If an IRB thinks that subjects might be at risk in a study, the researcher must be able to convince the Board that
A) the value of the knowledge to be gained in the study exceeds the potential harm to subjects.
B) appropriate medical or support services will be available to subjects who feel a need.
C) subjects will be informed of the risks and the researcher will obtain voluntary and written consent.
D) a and c
E) a, b, and c

Question

Quizplus · Accepted Answer

When an Institutional Review Board (IRB) evaluates a study that might put subjects at risk, the researcher must demonstrate that the potential benefits of the research outweigh the risks (A), that there will be adequate support services available for participants (B), and that participants will be fully informed of the risks and consent will be obtained in a voluntary and documented manner (C). Therefore, all three conditions (A, B, and C) are necessary to justify the study to the IRB.

If an IRB Thinks That Subjects Might Be at Risk