Question 8 of 20 Fundamentals Concept
What does an IRB or ethics committee review before a trial can start?
Short answer
An institutional review board (IRB) or independent ethics committee checks that the trial is ethical and that participants are protected. It reviews the protocol, the consent materials and process, payments to participants and the investigator's suitability. No participant may be enrolled before its documented approval.
Why
The committee is independent of the sponsor and the investigator, and only independent members vote. It asks whether the risks are justified by the expected benefit, whether the consent information is clear and complete, and whether vulnerable groups such as minors get extra protection. It reviews the amount and timing of payments, so that money does not pressure anyone to join or stay.
E6(R3) recommends at least five members, at least one whose main interest is outside medical science and at least one independent of the institution. US rules in 21 CFR 56.107 also require at least five members, including a nonscientific member and one not affiliated with the institution. Review continues after approval.
Protocol changes need approval before use, except a change needed to remove an immediate hazard to participants. In the EU, the ethics review sits inside each Member State's single authorization decision under the Clinical Trials Regulation, so the committee does not act on a separate track from the regulator.
A strong answer covers
- Independence from sponsor and investigator
- Risk and benefit, consent materials, payments and vulnerable groups
- No enrollment before documented approval
- Continuing review and approval of amendments
- Membership minimums in E6(R3) and 21 CFR 56.107
Common mistakes
- Thinking ethics approval is a one time event with no continuing review.
- Believing the sponsor or investigator can vote on their own trial.
- Assuming an approved consent form proves each participant understood it.
The interviewer might ask next
When may a site change a procedure before the ethics committee has approved the amendment?