Federal regulations require that in conducting the initial review of proposed research, Institutions Review Boards obtain information in sufficient detail to make the determinations required under 45 CFR 46.111 (or 21 CFR 56.111 for FDA regulated research) regarding risks, potential benefits, informed consent, and safeguards for human subjects. If you are not sure or need official documentation with the Research Administration’s determination of your study type, you are encouraged to contact Research Administration to receive an official determination.
There are three categories of research review:
Certain research studies may be considered exempt from the regulations. A determination of exempt status must be made by the IRB prior to study initiation.
Once a study is determined to be exempt the research activity is not monitored by the IRB and is not subject to continuing IRB oversight, assuming the project does not change. Exempt status does not, however, lessen the ethical obligations to subjects. Depending on the circumstances, investigators performing exempt studies may still obtain a modified form of informed consent, protect confidentiality, minimize risks, and address problems or complaints.
In order to have a research project recognized as exempt, investigators will need to submit a Request for Exemption from IRB Review form, along with other study related materials (e.g., consent forms, surveys, questionnaires, and interview scripts) to the IRB. The exemption request form can be found here. The IRB will evaluate exemption requests and notify investigators if their projects qualify to be designated as exempt.
Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult with RA to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.
2. Expedited Review
Certain types of research studies may be eligible for an expedited review process. Studies that are no more than minimal risk and fit under the categories for expedited still require IRB approval, but do not need full board review. Expedited review and approval by the IRB must occur prior to study initiation.
3. Full Board Review
Most studies that require full board review are more than minimal risk and/or involve interventions or procedures that do not qualify under expedited. IRB Full board review and approval must occur prior to study initiation.