Research
Research
Research
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Out lines
1- Introduction to ethics in research
Ethics
Ethics: principles for guiding decision making
and reconciling conflicting values
• eople
Peopley may disagree
ee on ‘ oncs’ ethics
usebecause
it is it –is
on people's
based on people personalnal alue
value systems
t one n s to be d or –
• What one person consider to be good or right-
maybe considered bad or wrong by another
person
Human Research Ethics
The basics
What is human research?
Human research is:
1-research conducted with people
2-research conducted about people
3. research dealing in their data or .1
tissue
Three types of human research
1. Analysis of Existing Data of Specimens
or Secondary analysis is a form of research that uses existing
data, or secondary data, collected previously to perform a new
study. Researchers might use quantitative or qualitative data
another research team or agency gathered or .1produced for different
reasons and analyze it in a new way.
2. Observational Studies.
In an observational study, the investigator simply records
observations and analyzes data, without assigning participants to a
specific intervention or treatment. These studies may focus on
observation of risk factors, natural history, variations in disease
progression or disease treatment without delivering or assigning an
intervention.
Three types of human research
3. Interventional Studies.
are clinical studies in which participants
are prospectively assigned to groups (e.g.,
experimental and control arms) to receive an
intervention(s) or a placebo/no interventions
.1 so that
researchers can evaluate the effects of the
interventions on biomedical or health-related
outcomes.
Why is Research Ethics Important?
- It is a reflection of respect for those who ‘take
part’ in research
- It ensures no unreasonable, unsafe or
thoughtless demands are made by
researchers
- It ensures sufficient knowledge is shared by all
concerned
- It imposes a common standard in all the above
respects
Why is Research Ethics Important
*It has become the norm as an expectation for
research activity
*…. a professional requirement for practitioners
in some disciplines e.g. psychology
*… a requirement for access to participants in
others e.g. health
*… and a requirement to comply with external
REF’s to obtain funding e.g. ESRC
Ethical Principles Guiding Research
Distributive justice
Harms and benefits –
7. Non-malfeasance
Duty to avoid, prevent or minimize harm
No unnecessary risk of harm
Participation must be essential to achieving
scientifically and societally important aims
that cannot be realized without the
participation of human subjects
Minimizing harm requires smallest number of
human subjects that will ensure valid data
8. Beneficence
-The duty to benefit others
-The duty to maximize net benefits
-Produce benefits for subjects themselves, other
individuals
-Produce benefits for society as a whole and for
the advancement of knowledge (usually the
primary benefit)
ETHICAL PRINCIPLES ACORDING TOBelmont
Report
The Belmont Report identified three principles
essential to the ethical conduct of research
with humans:
*Harm
*Informed Consent
*Confidentiality
*Deception
*Reporting Results and Plagiarism
Harm
-As mentioned before, researchers should
take every precaution to ensure that
participants are not subjected to undue harm
or stress
-Harm and discomfort can take many forms
;can be physical[eg, injury], emotional[ eg
,stress]social[eg,loss of social port]or
financial[eg, loss of wages]. Ethical
-researchers must use strategies to minimize
all types of harm and discomfort, even ones
that are temporary
Informed Consent
-Voluntary Informed Consent is essential for research
involving human subjects
-According to the APA, Informed Consent should include:
*Description of the nature of the research
*Statement that the research is voluntary and
participants can withdraw at any time
*Identification of Risks and Benefits
*Description of how confidentiality will be protected
*Description of compensation
*Description of what info researchers will share with
participants
*Identification of who is responsible for research with
contact information
Confidentiality
*All information collected in a research
project should remain confidential
-Participants should be assigned a HIPAA
compliant code
-Data should be locked away in a secure setting
-Electronic Databases should also be protected
What do you do if you bump into a
research participant in Wal-Mart?
Plagiarism
*Comes from the Latin word meaning “to
kidnap”
*Examples of plagiarism:
-Copying someone else’s words without proper
citation
-Stealing someone else’s ideas
-Stealing someone else’s intellectual property
Bottom Line: Cite sources properly and
minimize quotations in research reports
Treatment of Vulnerable groups
Beecher, H.K. 1966. “Ethics and Clinical Research.” New England Journal of Medicine 274(24):1354– •
1360.
Faden, R.R., and T.L. Beauchamp. 1986. A History and Theory of Informed Consent. New York: Oxford •
University Press.
Institute of Medicine (IOM). 2001. Preserving Public Trust: Accreditation and Human Research •
Participant Protection Programs.
Jonas, H. 1969. “Philosophical Reflections on Experimenting with Human Subjects.” Daedalus 98:219– •
247.
Katz, J. 1972. Experimentation with Human Beings. New York: Russell Sage Foundation. •
National Bioethics Advisory Commission (NBAC). 1997. Cloning Human Beings. 2 vols. Rockville, MD: U.S. Government •
Printing Office.
———. 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. 2 vols. •
Rockville, MD: U.S. Government Printing Office.
———. 1999a. Ethical Issues in Human Stem Cell Research. 3 vols. Rockville, MD: U.S. Government Printing Office. •
———. 1999b. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2 vols. Rockville, MD: •
U.S. Government Printing Office.
———. 2001. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2 vols. Bethesda, •
MD: U.S. Government Printing Office.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National •
Commission). 1979.
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: •
U.S. Government Printing Office.
Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973. Final Report. Washington, D.C.: U.S. Department of Health, •
Education, and Welfare.
19 •
Thank You
RESEARCH PROBLEM
THE PROBLEM
STATEMENT
Presented By:
Dr.Deepthi Athuluru
Dept. of Public Health Dentistry
DATA
• A dictionary defines data as facts or figures
from which conclusions may be drawn.
informati
Data on Information
• Direct Observation
• Experiments, and
• Surveys.
Methods
Mailing paper questionnaires to respondents,
who fill them out and mail them back
Having interviewers call to respondents on the
telephon and ask them the question in a
e interview
• telephone the interviewers to the
Sending
respondent’s home or office to administer
the questions in face-to-face
interviews
Depending upon the nature of the
variable data is classified into 2
broad categories
• Qualitative Data
• Quantitative Data:-
1. discrete
2. continuous
• Qualitative data :-
(characterized by words)
• Discrete data :-
when the variable under observation
takes only fixed values like whole numbers.
• Continuous data :-
if the variable can take any value in a
given range, decimal or fractional.
Quantitative: numbers breadth generalizability
Qualitative: words depth specific
• Questioning
Data domains
Cognitive -- paper and pencil
Affective -- interview
Psychomotor -- observation
Data Presentation
1970 5015
1975 5293
1980 5484
1985 7284
1990 18,981
• Classification by Space :-
Number of Literates in Rural and Urban Areas in India (state wise list).
1970 5015
1975 5293
1980 5484
1985 7284
1990 18,981
• Classification by attribute :-
1) When the data represent observations made
on a qualitative characteristic the classification in
such a case is made according to this qualities.
Tuberculoid 604
Lepromatous 272
Indeterminate 72
Borderline 48
TOTAL 996
Classification by the size of observations :-
1. when the data represent observations of
some characteristic on a numerical scale,
classification is made on the basis of the individual
observations.
1. Histogram
2. Frequency polygon
3. Frequency curve
4. Line graph
5. Scatter or dot diagram
Presentation of qualitative data is
through diagrams, the common
diagrams in use are:-
1. Bar diagram
2. Pie/sector diagram
3. Pictogram or picture diagram
4. Map diagram or spot map
Line diagram:
• This diagram is useful to study changes of
values in the variable overtime.
• Simplest type of diagram.
• On the X axis the time such as hours, days,
weeks, months or years are represented.
• The value of any quantity pertaining to this is
represented along the Y axis.
OP
500
450
467
400 380 400 402
367 38 0
350 346 354
NO OF OUT-PATIENT
Nov-06
Feb-06
May-06
Aug-06
Dec-06
Apr-06
Jan-06
Mar-06
Jun-06
Sep-06
Oct-06
Jul-06
Frequency polygon:
500 467 OP
Oct-06
Nov-06
Jan-06
Feb-06
Jun-06
Jul-06
Aug-06
Dec-06
Apr-06
May-06
Sep-06
Mar-06
• Multiple bar:
1. This diagram is used to compare qualitative data with
respect to a single variable.
2. This diagram is similar to the bar diagram except that
for each category of the variable we have a set of bars of
the same width corresponding to the different section
without any gap in between the width and the length
corresponds to the frequency.
OP
467
IP
500
450
400
402
380
380
367
400
354
346
350
300
NO OF PATIENT
289
265
300
250
250
154
200
120
150 102
90
86
78
100
70
67
60
59
48
45
50
0
Nov-06
May-06
Aug-06
Feb-06
Apr-06
Dec-06
Mar-06
Jun-06
Sep-06
Jan-06
Oct-06
Jul-06
Component bar diagram:
• This diagram is used to represent qualitative
data.
• It is desired to represent both the no of cases in
major groups as well as the subgroups
simultaneously
Histogram:
this diagram is used to
depict quantitative
data
1. It is a bar diagram
without gap between
bars.
2. If we draw frequencies
of each group or class
intervals in the form of
columns or rectangles
such a diagram is called
histogram.
3. It represents a frequency
distribution.
The histogram is constructed as follows:
1. On the X axis the size of the observation is marked.
2. Starting from 0 the limit of each class interval is
marked, the width corresponding to the width of the
class interval in the frequency distribution.
3. On the Y axis the frequencies are marked
4. A rectangle is drawn above each class interval with
height proportional to the frequency of that
interval.
Advantages of Histogram:
Easy to understand
Disadvantages of Histogram: