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 |