After receiving 49,000 comments in response to the draft guidelines for federally funded human embryonic stem cell research, the National Institutes of Health posted final guidelines for this important research effective July 7, 2009. Guidelines may be viewed entirely by visiting http://stemcells.nih.gov/policy/2009guidelines.htm

MCSCRC submitted comments in support of the NIH draft guidelines, with the following addition:

-- Section II B should be modified to include NIH funding for research on pre-existing stem cell lines as long as those lines were derived:

1. With informed consent
   
   
2. Without undue inducement
   
   
3. With oversight by an ethics advisory committee, such as an Internal Review Board (IRB)

• The guidelines, issued by the National Institutes of Health, set standards for Michigan as it begins a new era of research following voter approval of a constitutional amendment in November. Eventually, the state is expected to receive more federal funding for one of the most hopeful areas in medical research. – The Detroit News. July 7, 2009
  
  
• Dr. Sean Morrison, director of the University of Michigan's Center for Stem Cell Biology and MCSCRC Board Member comments in response to the National Institutes of Health Guidelines on Human Stem Cell Research:

These revised NIH policies, which make many more embryonic stem cell lines available to federally funded scientists, will dramatically accelerate progress in this field. The National Institutes of Health should be commended for taking a leadership role that will make these advances possible.

A major concern we had with the draft guidelines was that they created very specific standards for the language required in the informed-consent documents that embryo donors must sign.

Those exacting standards will be fine for lines derived in the future, but trying to retroactively apply them to lines derived five or ten years ago would have been a huge problem. Hundreds of existing embryonic stem cell lines---created according to the highest ethical standards of the day---would not have been eligible for federal funding.

The revised guidelines resolve this issue by appointing a working group within NIH that will consider lines derived prior to the implementation of this new policy, to determine whether such lines were derived in accordance with core ethical principles. This provides a mechanism to make existing lines eligible for NIH funding if they were ethically derived but do not meet the letter of the new informed consent requirements.

I expect that most existing lines will be found to have been ethically derived according to the core principles described in the NIH policy. This will eventually make hundreds of new stem cell lines available for use by NIH-funded scientists.

The revised guidelines also resolve another issue that had concerned many stem cell scientists. The revisions call for the creation of an NIH registry that will spell out exactly which embryonic stem cell lines adhere to NIH policy and are therefore eligible for federal funding.

Without such a registry, individual research institutions would have struggled to decide for themselves which cell lines abide by the NIH policy. Now, everyone can work from a common list that can be updated centrally.

These revised NIH guidelines represent a reasonable compromise, based on where the science stands today. But this field is evolving at an incredibly rapid pace, and it may be necessary, down the road, to revisit some of the elements of this policy as the science evolves.

Don't miss vital information from MCSCRC. Add info@stemcellresearchformichigan.com to your address book.

If you no longer wish to receive our e-mail, simply unsubscribe.

For further communication or contact information please visit our Contact Us page.

This message is from Michigan Citizens for Stem Cell Research & Cures, its affiliates and agents (MCSCRC), 27177 Lahser Rd, Suite 102, Southfield, MI 48034. If you'd prefer not to receive e-mail like this from MCSCRC in the future, please click here to unsubscribe.


© Copyright 2008 Michigan Citizens for Stem Cell Research & Cures. All rights reserved.