NIH Stem Cell Research Guidelines – Urgent Response Needed

This is a call for your help to support human embryonic and parthenote stem cell research. The deadline for action is Tuesday May 26.

Here’s a link to the most up to date version of the draft guidelines: 2009 Draft Guidelines on Human Stem Cell Research

A. The Problem:

On March 9, 2009 President Obama charged the National Institutes of Health, the primary funding agency for federally funded biomedical research, to draft a new set of ethical guidelines for embryonic stem cell research by July 2009. The President did not mean for the new guidelines to overturn the Dickey Amendment to the NIH budget which bans federal funding for the derivation of stem cell lines, but to expand the numbers and types of stem cells available for federal funding after they are derived.

The NIH has issued its draft guidelines and asks for public comment no later than Tuesday May 26, 2009. The NIH draft guidelines are a serious set-back to human embryonic stem cell research and continue the ban on parthenote stem cell research. The draft guidelines are so restrictive that many of the stem cell lines eligible for funding under President Bush would no longer be eligible.

B. What You Can Do To Support Human Embryonic Stem Cell Research:

Step 1. Go to the NIH Public Commentary Website:

http://nihoerextra.nih.gov/stem_cells/add.htm

Comments may also be mailed to :
NIH Stem Cell Guidelines, MSC 7997
9000Rockville Pike
Bethesda, Maryland, 20892-7997

Step 2. Upload your message (two are suggested here) or an alternative no later than Tuesday May 26, 2009.

 

Suggested Response One (from Dr. Ann Kiessling) (download RTF)

NIH Stem Cell Guidelines, MSC 7997
9000 Rockville Pike
Bethesda, MD   20892

Dear Dr. Kington and Stem Cell Guidelines Committee:

To comply with President Obama’s Executive Order #13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, the proposed Guidelines posted in the Federal Register April 23, 2009, need to be amended as follows:

I. no suggested changes.
I. A. no suggested changes
II.B. should read:  “Eligibility of human pluripotent stem cells: Human pluripotent stem cells may be used in research using NIH funds if the cells were derived from human embryos or oocytes donated for research purposes for which documentation for the following can be assured:
II.B.(1) and (2) no suggested changes
II.B. (3) “…where the embryos or oocytes were donated…”
II.B. (4) delete
II.B. (5) should read:  “At the time of donation, donors were informed that they retained the right to withdraw consent until the embryos or oocytes were actually used for research.
II.B. (6) should read:  “The attending physician responsible for clinical care and the researcher  proposing to utilize human pluripotent stem cells should not have been the same person.
II. B. (7) should read:  “Informed consent was obtained from individual(s) who elected to donate human embryos or oocytes for research purposes.  Such informed consent should comply with human subjects research guidelines such as those proposed by the National Academy of Science or other bodies who have carefully considered human pluripotent stem cell research such as the International Society for Stem Cell Research, or recognized human subjects review committees.”
II. B. (7. a. – i)  delete
II. C. no suggested changes
II. A. and B. no suggested changes
IV. A. no suggested changes, could be combined with III.
IV.B. delete

Yours truly,
Ann A. Kiessling, PhD
Director,
Bedford Research Foundation

 

Suggested Response Two (download RTF)

NIH Stem Cell Guidelines, MSC 7997
9000 Rockville Pike
Bethesda, MD   20892

Dear Dr. Kington and Stem Cell Guidelines Committee:

I urge the NIH to adopt alternative criteria that will allow federal money to be used with stem cell lines currently approved for NIH-funding. Eliminating federal support for use of these lines would seriously undermine current research programs. I recommend that the criterion for acceptable derivation be oversight of embryo and oocyte donation by an Institutional Review Board (IRB) or its equivalent. The IRB should ensure that the informed consent process conformed to accepted regulations and guidelines at the time and place of donation. This alternative IRB criterion for informed consent continues support for current research programs and supports use of an expanded set of valuable stem cell lines.

I also urge the NIH to develop a registry or data-base of NIH-approved stem cell lines. This registry would save tax payer dollars by eliminating the need for each research institution to conduct its own reviews of stem cell lines.

Finally, I support the use of NIH-funds with stem cell lines derived through parthenogenesis and nuclear transfer as long as they meet standards for ethical derivation.

Yours truly,