Is a study comparing new treatments for seasonal affected disorder (SAD) allowed to include pregnant women under Subpart B?

The inclusion of pregnant women in research studies is governed by specific ethical guidelines to ensure the safety of both the mother and the fetus. Subpart B of the federal regulations specifically focuses on research involving pregnant women and fetuses. It sets forth additional protections and requirements for conducting research with these populations due to their unique vulnerabilities and the potential risks involved.

In the case of studies on seasonal affective disorder (SAD) that do not directly involve interventions that could benefit pregnant women or are not aimed specifically at understanding or treating conditions directly related to pregnancy, these individuals may be excluded from participation. Here, the correct answer emphasizes that without clear benefits or relevance to the specific health concerns of pregnant women, it is generally not permitted to include them in the research under Subpart B due to ethical considerations and the potential risks to the fetus.

In conclusion, the regulations prioritize the safety and ethical treatment of pregnant women and fetuses in research, leading to restricting inclusion in studies that do not have a beneficial intent or appropriate justification for their involvement.