Certified Clinical Research Coordinator (CCRC) Practice Exam

Which group of individuals are considered Vulnerable Subjects in clinical trials?

1. Healthy adult volunteers

2. Individuals with curable conditions

3. Participants from affluent backgrounds

4. Patients with incurable diseases and minors

The correct answer is: Patients with incurable diseases and minors

Vulnerable subjects in clinical trials refer to populations that may have increased susceptibility to harm or undue influence during the research process. These individuals may face difficulties in providing informed consent, understanding the risks and benefits of participation, or may have limited alternatives in their own healthcare decisions. The correct choice includes patients with incurable diseases and minors. Patients with incurable conditions may feel desperate for treatment options and thus might agree to participate in studies without fully understanding the implications. Additionally, minors inherently lack the full capacity to make informed decisions due to their age, making them particularly vulnerable as well. Healthy adult volunteers, individuals with curable conditions, and participants from affluent backgrounds do not typically fall under the category of vulnerable subjects as they usually possess greater autonomy and understanding of the trial processes and implications.