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

Which organization establishes standards related to the inclusion of special populations in clinical research?

1. FDA

2. WHO

3. ICH

4. NIH

The correct answer is: ICH

The correct organization that establishes standards related to the inclusion of special populations in clinical research is the International Council for Harmonisation (ICH). The ICH plays a critical role in developing guidelines that aim to ensure that clinical research is conducted ethically and that vulnerable or special populations, such as children, pregnant women, and the elderly, are appropriately included in clinical studies. The guidelines set forth by ICH help ensure that researchers consider the unique needs and circumstances of these populations, promoting safety and efficacy in treatments. In contrast, the FDA (Food and Drug Administration) primarily focuses on the regulation of products to ensure public safety rather than establishing specific standards related to the inclusion of populations in research. The WHO (World Health Organization) addresses global health practices and policy but is less focused on the specifics of clinical research methodologies. The NIH (National Institutes of Health) does promote inclusive research practices; however, it is not the primary organization responsible for developing the international guidelines adopted by clinical researchers around the world, which is the domain of the ICH.