In regulatory affairs, what does an Institutional Review Board (IRB) primarily assess?

An Institutional Review Board (IRB) plays a crucial role in the oversight of research involving human subjects by primarily assessing the safety and ethical considerations associated with such research. The IRB evaluates whether the rights and welfare of the subjects are adequately protected and ensures that the research complies with ethical standards and regulatory requirements. This includes reviewing the research proposals to assess the potential risks to participants, the informed consent process, and the overall design of the study to ensure it is ethically sound.

The focus on safety and ethics is vital because research often involves interventions or experiments that may pose risks to participants. By approving or disapproving studies based on these criteria, the IRB ensures that human subjects are not exposed to unnecessary harm and that their participation is voluntary and informed.

In contrast, marketing strategies, financial viability, and post-approval device performance pertain to different domains of regulatory affairs and are not the primary concerns of an IRB. These aspects may be evaluated by other regulatory bodies or departments, but the IRB's mandate is specifically centered on protecting human subjects participating in research.