Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which entity is primarily charged with considering subject rights and well-being during clinical trials?

1. The Clinical Research Associate (CRA)

2. The Investigator's Brochure

3. The Institutional Review Board (IRB)/Independent Ethics Committee (IEC)

4. The research sponsor

The correct answer is: The Institutional Review Board (IRB)/Independent Ethics Committee (IEC)

The correct answer is the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) because these entities have the primary responsibility for overseeing the ethical aspects of clinical trials. Their main focus is to ensure that the rights, safety, and well-being of participants are protected throughout the study. This includes reviewing the study protocol, informed consent documents, and any other materials related to the trial to ensure they adhere to ethical standards and regulatory requirements. The IRB/IEC assesses the risks and benefits of the research, ensuring that the rights of subjects are prioritized and that they are adequately informed about their participation in the trial. This oversight is crucial in maintaining public trust in the research process and safeguarding the welfare of individuals who may be vulnerable to potential risks associated with clinical trials. In contrast, other options such as the Clinical Research Associate (CRA) are involved in monitoring and managing the trials but do not hold primary responsibility for ethical oversight. The Investigator’s Brochure serves as a reference document for investigators and contains essential information on the drug or device under investigation, but it does not involve itself in ethical considerations. The research sponsor may fund and support the trial but also does not provide the oversight required to protect participants' rights and well-being, which is specifically the role