When an IRB finds that risks to participants are unclear, what is their best course of action?

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When an Institutional Review Board (IRB) determines that the risks to participants in a study are unclear, the most appropriate action is to request further information and table the protocol for future review. This approach allows the IRB to ensure that participants' rights and welfare are protected before any research begins. It acknowledges the importance of having a clear understanding of potential risks associated with the study.

By requesting additional information, the IRB can encourage researchers to provide more detailed assessments of risks, thus facilitating a more informed decision-making process. This step is crucial because it allows the IRB to address concerns adequately and to ensure that all ethical standards are met, balancing the need for scientific inquiry with the obligation to protect participants.

The other options may not adequately address the IRB's responsibility to safeguard participant welfare. Continuing with the current information presented does not resolve the uncertainty regarding risks and runs the risk of exposing participants to unforeseen harm. Approving the study with stipulations might lead to oversights if the concerns about risks remain unresolved, while outright rejection may dismiss a potentially valuable study without fully understanding the implications and benefits. Therefore, tabling the protocol for further review until more clarity on the risks is obtained is the most prudent action.

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