Is it considered best practice to allow investigators to determine if their research qualifies as non-exempt human subjects research?

It is not considered best practice for investigators to independently determine whether their research qualifies as non-exempt human subjects research. This determination should be made in collaboration with or under the guidance of an Institutional Review Board (IRB) or a designated institutional official. The reasoning behind this practice is rooted in ensuring compliance with federal regulations, ethical standards, and institutional policies related to the protection of human subjects.

Research involving human participants often carries ethical considerations and various risks that require thorough review and oversight. An IRB is specifically tasked with evaluating research proposals to protect the rights and welfare of participants. Allowing investigators to make this determination independently could lead to inconsistencies, potential ethical violations, and insufficient protection for participants. Consequently, to uphold the integrity of research and the safety of participants, it is critical to involve an independent review body in the decision-making process regarding the classification of research as exempt or non-exempt.