Good Clinical Practice (GCP) Practice Exam

What do the additional protections in Subpart B of the HHS regulations focus on?

1. Children

2. Prisoners

3. Pregnant women, human fetuses, and neonates

4. Individuals with disabilities

The correct answer is: Pregnant women, human fetuses, and neonates

Subpart B of the HHS regulations provides additional protections specifically for pregnant women, human fetuses, and neonates involved in research. This section recognizes the unique ethical and safety concerns associated with conducting research involving these populations due to their vulnerabilities. Justifying the need for these additional protections, the regulations emphasize that research must ensure the well-being of both the mother and the fetus throughout the study. Importantly, the regulations mandate that research involving these groups must be carefully evaluated to ensure that risks are minimized and justified by potential benefits. This is crucial given that both pregnant women and their fetuses may face distinct risks in the context of clinical research, establishing guidelines that promote ethical considerations and safeguard their welfare. While children, prisoners, and individuals with disabilities are also recognized as vulnerable populations with specific regulatory protections, these groups are addressed under different subparts of the regulations. Each vulnerable population has tailored protections reflecting their unique ethical considerations, ensuring that research practices uphold ethical standards across a diverse range of participants.