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, 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 sections below describe the levels of review as defined by federal regulation (45 CFR 46).
Full Board*
The ACE IRB will conduct a full review (five members will review the application and proposal) when the following criteria are present:
- The chair determines that more than “minimal risk” is present to subjects
- Not covered under other review categories.
- Examples: surveys or interviews for research purposes, interventions, research with vulnerable populations, etc.
*The vast majority of IRB applications will be reviewed by the full board. ACE doctoral students, unless they are not using human subjects, should prepare for a full board review.
Expedited
The ACE IRB Chair will conduct a review of the IRB application and research proposal when the following criteria are present:
- Does not involve human subjects
- Research is conducted in noninvasive means
- Examples: research conducted with existing documents/records
Exempt
The IRB chair will review IRB submissions to determine if they are exempt from IRB review. Most applications/research proposals will not be eligible to be exempt. Research will typically be exempt if it is within the institution for the institution. An example of exempt review would be course evaluations. If a research proposal is exempt, no additional review will be needed for the research to be conducted.
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