Can a researcher collect data about fetuses exposed to high lead levels during pregnancy under Subpart B?

Subpart B of the federal regulations specifically addresses research involving pregnant women and fetuses, as well as neonates. When considering research involving fetuses exposed to high levels of lead during pregnancy, it’s important to note that such studies can be ethically justified if they provide potential benefits or are critical for advancing medical knowledge while minimizing risks.

In this context, option D identifies that research may involve neonates of uncertain viability, which indicates that the study parameters are aligned with acceptable practices under Subpart B. The key considerations include ensuring that the research does not pose undue risk to the fetuses or neonates and that the potential benefits of the research outweigh any risks involved. Since the question specifies exposure to a harmful substance, it suggests that understanding the consequences of such exposure can yield knowledge that may improve health outcomes.

This option emphasizes that as long as the research adheres to ethical standards and regulations, including the provision of possible direct benefits or addressing significant health issues, conducting research involving fetuses and neonates, particularly concerning lead exposure, is permissible.