What is the role of the Institutional Review Board (IRB)?

The role of the Institutional Review Board (IRB) is primarily to review research protocols and informed consent documents to ensure that research involving human subjects is conducted ethically and in compliance with regulatory guidelines. The IRB evaluates the potential risks to participants against the potential benefits of the research, ensuring that the rights and welfare of the participants are protected. This includes assessing whether the informed consent process is adequate and that participants are fully aware of the risks and benefits involved in the research study.

Other options present roles that do not align with the primary function of an IRB. For instance, marketing approved drugs falls under the purview of the pharmaceutical industry and regulatory agencies, while conducting safety assessments of marketed drugs is typically the responsibility of pharmacovigilance and regulatory authorities. The development of new drugs involves research and development teams and clinical trials, which might require an IRB’s oversight, but the IRB itself does not engage in the development process. Overall, the IRB's critical function is to uphold ethical standards in research involving human subjects, focusing on safeguarding participants' wellbeing.