Under the Common Rule, which IRB membership requirement is true?

Study for the Clinical Research and Ethical Considerations Test. Enhance your understanding with multiple choice questions covering essential ethical guidelines and research methodologies. Prepare effectively for your test!

Having diverse membership is essential for ethical and scientific review of human research. The Common Rule requires an IRB to have at least five members with varying backgrounds, including at least one member whose primary concerns are in non-scientific areas and at least one member who is not affiliated with the institution. Including someone with scientific expertise ensures the board can properly evaluate the study’s design, risks and benefits, and overall scientific validity.

So, having at least one member with scientific expertise is a true and important part of meeting the IRB’s structure. The other statements aren’t correct because an IRB does not need every member to be affiliated with the institution (unaffiliated members are required), it is not limited to unaffiliated laypersons only, and the board should include both scientific and nonscientific members, not just laypersons.