Certification for IRB Professionals (CIP) Practice Exam

When an Institutional Review Board (IRB) discovers serious non-compliance in a research study, one of its critical responsibilities is to notify the appropriate regulatory authorities. This is necessary because serious non-compliance can undermine the integrity of the research and potentially harm participants. Regulatory authorities, such as the Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA), have the authority to investigate further and ensure that appropriate measures are taken to protect human subjects and uphold ethical standards in research. Notifying these authorities allows for a coordinated response to the issues identified, and it helps to ensure that corrective actions are taken by the institution or study team. This is essential not only for the current study but also for establishing systemic changes that prevent future non-compliance. In contrast, ignoring the findings could lead to continued risks for participants and further ethical breaches. Sending a warning letter to the researcher might inform them of the issue, but it does not address the broader implications or involve the necessary oversight from regulatory bodies. Terminating all research activities immediately may not always be warranted, as a measured and appropriate response must be determined based on the specifics of the case. Thus, notifying the relevant authorities is the most responsible step an IRB can take