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Big Bang Theory: More Reason to Scrap Bush's Stem Cell Policy
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To the Editor: Rob Streiffer's rifle has a narrow bore but makes a big bang ("Informed Consent and Federal Funding for Stem Cell Research," May-June 2008). He shows deficiencies in the consent forms for most of the human embryonic stem cell lines that qualify under the Bush funding strictures, thus presenting a reason beyond embryo status for rejecting their use. With the Bush administration in its final days, the message here is twofold. First, institutions that have already approved research with the consent-deficient lines should halt that research. Second, future policy-makers and embryonic stem cell oversight committee members are on notice: to earn their pay, they will have to scrutinize the details of consent more than in the past.

His point is less sexy than other stem cell issues, but important. In his first days in office, the new president could direct his agency heads to fund research with lines beyond those created before August 9, 2001, just as President Clinton did on January 22, 1992, with regard to the moratorium on federal funding of fetal tissue research. Although both candidates support the Castle-DeGette stem cell bill, expanding funding through legislation will only delay the research. In either case, funding guidelines will then be needed, which could take several more months. The National Institutes of Health funding guidelines drafted at the end of the Clinton years are a good model, but they will need some jiggering and NIH and Department of Health and Human Services approval before money flows.

Streiffer reminds us that to conduct research ethically in a new regime, we'll need to take consent more seriously. Embryo issues, of course, will remain. The stickiest wickets will be whether to fund derivation of new lines, including lines from embryos created solely for research and lines created by nuclear transfer. There will also be donor issues, such as whether consent must be contemporaneous with donation, who should obtain it, and whether egg donors will receive payment, as they do for infertility treatment. More mundane but equally essential are the details of consent written down in that near-sacred document, the consent form.

To cover all the bases, consent forms should describe research uses, chimeras, confidentiality, and much else. The difficulty of doing so will demand more of the time of researchers, staff, institutional review boards, and embryonic stem cell oversight committees. At some institutions lawyers will also review the forms. At work here is the inexorable—to some execrable—march of bureaucracy in bioethics. The IRB process eats a lot of time and resources while failing in some cases to protect research subjects from harm. Adding another layer of review for stem cells—the ESCRO committees, which have in effect become mandatory—only complicates matters. Indeed, critics say there are no ethical issues here that an IRB could not handle. They see the ESCRO committee as a procedural fig leaf, a public wringing of hands to signal that all is well as we muck around at the very beginning of human life. Bioethical proceduralists, however, counter that we need an ESCRO committee's expertise to understand the research and ethical niceties involved. They further contend that once rules and guidelines are in place, the ESCRO committees will save IRB time.

It is too soon to resolve this. But the good news is that when we are worrying about the language of consent forms, we have entered a mature stage of the stem cell debate. Much of the hot air has escaped from the ethical balloon. We must now do the less glamorous work of getting consent right so that the research may ethically proceed.

To the Editor: The National Academies of Science's guidelines for informed consent to human embryonic stem cell research maintain that donors consent to using embryos in certain kinds of ethically controversial research, as Robert Streiffer points out. This includes research involving "genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models." In practice (since these guidelines are voluntary but are being adhered to in varying degrees by research institutions around the country), if potential embryo donors are unwilling to have their embryos used...



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