Reproductive Health Considerations in Clinical Research

Reproductive Health Considerations in Clinical Research

The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. The changing landscape of reproductive rights in the U.S. requires further consideration by clinical research stakeholders. Among other concerns, reproductive health intersects with clinical research with respect to the privacy of clinical trial participants.

The MRCT Center has started initial work to better understand whether and how reproductive privacy risks are addressed in study protocols, and particularly in informed consent documents. We are also exploring, through interviews with IRB chairs and research leaders across the country, existing approaches to reproductive health privacy protections and participant communication in single and multi-site trials.  

Through this process, we are also working to identify recommendations for improved practices, which we plan to develop into a practical toolkit. The toolkit will include guidance documents on key privacy considerations, recommendations for notifying participants of privacy risks and communicating the importance of pregnancy reporting, best practices for addressing incidental pregnancies in research, and guidelines on medical record documentation.  It will also explore the protections afforded by and the limits of Certificates of Confidentiality upon which the research community has relied.

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