An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study on the state of real and perceived liability around research conducted in pregnant and lactating persons, develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant and lactating persons.
The committee will conduct data collection and analysis of federal and state laws and regulations governing liability for conducting research, including informed consent provisions, and to which populations they apply.
The committee will generate a matrix of the relative liability for (1) currently on-market and off-patent therapeutics and vaccines, (2) currently on-market and on-patent therapeutics and vaccines, and (3) new therapeutics and vaccines under development. This liability assessment will address real and perceived risks to (a) private companies (e.g., vaccine manufacturers, biotech, pharmaceutical companies), (b) individual researchers and their institutions (e.g., private hospitals, state-funded hospital systems, community healthcare centers), and (c) the government for conducting research specifically on therapeutics and vaccines, including associated medical devices (e.g., diagnostic devices, drug delivery systems), for medical conditions experienced by pregnant and lactating persons. The assessment will distinguish liability issues between pregnant persons and lactating persons.
Based on its review of the information and other expert and public input, the committee will develop a report with its findings, conclusions, and recommendations for safely and ethically including pregnant and lactating persons in clinical research that substantially mitigates or avoids incurring liability (absent negligence or malfeasance). The report findings, conclusions, and recommendations may address:

• pre-clinical studies (e.g., reproductive toxicology studies), and different types of study design and methodologies to generate relevant evidence for decision-making;
• considerations for the treatment of obstetric/lactation conditions (e.g., preeclampsia, pre-term labor, mastitis) and conditions experienced during pregnancy (e.g., asthma, chronic pain);
• considerations and implications for trial participants of reproductive age who may become pregnant while enrolled in a study;
• ways to maximize the use of informed consent procedures with consideration of shared decision-making, provider-patient communication, and health literacy of trial participants; and
• potential policy changes that would address disparities in state laws and regulations while protecting research participants’ legal rights and providing researchers with protection against liability.