8 Criteria for IRB Approval of Research 45 CFR 46.111(a)
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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)?