Institutional Review Board (IRB) Flashcards

Which federal office is responsible for oversight of the protection of human research subjects in HHS-supported research?

Answer: Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides oversight, guidance, and enforcement for HHS-conducted or -supported human subjects research under 45 CFR 46.

How does FDA IRB oversight (21 CFR Part 56) differ from OHRP oversight (45 CFR 46)?

Answer: FDA oversight applies to research involving FDA-regulated products; OHRP applies to HHS-funded or -conducted research

FDA jurisdiction is product-based (drugs, devices, biologics), while OHRP jurisdiction is funding-based (HHS support), and many studies fall under both frameworks simultaneously.

What must an IRB member do when a study under review represents a conflict of interest for them?

Answer: Leave the room during discussion and the vote

An IRB member with a conflicting interest must leave the room during deliberation and the vote, though they may provide information before leaving if requested.

What is the role of a Federalwide Assurance (FWA) in human subjects research?

Answer: It is a binding commitment made by an institution to comply with the Common Rule for HHS-supported research

An FWA is a formal agreement between an institution and OHRP in which the institution commits to comply with 45 CFR 46 for all HHS-conducted or -supported research.

Under what limited circumstances may research involving human subjects proceed without prospective IRB review?

Answer: Emergency use of a test article under 21 CFR 50.23 and 56.104(c) when IRB review is not feasible

FDA regulations permit emergency use of an unapproved test article without prospective IRB approval when life-threatening situations exist and time is insufficient, but the IRB must be notified within 5 working days.

What is required for an IRB to grant a waiver of informed consent under the Common Rule?

Answer: The research involves no more than minimal risk, rights and welfare are not adversely affected, the research could not practicably be carried out otherwise, and subjects will be debriefed when appropriate

The Common Rule (45 CFR 46.116(f)) allows waiver of consent when four specific criteria are all met, including minimal risk and impracticability of the research without the waiver.

What is the purpose of a Data Safety Monitoring Board (DSMB) and how does it relate to IRB oversight?

Answer: A DSMB independently monitors accumulating safety and efficacy data and may recommend stopping a trial; the IRB remains the ethics overseer

DSMBs provide independent interim safety and efficacy monitoring, but the IRB retains independent ethical oversight authority and must receive DSMB reports as part of continuing review.