Informed consent, one of the most frequently used expressions in clinical trials, is posing a lot of uncertainty among researchers working in the field of embryonic stem cell research in the U.S.
The National Institutes of Health (NIH), under the direction of President Barack Obama, had recently come out with the draft guidelines for federal funding of embryonic stem cell lines. Unlike the former President George W. Bush’s policy of restricting federal funding to just 21 stem cell lines created prior to 2001, the NIH guidelines would make thousands of stem cell lines eligible for funding.
While this is indeed a very positive development, the fine print is causing a lot of heart burn among researchers. The specific mandates for obtaining the informed consent from parents — the owners of the embryos from which the stem cell lines have been derived — is one contentious point.
The NIH guidelines require nine consent elements to be documented. While many of these are indeed noble in intent, they are nevertheless new and hence not in line with the guidelines laid down earlier by the National Academy of Sciences (NAS) or the International Society for Stem Cell Research (ISSCR).
What it means
What that would mean is that many of the 21 stem cell lines that received federal funding may no longer be eligible. Also, many of the embryonic stem cell lines derived after 2001, according to the ethical guidelines of the Institutional Review Boards (IRB), may also not be eligible for funding.
So what will be the fate of such stem cell lines, and the researchers who have been using them? Will it mean that these researchers will now have to depend on new cell lines derived according to the new NIH guidelines to continue their research?
“Important research will need to be repeated …It’s as if the last 8 years of cell line creation and ethical self-regulation have just vanished,” notes a paper to be published in the June 5 issue of the journal Stem Cell.
The new guidelines would have served the purpose best by including the existing cell lines derived ethically and according to the standards of that time. But by insisting that all the nine elements of the consent be explicitly mentioned in the form, it has denied funding for many of the existing cell lines.
In other words, the new guidelines have not been retroactive. “Retroactivity has been a persistent issue in stem cell research,” the paper notes. When science progresses faster than regulation and when regulation is not retroactive, problems are bound to crop up.
The NAS posed the same problem when it came out with its guidelines. It is now the turn of the NIH.
Retroactivity is seen as a must in this case for several reasons. It is impractical for the IVF clinics to go back and get the nine consent elements inserted in the old consent documents. Secondly, science and the way science is practised can effectively be challenged by any administration by not introducing retroactivity.
It is after eight years that the U.S. is coming out of the embryonic stem cell winter. But by not following the guardian principle of retroactivity himself, President Obama is letting his new policy be undermined by any future right-wing administration. All that would be required is to change a few requirements to a crucial step and by not including retroactivity.
End of an era
“We have just emerged from an era of politics directed at control of science,” notes the paper. It certainly is not wise for the new administration to go back on Mr. Obama’s call on ending the war on science by not putting in place the retroactive provisions.