NHLBI Investigator's Guide to
HUMAN EMBRYONIC STEM CELL RESEARCH

National Heart, Lung, and Blood Institute
National Institutes of Health

February 4, 2002

The NIH is implementing a policy permitting Federal funding of research on existing human embryonic stem (ES) cell lines that fulfill President Bush's eligibility criteria. Links to human ES cell research information on the NIH Web site and a list of NHLBI contacts are given below.

Federally funded research using cell lines from the NIH Human Embryonic Stem Cell Registry has been authorized since December 7, 2001. Investigators proposing human ES cell research should consider contacting Dr. John Thomas for current information regarding research using human ES cells. He can provide you with

• advice on the steps and procedures involved in acquiring ES cell lines. For example, you do not need to wait for your application to be funded before initiating contact with ES cell providers.
• information on NIH funding mechanisms for ES cell research. Investigators may submit a new competing application, a competing renewal, or a competing supplement; grantees also may submit requests to re-budget existing funds or for administrative supplements.
• suggestions on details that should be considered before applying for funding. For example, ES cells are difficult to culture; investigators who do not have experience working with ES cells should consider getting specific training from the cell line provider or another laboratory.

After you have identified the cell line(s) and provider(s) on the NIH Human Embryonic Stem Cell Registry

• contact the provider. Providers may request a brief abstract of proposed research. Material transfer requirements may differ among providers and some of them will be interested in establishing collaborative research projects.
• contact your institution's technology transfer office regarding material transfer agreements (MTA) or memoranda of understanding (MOU), intellectual property issues, and mechanisms of payment. Technology transfer issues related to acquiring ES cell lines can be addressed while applying for funding

Links to Human Embryonic Stem Cell Research Information on the NIH Web site

The NIH Stem Cell Information Web site contains numerous links that may be useful. Resources include NIH reports and information for researchers, statements from federal officials, and recent congressional testimony.

The NIH Human Embryonic Stem Cell Registry

The NIH has posted the NIH Human Embryonic Stem Cell Registry based on the President's criteria in the NIH Guide for Grants and Contracts (Notice OD-02-005). Additional information has been published in the NIH Guide in Notices OD-02-006 and OD-02-007.

If a cell line is imported from an international source, permits from the United States Department of Agriculture and the Centers for Disease Control and Prevention may be required. Information about the clearances required for the receipt of human embryonic stem cells developed outside of the United States is provided in the NIH Guide announcement Federal Government Clearances for Receipt of International Shipment of Human Embryonic Stem Cells.

Frequently Asked Questions and Relevant Information for Researchers

In response to inquiries about the recent NIH Guide notices pertaining to policies on human embryonic stem cell research, the NIH is posting additional information to assist investigators and research administrators. This information will be provided in the form of answers to frequently asked questions, which are listed on the page titled Implementation Issues for Human Embryonic Stem Cell Research. Investigators should monitor the site frequently for additional information.

NHLBI Contact

The NHLBI has designated a single contact for inquiries about research using human ES cells:

Dr. John W. Thomas
E-mail: ThomasJ@nhlbi.nih.gov
Division of Blood Diseases and Resources
NHLBI / NIH / Two Rockledge Centre / Room 10154
6701 Rockledge Drive - Mail Stop 7950
Bethesda, MD 20892 - 7950
Telephone: (301) 435 - 0050
Fax: (301) 451 - 5453