Who Approves Affected Activities?

IRB Review

Upon initial review of your research project, the IRB may make one of the following determinations about how the review process will be handled:

• Exemption From IRB Review. Your project activities meet the criteria for exempt research as established in the regulations. Examples of exempt research are outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.101(b).)
• Expedited IRB Review. Your research activities present no more than minimal risk to the human subjects involved and meet the criteria for an expedited IRB review as established in the regulations. Information about the procedures for expedited IRB review is outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.110.)
• Full IRB Review. Your research activities involve minimal risk or greater than a minimal risk to the human subjects involved and your project must receive a full IRB review. Generally, when research activities are subject to a full IRB review, members of the IRB read the IRB application and the research protocols prior to the IRB meeting. At the meeting, a quorum of the IRB members must be present for review and approval of the research project and the protocols to take place.

Research activities, such as conducting a needs assessment or program evaluation, may require a full IRB review if they involve interviewing or surveying victims who are vulnerable to potential risks in connection with their participation in these evaluations, or if the research involves sensitive questions that participants are likely to find stressful or confusing. A full IRB review can take several months before approval is granted, so plan your evaluation timeline accordingly.