Notice Number: NOT-HD-18-003
Key Dates
Release Date: February 15, 2018
Response Date: April 2, 2018
None
Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Purpose
The 21st Century Cures Act established a Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), to advise the Secretary of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC is tasked with identifying these gaps and will report its findings back to the Secretary. A series of workshops, open to the public, are being held to develop this report. In addition, the NIH is publishing this Notice to solicit input from the wider scientific community and welcomes comments from the public.
Background
The 21st Century Cures Act states in part that the report will include:
- A plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies;
- Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research;
- Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women;
- Identification of Federal activities, including:
- The state of research on pregnancy and lactation;
- Recommendations for the coordination of, and collaboration on research related to pregnant women and lactating women;
- Dissemination of research findings and information relevant to pregnant women and lactating women to provides and the public; and
- Existing Federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women, lactating women, and related birth and pediatric outcomes, including with respect to pharmacokinetics, pharmacodynamics, and toxicities; and
- Recommendations to improve the development of safe and effective therapies for pregnant women and lactating women.
Details of the workshops, archived videocasts, materials and information on upcoming workshops can be found on the PRGLAC website.
Under the Common Rule (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html ), pregnant women are listed as an example of a vulnerable population. The revised common rule would no longer include pregnant women as an example of a vulnerable population, although the provisions of Subpart B (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#subpartb ) still need to be met; however, implementation of the revised rule has been delayed (https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html ). As part of the requirements of Subpart B, “If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained” (Subpart B, 46.204(e)). Once born, only one parent’s consent is required for research studies.
Information Requested
The NIH is interested in soliciting comments and suggestions from the scientific community regarding this topic.
The NIH is interested in responses to the following topics:
- Insight on possible changes if regulations on the protection of human subjects in research were changed to remove pregnant women as a “vulnerable population” and its effects on research.
- Differences in ethics considerations for conducting research with pregnant women and lactating women.
- Appropriateness of having different consent requirements for research involving the fetus or for research involving a child. (Currently, consent for research with a child can be by either parent, but consent for a pregnant woman to participate in research requires both maternal and paternal consent.)
- Ideas on how research design and research would be affected by the inclusion of pregnant and/or lactating women. (Please include specific examples to support your comments.)
- Specific needs of the scientific community in order to conduct more research on therapies used by pregnant and/or lactating women.
- Research opportunities and/or potential new research designs when pregnant or lactating women are included in research studies. (Please cite relevant examples.)
- Methods that may alleviate or alter reluctance to include pregnant or lactating women in research. (Please provide specific examples that showcase suggested methods.)
- Best practices or promising practices to reach pregnant and lactating women, their partners, and their health care providers when new clinical or practice guidelines are released.
How to Submit a Response
To ensure consideration, responses should be submitted by email to kaeserl@mail.nih.gov no later than Monday, April 2, 2018.
Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
Inquiries
Please direct all inquiries to:
Lisa Kaeser, JD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-0536
Email: kaeserl@mail.nih.gov
and Human Services (HHS)
