8 Criteria for IRB Approval of
Research
45 CFR 46.111(a)
Criterion #1 – Risks to Participants are
Minimized
• By using procedures which are consistent with
sound research design
• By using procedures which do not
unnecessarily expose subjects to risk
• When appropriate, by using procedures
already being performed on the subjects for
diagnostic or treatment purposes.
Criterion #1 – Questions IRB Must Ask
• What are the physical, psychological, social,
legal, and economic risks?
• Can fewer and/or alternative procedures
answer the scientific question and reduce the
likelihood and/or magnitude of harm?
• Does data exist (or will data be collected
anyway) that could be used to reduce the
likelihood and/or magnitude of harm?
Criterion #2 – Risks are Reasonable in
Relation to Anticipated Benefits
• The IRB should consider only those risks and
benefits that may result from the research (as
distinguished from risks and benefits of therapies
subjects would receive even if not participating in
the research).
• The IRB should not consider possible long-range
effects of applying knowledge gained in the
research (for example, the possible effects of the
research on public policy) as among those
research risks that fall within the purview of its
responsibility.
Criterion #2 – Questions IRB Must Ask
• What are the risks associated with
participation in the research?
• What are the benefits associated with
participation in the research?
• Is the importance of the aims clear?
• Is the research likely to achieve its proposed
aims? Research that cannot achieve its
proposed aims has no benefit.
Criterion #3 – Selection of Participants
is Equitable
• The IRB must take into account:
– Purposes of the research
– Setting in which the research will be conducted
– Vulnerable populations such as children,
prisoners, pregnant women, mentally disabled
persons, or economically or educationally
disadvantaged persons.
Criterion #3 – Questions IRB Must Ask
• Which populations are likely to enroll in the research?
• Are vulnerable populations likely participants?
• What safeguards exist to protect vulnerable
populations?
• How will prospective participants be recruited?
• Are the benefits/burdens of participation fairly
distributed among all populations?
• Are any populations unfairly targeted or excluded?
• What are the inclusion/exclusion criteria?
Criterion #4 – Informed Consent
• Must be sought from each prospective
participant or the participant's legally
authorized representative
• IRB may approve a consent procedure which
waives or alters some or all of the elements of
informed consent (as outlined in 45 CFR
46.116)
Criterion #4 – Questions IRB Must Ask
• What is the informed consent process, of which
the informed consent document is one
component?
• Is the information provided in understandable
language?
• Is the possibility of coercion or undue influence
minimized?
• Is the consent process free of exculpatory
language?
• Do participants have sufficient opportunity to
consider whether to participate?
Criterion #5 – Informed Consent is
Documented
• The IRB may waive the requirement to obtain a signed
consent form if:
– The only record linking the subject and the research
would be the consent document and the principal risk
would be potential harm resulting from a breach of
confidentiality.
or
– The research presents no more than minimal risk of
harm to subjects and involves no procedures for which
written consent is normally required outside of the
research context.
• Waiver not allowed if research is subject to FDA
regulations.
Criterion #5 – Questions IRB Must Ask
• Does the written summary (informed consent
document) contain all required elements?
• What information will the investigator disclose
if consent documentation is waived?
Criterion #6 – Data will be Monitored
to Ensure Participant Safety (When
Appropriate)
• Typically required in studies involving an
intervention and greater than minimal risk
Criterion #6 – Questions IRB Must Ask
• Does the research involved greater than
minimal risk?
• Is there an intervention?
• If a plan is required, how often will the data
and accompanying reports be reviewed?
• If a plan is required, who will review the data?
Criterion #7 – Privacy is Protected And
Confidentiality is Maintained
• Privacy is about people
– Privacy is in the eye of the participant
• Confidentiality refers to data
Criterion #7 – Questions IRB Must Ask
(Privacy)
• How will the privacy of participants be
protected?
• What expectations of privacy will participants
have?
• Will participants be comfortable in the
research setting?
Criterion #7 – Questions IRB Must Ask
(Confidentiality)
• Are there legal/ethical requirements that
necessitate confidentiality?
• Is the data anonymous (or could it be collected
anonymously)?
• Will the accidental release of data increase the
potential risk of harm (social, psychological,
economic, etc.)
• How will access to data be protected (locks,
passwords, encryption, etc.)
• How long will data be stored?
Criterion #8 – Safeguards Exist to
Protect Vulnerable Populations (When
Appropriate)
• Applicable when some or all of the participants
are likely to be vulnerable to coercion or undue
influence
– Examples include children, prisoners, pregnant
women, mentally disabled persons, students,
employees, or economically or educationally
disadvantaged persons
• How will the rights and welfare of these
participants be protected?
Criterion #8 – Questions IRB Must Ask
• Is the risk-benefit relationship appropriate to
the vulnerable populations?
• Have all reasonable steps been taken to
minimize the possible of coercion and undue
influence of the vulnerable populations?
• Are participants able to provide a truly
informed consent (is an assessment of the
participant’s capacity or the permission of a
legally authorized representative necessary)?