Main Page Content
Scope of IRB Review
IRB review is conducted to ensure that proposed research involving human participants meets the criteria for IRB approval in accordance with 45 CFR 46.111 and 21 CFR 56.111. Specifically, to approve a study, the IRB must find that:
- Risks to participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk.
- Risks to participants are reasonable in relation to: (a) anticipated benefits (if any) to participants and (b) the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research, as distinguished from risks and benefits to which participants would be exposed even if not participating in the research.
- Selection of participants is equitable. In making this assessment, the IRB takes into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, persons with disabilities, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective participant or the participant's legally authorized representative in accordance with and to the extent required by part 50.
- Informed consent will be appropriately documented in accordance with and to the extent required by 50.27.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- Where appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
- When some or all of the participants—such as children, prisoners, persons with disabilities, or economically or educationally disadvantaged persons—are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these participants.
- The principal investigator is qualified to conduct the proposed research.
The IRB is charged to review protocols according to criteria listed above. On occasion, it may be difficult for an IRB reviewer to adequately assess those criteria due to the quality of the submission. Poor quality may be indicated by, and include, the following: (a) inadequate or insufficient information to determine the criteria are met, (b) insufficient scientific justification for the research protocol or plan, or (c) improper or incorrect supporting documentation to the protocol or research plan. In such cases, PIs will be asked to make signficant revisions and resubmit their proposals.