The MRCT Center is working 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 developing a practical toolkit that 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. In addition, we are exploring other factors that may impact the participation of pregnant and lactating populations in clinical trials, such as unjustified exclusions in study eligibility criteria and the usability of digital/remote technologies in areas with limited or no access to maternity care.
Related Assets
- February 24, 2026: Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs
- September 28, 2025: E21 Inclusion of Pregnant and Lactating Women in Clinical Trials
We welcome feedback, suggestions, useful references, resources, and concerns.
