IRB review-type helper

FAQ

When can an IRB use expedited review?

Only for minimal-risk research. Under 45 CFR 46.110(b)(1) and 21 CFR 56.110(b), an IRB may use the expedited procedure for research on the published list of expedited categories that the reviewer finds involves no more than minimal risk, and for minor changes to previously approved research. Research that is greater than minimal risk goes to the convened (full board) IRB. Expedited reviewers may exercise all of the IRB’s authorities except disapproval; research can be disapproved only after review by the convened IRB.

Does a non-significant-risk (NSR) device determination make a study minimal risk?

No. FDA’s information sheet “Significant Risk and Nonsignificant Risk Medical Device Studies” (January 2006) tells IRBs not to confuse the SR/NSR determination with minimal risk: for a device study to be eligible for expedited review it must be an NSR study and present no more than minimal risk (21 CFR 56.110). An NSR study that is greater than minimal risk still goes to the full board, which is how this helper treats it.

What makes a device study significant risk?

Under 21 CFR 812.3(m), a significant-risk device is an investigational device that is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or is for a use of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, and presents a potential for serious risk to the health, safety or welfare of a subject, or that otherwise presents such a potential for serious risk. Per FDA’s information sheet, the sponsor makes the initial determination, the IRB reviews it and can modify it, and if FDA has already made the determination, FDA’s decision is final.

What does an NSR device study need before it starts?

Under the abbreviated requirements in 21 CFR 812.2(b)(1), an NSR study is considered to have an approved IDE if the sponsor, among other things, labels the device per 812.5, obtains IRB approval after giving the IRB a brief explanation of why the device is not significant risk, ensures informed consent under 21 CFR Part 50, monitors the study, keeps the required records and reports, and does not promote the device. If the IRB instead finds the device significant risk, it must notify the investigator and, where appropriate, the sponsor (21 CFR 812.66), and the study cannot start without an approved IDE application.

Can a device study be exempt from IRB review?

Rarely. For FDA-regulated clinical investigations, 21 CFR 56.104 exempts only narrow categories from IRB review, such as emergency use reported to the IRB within 5 working days, so the broader Common Rule exemptions in 45 CFR 46.104(d) (for example, certain secondary research) do not remove the FDA IRB requirement. A study that is exempt from the IDE regulations under 21 CFR 812.2(c) still needs IRB review, as FDA’s information sheet notes. This helper only suggests a possible exemption for non-device research with no intervention, and the IRB, not the investigator, should confirm it.

How do vulnerable populations affect the review path?

The IRB must pay particular attention to subjects vulnerable to coercion or undue influence, such as children, prisoners and individuals with impaired decision-making capacity, and make sure additional safeguards are in place (45 CFR 46.111(a)(3) and (b)). Subparts B, C and D of 45 CFR 46 add protections for pregnant women, fetuses and neonates, prisoners, and children, and 46.104(b) limits which exemptions apply to them. This helper flags these studies as likely full board, while noting that some minimal-risk studies may still qualify for expedited review.