Good Clinical Practice (GCP) Practice Exam

Which group of individuals is categorized as vulnerable subjects?

1. Individuals with strong support systems

2. Individuals who are highly educated

3. Individuals who may be influenced by expected benefits

4. Individuals fully capable of giving consent

The correct answer is: Individuals who may be influenced by expected benefits

The correct choice identifies individuals who may be influenced by expected benefits as a vulnerable subject group. Vulnerable populations are often characterized by their inability to provide fully informed consent or protect their own interests in clinical research. When individuals are in a position where they might be influenced by anticipated advantages, such as financial incentives or health improvements, their ability to consent freely and without coercion may be compromised. This susceptibility to undue influence makes it essential for researchers and ethics committees to ensure that additional safeguards are in place. Vulnerable subjects might include those who are economically disadvantaged, those with limited education or understanding of the research process, or those who may rely heavily on the healthcare system for support. In contrast, individuals with strong support systems or those who are highly educated typically have the resources and knowledge to make informed decisions regarding their participation in research studies, making them less vulnerable. Likewise, individuals who are fully capable of giving consent do not fit the definition of vulnerability, as they can understand the implications of their participation without external pressures affecting their choice.