The regulations stipulate that in making its decision to approve, modify, or disapprove proposed research activities, the Institutional Review Board must ensure that the risks to subjects are minimized, that the risks to subjects are reasonable in relation to anticipated benefits, and that the selection of subjects is equitable. Where appropriate, the Institutional Review Board must ensure that informed consent will be sought from each prospective subject or the subject’s legally authorized representative, when appropriate that informed consent will be documented, that data collection will be monitored to ensure the safety of the subjects, that the subjects’ privacy is protected and confidentiality of data is maintained, and that the rights and welfare of subjects from vulnerable populations are protected by additional safeguards. [34 CFR 97.111]
Once the researcher submits their IRB application to the ACE IRB, the IRB Chair will review the application to determine the level of review required: full board, expedited, or exempt. The following sections describe the levels of review as defined by federal regulation (45 CFR 46).
Full
The ACE IRB will conduct a full review (five members will review the application and proposal) when the following criteria are present:
- The IRB chair or designee determines that more than “minimal risk” is present to subjects.
Expedited
The ACE IRB Chair or designee will conduct a review of the IRB application and research proposal when the following criteria are present:
- Research does not involve human subjects
- Research is conducted in a noninvasive manner (i.e., research conducted with existing documents/records [archived data].
Exempt
The IRB chair or designee will review IRB submissions to determine if they are exempt from IRB review. In reviewing for exempt review status, the IRB chair or designee will consider the following: Use of certain instruments such as questionnaires/surveys and interviews, minimal harm to potential participants as part of their personal and/or professional lives, questions are non-invasive or leading.
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