The Institutional Review Board

(IRB)

Kareem Coomansingh, MSc, MPH

IRB Administrator
Office of Research
1
 Overview

At the end of this lecture, students will be able

to:

• Understand the structure and function

of Institutional Review Boards(IRBs)

• Understand the ethical considerations

of IRB review

• Write Applications for IRB submission

Institutional Review
Board (IRB)
 • There have been several studies in the past that
lead to serious harm
• Regulations are put in place to prevent future
Why do harm from occurring
IRB’s • Guidelines were determined by taskforces
charged with assessing what happened in the
Exist? past and setting forth rules to prevent them in
the future

 • An ethical review committee (IRB/REC) is a

committee established to independently
review, approve and monitor research
involving human subjects.
• It is responsible for safeguarding the rights,
Role safety and well being of research participants.
o This protects researchers from potential
conflicts between the pursuit of science
and the welfare of research participants.
*Many journals now require proof of IRB review*

 The IRB's assessment of risks and anticipated benefits involves a

series of steps. The IRB must:
• Identify the risks associated with the research;
• Determine that the risks will be minimized to the extent
possible;
• Identify the probable benefits to be derived from the
research;
IRB Function • Determine that the risks are reasonable in relation to be
benefits to subjects, if any, and the importance of the
knowledge to be gained;
• Assure that potential subjects will be provided with an
accurate and fair description of the risks or discomforts and
the anticipated benefits
• Determine that adequate provisions are in place for
monitoring the data collected.

 • Consists of members from different

IRB educational and professional backgrounds

(businessmen, clergymen, social workers…)
Composition • SGU’s IRB consists of members from SGU and
from the community

 • All projects that use human subjects no matter

Types of the mode of data collection

Projects – Experiments
– Clinical trials
Submitted to – Surveys

IRB – Observational behavioral studies

– Case studies

 • The probability and magnitude of harm or discomfort

anticipated in the research are not greater in and of
Minimal themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
Risk examinations or tests
• Source: 45 C.F.R. § 46.102(i)

 What are the Types of IRB Review?

Source: http://oprs.usc.edu/review/typesofirb/
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 • Physical risks
• Emotional distress
• Psychological trauma
• Embarrassment

Types of • Social stigmatization

• Loss of employment
Risks in • Shame or guilt
Research • Invasion of privacy

• Breach of confidentiality

• Source: NIH Protecting Human Research Participants training course

 • "when some or all of the subjects are likely to be

vulnerable to coercion (physical pressure) or undue
influence (moral pressure)” to participate…
Vulnerable
• Typical examples include children, prisoners,
Groups pregnant women, physically or mentally disabled
persons, or economically or educationally
disadvantaged persons

 • Provide complete information in the protocol regarding the

experimental design and the scientific rationale underlying
the proposed research, including the results of previous
animal and human studies.
• Assemble a research team with sufficient expertise and
experience to conduct the research.

Risk • Ensure that the projected sample size is sufficient to yield

useful results.

Safeguards • Collect data from standard-of-care procedures to avoid

unnecessary risk, particularly for invasive or risky procedures
(e.g., spinal taps, cardiac catheterization).
• Incorporate adequate safeguards into the research design
such as an appropriate data safety monitoring plan, the
presence of trained personnel who can respond to
emergencies, and procedures to protect the confidentiality of
the data (e.g., encryption, codes, and passwords).

Informed Consent
 Fully informing participants of the risks, benefits, and
procedures involved in a study is a standard requirement
in research with human participants.

Ethically and legally, consent is not considered to be

"informed" unless the investigator discloses all the facts,
risks, and discomforts that might be expected to

What is influence an individual's decision to willingly participate

in a research protocol.

Consent? This applies to ALL types of research including surveys,

interviews, and observations in which participants are
identified, and other experiments, such as diet, drug and
exercise studies.

Must be voluntary
 • Signed informed consent is the standard in research
with human participants.
– This is in the form of a document with the elements
of informed consent, signed and dated by the
participant and kept as a record by the researcher.
• In some circumstances, investigators can seek
alternatives to standard informed consent
Types of procedures, such as:
Consent – A waiver of using a signed consent form (e.g., giving
participants an information sheet but not collecting
signatures)
– A waiver of written consent (e.g., using oral consent
procedures)
– A waiver of some or all of the elements of informed
consent (e.g., in research that involves deception)

 • Consent – Adults
• Assent – Children
– In research involving minors, a parent must
Age of give permission to allow the child to participate
participants in the research, and children who are able to
understand information about participation are
matter asked to "assent" or agree to participate as
well.
– In research children can say no even if the
parent says yes.

 • When a research participant takes part in a

research activity
Implied – Common practice for surveys that are mailed
out
Consent
• Participants must still be provided with all the
information*

Research Misconduct
 Research • Fabrication, falsification, plagiarism in
proposing, performing, or reviewing research,
Misconduct or in reporting results.
 • Making up data or results and recording or
Fabrication reporting them.
 • Manipulating research materials, equipment,
or processes, or changing or omitting data or
Falsification results such that the research is not accurately
represented in the research record.
 • Using another person’s ideas, processes,
Plagiarism results, or words without giving appropriate
credit.
 • Can erode trust among:
– colleagues
– researchers and funding agencies
Consequences • Loss of confidence by the public in the ability
of Research and integrity of researchers
Misconduct • Misinformation in the medical literature
• Retraction of publications
• Damage to careers of researcher

 Writing IRB
Applications


 No research should begin prior
to approval by IRB

 • Have I carefully considered my research

question and how I will answer it?
Before • Have I carefully considered who will be needed
starting the to answer my research question?
IRB • Have I carefully considered potential risks to
participants in my research?
Application • Have I carefully considered how I will collect,
analyze and store my information?

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 • IRB application for review*

• Consent document/script*
• Questionnaire
What is • Other supporting documents (approvals/
support)*
Required? • CITI training course certificate in RCR*

*Available on IRB or Office of Research webpages

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 • Responsible Conduct of Research (RCR)

• Link: https://mycampus.sgu.edu/web/office-of-
research/citi

CITI Training

29

 • Human involvement
• Purpose
• Social Value
• Background
• Population
IRB •
•
Recruitment
Participant details
Application •
•
Methodology
Risks
Form • Benefits
• Data/sample collection, storage and use
Key Points • Confidentiality
• Informed consent
• Funding
• Conflict of interest

 • Person soliciting consent - Introduce yourself, name, title, position, institution.

• State the Research goal - Explanatory, ‘We are trying to…’, ‘What we will probably
find is…’ ‘What we hope will happen when we finish is that…’.

• Recruitment criteria - The only people who can help us do this research are …,
they must be …’.

IRB Consent • Participant’s role - ‘We will ask you to…’, ‘We will do this where, when, how many
times, for how long’, ‘You will have [how long, days/mins] to let me know your

Form decision’.

Key Points • Use and management of data - Explain type of sample/info, what you will do
with it, how long it will be kept, possible future use, who will have access. If data
might be embarrassing or stigmatizing to participants, describe protections for
confidentiality. If relevant, describe marketable product being designed or
tested).

• Probable benefits - Be realistic, ‘if you do this, you will …’, ‘your family might …’).

 • Possible harms - Describe discomfort and any other harm that might
occur to the participant or their family through participating. When
relevant, state who will provide and pay for medical care if needed as
a result of any harm incurred through participating.

• Understanding - Ask ‘what do you think we are trying to learn/do?’

IRB Consent and ‘how do you think this might help you?’, and ‘What else do you
want to know before you decide?’.

Form • Voluntariness - ‘You do not have to do this. If you do, you can stop at
any time. ‘Doctors and nurses at this clinic will still treat you when
Key Points you need help’, ‘Would you like to do this?’.

• PI Responsible -You can call [me/other] if you want to know the

results of your tests or the study outcome. You can call [me/other] if
you have any questions later about this, or if you have any problem
due to participating..



 Seven 1. Social value: is the research valuable? Can it lead to

improvements in health or wellbeing? Can it
components generate knowledge?
of Ethics 2. Scientific validity: is the research methodologically
Analysis rigorous and scientifically sound?
3. Fair subject selection: are people being excluded
that Guide from research without a valid reason? Are
Review participants elected based on scientific criteria?

 4. Favorable risk-benefit ratio: can the risks to

Seven individuals be minimized? Can the potential
components health related benefits to individuals be
enhanced?
of Ethics
Analysis 5. Independent review: to avoid conflict of
interests which can distort researchers’
that Guide judgment.
Review

 6. Informed consent: have individuals been informed

about the research? Do people understand that they
are participating in research? Have they understood
Seven the information? Have they provided their voluntary
consent?
components
7. Respect for enrolled subjects: will the privacy of
of Ethics subjects be protected? do they have the opportunity
Analysis to withdraw? Will they be provided with new info
such as results and access to treatment if appropriate?
that Guide
Source: Emanuel, Wendler and Grady, “What Makes Clinical Research Ethical” JAMA
Review 200;238:2701-11

 • Dependent on the nature of your study and the

characteristics of the people you intend to recruit.
• Research projects may be eligible for an exemption, for
which you should allow at least 2 weeks for IRB review.
• Research projects that involve only minimal risks may
be eligible for expedited review, for which you should
How long to allow at least 4 weeks for IRB review.
receive • Projects that involve greater than minimal risk to
participants will need to go to the convened full board
Approval? committee for review, which is scheduled as needed.
For applications requiring full board review, you should
allow at least 4-6 weeks for review and approval of your
study.

 • Use simple, clear language in your study

description
– IRB members include attorneys, ministers,
businessmen and women, as well as scientists
Tips to from many fields. If your project description
Reduce IRB assumes knowledge in your area, some IRB
members may not fully understand it.
Application • Provide an outline of procedures
Turnaround – If you have multiple measures with multiple

Time phases or interventions, a simple outline of

procedures will save IRB members review time
and can help them understand exactly what
happens to the subject at each step of the study.

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

 • Write your project description in present/future

tense
– Reviewers cannot tell whether studies or some parts
of studies, such as pilot research, have already been
done when descriptions are entirely in the past
Tips to tense.

Reduce IRB • Be aware that IRB uses a cost-benefit approach

– Not only does the IRB try to protect subjects, it also
Application weighs the predicted benefit of a study against the
risks.
Turnaround – A clear statement of why your research is important,
Time how it fills a need, how it addresses limitations of
previous research, and how it may directly or
indirectly benefit the subjects or others will add
points to the IRB's “benefits” column and make risks
more acceptable.

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

 • Show your awareness of your study's risks

– Not all risks need to be listed on the consent form, but all risks
should be clearly articulated on the study description. Do not be
Tips to “defensive” about risks. Instead, show the IRB you are fully
aware of all possible risks by listing them and then by

Reduce IRB commenting on how significant they might be, how frequently
they occur in this type of research, how you intend to address
them, if necessary, and how you will train experimenters.
Application • Give information on measurement validity
Turnaround – A measure of unknown validity can severely or completely
compromise a study's value and shift the risk/benefit ratio from
Time acceptable to unacceptable. Briefly mention the validity of
measurement procedures, either by citing literature and validity,
or by simply mentioning that they are standard measures for the
field and appear in published, peer-reviewed literature, if that is
the case.

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

 • Use advisors as reviewers

– Students should have their advisor review their
application.
• Justify any exclusions from your sample (such as age, race
Tips to or gender)
– No population should be excluded from research
Reduce IRB without clear justification

Application • Submit all scripts with the proposal

– The best way to help the IRB understand risks and how
Turnaround you will handle them is to provide precise scripts of
what you will tell subjects in recruitment conversations/
Time –
calls, in task instructions, etc.
IRB reviewers ask the question: “What information are
the subjects getting (or not getting) that would help
them decide to participate (or not) or to continue to
participate, and is this information being given as soon
as possible?”

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

 • Proofread very carefully to ensure accuracy and consistency

throughout the application
– As examples; some applications have listed conflicting numbers
Tips to of subjects, ages of subjects, and numbers of sessions.

Reduce IRB • DON'T use jargon or complex wording on the consent form
Application – One goal of the consent form is to have the subject understand
everything that is to happen to him or that she will be asked to
Turnaround do. Provide complete, but simple, descriptions of tasks, the
setting, the time required, etc.

Time –
–
Target the reading level of your consent form to the subjects.
Have someone outside your department read your form to see if
they understand every word in it and can explain it to you.

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

 Tips to • DON'T submit applications that do not have all

signatures
Reduce IRB
Application • Contact us with questions
– We can help with such dilemmas as “How do I
Turnaround get started,” “Is my project ‘research’ under
Time IRB,” etc.

Adapted from: https://research.olemiss.edu/irb/protocol/

tips

Want to know
more?

• http://www.sgu.edu/research/
institutional-review-board/
 • Goohi R.B. (2011). The Nuremberg Code – A Critique. Perspect Clin Res.
2011 Apr-Jun; 2(2): 72–76. Available at: http://www.ncbi.nlm.nih.gov/pmc/
articles/PMC3121268/

• The Belmont Report available at: http://videocast.nih.gov/pdf/

ohrp_appendix_belmont_report_vol_2.pdf.

• World medical Association Declaration of Helsinki. Available at: http://

www.wma.net/en/30publications/10policies/b3/17c.pdf.

• Office of Research Integrity. Introduction to the Responsible Conduct of

References Research, revised ed. Washington, DC: U.S. Department of Health and
Human Services, 2007 (available at https://ori.hhs.gov/sites/default/files/
rcrintro.pdf)

• Institute of Medicine and National Research Council, Integrity in Scientific

Research: Creating an Environment That Promotes Responsible Conduct,
2002.

 • Institute of Medicine. The Responsible Conduct of Research in the

Health Sciences, Washington, DC: National Academies of Science,
1989. (available at: http://www.nap.edu/books/0309062373/html)
• National Academy of Sciences. Committee on the Conduct of Science.
On Being a Scientist: Responsible Conduct in Research, 2nd ed.
Washington, DC: National Academy Press, 1995. (available at: http://
www.nap.edu/readingroom/books/obas/)
• ICJME Publication guidelines Available at http://www.icmje.org/icmje-
References •
recommendations.pdf
Information adapted from the Caribbean Research Ethics Initiative
(CREEi) training program.
• Cash, R, Wikler, D, Saxena, A, Capron, A (2009). Casebook on Ethical
Issues in International Health Research. World Health Organization.
ISBN 978 92 4 154772 7
• UCSB Office of Research - Responsible Conduct of Research. Retrieved
from: https://www.research.ucsb.edu/compliance/responsible-conduct-
of-research

 Kareem Coomansingh
IRB Administrator
Office of Research
Tel: (473) 444-4175 x
3221
Email:
Questions?
kcoomans@sgu.edu

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