What role do IRB members play when evaluating research protocols?

IRB members are essential in protecting the rights and welfare of human research participants. Their primary role when evaluating research protocols is to provide recommendations on ethical standards. They assess whether the proposed research adheres to ethical principles such as respect for persons, beneficence, and justice. This involves reviewing the informed consent process, evaluating risks versus benefits, and ensuring that participant selection is equitable.

The focus of an IRB is not to enforce legal penalties for violations, as this is typically outside their purview. While they may consider the broader implications of a study's funding, their main task is not to determine funding worthiness. Similarly, IRBs do not decide if a study is truly needed; rather, they evaluate how ethically the study is designed and whether it protects participants, regardless of its necessity. Thus, providing recommendations on ethical standards encapsulates the essence of an IRB's function in the research review process.