Researching with human participants (independently of their particularities, such as those mentioned) is regulated by the U.S. Federal regulations named “Common Rule Layout,” federally funded research using humans also need review by an IRB of the institution conducting the research.
They establish in chapter III “Standards and guidance for members of the research ethics committees, incise 3: “Selection of study population and recruitment of research participants Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research; these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear the risks of participating in the research is likely to benefit from the knowledge derived from the research. Also, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the purpose of the research, the risks and potential benefits of participating in the research, and other relevant details” (p.13)
The document: “Preg45CFR 46, Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research”, indeed specifies in detail those requirements also necessary to research with these groups. If determined research reviewed by the IRB as previously mentioned (even when women, minors, persons kept in detention and unborn fetuses are all considered vulnerable research participants) meet the requirements for the research, as specified elsewhere.
Therefore, the correct answer is A) the research can be authorized if the requirements for subpart b, additional protections for pregnant women, human fetuses and neonates involved in research are met because subpart b takes precedence over subpart d. The requirements of subparts a, b, c, and d are met.
