Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons

Webinar

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks Report Launch Event

April 10, 2024

11:00 AM - 12:00 PM (ET)

Past

Materials

Report Release Slide Deck

About

Pregnant and lactating patients and their clinicians must currently make decisions regarding what drugs and vaccines they should use during pregnancy and lactation without the benefit of high-quality evidence regarding the products’ safety and efficacy. Past studies have attributed their exclusion to concerns about legal liability for the investigators and organizations that conduct and sponsor clinical research. However, there has never been an extensive overview of the legal liability for conducting research with pregnant and lactating populations.

To address this concern for liability, Congress called on the National Academies of Sciences, Engineering, and Medicine to convene a committee to examine the real or perceived risk of liability arising from research conducted with pregnant and lactating women.

Please join us for a webinar to learn about this new National Academies’ report on Wednesday, April 10, 2024. Members of the report authoring committee will discuss the report’s key messages and recommendations and will answer questions from the audience about the report.

Speakers at this event will include:

Margaret Foster Riley (Chair), Professor of Law, Dorothy Danforth Compton Chair, Miller Center, University of Virginia
Bruce Kuhlik, Executive Vice President and General Counsel, Merck & Co., Inc. (Retired)
Brownsyne Tucker Edmonds, Professor of Obstetrics and Gynecology; Associate Dean for Health Equity Research, Indiana University School of Medicine
Anne CC Lee, Associate Professor of Pediatrics, Harvard School of Medicine;Director of Global Newborn Health, Brigham and Women’s Hospital, Harvard Medical School

Additional Information

Is it a Closed Session event?

Not Closed

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons Committee Meeting #5

September 27 - 28, 2023

Past

Materials

About

On September 27 and 28th, the Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons committee held its fifth meeting.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

All members were present.

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a meeting on September 27 and 28. On the first day in closed session, committee members deliberated on the report structure and individual chapters and ended the day discussing report recommendations. On the second day, committee members continued their discussion on recommendations in closed session and ended their meeting planning the next steps for the study and report.

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda
- Briefing Book

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons Meeting #6

October 20, 2023

10:30 AM - 5:00 PM (ET)

Past

About

On October 20th, the Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons committee will hold its sixth meeting.

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Margaret Foster Riley, Ifeyinwa Asiodu, Paul Beninger, Alexander M. Capron, Brownsyne T. Edmonds, Ahizechukwu Eke, Mary Hebert, Leslie Meltzer Henry, Patricia A. King, Bruce Kuhlik, Anna C. Mastroianni, JoNell Efantis Potter, Enrique Schisterman

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a meeting on October 20th. Committee members deliberated on the report recommendations and discussed the next steps and the study timeline.

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda
- Draft Report

Date of posting of Closed Session Summary:

October 25, 2023

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons Meeting #4

July 13 - 14, 2023

Past

About

On July 13-14th, the Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held their fourth committee meeting.

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Margaret Foster Riley, Ifeyinwa Asiodu, Paul Beninger, Alexander M. Capron, Patricia M. Danzon, Ahizechukwu Eke, Leslie Meltzer Henry, Patricia A. King, Bruce Kuhlik, Anna C. Mastroianni, JoNell Efantis Potter, Enrique Schisterman, Brownsyne Tucker Edmonds

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a closed session meeting on July 13 and 14. On the first day, committee members deliberated on the report structure and considered recommendations. On the second day, committee members continued their discussion on recommendations and relevant materials for the report. The committee also received a briefing from National Academies staff on communications strategies.

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda
- Briefing Book

Date of posting of Closed Session Summary:

July 19, 2023

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons Committee Meeting #3

June 15 - 16, 2023

Past

Materials

About

On June 15th, the Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons will hold their third committee meeting.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

All committee members were present.

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a hybrid meeting on June 15 and 16 involving both open and closed sessions. Following the completion of the open session on June 15, committee members met in closed session and deliberated on evidence gathered by and presented to the committee. One June 16, committee members met in closed session to receive briefings on the development of papers commissioned by the committee. The committee members ended the two-day event by considering recommendations and outlining the next steps for the study and report.

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda
- Briefing Book
- Commissioned Papers

Date of posting of Closed Session Summary:

June 28, 2023

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Research with Pregnant and Lactating Persons: Mitigating Risk and Liability and Committee Meeting #2

March 23 - 24, 2023

Past

Materials

About

On March 23rd, the Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons will hold a workshop to discuss how institutions and organizations make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in clinical research, and the role of liability, risk management, and trial insurance in those decisions. The workshop will also review existing compensation schemes for research-related injuries and potential to scale these models to serve the needs of research participants. The committee will hold a closed session meeting on March 24th.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

All committee members present.

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons met in person on March 23 for a workshop and on March 24 in closed session. Following the completion of the workshop, committee members met in closed session and identified key themes from the workshop. In the closed session on March 24, committee members reviewed the report outline and continued discussions on the statement of task. Due to the addition of a new committee member, the committee also held a bias and conflict of interest study discussion with a representative from the Health and Medicine Division Executive Office. The committee members ended the two-day event by reviewing the study timeline and outlining the next steps.

The following materials (written documents) were made available to the committee in the closed sessions:

- Agenda
- Briefing Book

Date of posting of Closed Session Summary:

March 28, 2023

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Meeting

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons Meeting #1

January 26, 2023

10:30 AM - 4:30 PM (ET)

Past

Agenda

Download the Agenda

About

This is the first meeting of this committee.

Additional Information

Is it a Closed Session event?

Partially Closed

The following committee members were present at the closed sessions of the event

All committee members present.

The following topics were discussed in the closed sessions:

Members of the Committee on Developing Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons met on January 26 virtually. During the Open Session, Committee members had the opportunity to interact with the study sponsor, The Eunice Kennedy Shriver National Institute of Child Health and Human Development. Members clarified information and the main purpose of the study with sponsors. In the Closed Session, committee members discussed the statement of task, their thoughts on liability, and the next steps for the study, such as requests for guest speakers. The committee also held the required bias and conflict of interest discussion with representatives from the Health and Medicine Division Executive Office.

The following materials (written documents) were made available to the committee in the closed sessions:

-Agenda
-Briefing book

Date of posting of Closed Session Summary:

February 02, 2023

Contact

Study Staff

PRGLACstudy@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

My Academies

Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons

Dropdown items

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks Report Launch Event