Good Clinical Practice (GCP) Practice Exam

What type of protections does Subpart C offer in the HHS regulations?

1. For prisoners

2. For pregnant women

3. For children

4. For individuals with mental illness

The correct answer is: For prisoners

Subpart C of the HHS regulations specifically focuses on providing protections for prisoners involved in research. The rationale for these protections stems from the recognition that prisoners are a vulnerable population with limited autonomy and potentially increased risks when participating in research studies. The regulations aim to ensure that their participation is voluntary and informed, minimizing coercion and undue influence, which are critical concerns in research ethics. These protections include requirements for additional oversight, ensuring that the research is reviewed and approved with special consideration to the prison environment and the unique circumstances of prisoner subjects. This ensures that their rights and welfare are prioritized, safeguarding them from exploitation. While protections exist for other vulnerable groups, such as pregnant women, children, and individuals with mental illness, these are addressed under different sections of the federal regulations (specifically Subparts B and D). Thus, Subpart C is uniquely dedicated to the ethical considerations and protections associated with research involving prisoners.