Final answer:
Research may be exempt from federal regulatory constraints if it meets specific criteria set forth by the IRB, which includes obtaining informed consent from participants after fully informing them of the study details and associated risks. Option D is correct.
Step-by-step explanation:
According to the federal regulations, research is eligible for exemption if it meets specific criteria. This question pertains to the ethical oversight of human subject research, which is a major concern under federal regulations governed by institutions such as the U.S. Department of Health and Human Services and enforced through Institutional Review Boards (IRB). A pivotal element of such regulations is informed consent, which ensures that all participants are well-informed of the research details, including any associated risks and the voluntary nature of participation, before agreeing to partake in the study.
Informed consent is not just a formality but a fundamental ethical requirement to protect the welfare and autonomy of research participants. If risks are minimized and informed consent is obtained, along with other specific IRB criteria being met, research may be exempt from certain regulatory constraints. Particularly sensitive is research involving vulnerable populations, which necessitates additional protections.