Institutional Review Board (IRB) Processes Flashcards

An IRB member is a co-investigator on a protocol being reviewed at the meeting. What is the appropriate action?

Answer: The member may not take part in the review except to provide information the IRB requests, and does not vote

Under 46.107(d), members with a conflicting interest may not take part in initial or continuing review except to provide requested information.

The Common Rule requires every IRB to include at least one member who is:

Answer: Not otherwise affiliated with the institution and not part of the immediate family of someone affiliated

At least one member must be unaffiliated with the institution so the community's perspective is represented.

When an IRB reviews research involving prisoners under Subpart C, which membership requirement applies?

Answer: At least one member must be a prisoner or a prisoner representative, and a majority must have no association with the prison

Subpart C requires a prisoner or prisoner representative, and a majority of members (excluding prisoner members) with no association with the prison.

An IRB invites an outside expert in pediatric oncology to help review a complex protocol. What role can that consultant play?

Answer: Provide expertise and take part in discussion, but not vote

Under 46.107(e), IRBs may invite consultants with special competence, but consultants may not vote.

How often must an IRB registration with OHRP be renewed?

Answer: Every 3 years

IRB registrations with OHRP must be renewed every three years.

What is a Federalwide Assurance (FWA)?

Answer: An institution's written commitment to HHS that it will comply with human subjects protection regulations

An FWA is the institution's formal assurance to OHRP that it will protect human subjects in federally supported research.

When an IRB regularly reviews research involving a vulnerable category of subjects, such as people with impaired decision-making capacity, the regulations say the IRB should:

Answer: Consider including one or more members knowledgeable about and experienced in working with those subjects

46.107(a) says IRBs should consider including members experienced with vulnerable populations they regularly review.