ Why is it important to test drugs, treatments

and devices on animal cells or subjects
before testing them on humans?
 Clinical Trials are Done in
Phases:
◼ Phase I
◼ Researchers test an experimental drug or
treatment in a small group of people
(approximately 20-80) for the first time. The
purpose is to evaluate its safety and identify
side effects. If this is a veterinary study, it is
conducted in animals.
 Where do the people come
from?
◼ Clinical Trials require people
to volunteer to be tested!
They are often paid.
◼ Would you volunteer to be a
subject in a Clinical Trial?
◼ What if it meant you
received a treatment for a
disease that wasn’t
available to anyone else?
 Phases of Clinical Trials:

◼ Phase II
◼ The experimental drug or treatment is
administered to a larger group of
people/animals (approximately100-300) to
determine its effectiveness and to further
evaluate its safety.
 Phases of Clinical Trials:
◼ Phase III
◼ The experimental drug or treatment is administered to
a large group of people/animals (300-3,000 or more)
to confirm its effectiveness, monitor side effects, and
compare it with standard or equivalent treatments.
 Research Concepts

◼ In many studies, the new drug is

compared to a placebo. A placebo is a
product that looks like the new drug, but it
does not have the active ingredient in it.
People do not know that they are getting
the placebo.

◼ Sometimes the test compares the new

treatment against an existing treatment to
see if better results can be obtained.
 Research Concepts

◼ Blind and Double Blind Trials are frequently

done.
◼ A Blind Trial is a trial in which the patients do not
know if they are receiving the treatment or a
placebo.
◼ A Double Blind Trial is a trial in which the
patients and the researchers do not know who is
receiving the treatment.
◼ Why would the above be good ideas?
 Research Concepts
◼ Randomization is the process by which patients
are assigned a group for the Clinical Trial.
◼ Groups are assigned randomly, not purposefully.
◼ Some people will receive the new treatment, some
may receive an already approved treatment, and
some may receive a placebo.
◼ If one treatment is found superior, the trial is
stopped so that the fewest patients possible
receive the less beneficial treatment.
 Approval must be gained:
◼ Once a drug has proven satisfactory after Phase III trials,
the trial results are usually combined into a large document
containing a comprehensive description of the methods
and results of human and animal studies, manufacturing
procedures, formulation details, and shelf life.
◼ This collection of information makes up the "regulatory
submission" that is provided for review to the appropriate
regulatory authorities like the U.S. Food And Drug
Administration (FDA) so they can then grant the sponsor
approval to market the drug, device or treatment.
U S Food and Drug Administration, Protecting and Promoting Your Health
 The Results!

◼ For approximately every 5,000 to 10,000

compounds that enter preclinical testing, only
one is approved for marketing.

◼ Cost of the failures has to be borne by the

price of the one success.
 Phases of Clinical Trials:
◼ Phase IV
◼ After a drug is licensed (approved by the FDA) or
treatment is launched, researchers track its safety,
seeking more information about a drug or
treatment’s risks, benefits, and optimal use. These
long-term studies involve large groups of
participants and are designed to reveal if any
unexpected side effects occur in a small
percentage of individuals. 2010 2011
 Timeline Estimate
◼ Below are some estimates on the amount of
time it takes for this process in cancer
treatment research.
◼ Pre-clinical Trials - 4.5 years
◼ Phases I-III - 8.5 years
◼ FDA Approval - 1.5 years
◼ Phase IV - Ongoing for the duration of the
use of the drug
◼ How long is this whole process?
 Costs
◼ On average, pharmaceutical
companies are spending anywhere
between $100 and $800 million per
each drug tested!
◼ Spending on clinical trials in the
U.S. is forecasted to rise to $32
billion by 2011.

◼ Why would anyone spend that

much money on drug development?
 Think about it:

◼ Why does it cost so much to conduct a

clinical trial?

◼ Why does it take so much time to conduct a

clinical trial?
 Mind Map

◼ To pull together what you have learned, you are going

to construct a “Mind Map” or concept map relating to
clinical trials.
◼ A Mind Map is a special form of a web diagram for
exploring knowledge.
◼ You start with the main idea and branch off from there.
◼ Use different shapes, sizes or colors to show different
ideas and use lines to connect the related ideas.
◼ On each of the lines, you must write the relationship
between the ideas or topics.
 Here are Two Simple
Mind Maps.

• Can you tell the main topic of each map?

• What do the lines mean?
• Notice that the words on the lines show relationships
between the topics.
Here is one made using a computer
program:

In this example, the relationships are not written on the lines yet.
This is used mainly to show the use of colors and shapes.
Here is a Population Mind Map
RESEARCH METHODOLOGY

Lecture - 3
Research Design
The term “research design” means ‘drawing for research’.

• It is a systematic planning of conducting research.

• It aims to achieve goals of the research.
• Selection of research topic/problem,
• Framing sampling design,
• Collection of data,
• Data analysis/editing, coding, processing and preservation
• Writing research reports
Characteristics of Good Research Design

• It should be flexible

• It should be economical

• It should be unbiased

• It should fulfill the objectives of the research

• It should guide to achieve correct results.

• It provides scientific base for research.

• It also should facilitate to complete the research work within the time.
Functions of Research Design
• It provides a blueprint of research.
• It limits (dictates) the boundaries of the research activities.
• It enables investigation to anticipate potential problems

Components of Research Design

• Title of the investigation
• Purpose of the study
• Review of related literature
• Statement of the problem
• Scope of the investigation
What is a Hypothesis ?
A tentative statement about a population parameter that might be
true or wrong.
• The purpose of hypothesis testing is to determine whether there is
enough statistical evidence in favor of a certain belief about a parameter.
• An hypothesis is a preliminary or tentative explanation or postulate by
the researcher of what the researcher considers the outcome of an
investigation will be.
• It is an informed/educated guess.
• It indicates the expectations of the researcher regarding certain
variables.
• It is the most specific way in which an answer to a problem can be
stated.
Characteristics of a Good Hypotheses

• Conceptual Clarity
• Specificity
• Testability
• Availability of Techniques
• Theoretical relevance
• Consistency
• Objectivity
• Simplicity
Sources of Hypotheses
• Theory
• Observation
• Analogies
• Intuition and personal experience
• Findings of studies
• State of Knowledge
• Culture
• Continuity of Research
The Difference Between Hypothesis and Problem

• Both a hypothesis and a problem contribute to the body of knowledge

which supports or refutes an existing theory.

• A problem is formulated in the form of a question; it serves as the basis

or origin from which a hypothesis is derived.

• A hypothesis is a suggested solution to a problem.

• A problem (question) cannot be directly tested, whereas an hypothesis

can be tested and verified.
 When is a Hypothesis Formulated

• A hypothesis is formulated after the problem has been stated

and the literature study has been concluded.

• It is formulated when the researcher is totally aware of the

theoretical and empirical background to the problem.
PURPOSE AND FUNCTION OF A HYPOTHESIS

• It offers explanations for the relationships between those

variables that can be empirically tested.

• It furnishes proof that the researcher has sufficient

background knowledge to enable him/her to make
suggestions in order to extend existing knowledge.

• It gives direction to an investigation.

• It structures the next phase in the investigation and therefore

furnishes continuity to the examination of the problem.
CHARACTERISTICS OF AN HYPOTHESIS

• It should have elucidating power.

• It should strive to furnish an acceptable explanation of the

phenomenon.

• It must be verifiable.

• It must be formulated in simple, understandable terms.

• It should correspond with existing knowledge.

Types of Hypotheses
1. Descriptive Hypotheses:
• These are propositions that describe the characteristics ( such as size, form
or distribution) of a variable. The variable may be an object, person,
organization etc. ,
e.g., The rate of unemployment among arts graduates is higher than that of commerce
graduates. The educational system is not oriented to human resource needs of a country.

2. Relational Hypotheses.
• These are propositions which describe the relationship between tow
variables.
e. g. , Families with higher incomes spend more for recreation
Upper – class people have fewer children than lower class people.
3. Causal Hypotheses
• It state that the existence of, or a change in one variable leads to an
effect on another variable.
• The first variable is called the independent variable, and the latter the
dependent variable.
• When dealing with causal relationships between variables the
researcher must consider the direction in which such relationship flow.

4. Working Hypotheses
• While planning the study of a problem, hypotheses are formed.
• Initially they may not be very specific. In such cases, they are referred to
as ‘ working hypotheses’ which are subject to modification as the
investigation proceeds.
5. Null Hypotheses
• This hypotheses are formulated for testing statistical significance,
since, this form is a convenient approach to statistical analysis.
• As the test would nullify the null hypotheses.
e.g., : There is a relationship between a family’s income and expenditure on
recreation, a null hypothesis may state: There is no relationship between
families income level and expenditure on recreation.

6. Statistical Hypotheses
• These are statements about a statistical population.
• These are derived from a sample.
• These are quantitative in nature in that they are numerically
measurable
eg: Group A is older than B’
7. Common Sense Hypotheses
• It state the existence of empirical uniformities perceived through day-
to-day observations.
e.g., “ Shop-assistants in small shops lack motivation”
8. Complex Hypotheses
• These aim at testing the existence of logically derived relationships
between empirical uniformities.
e.g., In the early-stage human ecology described empirical uniformities in the
distribution of land values, industrial concentrations, types of business and
other phenomena.
9. Analytical Hypotheses:
• It concerned with the relationship of analytic variables. These hypotheses
occur at the highest level of abstraction.
• These specify relationship between changes in one property and changes in
another.
Eg., The study of human fertility might show empirical regularities by wealth,
education, region, and religion.
 Translating
Basic Research to
Benefit Society
Lecture - 10
Why Government Should Fund Basic
Research?
Measuring the impact of research:
• Why government should fund science and at what level?
• How great are the benefits, and are they greater than the
level of investment?
• Government’s responsibility is to fund basic research
which will eventually lead to wealth, health & national
security. Hence demands for accountability & assessment
• Science not always seen as high political priority e.g.
health, education, pensions
• How to persuade governments to invest more?
The Dichotomy of Basic and
Applied Research!
“Basic research is the pacemaker of technological
progress.” Vannevar Bush, 1945

The conceptual dichotomy of basic and applied

research has proven to be an enduring one.
The late Daniel Koshland viewed basic and applied
science as “revolutionary” and “evolutionary,”
respectively, summarizing the difference thus:
“Basic research is the type that is not always practical
but often leads to great discoveries. Applied research
refines these discoveries into useful products.”

Credit: “Lost in Translation—Basic Science in the Era of Translational Research”

The Dichotomy of Basic and
Applied Research!

Basic research discoveries, such as

semiconductors and the structure of DNA,
have revolutionized electronics and biology,
making possible the laptop computer on which
this presentation is made and the molecular
research to which so many of us have devoted
our careers.
Basic Research and Serendipity!

• Marie Curie described how her discovery of

radium, which presaged the therapeutic use of
radioisotopes, was purely serendipitous:
“When radium was discovered no one knew that it
would prove useful in hospitals. The work was one
of pure science. And this is a proof that scientific
work must not be considered from the point of view
of the direct usefulness of it.”
Basic Research and Serendipity!

In her Nobel banquet speech, Christiane Nüsslein-

Vollhard recalled her discovery of the Toll gene
in Drosophila:

“We started out in our research with a deep interest

in understanding the origin and development of
pattern during embryogenesis. None of us
expected that our work would be so successful or
that our findings would ever have relevance to
medicine.”
Basic Research and Serendipity!
• American Society for Microbiology member Carol
Greider was pleasantly surprised when awarded the
Nobel Prize for her ground breaking work on
telomeres, which may lead to advances in the
treatment of cancer or the amelioration of aging, she
emphasized the following:

“We didn't know at the time that there were any particular
disease implications. We were just interested in the
fundamental questions… [this] is really a tribute to
curiosity-driven basic science”
Basic versus Translational Science

• The importance of translational science lies in its

practicality.
• Do not view basic and translational science as
one being more important than the other, but
rather as complementary areas of human
endeavour.
• Basic science findings often precede advances in
translational science.
• Translational or applied science can generate new
questions for fundamental research, as illustrated
from the fact that vaccination preceded the field of
immunology.
The Bayh-Dole Act- The USA Example
• In USA, the Bayh-Dole act allowed universities to patent knowledge
obtained with federal funding. Universities ascertained that certain
discoveries were enormously lucrative, and academic scientists began to
emerge in a new role: that of the discoverer-entrepreneur.
• The outcome was the blurring of the intellectual boundaries between
academia and industry.
• Hence, scientists that formerly worked solely on basic biological
mechanisms found greater freedom to develop their research along more
practical lines, with the encouragement of their institutions.
• Furthermore, universities learned that it was much easier to connect with
the public as well as with potential benefactors by highlighting their
translational advances rather than their basic science discoveries.
• Translational research generated revenue, brought publicity, and enhanced
public relations.

Thus, academia is no longer viewed as an impartial champion for basic research.

The Role of Scientists:
• The scientific community must educate politicians and the public
about how science really works, emphasize the complementary
relationship between basic and applied research, and advocate
more stable and sustained support of the nation's scientific
enterprise.

• We must draw renewed attention to the tenuous present condition

of basic research, which will continue to be the engine driving
humanity's hopes for curing disease, increasing productivity,
eliminating poverty, developing renewable sources of energy,
sustaining agriculture, and ameliorating climate change, to mention
only a few current challenges.

• In the current enthusiasm for translational research, we must not

forget that basic science is under threat.
The Role of Scientists:

• Medically related basic science research is particularly vulnerable

because the Government is the only source of support for much of
this work, whereas applied research may be supported by a mixture
of government, commercial, and private foundational sources.

• The time is ripe for a massive new national investment in science

that includes basic research.

• Until the pendulum swings and basic science re-emerges as a

national priority, basic scientists will have to be imaginative in
promoting the potential translational applications of their research.

• History has taught us that the path from basic discoveries to

scientific and technological applications is seldom a straight line.
 Ten Golden Rules to Translate

Basic Research to Benefit Society

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
Rule1: What Drives Science Does Not Drive
Business

• Scientists evaluate research by considering whether it makes an

original contribution to our understanding of the world.
• Businesses have a different rationale, which, by and large, is to
make money.
• And so it is with commercialization: scientists are not primed for
business (some would even say this goes against academic
freedom) and businesses are not, for the most part, so good at
science unless they have specialized research division.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• Scientists need to get business people who are “on the same
wavelength” on their team and who can explain and guide
them.

• Conversely, businesses have to be able to determine what

research universities have to offer and how it could be of
benefit.

• Interfaces such as university development offices to business

outreach organizations like BIRAC are valuable resources and
should be utilized by both scientists and potential business
partners.
Rule 2: There Is No Single Path To
Commercialization

• There are many routes for this: licensing, royalties,

incubation, and in-house development.
• Industry itself has also moved physically closer to large
universities (e.g. science parks) to share in the human capital.
• There are many ways to go from the laboratory bench to the
store: commercialization is just like any business process–
part art, part science; part inspiration, part perspiration.
• Most routes are essentially mechanistic, some work and some
don't—there is no secret way to do things.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
Rule 3: You Must Know Your Rights And
Those Of Colleagues

• It is important to know who owns and who has the right to

develop your research output.
• Most institutions (or less often, funders) own your research.
The institution may choose to protect your ideas with
copyrights, licenses, or patents, a wise idea if they are to have
commercial value.
• That protection is not on your behalf as the inventor, but on
behalf of the institution(s) where the work was done.
• You need to understand what this protection means in terms
of process, cost, and time involved.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• Research is collaborative, often with multiple institutions
involved, and this can greatly complicate the rights and
ownership of intellectual property.
• IP issues should be thoroughly reviewed and agreed with all the
relevant scientists before the research is disclosed. Good
scientific collaborations can be ruined by misunderstood
commercialization strategies.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
Rule 4: Consider The Implications Of Going
From Public To Private

• Academic research has many benefits, for example, collaboration,

data and knowledge sharing, and freedom to publish.
• When moving this research into the private sector, different rules
apply. There is a need to protect the intellectual property.
• In some cases, protecting that investment has implications for
follow-on developments and impacts academic freedom.
• For example, consider a situation where a company licensing a
technology from an academic institution also has the rights to
follow-on developments. Those rights could impact the academic
scientist's ability to freely publish those new developments.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
Rule 5: Decide How Much Of Yourself You Want
To Give

• At one extreme, you can give over your research completely and
have little or nothing to do with subsequent commercialization;
• At the other extreme you could be heavily involved in the
company commercializing your research or indeed found a
company to develop the research.
• The level of engagement with the commercialization is going to
define the time commitment and possibly financial reward
coming from the commercialization.
• This needs to be thought about carefully at the outset and
should be mapped to your longer-term career goals.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• Some academics want to, and do, make a successful transition to
business—perhaps as happy heads of research and development
(R&D), free from the administrative hassle, but a key part of the
business—and some of course stay in academia.
• Markets have no sentiment and don't care what you do: they just
care what you can contribute.
Rule 6: Separate The R And The D And Be
Realistic

• There is a big difference between basic research and the

development of such research to the point of commercialization.
• Generally, development is done by the entity commercializing
the product and could be considered the mid-point between
academic and commercial cultures.
• Development can be hugely expensive and time-consuming and
presents a huge financial risk to the investor, especially as it is a
front-loaded cost.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• The investor has to look at such topics as mass production
(scaling up from lab levels), distribution, logistics, pricing,
practicality, marketing, safety, the law, etc. Often times, one or
more of these proves difficult and the breakthrough has to
languish, possibly for decades, until a solution appears.
• Personal genomics is an example where extensive
commercialization of a number of ideas has had to wait until
next generation sequencing makes the products feasible.
• Scientists also need to be realistic in valuing the idea—they
typically have no concept of the development costs and often
feel the basic research represents the bulk of the value, which
is almost never the case.
Rule 7: The Market May Not Exist At The Outset
• The old fashioned method of working out what your factory
can make (being “production led” in the jargon) and then
seeing if there is a market is a largely discredited approach in
modern business.
• In the case of basic scientific research, of course, this is exactly
the situation—scientists invariably investigate things out of
intellectual curiosity without any view to commercialization.
• The original research will not be aimed at solving any
commercial, market-related problems, outside of obvious areas
such as pharmaceuticals and engineering, and so the
breakthrough is inevitably made in isolation of market
requirements.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• There are various anecdotes that illustrate the apparent lack of
market. “Who needs music on the move?” was one comment
about the Sony Walkman. “No one wants a tablet computer with
no keyboard”, and so on.
• Examples like these are often used to “prove” that a good idea
will make it anyhow, but it's simply not true in the majority of
cases.
• It conveniently sidesteps the point that if no ready market exists,
it has to be developed. That takes money, advertising, skill, and
time. All of which add to the development costs.
Rule 8: Consider The “Want” versus The “Need”
• There is a marketing axiom that products should always
address a need, not a want. People often express “wants”,
but they buy “needs”. Consumers want a Ferrari but they buy
a Toyota.
• It is so easy for an academic scientist to believe there is a
need for a product resulting from their research when in fact
it is a want (or to put it another way, it's a “nice to have” not a
“must have”).
• Thus, commercialization of a breakthrough needs to address
what people or other businesses will actually pay for—and
this is a complex issue.

Credit : Anthony C. Fletcher and Philip E. Bourne, PloS Comp. Bio 2012
• Generally, a fair amount of time and money needs to be spent
on market research to understand this—if people will not pay,
then no matter how good the idea, it will never be successfully
commercialized.
• Other market dynamics can also intervene: for example, a
common issue is that of technologies that are never
implemented because their payback time is greater than a
market will bear. Market-related short-termism has killed
many a promising idea.
Rule 9: Make It Comprehensible

• The people who are going to fund the development of your

research and subsequently take it to market will be business
people, not scientists, irrespective of whether the ultimate product
is aimed at technical buyers.
• At the earliest stage you need to boil down the research into an
“elevator pitch”—a few sentences the layperson can comprehend
and one that sets out a clear reason to purchase.
• A common problem is that the relationship of the research to the
final practical product may not be clear. One approach to solve this
is by association: “Our breakthrough is a distinct improvement
on…” Focus on the biggest profit opportunities in your early
pitches.
• Business people prefer to see a clear track to a clear market
opportunity rather than have to work it out for themselves.
Rule 10: Customers Are The Ultimate Peer Review

• The example of Henri Poincaré is useful here to illustrate the value of

peer review: the first version of his work on “The three-body problem”
contained a serious error that was picked up during peer review.
Alterations and changes then led to extremely important work on
modern chaos theory.
• In business, the analogy is the importance of testing out ideas and
products before a full launch and then to listen carefully to what the
ultimate consumers say.
• This market research is key; if the market is lukewarm, it doesn't
matter how great the research, a product won't happen.
• You need to be prepared for the eventuality that while the market
research does not indicate a product can arise as you envisioned, a
different product might be possible. Is that what you want?
In conclusion

- There is increasing emphasis worldwide for making better practical

use of fundamental scientific research from academia.
- Looking for a problem to fit your solution is always going to be tough
going. And it's probably even tougher to find someone who will back
you with money, time, and resources that will be needed to turn your
scientific research into something that will benefit society. But don't
give up.
- Do remember that as the originating scientist, knowledge and
recognition may be the only reward you get—others who take it to
market (and take the financial and commercial risk) might get the
majority of the money. But as an academic scientist, hopefully that's
not why you entered science in the first place. Having said that, it is
important that the scientist also gets a piece of that pie, deservedly so.

Be part of the change.

Ethics, Morality & Bioethics

Lecture - 11
Paper 2 - additional information
Writing Research Article

Lecture - 4
The questions to ask yourself
first…
 Is the paper worth writing?

▪ What’s in the literature?

▪ “So What?”

▪ It’s a lot of work (average 20-30 drafts).

Don’t do it unless its worth it.
You will be judged by how well you write because
nobody really knows how well you think (Gray, 1998, 140)

Critical Thinking
✓Application

✓Analysis

✓Synthesis

✓Evaluation
 Organizes Time

Planning
▪Things-to-do list

▪Calendar
Common Problems

▪Can’t find time to work on it

for more than an hour

▪After a while I lose my

place and forget what I
originally wanted to do
 What do I have to say?

➢A single question clearly stated with adequate

evidence for the answer.

➢Try stating the question and its answer in one

simple sentence.
Where does the outline come from?

Analysis & Synthesis ▪ Developing the outline can

be the most difficult part of
the process.

▪ Think about organization of

paper as go along.

▪ Keep ideas in
“miscellaneous” tab

▪ Sorting method

▪ Conceptual Framework
 Is it one or more papers?
▪ Putting too much in one
paper makes it diffuse and
less compelling than if its focused
 OK, So you want to/need to write
a paper --> next questions

a. What is the right format for the message

(original article/review?)

b. What is the right audience—who cares?

c. What journal should I choose?

 A scientific article as a critical
argument
a. Statement of problem; posing a question
b. Presentation of evidence
c. Assessment of the validity of the
evidence in the face of ..
a. strengths/weaknesses
b. other evidence
d. Conclusions
 Literature Search First

▪ What has been done and what can you

say that’s new?

▪ Be thorough in your search:---a high

sensitivity/low specificity search.
The Title Page: Do it early—title;

authors and their order; Affiliations

a. Establishes responsibilities in paper

writing

b. Avoids hurt feelings

 The Process of Paper Writing

▪ Create an outline first

▪ Plan on multiple drafts:

▪ Filename with dates

▪ One filename written over with new draft

▪ Tables/figures early: prompt more analysis

▪ Deadlines for you and coauthors

 The Results Section
▪ Organize around
90
tables/figures 80
▪ Present tabular 70

results selectively in 60
50 % Fellows
text 40 with Papers
▪ Past tense 30 Published
20
▪ No interpretation; 10
just the facts! 0
before after
▪ Tables should stand talk talk

on their own
 The Discussion Section
▪ 1st paragraph: answer
question/hypothesis

▪ Remainder:
▪ Evidence pro and con: literature review
▪ Strengths/limitations of your study
▪ Implications of findings (be conservative)
▪ Other findings of your study

▪ Last Paragraph: conclusion

 Proofread before Submitting

✓Are terms used consistently throughout?

✓Do numbers in abstract match numbers in text

and tables?

✓Do citations in text match references?

✓Are Syntax and Grammar acceptable

 Tools of Scholarly Research

Search Tool:
• Scopus
• Web Of Science
• Google Scholar

Reference Tool:

• EndNote
• Mendeley
Organizes Ideas
Integrated Outline

• Before writing begins the outline

incorporates the reading, notes,
interviews

• Entire notebook builds to create

the outline

• Conceptual Frameworks
 WORKFLOW

Name of the author needs to be included in each item

THINGS-TO- READIING INTEGRATED

DO LIST & NOTES OUTLINE DRAFT

Ideas Clarifying
Names & Analysis
Theories crafting
titles Synthesis
Facts creating
 Importance of Notes

▪ A form of “practice” writing.

▪ Use “persistence” in note taking.

▪ Deepens comprehension of books and articles.

Think while
you take notes
THANK YOU
RESEARCH METHODOLOGY

Lecture - 5
 How to do organised research…
• Please don’t afraid of it….but adopt a systematic process

• Access to resources

• Citation and reference management of all resources

• Giving credit to the aspirant

• Develop a culture to not to plagiarize

Access to Resources
Printed
• Books
• Journals
• Newspaper
• Grey literature

Online
• Database
• Internet
• E-books
• Social media
• E-journals

Other media
• Radio
• TV
• You tube
• Online images
 What is Plagiarism?
According to the Merriam-Webster Online Dictionary, “plagiarize”
means:
1) to steal and pass off (the ideas or words of another) as one's own
2) to use (another's production) without crediting the source
3) to commit literary theft
4) to present as new and original an idea or product derived from an
existing source.
 What is Plagiarism?
• It is also termed as “Copyright Infringement”
• Plagiarism occurs when you borrow another's words (or ideas)
and do not acknowledge that you have done so.
• It’s the Culture of an individual. Our words belong to us and cannot
be used without our permission.
• Plagiarism is a very serious offense.
• The best way to avoid plagiarism is to cite your sources - both
within the body of your paper and in a bibliography of sources you
used at the end of your paper.
 Avoiding Plagiarism - Cite Your Source
In writing a paper or report, it means:
• You show, in the body of your paper, where the words or information
came from, using an appropriate formatting style.
AND
• You provide complete information about the source (author, title, name
of publication, date, etc.) at the end of your paper, in the bibliography
(also called the works cited or references page, depending on the style
you use).
In giving formal presentations, it means:
• You acknowledge, on your slide, where the graph, chart or other
information came from.
 Avoiding Plagiarism
• Appropriate referencing
• You are free to quote from you own earlier work, published or
unpublished. But make sure that you give credit to yourself and
to the publisher.
• Even when you are taking material from Institution's reports,
published or unpublished, give credit to the authors and the
publisher.
 I. SOURCES NOT CITED
• The writer turns in another’s work, word-for-word, as his or her own.
• The writer copies significant portions of text straight from a single
source, without alteration.

• The writer tries to disguise plagiarism by copying from several different

sources, tweaking the sentences to make them fit together while retaining
most of the original phrasing.
• The writer altered the paper’s appearance slightly by changing key
words and phrases.

• The writer takes the time to paraphrase most of the paper from other
sources and make it all fit together, instead of spending the same effort
on original work.

• The writer “borrows” generously from his or her previous work,

violating policies concerning the expectation of originality adopted by
most academic institutions.
 II. SOURCES CITED (but still plagiarized!)
• The writer mentions an author’s name for a source, but neglects to include
specific information on the location of the material referenced.

• other forms of plagiarism by obscuring source locations.

• The writer provides inaccurate information regarding the sources, making it

impossible to find them.

• The writer properly cites a source, but neglects to put in quotation marks text
that has been copied word-for-word, or close to it. Although attributing the
basic ideas to the source, the writer is falsely claiming original presentation and
interpretation of the information.
• The writer properly cites all sources, paraphrasing and using
quotations appropriately.
The catch? The paper contains almost no original work!
It is sometimes difficult to spot this form of plagiarism
because it looks like any other well-researched document.

Well, we all know it doesn’t exist. In this case, the writer properly
quotes and cites sources in some places, but goes on to paraphrase
other arguments from those sources without citation. This way, the
writer tries to pass off the paraphrased material as his or her own
analysis of the cited material.
 What is Referencing?
• What is citation
• How do I cite sources
• Doesn't citing sources make my work seem less original
• When do I need to cite
• What's a Bibliography?
• what's an Annotated Bibliography?
• What is difference between References and Bibliography?
• What are Endnotes
• What are Footnotes?
• What's the difference between Footnotes and Endnotes
• If I cite sources in the Footnotes (or Endnotes), how's that different from a
Bibliography
 Referencing – why do it?
• Sources need to be acknowledged when you are writing your
project/Thesis / Dissertation/paper/ book/chapter etc.

• This allows your teacher to

– Check your work
– See which sources of information you have used
– Ensure you haven’t just made up the information
• This allows referees / reviewer / examiner to verify the contents
 What to cite?
When you write some paper / dissertation or thesis you may use:
• Words;
• Opinions;
• Statistics;
• Facts;
• Information from an author or any other source, and

• Pictorial representations,
 Citing a source
• Never copy more than 3-4 words in a row from a source without
using quotation marks (or going back and properly paraphrasing).
• Never use special words or phrases without properly quoting and
citing them
• When in doubt you should always cite your source
• Make it clear who said what and give credit to the right person.
• Evaluate referred Sources-Not all sources on the web are worth
citing
• Guidelines for citing sources properly
• Difference between Bibliography and References
• Use Plagiarism check detect tools such as TURNITIN etc.
 What does “citation” mean?
➢ Citation, in this context, simply means clearly giving credit where credit
is due.
➢ Proper citation involves clearly indicating
– the author, title, and publication information for the print, online, broadcast, and
interview-based texts that you use (Include a Bibliography, Works Cited, or References
section)
– which words and ideas come from which sources (Include in-text citations or
footnote/endnote notations)
– when you are moving from your own words and ideas to the words and/or ideas of
another (Include source writer’s name and signal phrase)
 Citation styles
• Humanities • Social Sciences
• Chicago • AAA (American Anthropological Association)
• Writer's Handbook: Chicago Style Documentation • Citations and Bibliographic Style for Anthropology
• Excellent FAQ on Usage in the Chicago Style Papers
• Writer's Handbook: Chicago Style Documentation • APA (American Psychological Association)
• MLA (Modern Language Association) • Writer's Handbook: APA Style Documentation
• Writer's Handbook: MLA Style Documentation • APA Style.org
• MLA Citation Style • APSA (American Political Science Association)
• Writer's Handbook: APSA Documentation
• Sciences
• Legal Style
• ACS (American Chemical Society)
• Legal Citation: Using and Understanding Legal
• AMA Citation Style Abbreviations
• IEEE (Institute of Electrical and Electronics
• Legal Research and Citation Style in the USA
Engineers)
• Other
• Electrical Engineering Citation Style
• General info on citing web documents
• NLM (National Library of Medicine)
• Recommended Multi-Style Links
• NLM Style Guide
• Recommended Multi-Style Links
• National Library of Medicine Recommended Formats for
Bibliographic Citation (PDF format)
• Vancouver (Biological Sciences)
• Introduction to the Vancouver Style
How do I know if something is public domain or not?
• The terms and conditions under which works enter the public domain are
a bit complicated. In general, anything published more than 75 years
ago is now in the public domain. Works published after 1978 are
protected for the lifetime of the author plus 70 years.
• The laws governing works published fewer than 75 years ago but before
1978 are more complicated, although generally copyright protection
extended 28 years after publication plus 47 more years if the
copyright was renewed, totaling 75 years from the publication date.
• If you are uncertain about whether or not a work is in the public domain,
it is probably best to contact a lawyer or act under the assumption that it
is still protected by copyright laws.
Introduction to Reference Management system
What is Mendeley?
Organize your documents + references
Collaborate by joining + creating groups
Discover statistics + recommendations

Stay up to date + Learn more

 What is Mendeley?
• Free Academic Software

• Cross-Platform (Win/Mac/Linux)

• All Major Browsers

Mobile

Desktop
Web
Mendeley Desktop Overview
Your Library Structure
Your References
Document Details
Adding Documents
 Adding Documents
Import your references from
BibTex, Endnote, RIS or Zotero
Select a file or folder to
add from your computer

Watch a folder

Add references
manually
Document Details Lookup
Look up documents by
title on Google Scholar if
they are flagged for
review
Enter the DOI,
PubMed, or ArXiv
ID and click on
the magnifying
glass to start
lookup

Mendeley adds missing info automatically

 Web Importer
Save research while browsing online
 Using the Web Importer
Click ‘Save to Mendeley’ to import
references from your search results

Select an
article and
import the
reference to
your library in
one click.
 Sync
Sync your library to the Mendeley Cloud to access
it anywhere & read on all your devices

• Mendeley backs up your library

online

• Access your articles anywhere

• Get customized suggestions and add

them to your library
 Manage Your Library
Open attached PDF files in integrated viewer

Star favorites
Mark as read/unread

Create category folders

See what type of document is attached

(.pdf, .ppt, .docx, excel, etc.)
 Search Your Documents
Full text search, or filter your results

Filter your
documents by
author, tag,
publication,
or keyword
The PDF Viewer
Read and Work in the PDF Viewer
Annotate and Highlight
Look Up Term Definitions
Install the Citation Plug-in
The Citation Tool Bar Appears
in Word Automatically

Mac

Windows
Generate In-Text Citations in Word
1. Click ‘Insert or Edit Citation’

2. Search by author, title or year, or

select a document from your
Mendeley library

3. Select the article or

book, and click ‘ok’ to
automatically cite that
text in Word
Inserting Your Bibliography

1. Click ‘Insert
Bibliography’

2. Choose your
style

3. Done!
 Create Groups

See the groups you

created, joined or
follow

Add documents to a
group by dragging
and dropping
Private Groups
Private groups let
you share full text
documents with a
limited number of
members

Nobody outside the

group can see the
group or its files or
members.
 Share Your Papers
Collaborate with Your Research Team

Share full-text
documents with
members of your
private group

Share highlights
and annotations

Each group member is assigned a different color for highlighting

Find Public Groups

Search public groups on

Mendeley Web
Browse Popular Groups

Browse by discipline to
discover new groups
 Create your research profile

Connect with
colleagues
and join new
communities

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 Connect with Colleagues

Search for people and click

‘Follow’ to get regular
updates.
 Literature Search
Search the
catalogue

Save new
research to
your library
with one click
If the full text is
available, you’ll
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Search the Catalog Online

Conduct advanced searches or

browse by discipline

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 Quickly Add New Research

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it’s a one-click
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Sampling Techniques
Lecture - 6
Objectives of this session:

• Understand meaning of sampling process and its importance

• Know the definations of different terms used in the sampling process

• Learn how to apply different random sampling & non-random

sampling techniques
Sampling in Epidemiology

• Why Sample?

• Unable to study all members of a population

• Reduce bias

• Save time and money

• Measurements may be better in sample than in entire

population

• Feasibility
Sampling

Sampling is the process or technique

of selecting a sample of appropriate
characteristics and adequate size.
 Representativeness (validity)

A sample should accurately reflect distribution of

relevant variable in population

• Person e.g. age, sex

• Place e.g. urban vs. rural
• Time e.g. seasonality

Representativeness essential to generalise

Ensure representativeness before starting,

Confirm once completed

 Sampling and representativeness

Sampling
Population
Sample

Target Population

Target Population ➔ Sampling Population ➔ Sample

Definitions

• Population – group of things (people) having one or more

common characteristics

• Sample – representative subgroup of the larger

population

• Used to estimate something about a population (generalize)

• Must be similar to population on characteristic being investigated

Population:
a set which includes all
measurements of interest
to the researcher
(The collection of all
responses, measurements, or
counts that are of interest)

Sample:
A subset of the population
Sampling Frame
• This is the complete list of sampling units in the target
population to be subjected to the sampling procedure.
• Completeness and accuracy of this list is essential for the
success of the study.

Sampling Units

These are the individual units / entities that make up the

frame just as elements are entities that make up the
population.
Sampling Error

This arises out of random sampling and is the discrepancies

between sample values and the population value.

Sampling Variation

• Due to infinite variations among individuals and their

surrounding conditions.

• Produce differences among samples from the population and

is due to chance.
• Example: In a clinical trail of 200 patients we find that
the efficacy of a particular drug is 75%

If we repeat the study using the same drug in another

group of similar 200 patients we will not get the same
efficacy of 75%. It could be 78% or 71%.

“Different results from different trails though all of

them conducted under the same conditions”
 How to sample ?
In general, 2 requirements

1. Sampling frame must be available, otherwise

develop a sampling frame.
2. Choose an appropriate sampling method to
draw a sample from the sampling frame.
The Sampling Design Process

Define the Population

Determine the Sampling Frame

Select Sampling Technique(s)

Determine the Sample Size

Execute the Sampling Process

 Sampling Methods
Probability Sampling Non-Probability Sampling

• Simple random sampling • Deliberate (quota) sampling

• Stratified random sampling • Convenience sampling

• Systematic random sampling • Purposive sampling

• Cluster (area) random • Snowball sampling

sampling • Consecutive sampling
• Multistage random sampling
Simple Random Sampling

• Equal probability
• Techniques
• Lottery method
• Table of random numbers
• Advantage
• Most representative group
• Disadvantage
• Difficult to identify every member of a population
 Random Number table
1 2 3 4 5
49486 93775 88744 80091 92732
94860 36746 04571 13150 65383
10169 95685 47585 53247 60900
12018 45351 15671 23026 55344
45611 71585 61487 87434 07498
89137 30984 18842 69619 53872
94541 12057 30771 19598 96069
89920 28843 87599 30181 26839
32472 32796 15255 39636 90819
 How to select a simple random sample

1. Define the population

2. Determine the desired sample size

3. List all members of the population or the potential subjects

• For example:
• 4th grade boys who have demonstrated problem behaviors

• Lets select 10 boys from the list

Potential Subject Pool

1. Ahamed 11. Riyaz 21. Fahad

2. Munir 12. Yaseen 22. Iqbal
3. Khalid 13. Jaffar 23. Jabbar
4. Ameer 14. Sattar 24. Aziz
5. Junaid 15. Ghouse 25. Anwar
6. Khadeer 16. Imran 26. Shohail
7. Shaffi 17. Khaleel 27. Shohaib
8. Rafi 18. Shabu 28. Rehaman
9. Ghayas 19. Shanu 29. Naeem
10. Fayaz 20. Javid 30. Rahim
So our selected subjects are with numbers 10, 22, 24, 15, 6, 1,
25, 11, 13, & 16.

1. Ahamed 11. Riyaz 21. Fahad

2. Munir 12. Yaseen 22. Iqbal
3. Khalid 13. Jaffar 23. Jabbar
4. Ameer 14. Sattar 24. Aziz
5. Junaid 15. Ghouse 25. Anwar
6. Khadeer 16. Imran 26. Shohail
7. Shaffi 17. Khaleel 27. Shohaib
8. Rafi 18. Shabu 28. Rehaman
9. Ghayas 19. Shanu 29. Naeem
10. Fayaz 20. Javid 30. Rahim
• Simple random sampling
• Estimate hemoglobin levels in patients with
sickle cell anemia
1. Determine sample size
2. Obtain a list of all patients with sickle cell anemia
in a hospital or clinic
3. Patient is the sampling unit
4. Use a table of random numbers to select units
from the sampling frame
5. Measure hemoglobin in all patients
6. Estimate the levels (normal & abnormal) of
hemoglobin
Systematic random Sampling

• Technique
• Use “system” to select sample (e.g., every 5th item in
alphabetized list, every 10th name in phone book)

• Advantage
• Quick, efficient, saves time and energy

• Disadvantage
• Not entirely bias free; each item does not have equal chance to be
selected

• System for selecting subjects may introduce systematic error

• Cannot generalize beyond population actually sampled
 Example
• If a systematic sample of 500 students were to be carried out in
a university with an enrolled population of 10,000, the sampling
interval would be:

• I = N/n = 10,000/500 =20

• All students would be assigned sequential numbers. The

starting point would be chosen by selecting a random number
between 1 and 20. If this number was 9, then the 9th student on
the list of students would be selected along with every following
20th student. The sample of students would be those
corresponding to student numbers 9, 29, 49, 69, ........ 9929,
9949, 9969 and 9989.
Systematic sampling
Stratified Random Sampling

• Technique
• Divide population into various strata
• Randomly sample within each strata
• Sample from each strata should be proportional

• Advantage
• Better in achieving representativeness on control variable

• Disadvantage
• Difficult to pick appropriate strata
• Difficult to Identify every member in population
Stratified Random selection for drug trail in hypertension

Mild Moderate Severe

 Sampling in Epidemiology

• Stratified random sample

• Assess dietary intake in adolescents
1. Define three age groups: 11-13, 14-16, 17-19
2. Stratify age groups by sex
3. Obtain list of children in this age range from schools
4. Randomly select children from each of the 6 strata
until sample size is obtained
5. Measure dietary intake
 Cluster (Area) random sampling
• Randomly select groups (cluster) – all members of
groups are subjects

• Appropriate when
• you can’t obtain a list of the members of the
population
• have little knowledge of population characteristics

• Population is scattered over large geographic area.

 Cluster sampling

Section 1 Section 2

Section 3

Section 5

Section 4
Cluster (Area) Sampling

• Advantage
• More practical, less costly

• Conclusions should be stated in terms of cluster (sample unit –

school)

• Sample size is number of clusters

Multistage random sampling

• Stage 1
• randomly sample clusters (schools)

• Stage 2
• randomly sample individuals from the schools selected
 Sampling Methods

Probability Sampling Non-Probability Sampling

• Simple random sampling • Deliberate (quota)

• Stratified random sampling sampling
• Systematic random • Convenience sampling
sampling • Purposive sampling
• Cluster (area) random • Snowball sampling
sampling • Consecutive sampling
• Multistage random
sampling
Deliberate (Quota) Sampling

• Similar to stratified random sampling

• Technique
• Quotas set using some characteristic of the population
thought to be relevant
• Subjects selected non-randomly to meet quotas (usu.
convenience sampling)

• Disadvantage
• selection bias
• Cannot set quotas for all characteristics important to study
Convenience Sampling

• “Take them where you find them” - nonrandom

• Intact classes, volunteers, survey respondents (low return), a

typical group, a typical person

• Disadvantage: Selection bias

 Purposive Sampling
• Purposive sampling (criterion-based sampling)
• Establish criteria necessary for being included in study and
find sample to meet criteria

• Solution: Screening
• Use random sampling to obtain a representative sample of
larger population and then those subjects that are not
members of the desired population are screened or filtered
out
• EX: want to study smokers but can’t identify all smokers
Snowball Sampling

In snowball sampling, an initial group of respondents is

selected.

• After being interviewed, these respondents are asked to

identify others who belong to the target population of
interest.
• Subsequent respondents are selected based on the
referrals.
Consecutive sampling

• Outcome of 1000 consecutive patients presenting

to the emergency room with chest pain
• Natural history of all 125 patients with HIV-
associated TB during 5 year period

Explicit efforts must be made to identify and

recruit ALL persons with the condition of
interest
Choosing probability vs. non-probability sampling
method
Probability Evaluation Criteria Non-probability
sampling sampling
Conclusive Nature of research Exploratory

Larger sampling Relative magnitude Larger non-sampling

errors sampling vs. error
non-sampling error

High Population variability Low

[Heterogeneous] [Homogeneous]

Favorable Statistical Considerations Unfavorable

High Sophistication Needed Low

Relatively Longer Time Relatively shorter

High Budget Needed Low

Suniti Solomon et al
Prevalence and risk factors of HIV 1 and HIV 2 infection in Urban and
rural areas in TN. Int. J. of STD & AIDS 1998;9:98-103
Objective: Find prevalence and risk factors.
Setting: Centres in metropolitancity & municipality. Subjects: Individuals in
Tamil nadu.
Sampling Porcedure:

“ Health camps were organised in 5 urban and 5 rural centres to cover entire
state graphically”
“ Every third person screened, in the active reproductive age group, were
recruited as a subject. At each camp the inclusion of subjects continued until 200
persons were recruited”
Mary Sexton et al.
Sex differences in the use of asthma drugs: Cross-sectional study.
BMJ 1998; 317: 1434-7

Objective : To assess the use of asthma drugs. Design : Cross-sectional study.

Setting: Six general practices in East Anglia.
Subjects : Adults aged 20-54 with Asthma

Sampling method
“identify cases with asthma received drugs one year before – through database from
each participating practices. The sample was stratified into three categories of
severity corresponding the prescribed drugs
Bronchodilator alone (mild) 38%
Steroids (moderate) 57%
Nebulizer treatment (severe) 5%
Use SRS to select subject in each practice based on proportion of use of each type of
drug within the practice
S. Anuradha
Genital ulcer disease and acquisition of HIV infection.
Indian J Med Microbiol 1992; 10(4):265-269

Objective : To find out the association of HIV infection with genital ulcer
disease . Setting : Dept. of STD, GGH, Chennai.
Subjects : Individials attending the STD dept.

Sampling procedure

‘ Blood samples from first 20 patients were taken for analysis once a
week for 40 weeks’.

Statistical analysis : Data were analysed by using SPSS/PC + ver 4.0. The
strength of association between the variables and HIV serological status was
estimated using odds ratio (OR) and their 95% Confidence Intervals(CI)
Reidy A et al.
Prevalence of series eye disease and visual impairement in a
north London population: Population based, cross sectional
study. BMJ 1998; 316:1643

Objective: To estimate eye disorders and of

visual impairement
Design: Cross-sectional survey.
Setting : General Practices in metropolitan in
England.
Subjects: aged 65 or older & registered
Sampling
17 general practice group
Procedure

Random sampling
7 were selected

People age 65 or older were registered with the

general practices. Total 750-850 in each Gen Pract

Use SRS to select eligible people in each practice

One third in each practices were selected to form survey sample

In Conclusion,
For any research, based on its study design and objectives an
appropriate random sampling technique should be used, so as to
generalize the findings.
RESEARCH METHODOLOGY

Lecture - 2
Research is the systematic process of collecting and

analyzing information (data) in order to increase our

understanding of the phenomenon about which we are

concerned or interested.
 Characteristics of Research

• Systematic
• Logical
• Empirical
• Reductive
• Replicable
Types of Research
1. Pure and Applied Research

2. Exploratory or Formulative Research

3. Descriptive Research
8. Analytical study or statistical Method
4. Diagnostic Study
9. Historical Research
5. Evaluation Studies
10. Surveys
6. Action Research 11. Case Study
7. Experimental Research
1. Pure and Applied Research
Pure
• it is the study of search of knowledge.

Applied
• It is the study of finding solution to a problem.
Purpose of Pure and Applied Research
• Pure
• It can contribute new facts
• It can put theory to the rest
• It may aid in conceptual clarification
• It may integrate previously existing theories.

Applied
• It offers solutions to many practical problems.
• To find the critical factors in a practical problem.
2. Exploratory Research

Exploratory research is preliminary study of an unfamiliar

problem about which the researcher has little or no
knowledge.
• To Generate new ideas
• To increase the researcher’s familiarity with the problem
• To Make a precise formulation of the problem
• To gather information for clarifying concepts
• To determine whether it is feasible to attempt the study.
3. Descriptive Research
Descriptive study is a fact- finding investigation with adequate
interpretation.

• It is the simplest type of research.

• It is designed to gather descriptive information and provides
information for formulating more sophisticated studies
• Data are collected using observation, interview and mail
questionnaire.
• It can focus directly on a theoretical point.

• It can highlight important methodological aspects of data

collection and interpretation.

• It obtained in a research may be useful for prediction about

areas of social life outside in the boundaries of research.

• Descriptive studies are valuable in providing facts needed for

planning social action programmes.
4. Diagnostic Study
• It is directed towards discovering what is happening, why is it
happening and what can be done about.

• It aims at identifying the causes of a problem and the possible

solutions for it. This study may also be concerned with
discovering and testing whether certain variables are
associated.

• To determine the frequency with which something occurs or

with which it is associated with something else.
5. Evaluation Studies
• It is one type of applied research.
• It is made for assessing the effectiveness of social or economic
programs implemented or for assessing the impact of
developmental projects area.
• The determination of the results attained by some activity
designed to accomplish some valued goal or objectives.
• It directed to assess or appraise the quality and quantity of an
activity and its performance.
• To specify its attributes and conditions required for its success.
 6. Action Research

Action research is a reflective process of progressive problem solving led

by individuals working with others in teams or as part of a "community of
practice" to improve the way they address issues and solve problems

• Researcher attempts to study and applied action.

E.g. Eradication of Malariya, Maritime Navigation

• A baseline survey of the pre-action situation

• A feasibility study of the proposed action programme

• Planning and launching the programme

• Concurrent evaluation of the programme

• Making modifications and changes in the programme.

7. Experimental Research
• Experimental research is commonly used in sciences such as
sociology and psychology, physics, chemistry, biology and
medicine etc.
• It is a systematic and scientific approach to research in which
the researcher manipulates one or more variables, and controls
and measures any change in other variables.
• Experiments are conducted to be able to predict
phenomenons.
• To maintain control over all factors
• A blueprint of the procedure that enables the researcher to test
his hypothesis
8. Analytical Study
• Analytical study is a system of procedures and techniques of
analysis applied to quantitative data.
• A system of mathematical models or statistical techniques
applicable to numerical data.
• It aims at testing hypothesis and specifying and interpreting
relationship.
• It concentrates on analyzing data in depth and examining
relationships from various angles by bringing in as many
relevant variables as possible in the analysis plan.
9. Historical Research
• The systematic collection and evaluation of data related to past
occurrences in order to describe causes, effects, and trends of those
events that may help explain present events and anticipate future events.
• Data is often archival-including newspaper clippings, photographs, etc.- and
may include interviews.
• To draw explanations and generalizations from the past trends in order to
understand the present and to anticipate the future.
• It enables us to grasp our relationship with the past and to plan more
intelligently for the future.
• The past contains the key to the present and the past and the present
influences the future.
• It helps us in visualizing the society as a dynamic organism and its
structures and functions as evolving, steadily growing and undergoing
change and transformation.
10. Survey Research
Survey research is one of the most important areas of measurement in
applied social research. The broad area of survey research encompasses any
measurement procedures that involve asking questions of respondents.
A "survey" can be anything form a short paper-and-pencil feedback form to an
intensive one-on-one in-depth interview.

• It is always conducted in a natural setting.

• It seeks responses directly from the respondents.
• It can cover a very large population
• A survey may involve an extensive study or an intensive study.
• A survey covers a definite geographical area, a city, district, state
11. Case Study
• A case study is a research methodology common in social science.

• It is based on an in-depth investigation of a single individual, group, or

event to explore causation in order to find underlying principles

• To examine limited number of variables

• case study methods involve an in-depth, longitudinal examination of a

single instance or event.

• It provides a systematic way of looking at events, collecting data,

analyzing information, and reporting the results
Field research

• Field research has traditionally been thought different from methods of

research conducted in a laboratory or academic setting.

Purpose

• The advantages of field research are that people are closer to real world
conditions and design the research in the best way to discover the particular
information required.
 RESEARCH AND RESEARCH ETHICS

Content of this unit

1. Instruction for the assignment to be submitted for this unit.
2. Research
• Meaning of research
• Objectives of research
• Motivation in research
• Types of research
• Research approaches
• Significance of research
• Research methods versus methodology
3. Research process
• Formulating the research problem
• Extensive literature survey
• Developing the hypothesis
• Preparing the research design
• Determining sample design
• Collecting the data
• Execution of the project
• Analysis of data
• Hypothesis testing
• Generalisations and interpretation
• Preparation of the report
4. Research Ethics
• Codes and Policies for Research Ethics
• Promoting Ethical Conduct in Science
• Animal Used In Research
• Ethical Issues In Agricultural Research
5. Short Questions with answers
RESEARCH

MEANING OF RESEARCH

1. Research is a derivative of the French word; „Researche‟ means quest, search, pursuit and search
for truth.
2. Research in common parlance refers to a search for knowledge.
3. It is a careful investigation or inquiry especially through search for new facts in any branch of
knowledge.
4. It is systematized effort to gain new knowledge.
5. According to Clifford Woody research comprises defining and redefining problems, formulating
hypothesis or suggested solutions; collecting, organizing and evaluating data; making deductions
and reaching conclusions; and at last carefully testing the conclusions to determine whether they fit
the formulating hypothesis.
6. D. Slesinger and M. Stephenson in the Encyclopedia of Social Sciences define research as “the
manipulation of things, concepts or symbols for the purpose of generalizing to extend, correct or
verify knowledge, whether that knowledge aids in construction of theory or in the practice of an art.”
7. Research is, an original contribution to the existing stock of knowledge making for its
advancement. It is the detection of truth with the help of study, observation, comparison and
experiment.
8. Research is the systematic approach concerning generalisation and the formulation of a theory.
9. The research refers to the systematic method consisting of enunciating the problem, formulating a
hypothesis, collecting the facts or data, analysing the facts and reaching certain conclusions either
in the form of solutions(s) towards the concerned problem or in certain generalisations for some
theoretical formulation.
10. Research means mission, search, hunt, and exploration for truth. The purpose of research is to
discover answers to questions or problems through the application of scientific procedures.
11. Scientific research is a systematic, controlled, empirical and critical investigation of hypothetical
propositions about the presumed relations among natural phenomenon.
12. Research is a careful, critical and disciplined enquiry, varying in technique and method.
13. According to the nature and conditions of the problem identified, research is directed towards
clarification or/and resolution of the problem. The purpose of research is to discover answers to
questions or problems through the application of scientific procedures.

OBJECTIVES OF RESEARCH

The purpose of research is to discover answers to questions through the application of scientific procedures.
The main aim of research is to find out the truth which is hidden and which has not been discovered as yet.
Though each research study has its own specific purpose, we may think of research objectives as falling
into a number of following broad groupings:
1. To gain familiarity with a phenomenon or to achieve new insights into it (studies with this object
in view are termed as exploratory or formulative research studies);
2. To portray accurately the characteristics of a particular individual, situation or a group (studies
with this object in view are known as descriptive research studies);
3. To determine the frequency with which something occurs or with which it is associated with
something else (studies with this object in view are known as diagnostic research studies);
4. To test a hypothesis of a causal relationship between variables (such studies are known as
hypothesis-testing research studies).
MOTIVATION IN RESEARCH

What makes people to undertake research? This is a question of fundamental importance. The possible
motives for doing research may be either one or more of the following:
1. Desire to get a research degree along with its consequential benefits;
2. Desire to face the challenge in solving the unsolved problems, i.e., concern over practical problems
initiates research;
3. Desire to get intellectual joy of doing some creative work;
4. Desire to be of service to society;
5. Desire to get respectability.
6. Curiosity about unknown
7. Desire to understand the cause and effect of wide spread social problems
8. Appearance of novel and unanticipated situations
9. Desire to discover new and test old scientific procedure as an efficient way to gain useful
and fundamental knowledge.
However, this is not an exhaustive list of factors motivating people to undertake research studies. Many
more factors such as directives of government, employment conditions, curiosity about new things, desire to
understand causal relationships, social thinking and awakening, and the like may as well motivate (or at
times compel) people to perform research operations.

TYPES OF RESEARCH

THE BASIC TYPES OF RESEARCH ARE AS FOLLOWS:

1. Descriptive vs. Analytical: Descriptive research includes surveys and fact-finding enquiries of
different kinds. The major purpose of descriptive research is description of the state of affairs as it
exists at present. In social science and business research we quite often use the term Ex post facto
research for descriptive research studies. The main characteristic of this method is that the
researcher has no control over the variables; he can only report what has happened or what is
happening. Most ex post facto research projects are used for descriptive studies in which the
researcher seeks to measure such items as, for example, frequency of shopping, preferences of
people, or similar data. Ex post facto studies also include attempts by researchers to discover
causes even when they cannot control the variables. The methods of research utilized in descriptive
research are survey methods of all kinds, including comparative and correlation methods. In
analytical research, on the other hand, the researcher has to use facts or information already
available, and analyze these to make a critical evaluation of the material.
2. Applied vs. Fundamental: Research can either be applied (or action) research or fundamental (to
basic or pure) research. Applied research aims at finding a solution for an immediate problem facing
a society or an industrial/business organisation, whereas fundamental research is mainly concerned
with generalisations and with the formulation of a theory. “Gathering knowledge for knowledge‟s sake
is termed „pure‟ or „basic‟ research.” Research concerning some natural phenomenon or relating to
pure mathematics are examples of fundamental research. Similarly, research studies, concerning
human behaviour carried on with a view to make generalisations about human behaviour, are also
examples of fundamental research, but research aimed at certain conclusions (say, a solution) facing
a concrete social or business problem is an example of applied research. Research to identify social,
economic or political trends that may affect a particular institution or the copy research (research to
find out whether certain communications will be read and understood) or the marketing research or
evaluation research are examples of applied research. Thus, the central aim of applied research is to
discover a solution for some pressing practical problem, whereas basic research is directed towards
finding information that has a broad base of applications and thus, adds to the already existing
organized body of scientific knowledge.
3. Quantitative vs. Qualitative: Quantitative research is based on the measurement of quantity or
amount. It is applicable to phenomena that can be expressed in terms of quantity. Qualitative
research, on the other hand, is concerned with qualitative phenomenon, i.e., phenomena relating to
or involving quality or kind. For instance, when we are interested in investigating the reasons for
human behaviour (i.e., why people think or do certain things), we quite often talk of „Motivation
Research‟, an important type of qualitative research. This type of research aims at discovering the
underlying motives and desires, using in depth interviews for the purpose. Other techniques of such
research are word association tests, sentence completion tests, story completion tests and similar
other projective techniques. Attitude or opinion research i.e., research designed to find out how
people feel or what they think about a particular subject or institution is also qualitative research.
Qualitative research is especially important in the behavioural sciences where the aim is to discover
the underlying motives of human behaviour. Through such research we can analyse the various
factors which motivate people to behave in a particular manner or which make people like or dislike a
particular thing. It may be stated, however, that to apply qualitative research in practice is relatively a
difficult job and therefore, while doing such research, one should seek guidance from experimental
psychologists.
4. Conceptual vs. Empirical: Conceptual research is that related to some abstract idea(s) or theory. It
is generally used by philosophers and thinkers to develop new concepts or to reinterpret existing
ones. On the other hand, empirical research relies on experience or observation alone, often without
due regard for system and theory. It is data-based research, coming up with conclusions which are
capable of being verified by observation or experiment. We can also call it as experimental type of
research. In such a research it is necessary to get at facts firsthand, at their source, and actively to
go about doing certain things to stimulate the production of desired information. In such a research,
the researcher must first provide himself with a working hypothesis or guess as to the probable
results. He then works to get enough facts (data) to prove or disprove his hypothesis. He then sets
up experimental designs which he thinks will manipulate the persons or the materials concerned so
as to bring forth the desired information. Such research is thus characterised by the experimenter‟s
control over the variables under study and his deliberate manipulation of one of them to study its
effects. Empirical research is appropriate when proof is sought that certain variables affect other
variables in some way. Evidence gathered through experiments or empirical studies is today
considered to be the most powerful support possible for a given hypothesis.
5. Some Other Types of Research: All other types of research are variations of one or more of the
above stated approaches, based on either the purpose of research, or the time required to
accomplish research, on the environment in which research is done, or on the basis of some other
similar factor. Form the point of view of time, we can think of research either as one-time research
or longitudinal research. In the former case the research is confined to a single time-period,
whereas in the latter case the research is carried on over several time-periods. Research can be
field-setting research or laboratory research or simulation research, depending upon the
environment in which it is to be carried out. Research can as well be understood as clinical or
diagnostic research. Such research follows case-study methods or in-depth approaches to reach
the basic causal relations. Such studies usually go deep into the causes of things or events that
interest us, using very small samples and very deep probing data gathering devices. The research
may be exploratory or it may be formalized. The objective of exploratory research is the
development of hypotheses rather than their testing, whereas formalized research studies are those
with substantial structure and with specific hypotheses to be tested. Historical research is that
which utilizes historical sources like documents, remains, etc. to study events or ideas of the past,
including the philosophy of persons and groups at any remote point of time. Research can also be
classified as conclusion-oriented and decision-oriented. While doing conclusion oriented research, a
researcher is free to pick up a problem, redesign the enquiry as he proceeds and is prepared to
conceptualize as he wishes. Decision-oriented research is always for the need of a decision maker
and the researcher in this case is not free to embark upon research according to his own inclination.
Operations research is an example of decision oriented research since it is a scientific method of
providing executive departments with a quantitative basis for decisions regarding operations under
their control.
RESEARCH APPROACHES

The above description of the types of research brings to light the fact that there are two basic approaches to
research, viz., quantitative approach and the qualitative approach.

1. The quantitative approach involves the generation of data in quantitative form which can be subjected
to rigorous quantitative analysis in a formal and rigid fashion. This approach can be further sub-
classified into inferential, experimental and simulation approaches to research.

• The inferential approach’s purpose is to research is to form a data base from which to infer
characteristics or relationships of population. This usually means survey research where a sample
of population is studied (questioned or observed) to determine its characteristics, and it is then
inferred that the population has the same characteristics.
• Experimental approach is characterised by much greater control over the research environment
and in this case some variables are manipulated to observe their effect on other variables.
• Simulation approach involves the construction of an artificial environment within which relevant
information and data can be generated. This permits an observation of the dynamic behaviour of a
system (or its sub-system) under controlled conditions. The term „simulation‟ in the context of
business and social sciences applications refers to “the operation of a numerical model that
represents the structure of a dynamic process. Given the values of initial conditions, parameters
and exogenous variables, a simulation is run to represent the behaviour of the process over time.”5
Simulation approach can also be useful in building models for understanding future conditions.

2. Qualitative approach to research is concerned with subjective assessment of attitudes, opinions and
behaviour. Research in such a situation is a function of researcher‟s insights and impressions. Such an
approach to research generates results either in non-quantitative form or in the form which are not
subjected to rigorous quantitative analysis. Generally, the techniques of focus group interviews,
projective techniques and depth interviews are used. All these are explained at length in chapters that
follow.

SIGNIFICANCE OF RESEARCH

“All progress is born of inquiry. Doubt is often better than overconfidence, for it leads to inquiry, and inquiry
leads to invention” is a famous Hudson Maxim in context of which the significance of research can well be
understood. Increased amounts of research make progress possible. Research inculcates scientific and
inductive thinking and it promotes the development of logical habits of thinking and organisation.

The role of research in several fields of applied economics, whether related to business or to the economy
as a whole, has greatly increased in modern times. The increasingly complex nature of business and
government has focused attention on the use of research in solving operational problems. Research, as an
aid to economic policy, has gained added importance, both for government and business.
Research provides the basis for nearly all government policies in our economic system. For instance,
government‟s budgets rest in part on an analysis of the needs and desires of the people and on the
availability of revenues to meet these needs. The cost of needs has to be equated to probable revenues and
this is a field where research is most needed. Through research we can devise alternative policies and can
as well examine the consequences of each of these alternatives.
Decision-making may not be a part of research, but research certainly facilitates the decisions of the policy
maker. Government has also to chalk out programmes for dealing with all facets of the country‟s existence
and most of these will be related directly or indirectly to economic conditions. The plight of cultivators, the
problems of big and small business and industry, working conditions, trade union activities, the problems of
distribution, even the size and nature of defense services are matters requiring research. Thus, research is
considered necessary with regard to the allocation of nation‟s resources. Another area in government,
where research is necessary, is collecting information on the economic and social structure of the nation.
Such information indicates what is happening in the economy and what changes are taking place. Collecting
such statistical information is by no means a routine task, but it involves a variety of research problems.
These days nearly all governments maintain large staff of research technicians or experts to carry on this
work. Thus, in the context of government, research as a tool to economic policy has three distinct phases of
operation, viz., (i) investigation of economic structure through continual compilation of facts; (ii) diagnosis of
events that are taking place and the analysis of the forces underlying them; and (iii) the prognosis, i.e., the
prediction of future developments.

Research has its special significance in solving various operational and planning problems of business and
industry. Operations research and market research, along with motivational research, are considered crucial
and their results assist, in more than one way, in taking business decisions. Market research is the
investigation of the structure and development of a market for the purpose of formulating efficient policies for
purchasing, production and sales. Operations research refers to the application of mathematical, logical and
analytical techniques to the solution of business problems of cost minimization or of profit maximization or
what can be termed as optimization problems. Motivational research of determining why people behave as
they do is mainly concerned with market characteristics. In other words, it is concerned with the
determination of motivations underlying the consumer (market) behaviour. All these are of great help to
people in business and industry who are responsible for taking business decisions. Research with regard to
demand and market factors has great utility in business. Given knowledge of future demand, it is generally
not difficult for a firm, or for an industry to adjust its supply schedule within the limits of its projected
capacity. Market analysis has become an integral tool of business policy these days. Business budgeting,
which ultimately results in a projected profit and loss account, is based mainly on sales estimates which in
turn depend on business research. Once sales forecasting is done, efficient production and investment
programmes can be set up around which are grouped the purchasing and financing plans. Research, thus,
replaces intuitive business decisions by more logical and scientific decisions.

Research is equally important for social scientists in studying social relationships and in seeking answers to
various social problems. It provides the intellectual satisfaction of knowing a few things just for the sake of
knowledge and also has practical utility for the social scientist to know for the sake of being able to do
something better or in a more efficient manner. Research in social sciences is concerned both with
knowledge for its own sake and with knowledge for what it can contribute to practical concerns. “This double
emphasis is perhaps especially appropriate in the case of social science. On the one hand, its responsibility
as a science is to develop a body of principles that make possible the understanding and prediction of the
whole range of human interactions. On the other hand, because of its social orientation, it is increasingly
being looked to for practical guidance in solving immediate problems of human relations.

In addition to what has been stated above, the significance of research can also be understood keeping in
view the following points:
(a) To those students who are to write a master‟s or Ph.D. thesis, research may mean a careerism or
a way to attain a high position in the social structure;
(b) To professionals in research methodology, research may mean a source of livelihood;
(c) To philosophers and thinkers, research may mean the outlet for new ideas and insights;
(d) To literary men and women, research may mean the development of new styles and creative work;
(e) To analysts and intellectuals, research may mean the generalisations of new theories.
Thus, research is the fountain of knowledge for the sake of knowledge and an important source of providing
guidelines for solving different business, governmental and social problems. It is a sort of formal training
which enables one to understand the new developments in one‟s field in a better way.

RESEARCH METHODS VERSUS METHODOLOGY

It seems appropriate at this juncture to explain the difference between research methods and research
methodology. Research methods may be understood as all those methods/techniques that are used for
conduction of research. Research methods or techniques*, thus, refer to the methods the researchers *At
times, a distinction is also made between research techniques and research methods. Research techniques
refer to the behaviour and instruments we use in performing research operations such as making
observations, recording data, techniques of processing data and the like. Research methods refer to the
behaviour and instruments used in selecting and constructing research technique. For instance, the
difference between methods and techniques of data collection can better be understood from the details
given in the following chart use in performing research operations.

In other words, all those methods which are used by the researcher during the course of studying his
research problem are termed as research methods. Since the object of research, particularly the applied
research, it to arrive at a solution for a given problem, the available data and the unknown aspects of the
problem have to be related to each other to make a solution possible. Keeping this in view, research
methods can be put into the following three groups:
1. In the first group we include those methods which are concerned with the collection of data. These
methods will be used where the data already available are not sufficient to arrive at the required
solution;
2. The second group consists of those statistical techniques which are used for establishing
relationships between the data and the unknowns;
3. The third group consists of those methods which are used to evaluate the accuracy of the results
obtained. Research methods falling in the above stated last two groups are generally taken as the
analytical tools of research.
Type Methods Techniques
1 Library research i. Analysis of Historical Recording of notes, Content analysis, Tape and Film listening and analysis
records
ii. Analysis of documents Statistical compilations and manipulations, reference and abstract guides,
contents analysis.
2 Field Research i. Non-participant direct Observational behavioural scales, use of score cards, etc
observation
ii. Participant observation Interactional recording, possible use of tape recorders, photo graphic
techniques
iii. Mass observation Recording mass behaviour, interview using independent observers in
public places.
iv. Mail questionnaire Identification of social and economic background of respondents.
v. Opinionnaire Use of attitude scales, projective techniques, use of socio-metric scales.
vi. Personal interview Interviewer uses a detailed schedule with open and closed questions.
vii Focused interview Interviewer focuses attention upon a given experience and its effects.
viii Group interview Small groups of respondents are interviewed simultaneously.
ix. Telephone survey Used as a survey technique for information and for discerning opinion; may
also be used as a follow up of questionnaire.
x. Case study and life history Cross sectional collection of data for intensive analysis, longitudinal
collection of data of intensive character.
3 Laboratory Small group study of Use of audio-visual recording devices, use of observers, etc
Research random behaviour play and
role analysis
From what has been stated above, we can say that methods are more general. It is the methods that
generate techniques. However, in practice, the two terms are taken as interchangeable and when we talk
of research methods we do, by implication, include research techniques within their compass.
Research methodology is a way to systematically solve the research problem. It may be understood as a
science of studying how research is done scientifically. In it we study the various steps that are generally
adopted by a researcher in studying his research problem along with the logic behind them. It is necessary
for the researcher to know not only the research methods/techniques but also the methodology.
Researchers not only need to know how to develop certain indices or tests, how to calculate the mean, the
mode, the median or the standard deviation or chi-square, how to apply particular research techniques, but
they also need to know which of these methods or techniques, are relevant and which are not, and what
would they mean and indicate and why. Researchers also need to understand the assumptions underlying
various techniques and they need to know the criteria by which they can decide that certain techniques and
procedures will be applicable to certain problems and others will not. All this means that it is necessary for
the researcher to design his methodology for his problem as the same may differ from problem to problem.
For example, an architect, who designs a building, has to consciously evaluate the basis of his decisions,
i.e., he has to evaluate why and on what basis he selects particular size, number and location of doors,
windows and ventilators, uses particular materials and not others and the like. Similarly, in research the
scientist has to expose the research decisions to evaluation before they are implemented. He has to specify
very clearly and precisely what decisions he selects and why he selects them so that they can be evaluated
by others also. From what has been stated above, we can say that research methodology has many
dimensions and research methods do constitute a part of the research methodology. The scope of research
methodology is wider than that of research methods. Thus, when we talk of research methodology we not
only talk of the research methods but also consider the logic behind the methods we use in the context of
our research study and explain why we are using a particular method or technique and why we are not
using others so that research results are capable of being evaluated either by the researcher himself or
by others. Why a research study has been undertaken, how the research problem has been defined, in what
way and why the hypothesis has been formulated, what data have been collected and what particular
method has been adopted, why particular technique of analysing data has been used and a host of similar
other questions are usually answered when we talk of research methodology concerning a research
problem or study.

Research and Scientific Method

For a clear perception of the term research, one should know the meaning of scientific method. The two
terms, research and scientific method, are closely related. Research, as we have already stated, can be
termed as “an inquiry into the nature of, the reasons for, and the consequences of any particular set of
circumstances, whether these circumstances are experimentally controlled or recorded just as they occur.
Further, research implies the researcher is interested in more than particular results; he is interested in the
repeatability of the results and in their extension to more complicated and general situations.”7 On the other
hand, the philosophy common to all research methods and techniques, although they may vary considerably
from one science to another, is usually given the name of scientific method. In this context, Karl Pearson
writes, “The scientific method is one and same in the branches (of science) and that method is the method
of all logically trained minds … the unity of all sciences consists alone in its methods, not its material; the
man who classifies facts of any kind whatever, who sees their mutual relation and describes their
sequences, is applying the Scientific Method and is a man of science.” Scientific method is the pursuit of
truth as determined by logical considerations. The ideal of science is to achieve a systematic interrelation of
facts. Scientific method attempts to achieve “this ideal by experimentation, observation, logical arguments
from accepted postulates and a combination of these three in varying proportions.”9 In scientific method,
logic aids in formulating propositions explicitly and accurately so that their possible alternatives become
clear. Further, logic develops the consequences of such alternatives, and when these are compared with
observable phenomena, it becomes possible for the researcher or the scientist to state which alternative is
most in harmony with the observed facts. All this is done through experimentation and survey investigations
which constitute the integral parts of scientific method.
Experimentation is done to test hypotheses and to discover new relationships, if any, among variables. But
the conclusions drawn on the basis of experimental data are generally criticized for faulty assumptions,
poorly designed experiments, badly executed experiments or faulty interpretations. As such the researcher
must pay all possible attention while developing the experimental design and must state only probable
inferences. The purpose of survey investigations may also be to provide scientifically gathered information
to work as a basis for the researchers for their conclusions.

The scientific method is, thus, based on certain basic postulates which can be stated as under:

1. It relies on empirical evidence;

2. It utilizes relevant concepts;
3. It is committed to only objective considerations;
4. It presupposes ethical neutrality, i.e., it aims at nothing but making only adequate and correct
statements about population objects;
5. It results into probabilistic predictions;
6. Its methodology is made known to all concerned for critical scrutiny are for use in testing the
conclusions through replication;
7. It aims at formulating most general axioms or what can be termed as scientific theories.

Thus, “the scientific method encourages a rigorous, impersonal mode of procedure dictated by the demands
of logic and objective procedure.”10 Accordingly, scientific method implies an objective, logical and
systematic method, i.e., a method free from personal bias or prejudice, a method to ascertain demonstrable
qualities of a phenomenon capable of being verified, a method wherein the researcher is guided by the rules
of logical reasoning, a method wherein the investigation proceeds in an orderly manner and a method that
implies internal consistency.

Importance of Knowing How Research is done?

The study of research methodology gives the student the necessary training in gathering material and
arranging or card-indexing them, participation in the field work when required, and also training in
techniques for the collection of data appropriate to particular problems, in the use of statistics,
questionnaires and controlled experimentation and in recording evidence, sorting it out and interpreting it. In
fact, importance of knowing the methodology of research or how research is done stems from the following
considerations:

(i) For one who is preparing himself for a career of carrying out research, the importance of knowing
research methodology and research techniques is obvious since the same constitute the tools of his
trade. The knowledge of methodology provides good training especially to the new research worker
and enables him to do better research. It helps him to develop disciplined thinking or a „bent of mind‟
to observe the field objectively. Hence, those aspiring for careerism in research must develop the skill
of using research techniques and must thoroughly understand the logic behind them.
(ii) Knowledge of how to do research will inculcate the ability to evaluate and use research results with
reasonable confidence. In other words, we can state that the knowledge of research methodology is
helpful in various fields such as government or business administration, community development and
social work where persons are increasingly called upon to evaluate and use research results for
action.

(iii) When one knows how research is done, then one may have the satisfaction of acquiring a new
intellectual tool which can become a way of looking at the world and of judging every day experience.
Accordingly, it enables use to make intelligent decisions concerning problems facing us in practical
life at different points of time. Thus, the knowledge of research methodology provides tools to take at
things in life objectively.

(iv) In this scientific age, all of us are in many ways consumers of research results and we can use them
 intelligently provided we are able to judge the adequacy of the methods by which they have been
obtained. The knowledge of methodology helps the consumer of research results to evaluate them
and enables him to take rational decisions.

RESEARCH PROCESS

Before embarking on the details of research methodology and techniques, it seems appropriate to present a
brief overview of the research process. Research process consists of series of actions or steps necessary to
effectively carry out research and the desired sequencing of these steps. The chart shown in Figure 1.1 well
illustrates a research process.

The research process consists of a number of closely related activities. The following order concerning
various steps provides a useful procedural guideline regarding the research process:
1. Formulating the research problem
2. Extensive literature survey
3. Developing the hypothesis
4. Preparing the research design
5. Determining sample design
6. Collecting the data
7. Execution of the project
8. Analysis of data
9. Hypothesis testing
10. Generalisations and interpretation
11. Preparation of the report or presentation of the results, i.e., formal write-up of conclusions
reached.

A brief description of the above stated steps will be helpful.

1. Formulating the research problem: There are two types of research problems, viz., those which relate
to states of nature and those which relate to relationships between variables. At the very outset the
researcher must single out the problem he wants to study, i.e., he must decide the general area of interest
or aspect of a subject-matter that he would like to inquire into. Initially the problem may be stated in a broad
general way and then the ambiguities, if any, relating to the problem be resolved. Then, the feasibility of a
particular solution has to be considered before a working formulation of the problem can be set up. The
formulation of a general topic into a specific research problem, thus, constitutes the first step in a scientific
enquiry. Essentially two steps are involved in formulating the research problem, viz., understanding the
problem thoroughly, and rephrasing the same into meaningful terms from an analytical point of view.

The best way of understanding the problem is to discuss it with one‟s own colleagues or with those having
some expertise in the matter. In an academic institution the researcher can seek the help from a guide who
is usually an experienced man and has several research problems in mind. Often, the guide puts forth the
problem in general terms and it is up to the researcher to narrow it down and phrase the problem in
operational terms. In private business units or in governmental organisations, the problem is usually
earmarked by the administrative agencies with which the researcher can discuss as to how the problem
originally came about and what considerations are involved in its possible solutions.

The researcher must at the same time examine all available literature to get himself acquainted with the
selected problem. He may review two types of literature—the conceptual literature concerning the concepts
and theories, and the empirical literature consisting of studies made earlier which are similar to the one
proposed. The basic outcome of this review will be the knowledge as to what data and other materials are
available for operational purposes which will enable the researcher to specify his own research problem in a
meaningful context. After this the researcher rephrases the problem into analytical or operational terms i.e.,
to put the problem in as specific terms as possible. This task of formulating, or defining, a research problem
is a step of greatest importance in the entire research process. The problem to be investigated must be
defined unambiguously for that will help discriminating relevant data from irrelevant ones. Care must;
however, be taken to verify the objectivity and validity of the background facts concerning the problem.

The statement of the objective is of basic importance because it determines the data which are to be
collected, the characteristics of the data which are relevant, relations which are to be explored, the choice of
techniques to be used in these explorations and the form of the final report. If there are certain pertinent
terms, the same should be clearly defined along with the task of formulating the problem. In fact, formulation
of the problem often follows a sequential pattern where a number of formulations are set up, each
formulation more specific than the proceeding one, each one phrased in more analytical terms, and each
more realistic in terms of the available data and resources.

RESEARCH PROCESS IN FLOW CHART

1. Define research problem

2. Review Concept & Theory

Review Previous Research Findings

3. Formulation of Hypothesis

4. Design research (including sample design)

5. Collect data (Execution)

6. Analyse data (Test hypotheses

7. Interpret and report

2. Extensive literature survey: Once the problem is formulated, a brief summary of it should be written
down. It is compulsory for a research worker writing a thesis for a Ph.D. degree to write a synopsis of the
topic and submit it to the necessary Committee or the Research Board for approval. At this juncture the
researcher should undertake extensive literature survey connected with the problem. For this purpose, the
abstracting and indexing journals and published or unpublished bibliographies are the first place to go to.
Academic journals, conference proceedings, government reports, books etc., must be tapped depending on
the nature of the problem. In this process, it should be remembered that one source will lead to another. The
earlier studies, if any, which are similar to the study in hand, should be carefully studied. A good library will
be a great help to the researcher at this stage.
3. Development of working hypotheses: After extensive literature survey, researcher should state in clear
terms the working hypothesis or hypotheses. Working hypothesis is tentative assumption made in order to
draw out and test its logical or empirical consequences. As such the manner in which research hypotheses
are developed is particularly important since they provide the focal point for research. They also affect the
manner in which tests must be conducted in the analysis of data and indirectly the quality of data which is
required for the analysis. In most types of research, the development of working hypothesis plays an
important role. Hypothesis should be very specific and limited to the piece of research in hand because it
has to be tested. The role of the hypothesis is to guide the researcher by delimiting the area of research and
to keep him on the right track. It sharpens his thinking and focuses attention on the more important facets of
the problem. It also indicates the type of data required and the type of methods of data analysis to be used.

How does one go about developing working hypotheses? The answer is by using the following approach:

(a) Discussions with colleagues and experts about the problem, its origin and the objectives in seeking
a solution;
(b) Examination of data and records, if available, concerning the problem for possible trends,
peculiarities and other clues;
(c) Review of similar studies in the area or of the studies on similar problems; and
(d) Exploratory personal investigation which involves original field interviews on a limited scale with
interested parties and individuals with a view to secure greater insight into the practical aspects of
the problem.

Thus, working hypotheses arise as a result of a-priori thinking about the subject, examination of the
available data and material including related studies and the counsel of experts and interested parties.
Working hypotheses are more useful when stated in precise and clearly defined terms. It may as well be
remembered that occasionally we may encounter a problem where we do not need working hypotheses,
especially in the case of exploratory or formulative researches which do not aim at testing the hypothesis.
But as a general rule, specification of working hypotheses in another basic step of the research process in
most research problems.

4. Preparing the research design: The research problem having been formulated in clear cut terms, the
researcher will be required to prepare a research design, i.e., he will have to state the conceptual structure
within which research would be conducted. The preparation of such a design facilitates research to be as
efficient as possible yielding maximal information. In other words, the function of research design is to
provide for the collection of relevant evidence with minimal expenditure of effort, time and money. But how
all these can be achieved depends mainly on the research purpose. Research purposes may be grouped
into four categories, viz., (i) Exploration, (ii) Description, (iii) Diagnosis, and (iv) Experimentation. A flexible
research design which provides opportunity for considering many different aspects of a problem is
considered appropriate if the purpose of the research study is that of exploration. But when the purpose
happens to be an accurate description of a situation or of an association between variables, the suitable
design will be one that minimises bias and maximises the reliability of the data collected and analysed.

There are several research designs, such as, experimental and non-experimental hypothesis testing.
Experimental designs can be either informal designs (such as before-and-after without control, after-only
with control, before-and-after with control) or formal designs (such as completely randomized design,
randomized block design, Latin square design, simple and complex factorial designs), out of which the
researcher must select one for his own project.
The preparation of the research design, appropriate for a particular research problem, involves usually the
consideration of the following:

(i) The means of obtaining the information;

(ii) The availability and skills of the researcher and his staff (if any);
(iii) Explanation of the way in which selected means of obtaining information will be organised and the
reasoning leading to the selection;
(iv) The time available for research; and The cost factor relating to research, i.e., the finance available for the
purpose.

5. Determining sample design: Sampling is the process of selecting units (e.g., people, organizations)
from a population of interest so that by studying the sample we may fairly generalize our results back to the
population from which they were chosen.

Population is the set of individuals, items, or data from which a statistical sample is taken it is also called
universe. Sample is representative part of the population which contains each characterizes that entire
population possesses.

Researchers rarely survey the entire population for two reasons. The cost is too high, and the population is
dynamic in that the individuals making up the population may change over time. The three main advantages
of sampling are that the cost is lower, data collection is faster, and since the data set is smaller it is possible
to ensure homogeneity and to improve the accuracy and quality of the data.

All the items under consideration in any field of inquiry constitute a „universe‟ or „population‟. A complete
enumeration of all the items in the „population‟ is known as a census inquiry. It can be presumed that in such
an inquiry when all the items are covered no element of chance is left and highest accuracy is obtained. But
in practice this may not be true. Even the slightest element of bias in such an inquiry will get larger and
larger as the number of observations increases. Moreover, there is no way of checking the element of bias
or its extent except through a resurvey or use of sample checks. Besides, this type of inquiry involves a
great deal of time, money and energy, not only this; census inquiry is not possible in practice under many
circumstances. For instance, blood testing is done only on sample basis. Hence, quite often we select only a
few items from the universe for our study purposes. The items so selected constitute what is technically
called a sample.

The researcher must decide the way of selecting a sample or what is popularly known as the sample
design. In other words, a sample design is a definite plan determined before any data are actually collected
for obtaining a sample from a given population. Thus, the plan to select 12 of a city‟s 200 drugstores in a
certain way constitutes a sample design. Samples can be either probability samples or non-probability
samples. With probability samples each element has a known probability of being included in the sample but
the non-probability samples do not allow the researcher to determine this probability.

Probability samples are those based on simple random sampling, systematic sampling, stratified sampling,
cluster/area sampling whereas non-probability samples are those based on convenience sampling,
judgement sampling and quota sampling techniques.
A brief mention of the important sample designs is as follows:

A. Deliberate sampling/ Purposive sampling: Deliberate sampling is also known as purposive or

non-probability sampling. This sampling method involves purposive or deliberate selection of particular
units of the universe for constituting a sample which represents the universe. When population
elements are selected for inclusion in the sample based on the ease of access, it can be called
convenience sampling. If a researcher wishes to secure data from, say, gasoline buyers, he may select
a fixed number of petrol stations and may conduct interviews at these stations. This would be an
example of convenience sample of gasoline buyers. At times such a procedure may give very biased
results particularly when the population is not homogeneous. On the other hand, in judgement sampling
the researcher‟s judgement is used for selecting items which he considers as representative of the
population. For example, a judgement sample of college students might be taken to secure reactions to
a new method of teaching. Judgement sampling is used quite frequently in qualitative research where
the desire happens to be to develop hypotheses rather than to generalize to larger populations.
B. Simple random sampling: This type of sampling is also known as chance sampling or probability
sampling where each and every item in the population has an equal chance of inclusion in the sample
and each one of the possible samples, in case of finite universe, has the same probability of being
selected. For example, if we have to select a sample of 300 items from a universe of 15,000 items, then
we can put the names or numbers of all the 15,000 items on slips of paper and conduct a lottery. Using
the random number tables is another method of random sampling. To select the sample, each item is
assigned a number from 1 to 15,000. Then, 300 five digits random numbers are selected from the table.
To do this we select some random starting point and then a systematic pattern is used in proceeding
through the table. We might start in the 4th row, second column and proceed down the column to the
bottom of the table and then move to the top of the next column to the right. When a number exceeds
the limit of the numbers in the frame, in our case over 15,000, it is simply passed over and the next
number selected that does fall within the relevant range. Since the numbers were placed in the table in
a completely random fashion, the resulting sample is random. This procedure gives each item an equal
probability of being selected. In case of infinite population, the selection of each item in a random
sample is controlled by the same probability and that successive selections are independent of one
another.
C. Systematic sampling: In some instances the most practical way of sampling is to select every 15th
name on a list, every 10th house on one side of a street and so on. Sampling of this type is known as
systematic sampling. An element of randomness is usually introduced into this kind of sampling by
using random numbers to pick up the unit with which to start. This procedure is useful when sampling
frame is available in the form of a list. In such a design the selection process starts by picking some
random point in the list and then every nth element is selected until the desired number is secured.
D. Stratified sampling: If the population from which a sample is to be drawn does not constitute a
homogeneous group, then stratified sampling technique is applied so as to obtain a representative
sample. In this technique, the population is stratified into a number of non-overlapping subpopulations
or strata and sample items are selected from each stratum. If the items selected from each stratum is
based on simple random sampling the entire procedure, first stratification and then simple random
sampling, is known as stratified random sampling.
E. Quota sampling: In stratified sampling the cost of taking random samples from individual strata is
often so expensive that interviewers are simply given quota to be filled from different strata, the actual
selection of items for sample being left to the interviewer‟s judgement. This is called quota sampling.
The size of the quota for each stratum is generally proportionate to the size of that stratum in the
population. Quota sampling is thus an important form of non-probability sampling. Quota samples
generally happen to be judgement samples rather than random samples.
F. Cluster sampling and area sampling: Cluster sampling involves grouping the population and then
selecting the groups or the clusters rather than individual elements for inclusion in the sample. Suppose
some departmental store wishes to sample its credit card holders. It has issued its cards to 15,000
customers. The sample size is to be kept say 450. For cluster sampling this list of 15,000 card holders
could be formed into 100 clusters of 150 card holders each. Three clusters might then be selected for
the sample randomly. The sample size must often be larger than the simple random sample to ensure
the same level of accuracy because is cluster sampling procedural potential for order bias and other
sources of error are usually accentuated. The clustering approach can, however, make the sampling
procedure relatively easier and increase the efficiency of field work, especially in the case of personal
interviews.
Area sampling is quite close to cluster sampling and is often talked about when the total geographical
area of interest happens to be big one. Under area sampling we first divide the total area into a number
of smaller non-overlapping areas, generally called geographical clusters, then a number of these
smaller areas are randomly selected, and all units in these small areas are included in the sample. Area
sampling is especially helpful where we do not have the list of the population concerned. It also makes
the field interviewing more efficient since interviewer can do many interviews at each location.
G. Multi-stage sampling: This is a further development of the idea of cluster sampling. This technique
is meant for big inquiries extending to a considerably large geographical area like an entire country.
Under multi-stage sampling the first stage may be to select large primary sampling units such as states,
then districts, then towns and finally certain families within towns. If the technique of random-sampling
is applied at all stages, the sampling procedure is described as multi-stage random sampling.
H. Sequential sampling: This is somewhat a complex sample design where the ultimate size of the
sample is not fixed in advance but is determined according to mathematical decisions on the basis of
information yielded as survey progresses. This design is usually adopted under acceptance sampling
plan in the context of statistical quality control.
In practice, several of the methods of sampling described above may well be used in the same study in
which case it can be called mixed sampling. It may be pointed out here that normally one should resort
to random sampling so that bias can be eliminated and sampling error can be estimated. But purposive
sampling is considered desirable when the universe happens to be small and a known characteristic of
it is to be studied intensively. Also, there are conditions under which sample designs other than random
sampling may be considered better for reasons like convenience and low costs.

The sample design to be used must be decided by the researcher taking into consideration the nature
of the inquiry and other related factors.

6. Collecting the data: In dealing with any real life problem it is often found that data at hand are
inadequate, and hence, it becomes necessary to collect data that are appropriate. There are several ways
of collecting the appropriate data which differ considerably in context of money costs, time and other
resources at the disposal of the researcher. Primary data can be collected either through experiment or
through survey. If the researcher conducts an experiment, he observes some quantitative measurements,
or the data, with the help of which he examines the truth contained in his hypothesis. But in the case of a
survey, data can be collected by any one or more of the following ways:

(i) By observation: This method implies the collection of information by way of investigator‟s own
observation, without interviewing the respondents. The information obtained relates to what is
currently happening and is not complicated by either the past behaviour or future intentions or
attitudes of respondents. This method is no doubt an expensive method and the information provided
by this method is also very limited. As such this method is not suitable in inquiries where large
samples are concerned.
 (ii) Through personal interview: The investigator follows a rigid procedure and seeks answers to a
set of pre-conceived questions through personal interviews. This method of collecting data is usually
carried out in a structured way where output depends upon the ability of the interviewer to a large
extent.
(iii) Through telephone interviews: This method of collecting information involves contacting the
respondents on telephone itself. This is not a very widely used method but it plays an important role
in industrial surveys in developed regions, particularly, when the survey has to be accomplished in a
very limited time.
(iv) By mailing of questionnaires: The researcher and the respondents do come in contact with
each other if this method of survey is adopted. Questionnaires are mailed to the respondents with a
request to return after completing the same. It is the most extensively used method in various
economic and business surveys. Before applying this method, usually a Pilot Study for testing the
questionnaire is conduced which reveals the weaknesses, if any, of the questionnaire? Questionnaire
to be used must be prepared very carefully so that it may prove to be effective in collecting the
relevant information.
(v) Through schedules: Under this method the enumerators are appointed and given training. They
are provided with schedules containing relevant questions. These enumerators go to respondents
with these schedules. Data are collected by filling up the schedules by enumerators on the basis of
replies given by respondents. Much depends upon the capability of enumerators so far as this
method is concerned. Some occasional field checks on the work of the enumerators may ensure
sincere work.
The researcher should select one of these methods of collecting the data taking into consideration the
nature of investigation, objective and scope of the inquiry, financial resources, available time and the
desired degree of accuracy. Though he should pay attention to all these factors but much depends upon the
ability and experience of the researcher. In collection of statistical data commonsense is the chief requisite
and experience the chief teacher.

7. Execution of the project: Execution of the project is a very important step in the research process. If the
execution of the project proceeds on correct lines, the data to be collected would be adequate and
dependable. The researcher should see that the project is executed in a systematic manner and in time. If
the survey is to be conducted by means of structured questionnaires, data can be readily machine-
processed. In such a situation, questions as well as the possible answers may be coded. If the data are to
be collected through interviewers, arrangements should be made for proper selection and training of the
interviewers. The training may be given with the help of instruction manuals which explain clearly the job of
the interviewers at each step. Occasional field checks should be made to ensure that the interviewers are
doing their assigned job sincerely and efficiently.

A careful watch should be kept for unanticipated factors in order to keep the survey as much realistic as
possible. This, in other words, means that steps should be taken to ensure that the survey is under
statistical control so that the collected information is in accordance with the pre-defined standard of
accuracy. If some of the respondents do not cooperate, some suitable methods should be designed to
tackle this problem. One method of dealing with the non-response problem is to make a list of the non-
respondents and take a small sub-sample of them, and then with the help of experts vigorous efforts can be
made for securing response.
8. Analysis of data: After the data have been collected, the researcher turns to the task of analysing them.
The analysis of data requires a number of closely related operations such as establishment of categories,
the application of these categories to raw data through coding, tabulation and then drawing statistical
inferences. The unwieldy data should necessarily be condensed into a few manageable groups and tables
for further analysis. Thus, researcher should classify the raw data into some purposeful and usable
categories. Coding operation is usually done at this stage through which the categories of data are
transformed into symbols that may be tabulated and counted. Editing is the procedure that improves the
quality of the data for coding. With coding the stage is ready for tabulation. Tabulation is a part of the
technical procedure wherein the classified data are put in the form of tables. The mechanical devices can be
made use of at this juncture. A great deal of data, especially in large inquiries, is tabulated by computers.
Computers not only save time but also make it possible to study large number of variables affecting a
problem simultaneously.
Analysis work after tabulation is generally based on the computation of various percentages, coefficients,
etc., by applying various well defined statistical formulae. In the process of analysis, relationships or
differences supporting or conflicting with original or new hypotheses should be subjected to tests of
significance to determine with what validity data can be said to indicate any conclusion(s). For instance, if
there are two samples of weekly wages, each sample being drawn from factories in different parts of the
same city, giving two different mean values, then our problem may be whether the two mean values are
significantly different or the difference is just a matter of chance. Through the use of statistical tests we can
establish whether such a difference is a real one or is the result of random fluctuations. If the difference
happens to be real, the inference will be that the two samples come from different universes and if the
difference is due to chance, the conclusion would be that the two samples belong to the same universe.
Similarly, the technique of analysis of variance can help us in analysing whether three or more varieties of
seeds grown on certain fields yield significantly different results or not. In brief, the researcher can analyse
the collected data with the help of various statistical measures.

9. Hypothesis-testing: After analysing the data as stated above, the researcher is in a position to test the
hypotheses, if any, he had formulated earlier. Do the facts support the hypotheses or they happen to be
contrary? This is the usual question which should be answered while testing hypotheses. Various tests,
such as Chi square test, t-test, F-test, have been developed by statisticians for the purpose. The
hypotheses may be tested through the use of one or more of such tests, depending upon the nature and
object of research inquiry. Hypothesis-testing will result in either accepting the hypothesis or in rejecting it. If
the researcher had no hypotheses to start with, generalisations established on the basis of data may be
stated as hypotheses to be tested by subsequent researches in times to come.

10. Generalisations and interpretation: If a hypothesis is tested and upheld several times, it may be
possible for the researcher to arrive at generalisation, i.e., to build a theory. As a matter of fact, the real
value of research lies in its ability to arrive at certain generalisations. If the researcher had no hypothesis to
start with, he might seek to explain his findings on the basis of some theory. It is known as interpretation.
The process of interpretation may quite often trigger off new questions which in turn may lead to further
researches.

11. Preparation of the report or the thesis: Finally, the researcher has to prepare the report of what has
been done by him. Writing of report must be done with great care keeping in view the following:

1. The layout of the report should be as follows: (i) the preliminary pages; (ii) the main text, and (iii) the
end matter.

In its preliminary pages the report should carry title and date followed by acknowledgements and foreword.
Then there should be a table of contents followed by a list of tables and list of graphs and charts, if any,
given in the report.
The main text of the report should have the following parts:

(a) Introduction: It should contain a clear statement of the objective of the research and an
explanation of the methodology adopted in accomplishing the research. The scope of the study
along with various limitations should as well be stated in this part.
(b) Summary of findings: After introduction there would appear a statement of findings and
recommendations in non-technical language. If the findings are extensive, they should be
summarized.
(c) Main report: The main body of the report should be presented in logical sequence and broken-
down into readily identifiable sections.
(d) Conclusion: Towards the end of the main text, researcher should again put down the results of his
research clearly and precisely. In fact, it is the final summing up.
(e) At the end of the report, appendices should be enlisted in respect of all technical data.
Bibliography, i.e., list of books, journals, reports, etc., consulted, should also be given in the end.
Index should also be given specially in a published research report.

2. Report should be written in a concise and objective style in simple language avoiding vague expressions
such as „it seems,‟ „there may be‟, and the like.

3. Charts and illustrations in the main report should be used only if they present the information more clearly
and forcibly.

4. Calculated „confidence limits‟ must be mentioned and the various constraints experienced in conducting
research operations may as well be stated.

Criteria of Good Research

Whatever may be the types of research works and studies, one thing that is important is that they all meet
on the common ground of scientific method employed by them. One expects scientific research to satisfy
the following criteria:

1. The purpose of the research should be clearly defined and common concepts be used.
2. The research procedure used should be described in sufficient detail to permit another researcher
to repeat the research for further advancement, keeping the continuity of what has already been
attained.
3. The procedural design of the research should be carefully planned to yield results that are as
objective as possible.
4. The researcher should report with complete frankness, flaws in procedural design and estimate
their effects upon the findings.
5. The analysis of data should be sufficiently adequate to reveal its significance and the methods of
analysis used should be appropriate. The validity and reliability of the data should be checked
carefully.
6. Conclusions should be confined to those justified by the data of the research and limited to those
for which the data provide an adequate basis.
7. Greater confidence in research is warranted if the researcher is experienced, has a good
reputation in research and is a person of integrity.
In other words, we can state the qualities of a good research as under:

1. Good research is systematic: It means that research is structured with specified steps to be
taken in a specified sequence in accordance with the well defined set of rules. Systematic
characteristic of the research does not rule out creative thinking but it certainly does reject the use
of guessing and intuition in arriving at conclusions.
2. Good research is logical: This implies that research is guided by the rules of logical reasoning
and the logical process of induction and deduction are of great value in carrying out research.
Induction is the process of reasoning from a part to the whole whereas deduction is the process of
reasoning from some premise to a conclusion which follows from that very premise. In fact, logical
reasoning makes research more meaningful in the context of decision making.
Problems Encountered by Researchers in India

Researchers in India, particularly those engaged in empirical research, are facing several problems. Some
of the important problems are as follows:

1. The lack of a scientific training in the methodology of research is a great impediment for
researchers in our country. There is paucity of competent researchers. Many researchers take a
leap in the dark without knowing research methods. Most of the work, which goes in the name of
research, is not methodologically sound. Research for many researchers and even to their guides,
is mostly a scissor and paste job without any insight shed on the collated materials. The
consequence is obvious, viz., the research results, quite often, do not reflect the reality or realities.
Thus, a systematic study of research methodology is an urgent necessity. Before undertaking
research projects, researchers should be well equipped with all the methodological aspects. As
such, efforts should be made to provide short duration intensive courses for meeting this
requirement.
2. There is insufficient interaction between the university research departments on one side and
business establishments, government departments and research institutions on the other side. A
great deal of primary data of non-confidential nature remains untouched / untreated by the
researchers for want of proper contacts. Efforts should be made to develop satisfactory liaison
among all concerned for better and realistic researches. There is need for developing some
mechanisms of a university—industry interaction programme so that academics can get ideas from
practitioners on what needs to be researched and practitioners can apply the research done by the
academics.
3. Most of the business units in our country do not have the confidence that the material supplied by
them to researchers will not be misused and as such they are often reluctant in supplying the
needed information to researchers. The concept of secrecy seems to be sacrosanct to business
organisations in the country so much so that it proves an impermeable barrier to researchers.
Thus, there is the need for generating the confidence that the information/data obtained from a
business unit will not be misused.
4. Research studies overlapping one another are undertaken quite often for want of adequate
information. This results in duplication and fritters away resources. This problem can be solved by
proper compilation and revision, at regular intervals, of a list of subjects on which and the places
where the research is going on. Due attention should be given toward identification of research
problems in various disciplines of applied science which are of immediate concern to the industries.
5. There is no existence of a code of conduct for researchers and inter-university and
interdepartmental rivalries are also quite common. Hence, there is need for developing a code of
conduct for researchers which, if adhered sincerely, can win over this problem.
6. Many researchers in our country also face the difficulty of adequate and timely secretarial
assistance, including computer assistance. This causes unnecessary delays in the completion of
research studies. All possible efforts be made in this direction so that efficient secretarial
assistance is made available to researchers and that too well in time. University Grants
Commission must play a dynamic role in solving this difficulty.
 7. Library management and functioning is not satisfactory at many places and much of the time and
energy of researchers are spent in tracing out the books, journals, reports, etc., rather than in
tracing out relevant material from them.
8. There is also the problem that many of our libraries are not able to get copies of old and new
Acts/Rules, reports and other government publications in time. This problem is felt more in libraries
which are away in places from Delhi and/or the state capitals. Thus, efforts should be made for the
regular and speedy supply of all governmental publications to reach our libraries.
9. There is also the difficulty of timely availability of published data from various government and
other agencies doing this job in our country. Researcher also faces the problem on account of the
fact that the published data vary quite significantly because of differences in coverage by the
concerning agencies.
10. There may, at times, take place the problem of conceptualization and also problems relating to the
process of data collection and related things.

RESEARCH ETHICS

Objectives in research ethics

1. The first and broadest objective is to protect human participants.
2. The second objective is to ensure that research is conducted in a way that serves interests of
individuals, groups and/or society as a whole.
3. Finally, the third objective is to examine specific research activities and projects for their ethical
soundness, looking at issues such as the management of risk, protection of confidentiality and the
process of informed consent.

Introduction: Research ethics involves the application of fundamental ethical principles to a variety of
topics involving scientific research.

The application of fundamental ethical principles to a topics like

1. The design and implementation of research involving human experimentation, animal

experimentation
2. Various aspects of academic scandal, including scientific misconducts (such as fraud, fabrication of
data and plagiarism),
3. Whistle blowing (wrongdoing within an organization to the public or to those in positions of
authority); regulation of research, etc. Research ethics is most developed as a concept in all the
scientific research.
4. Research in the social sciences presents a different set of issues than those in medical research.

The scientific research enterprise is built on a foundation of trust. Scientists trust that the results reported by
others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe
the world accurately and without bias. But this trust will endure only if the scientific community devotes itself
to exemplifying and transmitting the values associated with ethical scientific conduct.

There are many ethical issues to be taken into serious consideration for research. Sociologists need to be
aware of having the responsibility to secure the actual permission and interests of all those involved in the
study. They should not misuse any of the information discovered, and there should be a certain moral
responsibility maintained towards the participants. There is a duty to protect the rights of people in the study
as well as their privacy and sensitivity. The confidentiality of those involved in the observation must be
carried out, keeping their anonymity and privacy secure. As pointed out in the BSA for Sociology, all of
these ethics must be honoured unless there are other overriding reasons to do so - for example, any illegal
or terrorist activity.
Most people learn ethical norms at home, at school, in temple, in church or in other social settings. Although
most people acquire their sense of right and wrong during childhood, moral development occurs throughout
life and human beings pass through different stages of growth as they mature. Ethical norms are so
everywhere that one might be tempted to regard them as simple commonsense. On the other hand, if
morality were nothing more than commonsense, then why are there so many ethical disputes and issues in
our society?
One reasonable explanation of these disagreements is that all people recognize some common ethical
norms but different individuals interpret, apply, and balance these norms in different ways in light of their
own values and life experiences.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more
informal than laws. Although most societies use laws to enforce widely accepted moral standards and
ethical and legal rules use similar concepts, it is important to remember that ethics and law are not the
same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and
principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers
urged citizens to disobey laws in order to protest what they regarded as immoral or unjust laws. Peaceful
civil disobedience is an ethical way of expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as
philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who
studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective
for deciding how to act and for analyzing complex problems and issues. For instance, in considering a
complex issue like global warming, one may take an economic, ecological, political, or ethical perspective
on the problem. While an economist might examine the cost and benefits of various policies related to global
warming, an environmental ethicist could examine the ethical values and principles at stake.

Many different disciplines, institutions, and professions have norms for behavior that suit their particular
aims and goals. These norms also help members of the discipline to coordinate their actions or activities
and to establish the public's trust of the discipline. For instance, ethical norms govern conduct in medicine,
law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people
who conduct scientific research or other scholarly or creative activities. There is even a specialized
discipline, research ethics, which studies these norms.

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote
the aims of research, such as knowledge, truth, and avoidance of error. For example, prohibitions against
fabricating, falsifying, or misrepresenting research data promote the truth and avoid error. Second, since
research often involves a great deal of cooperation and coordination among many different people in
different disciplines and institutions, ethical standards promote the values that are essential to
collaborative work, such as trust, accountability, mutual respect, and fairness. For example, many ethical
norms in research, such as guidelines for authorship, copyright and patenting policies, data sharing policies,
and confidentiality rules in peer review, are designed to protect intellectual property interests while
encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to
have their ideas stolen or disclosed prematurely. Third, many of the ethical norms help to ensure that
researchers can be held accountable to the public. For instance, federal policies on research misconduct,
conflicts of interest, the human subject protections, and animal care and use are necessary in order to make
sure that researchers who are funded by public money can be held accountable to the public. Fourth, ethical
norms in research also help to build public support for research. It is seen that people more likely to fund
research project if they can trust the quality and integrity of research. Finally, many of the norms of research
promote a variety of other important moral and social values, such as social responsibility, human rights,
and animal welfare, compliance with the law, and health and safety. Ethical lapses in research can
significantly harm human and animal subjects, students, and the public. For example, a researcher who
fabricates data in a clinical trial may harm or even kill patients and a researcher who fails to abide by
regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or
the health and safety of staff and students.
CODES AND POLICIES FOR RESEARCH ETHICS

Given the importance of ethics for the conduct of research, it should come as no surprise that many different
professional associations, government agencies, and universities have adopted specific codes, rules, and
policies relating to research ethics. Many government agencies, such as the National Institutes of Health
(NIH), the National Science Foundation (NSF), the Food and Drug Administration (FDA), the Environmental
Protection Agency (EPA), and the Department of Agriculture (USDA) have ethics rules for funded
researchers. Other influential research ethics policies include the Uniform Requirements for Manuscripts
Submitted to Biomedical Journals (International Committee of Medical Journal Editors), the Chemist's Code
of Conduct (American Chemical Society), Code of Ethics (American Society for Clinical Laboratory Science)
Ethical Principles of Psychologists (American Psychological Association), Statements on Ethics and
Professional Responsibility (American Anthropological Association), Statement on Professional Ethics
(American Association of University Professors), the Nuremberg Code and the Declaration of Helsinki
(World Medical Association).

The following is a rough and general summary of some ethical principals that various codes address*:

1. Honesty: Strive for honesty in all scientific communications. Honestly report data, results, methods and
procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive
colleagues, granting agencies, or the public.
2. Objectivity: Strive to avoid bias in experimental design, data analysis, data interpretation, peer review,
personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is
expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests
that may affect research.
3. Integrity: Keep your promises and agreements; act with sincerity; strive for consistency of thought and
action.
4. Carefulness: Avoid careless errors and negligence; carefully and critically examine your own work and
the work of your peers. Keep good records of research activities, such as data collection, research
design, and correspondence with agencies or journals.
5. Openness: Share data, results, ideas, tools, resources. Be open to criticism and new ideas.
6. Respect for Intellectual Property: Honor patents, copyrights, and other forms of intellectual property.
Do not use unpublished data, methods, or results without permission. Give credit where credit is due.
Give proper acknowledgement or credit for all contributions to research. Never plagiarize.
7. Confidentiality: Protect confidential communications, such as papers or grants submitted for
publication, personnel records, trade or military secrets, and patient records.
8. Responsible Publication: Publish in order to advance research and scholarship, not to advance just
your own career. Avoid wasteful and duplicative publication.
9. Responsible Mentoring: Help to educate, mentor, and advise students. Promote their welfare and
allow them to make their own decisions.
10. Respect for colleagues: Respect your colleagues and treat them fairly.
11. Social Responsibility: Strive to promote social good and prevent or mitigate social harms through
research, public education, and advocacy.
12. Non-Discrimination: Avoid discrimination against colleagues or students on the basis of sex, race,
ethnicity, or other factors that are not related to their scientific competence and integrity.
13. Competence: Maintain and improve your own professional competence and expertise through lifelong
education and learning; take steps to promote competence in science as a whole.
14. Legality: Know and obey relevant laws and institutional and governmental policies.
15. Animal Care: Show proper respect and care for animals when using them in research. Do not conduct
unnecessary or poorly designed animal experiments.
16. Human Subjects Protection: When conducting research on human subjects minimize harms and risks
and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with
vulnerable populations; and strive to distribute the benefits and burdens of research fairly.
17. There are many other activities that do not define as "misconduct" but which are still regarded by most
researchers as unethical. These are called "other deviations" from acceptable research practices and
include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the
sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did
not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference
without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in
the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make
a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care
and Use Committee or Institutional Review Board for Human Subjects Research without telling the
committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Rejecting a manuscript for publication without even reading it
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic
benefits

These actions would be regarded as unethical by most scientists and some might even be illegal. Most of
these would also violate different professional ethics codes or institutional policies.
Promoting Ethical Conduct in Science

Many of you may be wondering why you are required to have training in research ethics. You may believe
that you are highly ethical and know the difference between right and wrong. You would never fabricate or
falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and
that there is no ethics problem in research.

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the best evidence we have
shows that misconduct is a very rare occurrence in research, although there is considerable variation
among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers
per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of
researchers per year (based on self-reports of misconduct on anonymous surveys).

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has
become ethically corrupt. However, even if misconduct is rare, it can have a tremendous impact on
research. Consider an analogy with crime: it does not take many murders or rapes in a town to erode the
community's sense of trust and increase the community's fear and paranoia. The same is true with the most
serious crimes in science, i.e. fabrication, falsification, and plagiarism. However, most of the crimes
committed in science probably are not tantamount to murder or rape, but ethically significant misdeeds that
are classified by the government as 'deviations.' Moreover, there are many situations in research that pose
genuine ethical dilemmas.

Will training and education in research ethics help reduce the rate of misconduct in science? It is too early to
tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There
are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most
scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or
psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because
science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat
the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.
According to the "stressful" or "imperfect" environment theory, misconduct occurs because various
institutional pressures, incentives, and constraints encourage people to commit misconduct, such as
pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor
supervision of students and trainees, and poor oversight of researchers. Moreover, defenders of the
stressful environment theory point out that science's peer review system is far from perfect and that it is
relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without
being detected for years. To the extent that research environment is an important factor in misconduct, a
course in research ethics is likely to help people get a better understanding of these stresses, sensitize
people to ethical concerns, and improve ethical judgment and decision making.

Misconduct probably results from environmental and individual causes, i.e. when people who are morally
weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in
research ethics is useful in helping to prevent deviations from norms even if it does not prevent misconduct.
Many of the deviations that occur in research may occur because researchers simple do not know or have
never thought seriously about some of the ethical norms of research. For example, some unethical
authorships practices probably reflect years of tradition in the research community that has not been
questioned seriously until recently. If the director of a lab is named as an author on every paper that comes
from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just
the way it's done, one might argue. If a drug company uses ghostwriters to write papers "authored" by its
physician-employees, what's wrong about this practice? Ghost writers help write all sorts of books these
days, so what's wrong with using ghostwriters in research?
Another example where there may be some ignorance or mistaken traditions is conflicts of interest in
research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting
stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues.
Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from
a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300
finder‟s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically
on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by
improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, training in research ethics should be able to help researchers grapple with ethical dilemmas by
introducing researchers to important concepts, tools, principles, and methods that can be useful in resolving
these dilemmas. In fact, the issues have become so important that the NIH and NSF have mandated
training in research ethics for graduate students

ANIMAL USED IN RESEARCH

Animals play a significant role in research. They are used in a variety of ways by researchers, such as for
testing new pharmaceuticals, as teaching tools for medical students and as experimental subjects for new
surgical procedures. Research with animals is necessary and vital to biomedical research because animal
research is frequently a necessary first step towards research involving new medical treatments and
pharmaceuticals intended for human use.

Many dedicated organizations and individuals are interested in protecting and safeguarding animal subjects
as regards their use in research. Some organizations are interested in eliminating the use of animals in
research. Others consider research with animals a necessary evil to the advancement of medicine, but still
aim to eliminate unnecessary suffering, pain and poor facility conditions for animal subjects.

To protect animals, research projects that use animals have to be reviewed. These review processes
assess the risks and benefits of using animals in research. This can prove difficult for project reviewers and
often makes for intense debates and arguments about the appropriate use of animal subjects, particularly
because the animal subjects usually bear all the risks while human beings realize all the benefits. Debates
also center on judging how much pain is too much, whether or not animals experience pain in the same way
that humans do and whether or not these ideas should even factor into the debate at all.

To assure that research with animals is conducted ethically and responsibly, the government has created
regulations involving the use and care of animals involved in teaching, testing, and research.

Animals are used for many purposes within schools, universities and research establishments. Others are
studied within their natural habitats. The purposes for which they are used and the impact on these animals
themselves varies considerably. In all cases, it is essential that the individual animal is treated in humane
and considerate manner.

Regulation and Controls

Research and teaching using animals may only be performed when they are essential:

• To obtain and establish significant information relevant to the understanding of humans and/or animals;
• For the maintenance and improvement of human and/or animal health and welfare;
• For the improvement of animal management or production;
• To obtain and establish significant information relevant to the understanding, maintenance or
improvement of the natural environment; or
• For the achievement of educational objectives.

Projects using animals may only be performed after a decision has been made that they are justified,
weighing the predicted scientific or educational value of the research against the potential effects on the
welfare of the animals.

Investigators and teachers must submit a written proposal to an Animal Ethics Committee for all animal
projects which must take into account the expected value of the knowledge to be gained, the justification for
the project and all ethical and animal welfare aspects taking into account the 3RS - Replacement, Reduction
and Refinement as outlined in the Australian Code of Practice for the Care and Use of Animals for Scientific
Purposes.

In South Australia compliance with the Australian Code of Practice for the Care and Use of Animals for
Scientific Purposes (the Code) is mandatory and a legal requirement. Breaches of the Code can incur
penalties under the Animal Welfare Act 1985. The purpose of the Code is to ensure the ethical and humane
care and use of animals in research and teaching. The principles set out in the Code are for guidance of
investigators, teachers, institutions, Animal Ethics Committees (AECs) and all people involved in the care
and use of animals for scientific purposes.

The Code emphasizes the responsibilities of investigators, teachers and institutions using animals to ensure
that the use of animals is justified, that the welfare of the animals is always considered, to promote the
development of techniques that replace the use of animals, to minimise the numbers of animals used and to
refine procedures to avoid pain or distress in animals.

The 3 Rs: Replacement, Reduction and Refinement

Encapsulated in the code of practice for the care and use of animals for scientific purposes is the
requirement for scientific and teaching activities to consider the 3Rs.

1. Replacement: Techniques that totally or partially replace the use of animals for scientific purposes must
be sought and used wherever possible.
2. Reduction: Each project must use no more than the minimum number of animals necessary to ensure
scientific and statistical validity. The principle of reducing the number of animals used should not be
implemented at the expense of greater suffering of individual animals. Scientific and teaching activities
involving the use of animals must not be repeated unless essential for the purpose or design of the project.
Teaching activities must involve no more than the minimum number of animals required to reach the
educational objectives. Overproduction of animals bred for scientific purposes should be avoided so that the
need to kill healthy animals is minimized.
3. Refinement: Animals must be suitable for the scientific purpose taking into account their biological
characteristics including behaviour, genetic attributes and nutritional, microbiological and general health
status. The design and management of animal accommodation should meet with species-specific needs.
Special consideration is required where this is precluded by the requirements of the project. Animals should
be transported, housed, fed, watered, handled and used under conditions that meet species-specific needs

The welfare of the animals must be a primary consideration in the provision of care, which should be based
on behavioural and biological needs. Wildlife should not be taken from natural habitats unless animals bred
in captivity are not available or are not suitable for the specific scientific purpose. Investigators and teachers
who use animals for scientific purposes must employ the best available scientific and educational
techniques and be competent in the procedures they perform or must be under the direct supervision of a
person competent in the procedure.

Projects should be designed to avoid both pain and distress in animals. If this is not possible, pain or
distress must be minimized. Pain and distress cannot be evaluated easily in animals and therefore
investigators and teachers must assume that animals experience these in a manner similar to humans
unless there is evidence to the contrary. Decisions regarding the animals' welfare must be based on this
assumption. An animal with signs of pain or distress not predicted in the proposal must have the pain or
distress alleviated promptly. Alleviation of such pain or distress must take precedence over completing the
project. If this is not possible the animal must be euthanized without delay.

Scientific and teaching activities that may cause pain or distress of a kind or degree for which anesthesia
would normally be used in medical or veterinary practice must be carried out using anesthesia appropriate
to the species and the procedure. Pain management appropriate to the species, the procedure and the
circumstances must be provided. The use of local or general anesthetic, analgesic or tranquilizing agents
must be appropriate to the species, and should at least parallel their use in current medical or veterinary
practice. Where it is established that the purpose of the project precludes the use of anesthetic or analgesic
agents to alleviate pain, the planned endpoint of the project must be as early as feasible to avoid or
minimise pain or distress in the animals. Neuromuscular blocking agents must not be used without
appropriate general anesthesia, except in animals where sensory awareness has been eliminated. If such
agents are used, continuous or frequent monitoring of paralyzed animals is essential to ensure that the
depth of anesthesia is adequate to prevent pain or distress. Death as an end point must be avoided
wherever possible. Scientific and teaching activities involving the use of animals must be of minimum
duration compatible with the objectives of the project.

ETHICAL ISSUES IN AGRICULTURAL RESEARCH

1. Sustainability: The ethical dilemmas arise when short term problems are preferred over long term
ones. Institutional capacities to address long term problems require different kinds of reinforcement
than otherwise. Ethical dilemma also arises when certain sectors, segments, social classes and
seasons are preferred over others while choosing problems, or locating them, solving them or diffusing
the solutions obtained. Inter species and inter sectoral concerns also influence the sustainability of the
outcomes. Not all local practices need to be sustained. Sustainability is as much about continuity as
about discontinuity (that is innovations or fundamental change in values).
2. Eco system health: When scientists know about the concomitants of the eco system health and yet
develop technologies which impair the health, they are not only making a trade off but also passing a
value judgment. Transferring costs of near term trade offs over the longer term stakeholders may
neither be ethical nor economically very judicious. Eco system health is also affected when long term
consequences of certain chemical inputs are known or anticipatable, and yet these are continued to be
used. Judgments are involved when chemicals banned in western countries are allowed to be used in
developing countries, when the precautionary principle is applied or not applied, and while technologies
are transferred to countries which may or may not have capacity to assess the consequences.
3. Responsiveness: In any context, not everybody‟s problem is equally important. Michael Lipton once
drew attention to the biases that existed in favour of interesting pests‟ vis-à-vis the relevant ones. When
certain problems remain unsolved or unaddressed for centuries, surely it says something about the
dominant ethics in the society which does not generate a dilemma or a discomfort despite sustained
inertia and indifference. A good example is the cooking stove used by millions of women or carrying
water pots on the head for long distance, transporting grass or twigs on head on the hill slopes by
women or transplanting paddy by keeping feet under water and thus getting fungal infections, etc.
4. Accountability: Researchers seldom share their findings with the people from whom they collect the
data. Not only that. They often do not even calibrate their criteria of relevant or not so relevant
research by involving the users of research in calibration. Ethical dilemma also arise when a large multi
national corporations inform the consumers of its chemical inputs about a desirable resource use
practice in west but which they do not share in the developing countries. The community of
corporations has to evolve its own code of conduct censoring such behaviour.
5. Capacity building: Any society which has to grapple with risk and uncertainty inherent in agricultural
resource management has to learn to create capacity not only to anticipate but also address the future
problems. The education and training of young minds thus becomes a very important determinant of the
capacity to face emerging challenges in future. When the education system does or does not include
content or pedagogical means which make a potential leader aware of the challenges, an ethical
judgment has been made. When certain crops and/or other agricultural products are deliberately
portrayed as inferior in the educational curriculum, on cultural grounds rather on nutritional or other
scientific grounds, values have already been expressed. Lack of periodic review of the skills that are
being developed to address such concerns about externality, diversity, inter sectoral linkages, etc.,
invariably involve making trade offs about what should be told and what should young people learn on
their own.
6. Location specificity: It is well known that agro ecological environment in rainfed regions is much more
heterogeneous. Developing technologies which would diffuse only in a small region poses an
institutional challenge apart from technological challenge. Organization incentives are often provided,
commensurate with the diffusion or potential reach of a solution. If a technology is addressing problems
of small community, it may not invoke a significant encouragement or incentive. Consequently, either
such problems don‟t get addressed or the people who address such problems become marginalized. In
either case ethical judgments have to be made by the decision makers. When research infrastructure,
allocation of human resources and priority in research are biased in favour of better endowed regions
and communities, the ethics of neglecting the bypassed communities and regions has to be made
explicit. When hand tools receive less attention than energy intensive technologies, judgments have
been made.
7. Asymmetry in rights of and responsibilities towards knowledge holders: No agricultural research
council in developed or developing countries ever requires the asymmetry between rights and
responsibilities towards the knowledge holders of informal sectors be deliberately overcome. The
respondents in research with communities are not acknowledged, do not receive the findings of the
research for which they provide data and do not receive any share in the benefits that are generated
from the application or commercialization of the knowledge provided by the respondents/knowledge
providers.
8. Empowerment of informal innovators and knowledge holders: It is obvious that creativity exists in
formal as well as informal sectors. Just as the scientists can generate a creative and innovative
solution to a problem, a farmer or an artisan can too1. The global bias against innovations in informal
sector is very obvious. Inability of formal research system to listen to and learn from informal
innovators not only deprives the organized sector of agricultural research and technology of the insights
from the margin but also prevents it from being inspired by the values of many of the grassroots
innovators.

The ethical trade offs in such matters invariably affect the efficiency, equity, excellence and environmental
consequences of resource and institutional management.