Module 1: Introduction: What is Research?

Learning Objectives
By the end of this module, you will be able to:

 Explain how the scientific method is used to develop new knowledge

 Describe why it is important to follow a research plan

Research is a process to discover new knowledge. In the Code of Federal Regulations (45 CFR 46.102(d))
pertaining to the protection of human subjects research is defined as: “A systematic investigation (i.e., the gathering
and analysis of information) designed to develop or contribute to generalizable knowledge.” The National Academy of
Sciences states that the object of research is to “extend human knowledge of the physical, biological, or social world
beyond what is already known.” Research is different than other forms of discovering knowledge (like reading a book)
because it uses a systematic process called the Scientific Method.

The Scientific Method consists of observing the world around you and creating a hypothesis about relationships in the
world. A hypothesis is an informed and educated prediction or explanation about something. Part of the research process
involves testing the hypothesis, and then examining the results of these tests as they relate to both the hypothesis and the
world around you. When a researcher forms a hypothesis, this acts like a map through the research study. It tells the
researcher which factors are important to study and how they might be related to each other or caused by
a manipulation that the researcher introduces (e.g. a program, treatment or change in the environment). With this map,
the researcher can interpret the information he/she collects and can make sound conclusions about the results.

Research can be done with human beings, animals, plants, other organisms and inorganic matter. When research is done
with human beings and animals, it must follow specific rules about the treatment of humans and animals that have been
created by the U.S. Federal Government. This ensures that humans and animals are treated with dignity and respect, and
that the research causes minimal harm.

No matter what topic is being studied, the value of the research depends on how well it is designed and done. Therefore,
one of the most important considerations in doing good research is to follow the design or plan that is developed by an
experienced researcher who is called the Principal Investigator (PI). The PI is in charge of all aspects of the research and
creates what is called a protocol (the research plan) that all people doing the research must follow. By doing so, the PI
and the public can be sure that the results of the research are real and useful to other scientists.

Module 1: Discussion Questions

1. How is a hypothesis like a road map?

2. Who is ultimately responsible for the design and conduct of a research study?

3. How does following the research protocol contribute to informing public health practices?
Module 2: Research Design 

Learning Objectives
This module is divided into two sections, Descriptive Studies and Experimental Studies

By the end of this module, you will be able to:

 Explain how research is designed to gain new knowledge

 Describe the role(s) of research support staff in enhancing research integrity

According to Trochim (2005), research design "provides the glue that holds the research
project together. A design is used to structure the research, to show how all of the major
parts of the research project work together to try to address the central research questions."
The research design is like a recipe. Just as a recipe provides a list of ingredients and the
instructions for preparing a dish, the research design provides the components and the plan
for successfully carrying out the study. The research design is the "backbone" of the
research protocol.

Research studies are designed in a particular way to increase the chances of collecting the information needed to answer
a particular question. The information collected during research is only useful if the research design is sound and follows
the research protocol. Carefully following the procedures and techniques outlined in the research protocol will increase the
chance that the results of the research will be accurate and meaningful to others. Following the research protocol and
thus the design of the study is also important because the results can then be reproduced by other researchers. The more
often results are reproduced, the more likely it is that researchers and the public will accept these findings as true.
Additionally, the research design must make clear the procedures used to ensure the protection of research subjects,
whether human or animal, and to maintain the integrity of the information collected in the study.

 There are many ways to design a study to test a hypothesis. The research design that is chosen depends on the type of
hypothesis (e.g. Does X cause Y? or How can I describe X and Y? or What is the relationship between X and Y?), how
much time and money the study will cost, and whether or not it is possible to find participants. The PI has considered each
of these points when designing the study and writing the research protocol.

There are many kinds of research, however, most of them fall into two categories: descriptive and experimental.
Module 2: Research Design - Section 1

Section 1: Descriptive Studies

Definition: A descriptive study is one in which information is collected without changing the environment (i.e., nothing is
manipulated).

A descriptive study is one in which information is collected without changing the environment (i.e., nothing is
manipulated). Sometimes these are referred to as " correlational " or " observational " studies. The Office of Human
Research Protections (OHRP) defines a descriptive study as "Any study that is not truly experimental." In human
research, a descriptive study can provide information about the naturally occurring health status, behavior, attitudes or
other characteristics of a particular group. Descriptive studies are also conducted to demonstrate associations or
relationships between things in the world around you.

Descriptive studies can involve a one-time interaction with groups of people (cross-sectional study) or a study might follow
individuals over time (longitudinal study).

Descriptive studies, in which the researcher interacts with the participant, may involve surveys or interviews to collect the

necessary information.

Descriptive studies in which the researcher does not interact with the participant include observational studies of people in
an environment (e.g., "fly on the wall") and studies involving data collection using existing records (e.g., medical record
review).

Case Example For A Descriptive Study

A researcher wants to know why individuals in Community A have a higher rate of a rare form of cancer when compared
to those living in Community B. To find out the reasons for the differences in cancer rates in these two communities, the
investigator surveyed residents about their lifestyle, noted the types of businesses that were present in the community and
searched medical records. The researcher found that the headquarters for the Toxico Chemical Plant is located in
Community A, there is a higher rate of cigarette smoking in this community and residents tended to delay or skip going to
the doctor for an annual checkup. In Community B, the largest employer was a department store and on average,
residents did not smoke as much as residents from Community A. However, like individuals from Community A,
Community B residents tended to delay or skip their annual checkup with their doctor.
Module 2: Research Design - Section 2
Section 2: Experimental Studies

Unlike a descriptive study, an experiment is a study in which a treatment, procedure, or program is intentionally introduced
and a result or outcome is observed. The American Heritage Dictionary of the English Language defines an experiment as
"A test under controlled conditions that is made to demonstrate a known truth, to examine the validity of a hypothesis, or
to determine the efficacy of something previously untried."

True experiments have four elements: manipulation, control , random assignment, and random selection. The most
important of these elements are manipulation and control. Manipulation means that something is purposefully changed by
the researcher in the environment. Control is used to prevent outside factors from influencing the study outcome. When
something is manipulated and controlled and then the outcome happens, it makes us more confident that the
manipulation "caused" the outcome. In addition, experiments involve highly controlled and systematic procedures in an
effort to minimize error and bias, which also increases our confidence that the manipulation "caused" the outcome.

Another key element of a true experiment is random assignment. Random assignment means that if there are groups or
treatments in the experiment, participants are assigned to these groups or treatments, or randomly (like the flip of a coin).

This means that no matter who the participant is, he/she has an equal chance of getting into all of the groups or
treatments in an experiment. This process helps to ensure that the groups or treatments are similar at the beginning of the
study so that there is more confidence that the manipulation (group or treatment) "caused" the outcome. More information
about random assignment may be found in section Random assignment.

Definition: An experiment is a study in which a treatment, procedure, or program is intentionally introduced and a result
or outcome is observed.

Case Example for Experimental Study

Experimental Studies — Example 1

An investigator wants to evaluate whether a new technique to teach math to elementary school students is more effective
than the standard teaching method. Using an experimental design, the investigator divides the class randomly (by
chance) into two groups and calls them "Group A" and "Group B." The students cannot choose their own group. The
random assignment process results in two groups that should share equal characteristics at the beginning of the
experiment. In Group A, the teacher uses a new teaching method to teach the math lesson. In Group B, the teacher uses
a standard teaching method to teach the math lesson. The investigator compares test scores at the end of the semester
to evaluate the success of the new teaching method compared to the standard teaching method. At the end of the study,
the results indicated that the students in the new teaching method group scored significantly higher on their final exam
than the students in the standard teaching group.

Experimental Studies — Example 2

A fitness instructor wants to test the effectiveness of a performance-enhancing herbal supplement on students in her
exercise class. To create experimental groups that are similar at the beginning of the study, the students are assigned into
two groups at random (they can not choose which group they are in). Students in both groups are given a pill to take
every day, but they do not know whether the pill is a placebo (sugar pill) or the herbal supplement. The instructor gives
Group A the herbal supplement and Group B receives the placebo (sugar pill). The students' fitness level is compared
before and after six weeks of consuming the supplement or the sugar pill. No differences in performance ability were
found between the two groups suggesting that the herbal supplement was not effective.
Module 2: Research Design - Section 2 Discussion  

Section 2: Discussion Questions

1. What makes both of these studies experimental?

2. What type of information might the investigator collect in these two studies to see if the treatment (e.g.
new teaching method or herbal supplement) is effective?

3. Can the researcher establish cause and effect in either or both of these two studies?

4. What would happen if the researcher allowed the students to study together or talk about the different
methods that were being used to teach the math lesson? Would this be a good or a bad idea? How would
this influence the study results?

5. What if the fitness instructor allowed participants to take other herbal supplements in addition to the
supplements being tested? Would this be a good or a bad idea? How would this influence the study
results?

Descriptive studies are usually the best methods for collecting information that will demonstrate relationships and describe
the world as it exists. These types of studies are often done before an experiment to know what specific things to
manipulate and include in an experiment. Bickman and Rog (1998) suggest that descriptive studies can answer questions
such as "what is" or "what was." Experiments can typically answer "why" or "how."

 
Module 2: Research Design – Quiz

Module 2: Quiz Questions

1. Scenario: You are a Health Educator in a nutrition study that examined the effects of exercise and a low-salt diet
on high blood pressure risk reduction. You are responsible for translating the study results and sharing them with
local community organizations that may benefit from learning about the study results. The study had significant
findings for exercise, but not the low-salt diet. The low-salt diet did not have the expected effect on high blood
pressure. However, you really believe in the low-salt diet program and participants in the study really liked the
low-salt recipes. What should you do?

Select the best answer.

a. Report only the positive effect of exercise because that is all that was found.
b. Report the positive effect of exercise, but also explain that no effect was found for a low-salt diet.
c. Report the positive effect of exercise, but also explain the importance of a low-salt diet even though no
effect was found for a low-salt diet.
d. Contact the program manager or PI to explain your worry and ask how it is best for you to proceed.

2. health problem. They designed a Randomized Controlled Trial so that some people would receive the new
medicine and others would not. The Institutional Review Board (IRB) reviewed the plan and approved the
research study. You are hired as a screening coordinator to recruit participants who meet the eligibility
requirements to participate in the study. At the health clinic, you approach a potential participant. You explain the
purpose of the study and the eligibility requirements for becoming a participant. He asks, "Why there are so many
eligibility requirements for people to participate in the study?" How would you respond?

3. One of the responsibilities of research personnel is to follow the research protocol.

a. A. True

b. False

4. Why is it important for research staff to maintain the integrity of the research protocol?

a. To provide a better work environment for the research team

b. To make the study look more professional
c. To ensure the study is conducted correctly
d. To guarantee publication of the study results

5. Why do you need to pay attention to the details outlined in the study protocol?

a. To learn how to conduct a research study

b. To follow my responsibilities adequately
c. To provide information to a participant's family
d. None of the above
Module 3: Elements of Research 
By the end of this module, you will be able to:

 Explain how associations between variables are used to answer research questions.
 Explain why random assignment and random selection are used in research.
 Explain why some information about a research study cannot be told to a research participant.

An understanding of the basic elements of research is essential for good research practices. Among the most important
elements to be considered are variables, associations, sampling, random selection, random assignment, and blinding. For
a more detailed explanation of other research concepts, please see the list of references provided at the end of this
curriculum.

Module 3: Elements of Research - Section 1 

Section 1: Variables
The purpose of all research is to describe and explain variance in the world. Variance is simply the difference; that is,
variation that occurs naturally in the world or change that we create as a result of a manipulation. Variables are names
that are given to the variance we wish to explain.

A variable is either a result of some force or is itself the force that causes a change in another variable. In experiments,
these are called dependent and independent variables respectively.

When a researcher gives an active medication to one group of people and a placebo, or inactive medication, to another
group of people, the independent variable is the medication treatment. Each person's response to the active medication
or placebo is called the dependent variable.

This could be many things depending upon what the medication is for, such as high blood pressure or muscle pain.
Therefore, in experiments, a researcher manipulates an independent variable to determine if it causes a change in the
dependent variable.

As we learned earlier in a descriptive study, variables are not manipulated. They are observed as they naturally occur and
then associations between variables are studied. In a way, all the variables in descriptive studies are dependent variables
because they are studied in relation to all the other variables that exist in the setting where the research is taking place.
However, in descriptive studies, variables are not discussed using the terms "independent" or "dependent." Instead, the
names of the variables are used when discussing the study. For example, there is more diabetes in people of Native
American heritage than people who come from Eastern Europe. In a descriptive study, the researcher would examine how
diabetes (a variable) is related to a person's genetic heritage (another variable).

Definition: A variable is either a result of some force or it is the force that causes a change in another variable. In
experiments, these are called dependent and independent variables respectively.

Case Examples for Independent and Dependent Variables

Example 1:
In an experimental study looking at classical music exposure and reading ability in children, the researcher divided the
children into two groups (Groups A and B). In Group A, the children listened to Mozart for one hour every day for one
month. In Group B, parents were instructed to refrain from playing classical music around the child for one month. At the
end of the month, all children were given a reading comprehension test. Those who listened to Mozart daily (Group A)
scored significantly higher on the reading test. In this case, the reading comprehension test score is the dependent
variable and exposure to Mozart’s music is the independent variable. This is because the test score is  dependent on
whether or not the child listens to Mozart’s music. The independent variable, exposure to Mozart’s music,
is independent because it is something that can be manipulated or changed by the researcher.

Example 2:

In a study with a similar design as the previous example, researchers looked at the effects of nutrition on reading
ability. In Group A, children ate at least three ounces of dark green vegetables every day for one month. In Group B,
children were fed their regular diet. At the end of the month, the children took a reading comprehension test. Those who
ate the green vegetables every day for one month (Group A) did not vary in their test scores when compared to Group B.

Section 1: Discussion Questions

1. In the second example what is the independent variable? Why?

2. In the second example, what is the dependent variable? Why?

3. Identify which variables are dependent and independent in the following examples:

Example:

a. Physical activity and weight loss

Dependent Variable: weight loss

Independent Variable: physical activity

a. Positive feedback and self confidence

Dependent Variable: 

Independent Variable: 

b. Headache and aspirin

Dependent Variable: 

Independent Variable: 

c. Muscle mass and weight-training

Dependent Variable: 

Independent Variable: 

d. Calcium consumption and bone density

Dependent Variable: 
 Independent Variable: 

e. Blood pressure and salt intake

Dependent Variable: 

Independent Variable: 

Variables are important to understand because they are the basic units of the information studied and interpreted in
research studies. Researchers carefully analyze and interpret the value(s) of each variable to make sense of how things
relate to each other in a descriptive study or what has happened in an experiment.

Definition: Variables are characteristics studied in research that can take on different values (e.g., weight, height,
exposure to a substance, demographics (i.e., where you live, your ethnicity, how much income you have, medical
background).

Case Example for Descriptive Study Variables

See if you can identify the variables that are under investigation in the following descriptive study:

Many children who live in the Bronx, a borough of New York City, are developing asthma. In a descriptive study
investigating this problem, parents whose children have asthma are asked about whether they smoke around their child,
whether they live near a freeway, whether their child regularly sees a healthcare provider, their family income level and
also if there is a history in their family of asthma. Prior research has shown that these factors may have an influence on
the development of asthma in children.

Section 1: Discussion Questions

1. What are the variables that are under investigation in this study?

2. If you were the researcher, what other variables would you study to see if it may contribute to developing
asthma? Why?

3. Given the variables presented in the example and the variables that you thought of, why would these
variables be useful to the researcher?
Module 3: Elements of Research - Section 2 

Section 2: Associations and Cause and Effect

Definition: The term association means that two or more things are related or connected to one another.

The term association means that two or more things are related or connected to one another like height and weight,
cholesterol level and heart failure or exercise and weight loss. Associations can be positive or negative (the positive and
negative associations do not necessarily mean that the association is ‘good’ or ‘bad’). Positive associations suggest that
when one variable is increased, the value of another variable increases (e.g., as height increases, so does weight; as
cholesterol level increases, so does the risk of heart failure). Negative associations mean that when a variable is
increased, the value of another variable decreases (e.g., exercise is introduced (or increased) and weight decreases).
Associations can be found in experimental or descriptive studies. Finding significant associations, either during descriptive
or experimental studies, may lead to the development of programs or treatments to remedy a particular problem.

The variable  X is the independent variable.

The variable  Y is the dependent variable.
 

Case example for Associations and Cause and Effect

One example of an association is seen with aspirin use and prevention of heart attacks. The more aspirin that a former
heart-attack patient takes, the less likely it is that he/she will have another heart attack ( American Heart Association,
"Aspirin and Heart Disease," , Accessed September 9, 2015).

Examples of Positive and Negative Associations:

Direction of
Variable 1 Variable 2 Explanation
Association
Positive
As education level increases, so does
Education level Income level
income level.

Negative
As exercise increases, weight
Exercise Weight
decreases

Study time Test score Positive As study time increases, test score
increases
 Direction of
Variable 1 Variable 2 Explanation
Association

Negative
Work As number of sick days increases,
Sick days
productivity work productivity decreases

Module 3: Elements of Research - Section 3 

Section 3: Sampling
Sampling is the process of choosing participants for a research study. Sampling involves choosing a small group of
participants that will represent a larger group. Sampling is used because it is difficult or impractical to include all members
of a group (e.g., all Latina women in the United States; all male college athletes). However, research projects are
designed to ensure that enough participants are recruited to generate useful information that can be generalized to the
group represented.

Definition: Sampling is defined as the method by which some members of a larger group are selected. The usual goal is
sample those members so that they are representative of the group as a whole.

Case Example for Sampling

An investigator will be studying nutrition among Latina women. To find participants to interview, she requested a list of
names and contact information for all Latina women from a community clinic. These women had already provided consent
and had agreed to be contacted about participating in future research studies. The list included 1,000 names of potential
participants for the nutrition study. The investigator chose 200 of the women from this list to contact for possible inclusion
in the study.

Section 3: Discussion Questions

1. What is the purpose of selecting a smaller group of participants from a larger group?

2. Do the women included on this list represent the larger group?

3. Would you choose participants differently if this was your study? If so, how would you do it?

4. What would happen if the investigator chose individuals from the list that she knew? Would this affect the
results of the study?
Module 3: Elements of Research - Section 4 

Section 4: Random Selection

Random selection is a form of sampling where a representative group of research participants is selected from a larger
group by chance. This can be done by identifying all of the possible candidates for study participation (e.g., people
attending the County fair on a Tuesday) and randomly choosing a subset to participate (e.g., selecting every 10 th person
who comes through the gate). This allows for each person to have an equal chance of participating in the study.

Allowing each person in the group an equal chance to participate increases the chance that the smaller group possesses
characteristics similar to the larger group. This produces findings that are more likely to be representative of and
applicable to the larger group. Therefore, it is extremely important to adhere to this procedure if it is included in the
research design. Ignoring or altering random selection procedures compromises the research design and subsequent
results. For example, friends or relatives may be easier or more convenient to recruit into a research study, but selecting
these individuals would not reflect a random selection of all of the possible participants. Similarly, it would be wrong to
select only individuals who may potentially benefit from study participation rather than randomly selecting from the entire
group of individuals being studied. Ignoring random selection procedures when they are called for in the research design
reduces the quality of the information collected and decreases the usefulness of the study findings.

 Definition: Random selection is the process of selecting a smaller group of individuals from a larger group to be
participants in a study. Every person has an equal chance of being selected, which allows each of the individuals in the
group the same chance of participating.

 Case Example for Random Selection

The investigator selects 200 names from a list of 50,000 Latina women by placing all of their names in a hat. Each name
is put on a separate piece of paper and names are drawn until 200 names have been picked. This procedure to select
names at random can also be done by using special computer programs. A computer program would probably be used for
this process when there are hundreds of participants to randomly choose.

 Section 4: Discussion Questions

1. Do the women included on this list represent the larger group?

2. Would you choose participants differently if this was your study? If so, how would you do it?

3. What if the researcher decided to ignore the random selection procedures as described in this example
(e.g. pulling names from a hat, using a computer program to generate random numbers)? How would this
affect the results of the study?
Module 3: Elements of Research - Section 5 

Section 5: Random Assignment

Random assignment is a procedure used in experiments to create multiple study groups that include participants with
similar characteristics so that the groups are equivalent at the beginning of the study. The procedure involves assigning
individuals to an experimental treatment or program at random, or by chance (like the flip of a coin). This means that each
individual has an equal chance of being assigned to either group. Usually in studies that involve random assignment,
participants will receive a new treatment or program, will receive nothing at all or will receive an existing treatment. When
using random assignment, neither the researcher nor the participant can choose the group to which the participant is
assigned.

The benefit of using random assignment is that it "evens the playing field." This means that the groups will differ only in
the program or treatment to which they are assigned. If both groups are equivalent except for the program or treatment
that they receive, then any change that is observed after comparing information collected about individuals at the
beginning of the study and again at the end of the study can be attributed to the program or treatment. This way, the
researcher has more confidence that any changes that might have occurred are due to the treatment under study and not
to the characteristics of the group.

A potential problem with random assignment is the temptation to ignore the random assignment procedures. For example,
it may be tempting to assign an overweight participant to the treatment group that includes participation in a weight-loss
program. Ignoring random assignment procedures in this study limits the ability to determine whether or not the weight
loss program is effective because the groups will not be randomized. Research staff must follow random assignment
protocol, if that is part of the study design, to maintain the integrity of the research. Failure to follow procedures used for
random assignment prevents the study outcomes from being meaningful and applicable to the groups represented.

Definition: Random assignment is a procedure used in experiments to create study groups with similar characteristics so
that the groups are equivalent at the beginning of the study.

  Case Example for Random Assignment

In a study to help individuals quit smoking, investigators randomly assigned participants to one of two groups. In Group A,
participants took a class to quit smoking. The classes took place each week for 10-weeks and included information about
the benefits of quitting smoking. In addition, participants in the class received strong social support from mentors or
"buddies." In the Group B, participants read a 3-page pamphlet created by the American Cancer Association that explains
the benefits of quitting smoking. The investigator randomly assigned participants to one of the two groups. It was found
that those who participated in the class and received support from their buddies were more likely to quit smoking
compared to those in the other group that received only the pamphlet.
Module 3: Elements of Research - Section 6 

Section 6: Blinding
Blinding is a technique used to decrease bias on the part of the researcher or the participant. In some studies, the
participant is not told to which group they have been assigned. This is called single blinding. There is another level of
blinding called double blinding where neither the researcher nor the participant know which group the participant is in until
this information is revealed at the end of the study. Blinding can reduce the temptation to ignore random assignment
procedures and can reduce any expectations about the potential effectiveness of the treatment or program since group
assignment remains unknown by the participant, the researcher or both the participant and researcher. The results are
more likely to provide information about the true effect of the treatment or program being tested when blinding is used.

Definition: Blinding is a technique used to decrease bias on the part of the researcher or the participant where the
participant, or both the researcher and the participant are not told to which group they have been assigned.

Case Example for Blinding

In a study investigating the effects of a new anti-itch cream, participants with minor skin rashes were randomly divided into
one of three groups. In the first group, participants received a new anti-itch cream that contained 3% hydrocortisone. In
the second group, the participants received the standard cream available over-the-counter which contains 1%
hydrocortisone. The third and final group members received a cream that contained 0% hydrocortisone. The participants
did not know to which group they were assigned. Participants used the cream for three days to relieve itching symptoms
caused by the rash. After three days, each participant’s rash was examined to determine if itching symptoms subsided. If
this was not the case, the participant was provided with the standard treatment, which is known to relieve itching.

Section 6: Discussion Questions

1. Why are participants not told (blind to) their group assignment?

2. Is this a single or double blind study?

3. Do you think knowledge of group assignment (no blinding) would affect the results? Why or why not?

4. Do you think that the researcher’s knowledge of group assignment would affect the results? Why or why
not?
Module 3: Elements of Research - Quiz

Module 3: Quiz Questions

1. In a study that uses random assignment, ignoring the random assignment procedures would result in:

a. Reducing the validity and usefulness of the study results.

b. Conducting bad science
c. Violating the protocol
d. All of the above

See Answer

2. Telling the research participant the group they are in during a blinded study is...

a. Acceptable because this knowledge of group assignment would help participants understand how they should
behave during the study
b. Unacceptable, because this knowledge of group assignment can influence how people behave and result
in unreliable data.
c. Honest because you should tell the participant everything about the study
d. Harmful because if the participant knows what group they are in, they may be injured.

See Answer

3. Scenario: You are a community health worker involved with a nutrition study investigating the effects of a low-
sodium diet on women with high blood pressure. Your responsibilities include recruiting women ages 30-50 who
are not pregnant and who do not plan to become pregnant within the next year. In addition to recruiting and
enrolling participants, you will collect measurements every 3 months over the course of one year. At the end of
every completed measurement visit, the participant will receive $50 for their participation. The eligibility criteria,
study activities and incentive payments are explained to the participant at enrollment. During the first
measurement session with a participant you find out that she is 20 weeks pregnant. You wonder if she was
unaware of her pregnancy when you enrolled her, or, perhaps she didn’t disclose her pregnancy because she
wanted to participate. What should you do?

a. Let the participant remain in the study and complete all measurements as required. If she hid the pregnancy at
enrollment she likely needs the participation money.
b. Explain to the participant that she is no longer eligible to take part in the study. Furthermore, participation
would require her to modify her diet, which may be unsafe for her baby’s development.
c. Complete the measurement visit with the participant. Afterwards, check with the study team about
whether the participant can continue in the study since she no longer meets the eligibility criteria.

4. When a participant has an equal chance of getting into all groups or treatments in an experiment it is
called 
 a. a.random selection
b. random assignment
c. random error
d. none of the above

Module 4: Methods of Information Collection 

Module 4: Learning Objectives

By the end of this module, you will be able to:

 Explain how data management can influence interpretation of research results.

 Explain how reliability and validity can influence interpretation of research results.

Research is designed to gather accurate information to explain concepts or events that are not well understood. Gathering
accurate information is a critical part of research. Information gathered for research can be collected in many ways
depending on the type of research design that is being used. The method used to gather information depends on the
questions that the research will attempt to answer.

Module 4: Methods of Information Collection - Section 1

Section 1: Examples of Information Collection Methods

There are many ways to collect information in research. The method that is chosen by the researcher depends on
the research question that is being asked. Examples of information collection methods include surveys, interviews, tests,
physiological assessments, observations, existing record reviews and biological samples.

A survey is a set of questions for research participants to answer. Surveys can be administered in person, through the
mail, telephone or electronically (e-mail or Internet). A survey can be administered to an individual or in a group setting.
Surveys are used to gain information about many individuals and may include multiple/forced choice or open-
ended questions (e.g., demographics , health, knowledge, opinions, beliefs, attitudes or skills).

An interview is an interaction that involves the researcher and the participant(s) in which questions are presented in
person, over the telephone or even electronically (email or Internet). During an interview, questions are asked to obtain
detailed information from the participant about the topic under study. The questions may be similar to those asked in a
survey.

A test is a form or a physical or mental task for which a normal standard has been determined or for which there are
correct answers. A participant's performance on the test is then compared to these standards and/or correct answers.
Tests are used in research to determine a participant's aptitude, skill, knowledge, health, or mental status as compared to
the general population. Tests can be administered in person or through a paper or electronic medium. An example would
be students taking a standardized test for academic achievement (e.g., SAT, MCAT, GRE).

Physiological assessments are measurements in which a participant's physical characteristics are evaluated such as
blood pressure, heart rate, or physical strength. In health-related research, physiological assessment may be used to
determine the participant's health status prior to, during, or after the completion of the study. An example would be older
adults touching their toes to assess flexibility and reach.

Observations are recordings that are taken of the participant without requiring interaction. These recordings are made
while participants are engaged in routine behaviors and are used as an indicator of what participants actually do rather
than relying completely on self-reports of participants' behaviors. An example would be a researcher observing an
ongoing lesson plan used in a classroom by a public school teacher.
Record reviews take place when the researcher examines and extracts information from documents that include
information about the participant. Records that are reviewed in research may be either public or private. An example is a
researcher collecting information about a disease from patient medical records.

Biological samples are substances (blood, urine, saliva) that are taken from an individual and used to measure
physiological information. An example would be drawing blood to assess the sugar content in a diabetic patient.

No matter what kind of information is collected in a research study or how it is collected, it is extremely important to carry
out the collection of the information with precision (i.e., reliability), accuracy (i.e., validity), and minimal error. The integrity
and usefulness of the research may be compromised if the study measurements are not carried out correctly. Factors that
contribute to effective information gathering are discussed in the next few sections.

Module 4: Methods of Information Collection - Section 2:1  

Section 2: Factors in Effective Information Gathering

Three major concepts are important to understand in order to collect useful and valuable research information: precision
(i.e., reliability), accuracy (i.e., validity), and error.

2.1 Precision (i.e., Reliability)

It is very important to make sure the information gathering methods are precise (i.e., reliable). This means that a method
measures the same thing every time you use the method.

There are many things that can affect an instrument's or a method's precision (i.e., reliability). This includes the form of the
instrument (e.g. oral or written), the environment in which it is administered, how the staff administers it, the difference in
participants from group to group and across time, and the time of the day it is administered (among many others). The
researcher can also influence precision (i.e., reliability) by either overtly or inadvertently praising, complimenting or
admonishing the participant. The principal investigator is responsible for providing proper training and “spot checks” for
how instruments or methods are administered to ensure that the research study is conducted with precision.

Research studies are often criticized because they did not use precise methods to gather data. Precision (i.e., reliability)
helps to promote research that is of greater value because you can be more confident that the findings are real.

Definition: Precision (i.e. reliability) means that a method measures the same thing every time you use the method.

Here is an example illustrating reliability (precision) and validity (accuracy) in reaching the target (e.g., center of the
circle).

Case Example for Precision (i.e., Reliability)

A study is designed to see if a new anti-hypertension drug is effective in reducing blood pressure. Participants in the study
have their blood pressure measure to see if the drug has an effect on lowering blood pressure. The study design requires
that blood pressure is taken when the individual is in a quiet location using a digital blood pressure monitor.

  Section 2.1: Discussion Questions

1. Imagine that the researcher decides to take the participant's blood pressure after he or she has
completed a vigorous exercise routine. Would this be consistent with the research design? Why or why
not?

2. In another situation, the researcher takes an individual's blood pressure in a noisy household where
many young children are playing in the same room. Would this be consistent with the research design?
Why or why not?
 3. A researcher accidentally breaks the digital blood pressure monitor and decides to use a manual blood
pressure cuff like a nurse would use during a routine check up. Would this be consistent with the
research design? Why or why not?

 Module 4: Methods of Information Collection - Section 2:2  

2.2 Accuracy (i.e., Validity)

It is also very important to make sure the information gathering methods are accurate (i.e., valid). Accuracy (i.e., validity)
refers to whether or not an instrument or method truly measures what you think it measures. Researchers want accurate
or valid study procedures so that study results are useful and meaningful.

There are many things that affect the accuracy (i.e., validity) of an instrument or method. These include the cultural
appropriateness, the theoretical constructs used to develop the instrument or method, and the appropriateness of the
testing method or form of the instrument for the participants' abilities (among many others).

 To demonstrate that study measures are accurate, researchers will sometimes collect different kinds of information to
measure the same thing. They then look to see if all of the methods or instruments provide the same or similar
conclusions. If they do, the researcher can be confident that what they have found actually represents what they intended
to study.

Along with lack of precision (i.e., reliability), research studies are often criticized because of the use of inaccurate methods
to gather information. Measurement accuracy (i.e., validity) is essential in order to guarantee the quality and integrity of
the research findings.

Definition: Accuracy (i.e., validity) refers to whether or not an instrument or method truly measures what you think it
measures.

 Case Example for Accuracy (i.e., Validity)

In a study involving a weight loss program, the researcher weighs participants to determine if the program is effective in
helping individuals lose weight. To accurately measure weight, the scale must be working properly. To check the accuracy
of the scale, a 25 pound weight is placed on a digital scale three times to make sure that a 25 pound reading is found
each time.

In another study, researchers want to determine whether participants have reduced their smoking. To find out, the
researcher asks the individual a series of questions on a survey about their smoking habits over the last two weeks. To
verify the accuracy of the survey responses, the researcher also does a test to measure chemicals in saliva that increase
with smoking.

 Section 2.2: Discussion Questions

1. What would happen in each of the previous examples if an accuracy check was not conducted?

2. What are some other ways to check for accuracy in these studies?

2.3 Error
When we measure something or collect information, there are many reasons that our findings might be wrong. The most
obvious reason is that we could simply make a mistake in writing something down. This kind of mistake is how we might
usually think about error. However, there are other kinds of errors that we might not see unless we knew to look for them.
These errors are not mistakes in the sense that we have done something wrong. These types of errors can decrease the
reliability or accuracy of what we do, but often because of things that we cannot control.
 One of these is called Random Error. An error is considered random if the value of what is being measured sometimes
goes up or sometimes goes down. A very simple example is our blood pressure. Even if someone is healthy, it is normal
that their blood pressure does not remain exactly the same every time it is measured. If several measurements of blood
pressure were taken over time, some would be higher and some would be lower. The reason for this random error is to be
expected because of variation in normal processes in the body and in the way that the measuring device works. If error is
truly random, and if we take enough measurements, then it is still possible to get a good estimate of what we are
measuring. However, if random error is large, then our measurements will be unpredictable, inconsistent and they will not
represent the true value of what we are measuring.

The second type of error is called Systematic Error. An error is considered systematic if it consistently changes in the
same direction. For example, this could happen with blood pressure measurements if, just before the measurements were
to be made, something always or often caused the blood pressure to go up. Or this could happen because our device for
measuring blood pressure was defective so that it always gave a result higher, or always gave a result lower, than the true
value. In these cases, even if our measurements were predictable and consistent, the results would still not be accurate.

Definition: Error in research is anything that interferes with making a confident conclusion about the study.

Case Examples for Systematic and Random Error

Systematic Error

In a study on weight loss, researchers determined at the end of the study that the scale that was used to measure
participant’s weight was inaccurate. The scale added 10 pounds to the person’s actual weight every time the scale was
used. Because the researcher realized that the scale consistently added ten pounds to each participant’s weight, they
adjusted for this problem when analyzing the results.

 
Module 4: Methods of Information Collection - Section 2:3  

2.3 Error

When we measure something or collect information, there are many reasons that our findings might be wrong. The
most obvious reason is that we could simply make a mistake in writing something down. This kind of mistake is how we
might usually think about error. However, there are other kinds of errors that we might not see unless we knew to look for
them. These errors are not mistakes in the sense that we have done something wrong. These types of errors can
decrease the reliability or accuracy of what we do, but often because of things that we cannot control.

 One of these is called Random Error. An error is considered random if the value of what is being measured sometimes
goes up or sometimes goes down. A very simple example is our blood pressure. Even if someone is healthy, it is normal
that their blood pressure does not remain exactly the same every time it is measured. If several measurements of blood
pressure were taken over time, some would be higher and some would be lower. The reason for this random error is to be
expected because of variation in normal processes in the body and in the way that the measuring device works. If error is
truly random, and if we take enough measurements, then it is still possible to get a good estimate of what we are
measuring. However, if random error is large, then our measurements will be unpredictable, inconsistent and they will not
represent the true value of what we are measuring.

The second type of error is called Systematic Error. An error is considered systematic if it consistently changes in the
same direction. For example, this could happen with blood pressure measurements if, just before the measurements were
to be made, something always or often caused the blood pressure to go up. Or this could happen because our device for
measuring blood pressure was defective so that it always gave a result higher, or always gave a result lower, than the true
value. In these cases, even if our measurements were predictable and consistent, the results would still not be accurate.

Definition: Error in research is anything that interferes with making a confident conclusion about the study.

Case Examples for Systematic and Random Error

Systematic Error

In a study on weight loss, researchers determined at the end of the study that the scale that was used to measure
participant’s weight was inaccurate. The scale added 10 pounds to the person’s actual weight every time the scale was
used. Because the researcher realized that the scale consistently added ten pounds to each participant’s weight, they
adjusted for this problem when analyzing the results.

 Section 2.3: Discussion Questions

1. If you were the researcher, how would you handle this problem if you found out about it at the end of the study?

2. What are some things the researcher should have done in the first place to avoid this problem?

3. Is systematic error problematic in research in general if it can be corrected? What if the researcher doesn't know
about the systematic error?

Random Error
In a study on weight loss, a scale was used that added a few pounds more or a few pounds less each time the scale was
used. The researcher did not know that the scale did not measure the participant’s exact weight. Because the researcher
did not realize this, the researcher could not adjust for this problem when analyzing the results. This caused the study
results to include some error.

 Section 2.3: Discussion Questions

1. Are the results of this study accurate? Why or why not?

2. Does the use of a slightly inaccurate scale cause serious problems with the study results?

3. Is there anything that the researcher should have done to avoid this problem?

4. Which do you think is a more serious problem in research – systematic or random error?

5. Which type of error – random or systematic - is easier to control?

Module 4: Methods of Information Collection - Quiz 

Module 4: Quiz Questions

1. At what point in the study is it most appropriate to document information:

a. Months after the study is completed.

b. After you’ve had time to think about your personal interpretation of what you observed.
c. After you talk to all of your colleagues about the most accepted way of documenting the results.
d. None of the above

2. A study involves a self-report survey completed by the participant. Will the results be affected if
the research assistant reads the questions to the person and records the answers?

a. Yes, this change in how the survey is administered can change the results of the study.
b. No, how the survey is administered doesn’t make a difference.

3. It is important for measurements in research to be accurate or valid so that:

a. The method you are using measures what you think you are measuring.
b. The method you are using measures the same thing every time the method is used.
c. You are confident that the method you are using is precise.
d. The method you are using finds the answer you expected to find.

4. It is important for measurements in research to be precise or reliable so that:

a. The method you are using measures the same thing every time the method is used.
b. The method you are using measures what you think you are measuring.
c. You are confident that the method you are using is accurate.
d. The method you are using finds the answer you expected to find

5. In a study involving blood pressure, it is acceptable and consistent to use a manual cuff for one
participant and a digital blood pressure machine for another participant.
 a. True, the type of blood pressure machine would not affect the results.
b. False, the type of blood pressure machine that is used should be consistent, or the same, for each
participant.

Module 5: Handling Information

Module 5: Learning Objectives

 Explain the importance of good data management in ensuring research integrity.
 Describe why changing or manipulating data can compromise interpretation of the results.

This section includes a brief overview of some issues related to responsibly handling information collected in research. To
maintain the confidentiality and accuracy (i.e., validity) of the information collected during research, any information
collected about an individual should be handled with care through proper documentation and secure storage. Failure to
properly handle research information may result in wasting resources, violating confidentiality, and failing to answer the
research question(s) (i.e., adding unknown (random) error to the study). To avoid these serious consequences, research
information should be properly documented and stored and the information provided by a research participant should
never be changed or altered.

Module 5: Handling Information - Section 1 

Section 1: Security and Storage

The ethical conduct of research, with human subjects especially, depends in part on protecting the confidentiality of
sensitive information such as name, age, occupation, income level, education level, job title, health status, family history,
photographic images, survey answers, and interview responses. Even biological samples may reveal information about an
individual that could be very sensitive (such as a positive HIV test). Carefully handling information according to the
research design will help to ensure that sensitive information collected for research will remain private.

Research information should always be stored in a secure location. Forms and other study materials that include
confidential information (e.g., blood or tissue samples, audio/video-tapes, informed consent forms) should be stored in a
locked facility to which only authorized personnel have a key. Computers should be password protected and the user
should log-off when the computer is not in use.

Research information is often stored for several years after the study is completed. This is done for several reasons. First,
long term storage may be necessary to comply with professional standards, institutional requirements, or federal law. For
example, federal regulations require that informed consent documents be stored for at least three years. Second,
researchers may want to keep raw data to prove the accuracy (i.e., validity) and precision (i.e., reliability) of the
information they collected during a study. Third, samples or other information such as interview transcripts may be kept for
future analyses. When data are kept in a digitized form, there should be at least one additional place where the
information is kept in case the original data source is lost or damaged.

Definition: Research information should always be stored in a secure location.

  Case Example for Security and Storage
In a needs assessment study on helping a clinic reach individuals without health insurance, the study forms included
sensitive health information along with the person's name and phone number. Before returning to the research office, the
staff member left the information at home on her kitchen counter. That night, some of her friends came over for dinner,
saw through the papers, and recognized the names of some of the individuals in the study.

Module 5: Handling Information - Section 1 Discussion  

Section 1: Discussion Questions

1. What is the harm of her friends seeing this research information?

2. How could this type of situation be avoided?

3. How does this type of situation affect the integrity of the study? How does this type of situation affect the
participants?

4. Why is it important to securely store research information?

1.1 Documentation
The ethical conduct of research is also measured by the degree to which the information collected is accurate and
precise. Information should be recorded and documented carefully according to the research design so that the potential
for error is reduced. Documentation is the act of recording, summarizing and/or coding information for future use.

Documentation must be accurate so that the records of research activity represent what actually occurred during
testing/participation. Accurate documentation also allows others to more easily detect any errors that may be included in
the information collected. If information is recorded inaccurately, the results of the study may not be useful.

Documentation should be completed as the research occurs, not at a later time. Information is likely to be more accurate
when recorded as soon as possible rather than recalling information from memory, which can be mistaken.

Definition: Documentation is “the collation, synopsizing, and coding of printed material for future reference” (American
Heritage Dictionary of the English Languages).

Case Example for Documentation

 In a weight loss study, the research assistant failed to measure the participant's weight at the beginning of the study.
Later, when it was time to review the results of the study, the assistant realized that he did not have the weight for the
participant.

  Section 1.1: Discussion Questions

 1. How does this type of situation affect the integrity of the study?

2. What should you do if you forget to document important information in the beginning of the study?

3. Why is it important to accurately document research information?

Module 5: Handling Information - Section 2

Section 2: Excluding and Changing Information

At times, it may be appropriate to exclude or omit information from the research record. For example, if the participant
discloses information that is unrelated to the study, this information can be excluded. Another example is when a

participant writes in a response on a multiple-choice surv ey that is not one of the multiple-choice options. This
information may also be excluded from the final data set. However, the decision to exclude or omit information should
always be made with the full knowledge and understanding of the Principal Investigator and disclosed in any public
presentation of the results of the study such as a presentation at a conference or a published paper.

Changing or altering information about a research participant or changing information that the research participant
provides is never appropriate. Changing study information can seriously damage the credibility of the results.

 Case Examples for Excluding and Changing Information

Here are two examples about when it is appropriate to exclude or change research information.

Excluding Information

In a study on improving literacy skills, researchers developed a tutoring program at a public library. The researchers want
to determine whether the tutoring helps the participants to obtain a job. Since the research is conducted at a public library,
however, the researchers are required to offer the program to all individuals regardless of their employment status. Since
the researchers are only interested in the effect of this program on unemployed individuals, the information collected from
employed individuals is excluded.

 Module 5: Handling Information - Section 2 Discussion  

Section 2: Discussion Questions

1. Why did the researchers exclude information about employed individuals?

2. What other situations can you think of when it would be appropriate to exclude information collected for research
purposes?

3. How would the results be affected if the information from all participants was included? 
Changing Information
A research assistant is responsible for recruiting families with children ages 12 to 24 months old for a study of language
and learning. She is having trouble finding families who are interested in participating. However, she finds a family who
are willing to participate with 27 month-old twins. So that she can include the twins in the study, she records their age as
24 months instead of their real age. The twins are enrolled in the study and the Principal Investigator publishes
information on the normal development of 24 month olds based on the data collected from these older children. This
information is used to affect recommendations for parents on how to stimulate their child's learning and language
development. 

Section 2: Discussion Questions

1. How do the research assistant's actions affect the integrity of the study?

2. What should you do if you are having trouble recruiting participants who meet the study eligibility
requirements?

3. Why is it important to adhere to the study eligibility requirements when recruiting participants?

Module 5: Handling Information - Quiz 

Module 5: Quiz Questions

1. Which of the following is not an appropriate way to store confidential research information?

a. Receiving data on a password-protected computer to which research staff only have access.
b. Storing completed questionnaires in a locked filing cabinet.
c. Assigning codes to identifiable information and storing the master code list in a separate location from the
data.
d. Leaving completed surveys that include sensitive information with the participant's name and contact
information on the desk of the research staff member.

2. Why is research information often stored for several years?

a. Because it is illegal to destroy research information.

b. Because it may be necessary to prove the authenticity of the information.
c. So that the researcher can make photocopies to distribute to the other participants.
d. For liability purposes in the case of a law-suit.

3. Scenario: You are a research assistant in a research study on physical activity. Your responsibilities include
collecting paperwork such as attendance sheets from the health educator leading the exercise classes. In your
most recent visit to an exercise class, the health educator informs you that she is missing some paper work
because she left it at home. You also notice that the class started 10 minutes late. You know this is
unprofessional behavior that is reducing the amount of exercise time the participants should receive. What should
you do?

a. As long as the health educator submits the paperwork within the next week there is no need to worry
about it and you will wait to see if this health educator starts other classes late as well before stepping in.
At this moment no action is necessary from your part.
b. You talk to the health educator about the importance of starting the class on time and of the risks posed
to the privacy of the participants by not having the paperwork stored in a safe location. You ask her to
submit the paperwork to you as soon as possible and to make sure all her future classes start on time.
Document the conversation and let your program manager know what happened.
c. Contact others who have positions similar to yours to ask their advice about how best to proceed.
d. Contact the Institutional Review Board (IRB) to report your worry and ask what should be done.
4. It is appropriate to exclude information from the research record when the information does not match
the response that the researcher expects.

a. True
b. False

5. When is it appropriate to change research information?

a. When the participants provide controversial responses

b. When it appears that the results will disprove the researcher's hypothesis
c. When there is a missing response in the research record
d. It is never acceptable to change research information

6. In a study of the “over 55” population, a researcher recruits a 54-year-old woman, but notes in the
research records that she is 56 years old. How does this affect the study results?

a. This decision will help senior citizens over the age of 55.
b. This decision will cause misleading and invalid study results.
c. This decision will not affect the study results in any way.
d. This decision will help the 54 year-old woman in the study.