SOCRA - Society of Clinical Research Associates Institutional Review Board (IRB) Questions and Answers 2

Question 1

What is the minimum IRB membership composition?

Accepted Answer

At least 5 members with diverse backgrounds, including one non-scientific and one unaffiliated member

Answer

Per 21 CFR 56.107, at least 5 members with varying backgrounds including non-scientific and unaffiliated members.

Question 2

Full board review vs expedited review?

Accepted Answer

Full board requires quorum with discussion and vote; expedited allows chair to review minimal risk research

Answer

Full board requires a convened meeting with quorum; expedited allows designated member(s) to review minimal risk research.

Question 3

What is continuing review and how often?

Accepted Answer

At least annually, at intervals appropriate to the degree of risk

Answer

Per 21 CFR 56.109, continuing review must occur at least annually.

Question 4

What must the IRB consider when reviewing a protocol?

Accepted Answer

Protocol, consent, investigator qualifications, recruitment, risk/benefit assessment, and participant protections

Answer

The IRB must review the complete protocol, consent, qualifications, recruitment, risk/benefit, and monitoring plans.

Question 5

What are IRB responsibilities for unanticipated problems?

Accepted Answer

Must have procedures for receiving, reviewing reports, and determining appropriate actions

Answer

Per 21 CFR 56.108, IRBs must have written procedures for receiving and reviewing reports of unanticipated problems.

(SOCRA) Society of Clinical Research Associates Practice Test