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

What does an IRB/IEC evaluate in a clinical trial?

1. Financial implications

2. The scientific validity of the trial

3. Marketing strategies

4. Patient recruitment methods

The correct answer is: The scientific validity of the trial

An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in protecting the rights and welfare of participants involved in clinical trials. Their evaluation primarily focuses on the scientific validity of the trial, which encompasses several critical aspects. Firstly, the scientific validity refers to whether the research question is scientifically sound and worthy of investigation. This involves assessing the study design, methodology, and overall approach to ensure that the trial is capable of yielding meaningful and reliable results. A well-designed study is essential not just for producing credible data but also for ensuring that the conclusions drawn from the research will contribute positively to medical science and patient care. Secondly, the IRB/IEC evaluates whether the potential benefits of the trial justify the risks to the participants. This includes scrutinizing how the trial is structured to minimize risks and protect participants, thereby maintaining ethical standards in research. By focusing on the scientific validity of the trial, the IRB/IEC helps to ensure that resources are allocated to studies that are not only ethically sound but also likely to advance knowledge in the field. In contrast, evaluations regarding financial implications, marketing strategies, and patient recruitment methods do not fall within the primary responsibilities of an IRB/IEC, which is concerned primarily with the ethical oversight