November 8, 2001
Dear Colleagues:
On November 7, 2001, NIH posted the embryonic stem (ES) cell registry on its website. This registry lists the cell lines that may be used in NIH-supported research. Providers of these cells have assured the government that they meet the President’s eligibility criteria for ES cells that we may use. These providers are prepared to establish collaborations and material transfer agreements with NIH scientists to convey the cells to us.
I am hoping to help support a central core facility to maximize our efficiency and speed in acquiring the cells and learning about them. In the meantime, intramural scientists who are prepared to begin work more quickly may proceed to make individual lab arrangements with cell providers.
For each cell line, the Registry lists a unique NIH identifying code, as well as information on the providers of the cell lines. Scientists who want to work with these cells should discuss their plans with their Lab Chiefs and Scientific Directors and then contact the providers of the cells. On December 7, 30 days after the posting of the Registry, and withdrawal of the old ES cell guidance (NIH Guidelines for Research Using Pluripotent Stem Cells as Applied to Human ES Cells), scientists may transfer government funds to obtain the cells, bring them into NIH labs, and begin research on them.
NIH is accountable for all uses of ES cells. To this end, you must track the unique identifier of all ES cell lines that you use throughout your work. Specifically:
1. You must obtain written permission from your Institute Director, through your Scientific Director and Lab Chief, for each acquisition of an ES cell line. Your memo of acquisition must include
The unique identifier for each line you will be getting
The names of intramural staff who will be using the cells
The status of the cells with respect to human subjects research requirements
(see below)
A copy of the Material Transfer Agreement with the cell provider (NIH
has negotiated a model
MTA with the Wisconsin group only (WA-series cells)
For all cells that come from foreign sources (ES-, SA-, KA- NC-, RL- or
TE-series cells), you should indicate that you have completed and filed
three import forms and paid the associated fees:
— Permits to Import or Transport Controlled Material or Organisms or Vectors Forms 16-3 and 16-7 from the USDA. (To obtain information and the forms, visit this site.)
— CDC’s Application for Permit for Import or Transport of Agents or Vectors of Human Disease (Document #101000—may be obtained from this site) should be filed with the Quarantine Permit Service Office at NIH (301-496-2960). They will provide a courtesy letter to help with customs clearance. Do not send the application to CDC.
2. Scientific Directors must report all ES cell acquisitions to the Office of Intramural Research by forwarding a copy of the approved memos of acquisition to the DDIR (Bldg. 1, Rm.114, NIH, 20892-0001).
3. Each lab should be able to link its data and re-plated cells back to an original acquisition and cell line identifier.
4. Every report of research on the cells, including your ZO1 annual report and all publications, must include the unique identifier for the cells used.
Even with the approved cell lines, certain uses of ES cells are not allowed: Human pluripotent stem cells may not be used to create or contribute to a human embryo. The cells may not be used for research in which human pluripotent stem cells are combined with an animal embryo; and may not be used in combination with somatic cell nuclear transfer for the purposes of reproductive cloning of a human. Derivation and study of embryo germ (EG) cells—because they come from fetal tissue—fall under existing regulations regarding the use of fetal tissue in NIH-supported studies (additional guidance is expected; for now see this site).
The Office for Human Research Protections, DHHS, gives the following guidance on research involving human embryonic stem cells or human embryonic germ cells derived from fetal tissue:
In vitro research using cell lines that are already derived and established, and for which the identity of the donors cannot be determined, does not require IRB review and approval.
Research using cell lines that are identifiable with a donor, including cells that retain links to coded information that would allow identification of donors, is generally considered human subjects research. For cases in which the investigator obtains a written agreement from the holder of the identifiable private information (e.g., the deriver of the cell line) that such information will not be released to the investigator under any circumstances, IRB review and approval is not required.
For intramural scientists, this means you should determine with the provider whether the cells you seek can be linked to the donors. If so, you should contact the NIH Office of Human Subjects Research (301 402-3444) to determine what steps you need to follow.
At this time, an NIH committee is considering the establishment of an NIH ES Cell Core Facility which will be dedicated to acquiring, culturing, and distributing approved stem cell lines to intramural investigators. The Core may also establish and maintain a shared storehouse of knowledge on the cells, receiving and posting data as they and other NIH scientists collect it.
Additional information on stem cells, including the answers to frequently asked questions, is available on the web. More background is posted at this site. If you have further questions, you should send them to the deputy director for extramural research.
—Michael
Gottesman, M.D.
Deputy
Director for Intramural Research