SOCRA Institutional Review Board (IRB) 5

Question 1

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

Accepted Answer

Office for Human Research Protections (OHRP)

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

Leave the room during discussion and the vote

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Institutional Review Board (IRB) 5