Editorial: Clearing the final hurdle

Published in The Hindu on August 11, 2009

The suspense over the eligible human embryonic stem cell lines for federal funding has been finally removed after the National Institutes of Health (NIH) announced the rules recently. The draft guidelines issued earlier by the NIH, after President Barack Obama signed an executive order overturning the eight-year-old ban on federal funding of stem cell lines, had specific requirements of informed consent by individuals who wished to donate their embryos for research. The 700 or so stem cell lines derived after 2001, and the 21 cell lines already approved for federal funding, were developed from extra embryos created by in vitro clinics after obtaining informed consent. This conformed to the guidelines laid down in 2005 by the National Academies of Sciences (NAS) or derived according to the ethical protocols approved by institutional review boards. But the stringent condition of informed consent laid down by the NIH would have made most of these cell lines, including the ones already funded, ineligible for federal funding. That would have been a severe setback to embryonic stem cell research. Nearly all ongoing experiments using federally funded cell lines and those created after 2001 would have been stopped. They would have needed to start afresh, using new cell lines obtained in accordance with the new rules. Little wonder that most stem cell researchers were aghast at the NIH proposal. The national body had clearly acted without applying its mind on such a vital matter.

Biological sciences, especially stem cell science, have been progressing at an astonishing pace over the last few years. When science progresses faster than regulation, it is inconceivable that retroactivity, the cornerstone of science regulation, was overlooked while framing the guidelines. It became all the more unfathomable as the NAS guidelines, the gold standard for the conduct of stem cell research in the U.S., permit retroactivity on cell lines already approved by the NIH. In fact, all the 21 cell lines identified for federal funding by the NIH itself in 2001 would have become ineligible for continued funding had the NIH not corrected the anomaly. Scientists may now become eligible to receive financial support from the government if the NIH is convinced that the creation of the stem cell lines adhered to the spirit, if not the letter, of the new regulations. However, what criteria the national body will use to determine whether a cell line that has not been collected in accordance with the newly laid down ‘informed consent’ rules is eligible for funding is yet to become clear.