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

Which group is NOT classified as "vulnerable subjects" in clinical trials?

1. Members of the armed forces

2. Junior members of the medical profession

3. Senior citizens in nursing homes

4. Employees of the pharmaceutical industry

The correct answer is: Senior citizens in nursing homes

The classification of "vulnerable subjects" in clinical trials refers to individuals who may have an increased risk of coercion or undue influence, making them less able to provide informed consent. Senior citizens in nursing homes, while they may face some vulnerabilities related to their health or living conditions, are generally not classified as a distinct group of vulnerable subjects in the same way that other groups might be. Members of the armed forces, junior members of the medical profession, and employees of the pharmaceutical industry may possess power imbalances, be subject to coercive pressures, or be in situations where they might not be able to fully exercise free will in their participation. For example, members of the armed forces may be influenced by hierarchical structures, and junior medical professionals may feel pressured by senior colleagues. Employees of the pharmaceutical industry could face conflicts of interest that compromise their ability to consent freely. In contrast, senior citizens in nursing homes, while potentially vulnerable due to health considerations, do not inherently fall into the same categories of dual obligations or coercive power dynamics as the other groups listed, thus making them not classified as “vulnerable subjects” in this context.