Obama's Ethics Tough On Approval of New Stem Cell Lines

On March 9, 2009, President Barack Obama issued Executive Order 13505, entitled Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.  This was the order that over turned the much maligned Bush restrictions on federally funding human embryonic stem cells research.  Most researchers in the field thought that better times had come, and in most instances they have.  However, The NIH was mandated with the task of setting forth ethical guidelines that new stem cell lines must meet in order to receive federal funds.  This has much to do with the patient informed consent process, a sometimes tricky ordeal of getting the proper verbiage and language in a signed document, and not with the actual science of stem cells.

The USA Today has run a great article on how tough these ethical guidelines are to meet in some instances and what the cost to science is for those lines that do not meet the standards.

For a decade, Oleg Verlinsky and colleagues at Chicago's Regenerative Genetics Institute created human embryonic stem cells marked with these diseases and others — made from embryos donated by suffering families — hoping to combat these illnesses.

On Thursday, A National Institutes of Health panel ruled one sentence of legal language in the consent form used by RGI meant these hundreds of cell "lines", or colonies, shouldn't receive federal research funding. "They will remain frozen, or discarded, forever," Verlinsky says. "Without federal support, no one will use them for research."

The trouble came from a sentence at the end [of the patient consent form], "We further agree that we, our heirs, successors, relatives, representatives, and/or agents will not bring any action in law or in equity, or in any administrative setting, related to our participation in this study."

That's "exculpatory" language, which waives a patient's rights to sue for negligence or harm, 4 of the 5 ACD panel members agreed, something forbidden under the federal "Common Rule" governing research. One panel member suggested the sentence only applied to lawsuits over profits from any "Patents and Discoveries" made from the cells, but was outvoted.

"There were some enterprising lawyers who probably felt that language needed to be in the consent and didn't appreciate what it might mean," Collins said, at the meeting. "But if we have guidelines, we have to stick to them in order to maintain their credibility." NIH has yet to issue Collins' final decision on the panel's guidance, which recommended approval for the six lines from other institutions.

Many people have asked me lately about the effects of lifting the Bush restrictions and the Obama Administration's support for stem cell research.  While Obama's executive order has been a great thing for the field of stem cell biology and regenerative medicine, It shouldn't be taken to mean that it is now easy to do this research. We can't just go running through the streets doing anything we want with stem cells and human embryos.  It is still a heavily regulated field in which rigorous ethical guidelines must be followed.   Progress is being made, albeit slowly, and we are doing it in an ethical and responsible manner.