Key Dates

Related Announcements

• December 2, 2009 - First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research. See notice NOT-OD-10-020.
• July 15, 2009 - Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research. See notice NOT-OD-09-123.
• July 6, 2009 - NIH Guidelines for Human Stem Cell Research. See NOT-OD-09-116.
• April 24, 2009 - Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009. See NOT-OD-09-086.
• April 17, 2009 - Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. See NOT-OD-09-085.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

NIH is assessing research areas ripe for modernization and is seeking public comment on the robustness of emerging biotechnologies to reduce or potentially replace reliance on human embryonic stem cells (hESCs) for research. During this review, NIH is pausing review and approval of applications for new hESC lines to be added to the NIH Human Embryonic Stem Cell Registry. 

Background

Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells (2009), provided the Secretary of Health and Human Services, through the Director of NIH, with the authority to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research. In response to Executive Order 13505, the NIH Guidelines for Stem Cell Research established policy and procedures under which the NIH would fund such research, in accordance with ethical responsibilities, scientific practices, and applicable laws. Additionally, NIH maintains the NIH Human Embryonic Stem Cell Registry (Registry),  which publicly lists hESC lines that comport with the NIH Policy and are eligible for use in NIH-funded research. Currently, 503 hESC lines have been approved for NIH-supported research, including more than 200 cell lines that have mutations associated with diseases. 

The biomedical research landscape has greatly evolved since the NIH Guidelines for Stem Cell Research were established in 2009. There has been a decline in the number of cell lines submitted for review to be added to the NIH Registry, with the last approved cell line added in December 2023. The increasing adoption of newer, more advanced biotechnologies involving nonembryonic (adult/somatic) stem cells and human induced pluripotent stem cells (hiPSCs) offer considerable potential for complementing or, in some instances, replacing models requiring more resources and oversight for acquisition and use. Additionally, NIH support for hESCs has generally plateaued since 2019, whereas NIH support for hiPSCs is steadily increasing. 

Implementation

Given the decline in requests to NIH for new hESC line approvals, NIH is pausing its review and approval of applications for new hESC lines to be added to the NIH Human Embryonic Stem Cell Registry while it undertakes an assessment of the scientific utility of hESCs. Previously approved hESC lines listed on the Registry may continue to be used in NIH-funded research. The derivation of hESCs from human embryos continues to be prohibited in NIH-supported research.

Request for Information

Now is an opportune time to assess the utility of hESCs in biomedical research, specifically, areas of research that could not occur, or areas in which newer, validated models could serve as a replacement. Accordingly, NIH is requesting public input on the following research areas:

1. Research areas in which currently approved hESC lines sufficiently meet the needs of the research community as well as research areas for which new hESC lines are needed;
2. Research areas for which hESCs are the gold standard and could not be pursued if hESCs were unavailable;
3. Research areas in which the robustness of emerging biotechnologies such as induced pluripotent stem cells, adult stem cells, etc., can replace the use of hESCs;
4. Research areas in which additional investments should be made to bolster validated models to replace use of hESCs. 

How to Submit a Response

Comments should be submitted electronically to the following webpage: https://osp.od.nih.gov/comment-form-reducing-reliance-on-human-embryonic-stem-cells-in-nih-supported-research/ Responses will be accepted through April 24, 2026. Responses to this RFI are voluntary and may be submitted anonymously. You may also voluntarily include your name and contact information with your response. Other than your name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After the Office of Science Policy (OSP) has finished reviewing the responses, the responses may be posted to the OSP website without redaction.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy

[email protected]