New stem cell guidelines released today

Today, the National Institutes of Health (NIH) announced its guidelines regarding stem cell research. Mathew “Willy” Lensch, MD, a stem cell researcher at Children’s Hospital Boston, describes the changes.

I listened to the NIH press conference today with a degree of anticipation that I haven’t felt since President Bush’s comments in August of 2001. It was good news this time, and was all about HOW not IF human embryonic stem cell (hESC) research was going to be funded. I, for one, was fairly pleased, though there are still some rough spot, as I’ll describe.

I was among the 49,000 people who submitted comments on the draft NIH guidelines during the public commentary period that ended some weeks ago. Unfortunately, one of the things that I asked the NIH not to do is something that will now be required going forward, namely, to require investigators to submit documentation for their hESC lines to a national review committee for approval prior to being deemed eligible for NIH funding.

First off, there were many who feared that under new guidelines, most—if not all—of the existing hESC lines worldwide (including the ones we’ve generated here at Children’s Hospital Boston) would have been completely disqualified from federal funding. I’m relieved that didn’t happen. The reasons for this possible ineligibility related to some specific language in the draft guidelines regarding consent form wording and guidance that embryo donors would read and sign prior to donating their embryos to research. The point here is that potential donors need to understand what they are doing—a point on which we all agree. However, this specific language was not available years ago when we began our own work and thus, was obviously unable to be included in our own well thought-out, highly-vetted and institutionally-approved consent forms.

Would our hESC lines be left ineligible for NIH funding going forward as a result? The answer is that they may ultimately qualify for funding, but only after passing muster with an “alternative route” involving a yet to be convened (or even appointed, I think) review committee at the NIH. I would have recommended instead that at least hESC lines derived at academic institutions in the USA under the guidance of their NIH-approved IRBs be automatically eligible. Investigators could have simply provided that IRB-approval information as part of their grant application. But at least there is a way and I am confident that what we’ve done here at Children’s (and how we’ve done it) will be met with approval at the NIH. My practical worry is that anything reviewed at the national level has the potential to take a long time. Again, despite these delays, there is a way ahead and I’m happy for that.

The second rough bit is that projects working on nuclear transfer, parthenogenesis, and hESC line derivation will continue to be ineligible for NIH support. This means that the private foundation and individual philanthropic dollars that have gotten these areas of research as far as they are today will continue to be of central importance going forward. It would have been wonderful to bolster that support with NIH money though the NIH guidelines do mention that the plan will be revisited from time to time. The bottom line is that the field is better off than it was at this same time last year. The NIH has some important procedural bits to figure out to make all of this work well but again, difficulty also presents the opportunity for leadership.

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Children’s Stem Cell Program is making some of the most important breakthroughs and discoveries in this field and is run by some of the world’s leading stem researchers and foremost clinicians, including George Daley, MD, PhD, and Len Zon, MD. Watch videos of them discussing stem cells: