Institutional Review Board (IRB) Processes Flashcards

Which of the following is NOT one of the IRB's criteria for approving research under 45 CFR 46.111?

Answer: The study is likely to produce statistically significant results

The 46.111 criteria cover risks, benefits, equitable selection, consent, monitoring, and privacy, not guaranteed statistical outcomes.

When weighing risks against benefits, which consideration should an IRB NOT include?

Answer: Possible long-range effects of applying the knowledge gained, such as effects on public policy

46.111(a)(2) tells IRBs not to consider long-range effects of applying the knowledge gained as research risks.

Which is one of the required criteria for an IRB to waive informed consent under 45 CFR 46.116(f)?

Answer: The research involves no more than minimal risk to subjects

A waiver requires minimal risk, impracticability without the waiver, and no adverse effect on subjects' rights and welfare, among other criteria.

Under the 2018 revised Common Rule, which review model is generally required for federally funded cooperative research at multiple US sites?

Answer: A single IRB of record for all US sites

Since January 2020, most US-based cooperative research must rely on a single IRB under 46.114(b).

An IRB votes to approve a study on the condition that the investigator makes specific, minor wording changes to the consent form. Who typically confirms that those changes were made?

Answer: The IRB chair or a designee, without another convened meeting

For approval with specific minor conditions, the chair or a designee can confirm that the changes were made.

The IRB disapproved a study, but a dean strongly supports it. What can institutional officials do?

Answer: They cannot approve research that the IRB disapproved

Under 46.112, officials may further review and disapprove IRB-approved research, but they cannot approve research the IRB has disapproved.

Which activity matches an OHRP expedited review category (Category 2)?

Answer: Blood collection by venipuncture from healthy, nonpregnant adults weighing at least 110 lb, not exceeding 550 mL in 8 weeks

Expedited Category 2 covers limited blood draws by finger stick, heel stick, ear stick, or venipuncture within set volume and frequency limits.