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

True or False: An IRB/IEC may request additional information if it is deemed to enhance subject protection.

1. True

2. False

3. Depends on the clinical trial

4. True only if requested by sponsors

The correct answer is: True

An IRB (Institutional Review Board) or IEC (Independent Ethics Committee) plays a crucial role in overseeing the ethical aspects of clinical trials and research involving human subjects. One of their primary responsibilities is to ensure that the rights, safety, and well-being of the participants are protected throughout the study. When an IRB/IEC reviews a study protocol, they may identify gaps or areas where additional information could enhance the understanding of potential risks or improve the proposed protections for subjects. In such cases, the board may request further information from the researchers to address these concerns. This additional information could include clarification on study procedures, risk management strategies, or monitoring practices. The ability of an IRB/IEC to request additional data underscores their commitment to ethical oversight and highlights the iterative nature of the review process. It ensures that the research conforms to ethical standards, aligns with regulatory requirements, and considers the welfare of participants as paramount. Thus, it is valid to assert that they have the authority to request additional information aimed at enhancing subject protection, which is why the statement is true.