Which entity acts as a key institution responsible for reviewing research proposals involving PHI?

The Institutional Review Board (IRB) serves as a critical entity responsible for reviewing research proposals involving Protected Health Information (PHI). The primary function of an IRB is to ensure that research involving human subjects is conducted ethically and in accordance with applicable regulations. This includes evaluating the risks and benefits of the research, ensuring that the rights and welfare of participants are protected, and that appropriate measures are in place to safeguard their PHI.

The review process conducted by the IRB is essential in safeguarding patient confidentiality and ensuring that researchers comply with HIPAA regulations regarding the use of PHI. The IRB assesses whether the researchers have adequately addressed informed consent and how they will handle and protect PHI throughout the research process.

In contrast, while the Food and Drug Administration (FDA) also oversees research, particularly related to drug and medical device trials, its focus is more on the safety and efficacy of these products rather than the direct handling of PHI. The Department of Health and Human Services (HHS) provides oversight for HIPAA compliance generally, but it does not specifically review individual research proposals. Similarly, State Health Departments play roles in public health and regulation within their jurisdictions but do not conduct the same level of scrutiny on research proposals involving PHI as IRBs