Draft NIH Human Stem Cell Guidelines Comments Information

Comments Deadline:  11:00 p.m. EST on May 26, 2009

View the NIH draft guidelines.

Comment Submission link: http://nihoerextra.nih.gov/stem_cells/add.htm

SAMPLE LETTER
(NOTE: personalized information areas are highlighted in red.)

Dear NIH:

President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. The NIH deserves credit for producing draft Guidelines quickly to provide time for public comment.  However, I am worried that that the NIH proposal will exclude funding for many existing stem cell lines ethically created over the last eight years.  I appreciate the opportunity to comment on the Draft National Institutes of Health Guidelines for Human Stem Cell Research and urge you to take the following into consideration:

[1] Develop final Guidelines that allow the NIH to fund research utilizing established hESC lines derived in accordance with the core principles in the ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research. These guidelines recommend independent oversight, voluntary and informed donor consent and no undue inducements. Most established hESC lines that are widely used in research today have been obtained in accordance with these principles. To ensure continued international collaboration, these principles should be applied to the evaluation of existing lines.

      [If you are utilizing specific lines in research, it would be helpful to mention the lines you are using and the nature of your research.  In addition, it would be useful if you would cite publications by yourself or others concerning existing lines, and point out that the sort of research that would not have been, or will not be fundable by the NIH if the lines used or generated in that research were not  eligible for funding. ]

      [If you perform work internationally, it would be helpful to describe the nature of your collaborations.]

[2] Most existing U.S. lines have been derived in accordance with the core principles in the ISSCR’s guidelines and consistent with the established federal regulatory framework involving IRB oversight and approval. In some instances, additional specialized embryonic stem cell research oversight committees (ESCROs), and other oversight methods in other countries (referred to as SCROs in ISSCR Guidelines), have also provided oversight. Established policy has demonstrated that this self-regulatory structure has provided a sound ethical foundation for stem cell research.  In developing the final Guidelines the NIH should consider this well-established framework of independent oversight and give weight to its determinations.

      [If you have had a research protocol reviewed, it would be helpful to describe the comprehensive nature of the review and oversight.]

[3] Specifically, for funding eligibility purposes, the ethical provenance of existing U.S. cell lines should be judged based on the standards that prevailed at the time they were derived, provided the protocol under which donations were accepted, and any amendments, were approved by an IRB operating under federal regulations.   Non-US lines should be eligible for funding within the US if the IRB and/or SCRO for the US institution receiving NIH funding determines that the protocol under which the underlying donation occurred met operative standards of the time and core ethical principles.   In addition, new requirements that go beyond established U.S. and international practice should be applied prospectively only, and after a time period for affected parties, including IVF clinics, to adapt.   We specifically ask the NIH to reconsider those aspects that go beyond existing ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the proposed requirement that the informed consent form is the sole source for ethical validation. 

[4] It will be essential that investigators know with some certainty what lines are eligible for funding.   I therefore urge the NIH to work with organizations such as the ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The ISSCR has in development a registry to document that hESC derivation was performed in accordance with ethical requirements, and make associated documentation available to reviewing IRBs and stem cell oversight bodies. Such a registry would reduce uncertainty and improve research efficiency.  While that registry is being finalized, a useful and easy place to start in the meantime would be for the NIH to publish, on a Web site, the lines that are determined to be fundable based on IRB and SCRO determinations.

[Add other concerns or specific points you would like to raise.]

Thank you for the opportunity to comment on the draft Guidelines.

Posted May 12, 2009