More Reasons to Scrap Bush’s Stem Cell Policy

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.
John A. Robertson
University of Texas at Austin
School of Law
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 for these controversial
purposes, then they cannot donate them for any purposes whatsoever.
letters
Big Bang Theory:
More Reason to Scrap Bush’s Stem Cell Policy
The good news is that when we are worrying about consent form language, we have entered a mature stage of the debate. Much of the hot air has escaped
from the hESC ethical balloon.
November-December 2008
This guideline prevents the use not only of some of the cell lines approved
for federally funded research, as Streiffer observes, but also of some developed
with corporate and charitable funding.
This seems wasteful and disrespectful of
donors.
One way of addressing this difficulty would be to allow the use of donated
materials for either more or less controversial purposes, depending on the
choice of the donor. Although allowing donation for less controversial purposes
would present barriers to certain research with these cells and the materials
developed from them, the relative ease of developing induced pluripotent stem
cell lines with donor consent should allow new lines to be created for these
uses. This could lead to a need to redo some studies. However, allowing altruistically
motivated potential donors to provide embryos or somatic cells for
pluripotent research in ways that accord with their convictions seems worth the inconvenience.
Streiffer focuses on the failure of some NIH-approved cell lines to conform
to NAS guidelines. An even more fundamental problem with current federal
policy regarding NIH lines is that ethical oversight of their use is minimal.
It is based on three vague criteria for embryo donation set out in a speech by
President Bush in 2001 (no executive order was issued) that have never been
clarified by the NIH Stem Cell Task Force or the President’s Council on
Bioethics. Those carrying out national stem cell research policy have given no
consideration to other ethical issues raised by pluripotent stem cell research
beyond the moral significance of the early human embryo. Hopefully, a new
administration will address the full cohort of ethical issues raised by stem cell
and induced pluripotent stem cell research with the aid of a national stem
cell oversight committee such as the one
developed in Canada.
Cynthia B. Cohen
Georgetown University