Office of the Vice President for Global Communications

Tuesday, September 8, 2009

Statement on revised stem cell research guidelines

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.