When is IRB review necessary?

IRB review is necessary for all research involving human subjects conducted at or by an institution because it is a critical safeguard designed to protect the rights and welfare of those participants. Institutions must ensure that any research involving human subjects adheres to ethical standards and regulatory requirements. This includes assessing the potential risks of the research, obtaining informed consent from participants, and ensuring privacy and confidentiality.

The requirement for IRB review encompasses a broader scope beyond funding sources or specific groups conducting research. It includes all forms of research that involve human interaction, thereby upholding ethical standards across the board, regardless of who is conducting the research or where it is funded. This comprehensive approach ensures the well-being of participants and fosters trust in the research process, which is vital for legitimate scientific inquiry.