The 2018 Federal Regulations (45 CFR 46) exemption categories define specific protocols that are exempt from the federal regulation requirements. Protocols that qualify for exemption are still submitted to iProtocol for limited IRB review. The following categories are most likely to be used in a social and behavioral sciences study:
- Flexible consent procedures: the Board can allow more flexibility in how consent is provided and documented (if at all).
- No full board review: An exempt protocol does not need full board review; modifications do not need to be reviewed at a full board meeting unless the protocol modifications change the exemption status.
- Shorter review time: Limited IRB review time should be shorter, generally two to four weeks depending on the protocol load. A full board protocol is reviewed at the full board as well as any continuations or major modifications (some minor edits can be approved administratively), which can take a month or longer.
- Continuation review not required: Exempt protocols only need to be reviewed once (unless a protocol needs to be modified or there is an unexpected adverse event). You will complete an annual Protocol Status Update to verify that the protocol is still active.
- Submission requirements and pre-review requirements are the same.
- Modifications: Your protocol should always reflect your study's practice and if it doesn't, you need to modify the protocol. Exempt modifications receive limited IRB review but please consider grouping modifications into one submission. If you are changing personnel, use the Personnel Management Tool instead of submitting a modification for this change.
- Update Protocol Status: Exempt protocols do not require an annual continuation review; rather you will be asked on an annual basis to update your protocol's status (if you haven't submitted a modification for review over the previous year). You will receive an email notification one month prior to your protocol's annual notification date with information about how to complete the simple Protocol Status Update form. Failure to complete the form could result in study closure.
- Unexpected Event Report: Research doesn't always go according to plan and if that happens, you may need to submit an unexpected event report.
- Study Closure: Once a study is complete, the protocol needs to be closed.