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

For a Subject's Informed Consent, what must be provided before they can participate in a trial?

1. A financial incentive

2. A clear explanation of risks, benefits, and study procedures

3. A summary of the investigational product

4. Approval from a family member

The correct answer is: A clear explanation of risks, benefits, and study procedures

Informed consent is a foundational ethical and legal requirement in clinical trials, ensuring that participants have an understanding of what they are agreeing to before joining a study. The necessity for a clear explanation of risks, benefits, and study procedures ensures that subjects are fully aware of what participation entails, which is critical for making an informed decision. Providing this clear explanation allows participants to evaluate the possible risks they might face compared to the potential benefits they might receive from the study. Understanding the study procedures is equally important because it helps participants know what to expect during their involvement, including the nature of the interventions and the time commitment required. This transparency fosters trust between the participants and the researchers and supports ethical research conduct. Other options offered do not fulfill the essential requirements of informed consent. While financial incentives may encourage participation, they do not substitute for the need for understanding the study's implications. Summaries of the investigational product can be helpful, but they do not encompass the comprehensive information required for informed consent. Approval from a family member is not a requisite component in obtaining consent, as individuals must be allowed to make their own informed decisions about participating in research.