Uncertainty surrounding NIH stem cell guidelines

At the ISSCR meeting in Barcelona, Harvard’s Kevin Eggan told reporters he isn’t sure that any human embryonic stem cells are eligible for U.S. federal funding right now. The principles of the just-released US NIH guidelines are clear on what’s fundable; the details are anything but. And until those details are unclear, Eggan and others are worried that some institutions won’t let researchers use resources acquired with federal dollars; another worry is that institutions won’t let awarded NIH grant funds flow to researchers.

Over the upcoming months, a group of to-be-assembled experts must decide what existing ES cell lines will make it onto an NIH registry of lines that can be studied with federal funding. This means, among other things, convincing the experts that the embryos donated for the creation of the lines were obtained with appropriate informed consent, according to accepted criteria at the time. The older forms are not as good, and some institutions’ forms are better than others, that could, perhaps, lead to a backlash against certain lines. (See When the past catches up with the present ) To mitigate this problem, research institutions could proactively move to reconsent as many donors as they can; having such documentation at the ready could help the NIH expert groups move more swiftly.

Additionally, some research may just fall through gaps of bad timing. For instance, lines created after July 7 must follow specific guidelines in the new criteria. That could mean that some embryos already donated for research can’t be used for making lines because some in vitro fertility clinics haven’t yet modified their forms and procedures.

Clearly it is not President Obama’s intention for the NIH to stall human embryonic stem cell research. The NIH has told researchers it will act expeditiously. But the Institutes also cannot be a rubber stamp; the public must be able to trust the NIH to hold researchers to carefully considered criteria. As Eggan said about moving stem-cell technologies from the laboratory into the clinic: “the fastest way is the careful way.” The NIH should act expeditiously, but it should also take the time it needs to assemble the registry rigorously.

In the meantime, individual institutions will be left in an uncomfortable position of deciding what research they will permit. Research institutions understandably shun the possibility of bad publicity. But, in the absence of compelling new reasons, they should be equally committed to standing behind research that has already passed the scrutiny of ethics committees.

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