Who must provide oversight for the ethical conduct of clinical trials?

The ethical conduct of clinical trials is overseen primarily by the Institutional Review Board (IRB). The IRB is a committee established to review and approve research involving human subjects, ensuring that the rights, welfare, and well-being of participants are protected. It evaluates the study protocol, informed consent documents, and any potential risks associated with the research.

The IRB's role is crucial because it provides an independent assessment of the ethics of the research proposal, something that is essential to maintain public trust in clinical research. By requiring that research proposals be approved by an IRB before they can proceed, participants are assured that there is oversight regarding ethical standards and compliance with regulations. This helps ensure that the risks are minimized to acceptable levels, participant rights are upheld, and that the science conducted benefits society while respecting individual participants.

While the sponsor, FDA, and investigator play important roles in clinical trials—such as funding, regulatory compliance, and conducting research—the primary responsibility for ethical oversight resides with the IRB. This distinguishes the functions of various entities in the clinical research environment, highlighting the IRB’s unique position dedicated explicitly to safeguarding ethical practices.