IT WASN’T that long ago — March 2009, to be precise — that sighs of relief echoed through the halls of science, as President Obama signed an executive order that lifted Bush-era restrictions on research with embryonic stem cells. That allowed scientists in government-funded labs to study these special cells, which are created from human embryos and have the potential to turn into any type of tissue in the body. It’s only too bad that the National Institutes of Health, the very institution charged with propelling these advances into scientists’ hands, recently dealt the effort a major blow because of a technicality: problematic language in the consent form signed by couples who donated embryos.
There is no chance that the language in the waiver will cause any harm to the couples — they knew they were donating the embryos, which otherwise would have been discarded. But there is a substantial chance that depriving researchers of 47 disease-specific stem-cell lines will slow the progress toward cures of diseases including muscular dystrophy, cystic fibrosis, and breast cancer. The NIH was following its latest guidelines in making the decision, and the agency instructed its expert advisers not to consider the scientific value of the cells in evaluating whether federally-funded researchers should be allowed to use them. This was shortsighted.
Though privately funded researchers could still use the cells, the NIH should reconsider — and be more lenient in similar cases.
NIH Director Francis Collins made the decision on Monday, heeding the advice of an expert advisory panel. The Reproductive Genetics Institute (RGI), a Chicago-based fertility clinic, had submitted the 47 stem-cell lines for approval into the growing list of lines sanctioned for study with federal funds. The RGI cells are unique because they carry genes for specific diseases. They include neurofibromatosis and Huntington’s disease, in addition to muscular dystrophy, cystic fibrosis, and breast cancer. Growing cells from patients with these maladies is often quite challenging, if not impossible. Having an infinite reservoir of cells that may be turned into the relevant tissues is of incalculable potential.
The NIH’s rejection was primarily based on objectionable, if still legal, language in the informed consent document that couples signed years ago when donating their embryos. The clause was as comprehensive as it was powerful: “We further agree that we, our heirs, successors, relatives, representatives and/or agents will not bring any action in law or equity, or in any administrative setting, related to our participation in this study.”
Such so-called “exculpatory language” — in which a study volunteer is asked to waive future rights — is generally considered unethical in human studies, because volunteers could suffer in ways that they cannot imagine now. The government takes this issue so seriously that exculpatory language is banned from informed consent documents signed by subjects in government-funded research. The guidelines set by NIH in 2009 to evaluate stem cell lines for approval also follow this principle, and most labs that derive stem-cell lines are already in compliance.
But for lines that existed before 2009, some exceptions make sense. RGI’s troublesome wording was designed in 2002. The clinic, as a private enterprise, didn’t need to adhere to federal research guidelines. Even then, its consent form was quite specific, starting with its title: “Consent to donate human embryos for research study to establish human embryonic stem cell lines.’’ Far from protecting the couples who signed it from future harm, the NIH’s decision thwarts their wishes.
Collins’ refusal wasn’t without regret. He said it was “frankly rather painful” for his advisory committee to recommend against approval of the cell lines, but that “rigorous guidelines are only meaningful if they are rigorously applied.”
That sentiment is admirable, but in this case a “rigorous’’ application of the consent rules worked against the greater good. Approving the stem cell lines would give hope and confidence both to researchers and to families confronting some of the most painful and lethal diseases.