What is the primary responsibility of the Institutional Review Board/Independent Ethics Committee (IRB/IEC)?

Boost your GCP E6 (R3) exam readiness. Improve your understanding with engaging, insightful questions. Test yourself with hints and detailed explanations. Prepare effectively!

Multiple Choice

What is the primary responsibility of the Institutional Review Board/Independent Ethics Committee (IRB/IEC)?

The core duty is to protect people who take part in research. An IRB/IEC is an independent group that reviews study plans to ensure the rights, safety, and welfare of participants are protected throughout the trial. They examine whether risks are minimized and reasonable compared with the potential benefits, verify that informed consent will be obtained and understandable, and check that participants are chosen fairly and without exploitation. They also look at privacy and confidentiality safeguards and require ongoing safety oversight, including continuing review and adverse event reporting. This protection-focused role is central to ethical conduct in clinical research and aligns with established standards like GCP and the Declaration of Helsinki. The goals of maximizing efficiency, recruiting participants, or boosting sponsor profits do not fall within their mandate.

The core duty is to protect people who take part in research. An IRB/IEC is an independent group that reviews study plans to ensure the rights, safety, and welfare of participants are protected throughout the trial. They examine whether risks are minimized and reasonable compared with the potential benefits, verify that informed consent will be obtained and understandable, and check that participants are chosen fairly and without exploitation. They also look at privacy and confidentiality safeguards and require ongoing safety oversight, including continuing review and adverse event reporting. This protection-focused role is central to ethical conduct in clinical research and aligns with established standards like GCP and the Declaration of Helsinki. The goals of maximizing efficiency, recruiting participants, or boosting sponsor profits do not fall within their mandate.

More practice questions