Certification for IRB Professionals (CIP) Practice Exam

Which group is protected under Subpart B in federal regulations regarding human subjects?

1. Children

2. Prisoners

3. Pregnant women and human fetuses

4. Elderly adults

The correct answer is: Pregnant women and human fetuses

Subpart B of the federal regulations provides specific protections for pregnant women and human fetuses participating in research. This subpart recognizes the unique ethical and legal considerations involved when research subjects include pregnant individuals and the potential risks to both the mother and the fetus. The regulations ensure that risks are minimized and that the potential benefits of the research justify any risks involved. Additionally, researchers must adhere to specific requirements regarding informed consent that takes into account the complexities of pregnancy and fetal development. Therefore, the emphasis on safeguarding the health and well-being of both pregnant women and their fetuses reflects a commitment to ethical research practices. The other groups mentioned, while they are certainly protected under different provisions of the federal regulations, do not fall under the specific protections outlined in Subpart B. For instance, protections for children are primarily covered under Subpart D, while prisoners are protected under Subpart C. Elderly adults, although they may be considered vulnerable, are not explicitly covered by a specific subpart in the same way as pregnant women and fetuses.