Question

Exempt research is research with human subjects. However, it is "exempt" from the provisions stated in Title 45, Part 46, Subpart A (the Common Rule). Federal guidance recommends that investigators not be allowed to self-determine whether a study qualifies for exemption. Therefore, exempt studies generally are reviewed and determined by the IRB, or its representative. Expedited and Full/Convened Board reviews both require IRB approval

Answer 1

IRBs play a vital role in the ethical oversight of research involving human subjects, focusing on informed consent, participant safety, and confidentiality. Exempt research still requires an IRB review to ensure compliance with ethical guidelines.

Step-by-step explanation:

Institutional Review Boards (IRBs) are essential in overseeing research involving human subjects. An IRB is a committee that contains administrators, scientists, and community members. Its purpose is to ensure research is conducted in an ethical manner, adhering to federal regulations which protect human participants.

The key aspects they look at include minimizing risks to participants, ensuring informed consent, and maintaining participant confidentiality. Research deemed exempt is that which involves minimal risk to participants and falls under specific categories identified by regulation.

While the review of exempt research might be less comprehensive compared to non-exempt research, it nonetheless requires review by the IRB to ensure all guidelines and ethical considerations are met.