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

Any number from one department

Answer

Only 2 physicians

Answer

No requirements

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

No difference

Answer

Expedited is less thorough

Answer

Full board only for Phase III

Question 3

What is continuing review and how often?

Accepted Answer

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

Answer

Optional

Answer

Only at study completion

Answer

Only for studies over 5 years

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

Only budget and timeline

Answer

Only the statistical plan

Answer

Only manufacturer info

Question 5

What are IRB responsibilities for unanticipated problems?

Accepted Answer

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

Answer

No responsibility

Answer

Only sponsor handles them

Answer

Only reported to FDA

Question 6

Can an IRB suspend or terminate a trial?

Accepted Answer

Yes, for non-compliance or unexpected serious harm per 21 CFR 56.113

Answer

Only FDA can

Answer

Only the sponsor can

Answer

IRBs can only recommend