Who has the responsibility for protecting research participants during a clinical trial?

The responsibility for protecting research participants during a clinical trial primarily lies with the independent Institutional Review Board (IRB) or Independent Ethics Committee (IEC). These bodies are tasked with reviewing the study protocol before the trial commences to ensure that the rights, safety, and well-being of participants are prioritized. This includes evaluating the informed consent process to ensure that participants are fully aware of the potential risks and benefits involved in the study.

The IRB/IEC also monitors ongoing studies to ensure compliance with ethical standards and regulatory requirements throughout the trial. Their independent nature provides an essential layer of oversight to protect participants, distinguishing their role from other stakeholders involved in the trial.

While the principal investigator, the research institution, and the funding sponsor all have responsibilities related to the conduct of the trial and participant safety, the IRB/IEC acts as an independent entity that specifically focuses on ethical considerations and participant protection. Thus, their role is crucial in upholding ethical standards throughout the clinical research process.