Toolkit
Released on: April 29, 2026
The MRCT Center has released the first three tools in the Pregnancy Privacy Protections for Participants (P4) Toolkit. These resources inform research teams, IRBs, and participants about data privacy risks if a participant becomes pregnant during a study.
Following the Dobbs decision, the changing landscape of reproductive rights in the U.S. has introduced new challenges for clinical trials, both for studies of pregnancy-related conditions and for any trial involving participants who could become pregnant. Because pregnancy testing and outcomes may be tracked during screening and throughout a trial, it is important to carefully consider how, and how well, clinical trial data can be protected, and how to communicate pregnancy privacy risks to potential and enrolled participants. These issues were explored in a MRCT Center Bioethics Collaborative forum, “Impact of Dobbs on Reproductive Health: Unintended Consequences for and on Research” and in the recent NEJM Evidence paper “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.“
The three tools are:
- Local Context: Reproductive Health Information for the Research Team and the IRB
- Recommended Language for Informed Consent Forms: Guidance for Researchers on Pregnancy Privacy Protections
- Privacy Protections: Considerations for Pregnant Participants
The first two are directed toward clinical research teams and IRBs. The third is for research staff to adapt and share with participants; it is written in plain language and highlights terms defined in the MRCT Center’s Clinical Research Glossary. Each tool is a prototype; the introductory page instructs teams to revise content according to their specific study and local legislative and site context.
The work draws on MRCT Center efforts in the Impact of Privacy Laws, the Bioethics Collaborative, and Inclusion of Pregnant and Lactating Populations (within the Representation in Research portfolio).
We welcome your feedback as we develop additional tools to complete the P4 Toolkit.
Related Resources
Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.