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

Completed

Topics

Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, pregnant and lactating persons are often excluded from clinical trials, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing fetus or newborn baby. An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant and lactating persons.

About Publications/Resources Past Events

Events

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 (EDT)
  • Webinar
  • Past

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...

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

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.
Meetings

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 (EDT)
  • Closed
  • Past

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.

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
  • Closed
  • Past

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 me...

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
  • Meeting
  • Past

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 m...

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

  • March 23 - 24, 2023
  • Meeting
  • Past

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...

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 (EST)
  • Meeting
  • Past

This is the first meeting of this committee.
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