IRB review focuses on several critical aspects of the research protocol:
1. Risk-Benefit Analysis: The IRB assesses whether the potential benefits of the research outweigh the risks to participants. 2. Informed Consent: The IRB evaluates the process for obtaining informed consent from participants, ensuring that it is clear, comprehensive, and voluntary. 3. Confidentiality Protections: Measures to protect the privacy and confidentiality of participants' data are scrutinized. 4. Vulnerable Populations: Special considerations are given to studies involving vulnerable populations, such as children, pregnant women, and prisoners.
