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Jonathan D Moreno & Richard O Hynes
Responding to a lack of US government leadership on the conduct of human embryonic stem cell research,
a National Academies panel has proposed the creation of new institutional oversight committees.
also reviewed relevant US reports and inter- IRBs will continue to review aspects of possibility that hES cells could contribute to the
national guidelines, policies and procedures, research that involve human subjects, such as germ line in such chimeras. Finally, no animal
including those of the United Kingdom and gamete or blastocyst donors, or patients who embryonic stem cells should be transplanted
Canada. Fourteen external reviewers from vari- are to receive stem cell therapy. A rigorous into a human blastocyst.
ous disciplines provided important critiques of donor consent process must be in place, and Although the guidelines are directed at US
the penultimate draft. all donors must give explicit, informed consent investigators and institutions, they specify that
for use of their materials in hES cell research. international collaboration is permissible if the
Summary of the recommendations To avoid financial conflicts of interest, no pay- ESCRO committee at the US institution finds
A key part of our recommendations is that ments beyond direct expenses should be made that the collaborating institution provides pro-
© 2005 Nature Publishing Group http://www.nature.com/naturebiotechnology
all hES cell research protocols be reviewed by for gametes or blastocysts, either to the donors tections consistent with the guidelines.
a new institutional panel, an embryonic stem or to the in vitro fertilization clinic. Researchers Finally, our report recommends that a
cell research oversight (ESCRO) committee. may not propose that more blastocysts be cre- national independent body be constituted
Although we recognized the implications of ated by in vitro fertilization clinics than are to review periodically whether the guidelines
recommending another level of bureaucracy, we intended for reproductive purposes. Only after should be updated in light of evolving public
concluded that the burden in this case was justi- reproductive efforts have ceased may potential attitudes and unforeseen advances in stem
fied given the novel and controversial nature of donors be asked to consent to the research use cell science. Although a National Academies
hES cell research and the complexities likely to of leftover blastocysts. Many other protections report cannot assign such responsibilities to
be associated with organizing its oversight. must also be in place for donors, including con- the Academies, they would seem to be one
The ESCRO committee does not replace fidentiality and protection of privacy. possible host of this important public over-
other research compliance bodies, such as The guidelines rule out certain experiments. sight activity.
institutional review boards (IRBs), whose Following a recommendation from a previous
purview is oversight of research on human National Academies report, nuclear transfer The road ahead
subjects, but is intended to complement and must not be used in attempts to reproduce a In the weeks since their publication, the guide-
help coordinate the involvement of IRBs and human being, and no human embryos used in lines have been endorsed by numerous aca-
other pertinent bodies, including animal care research should be grown in culture for longer demic and research organizations. Although
and use committees, biosafety committees and than 14 days or the formation of the primitive our recommendations are not legally binding,
radiation safety committees. ESCRO commit- streak. There is no scientific rationale for the it is our hope and expectation that all interested
tees should include experts in biology and production of a human via nuclear transfer, parties, including investigators, their institu-
stem cell research, legal and ethical experts, and the 14-day standard has been widely recog- tions, private industry and journal editors, will
as well as representatives of the public. The nized since the UK’s Warnock Report of 1984. voluntarily adhere to them and assist in enforc-
ESCRO committee will be the key point of Research will require the creation of chi- ing them. For example, the guidelines could
contact for all investigators working with hES meras—the products of mixing human and be incorporated by reference into university
cells; they should register their lines with their animal cells—both for investigations of the research rules and industry contracts, founda-
institution’s ESCRO committee even if their developmental potential of stem cells (embry- tions could specify adherence to the guidelines
research is limited to in vitro studies not subject onic or adult) or their derivatives and to satisfy as a condition for awarding of grants and jour-
to review by existing human subjects or ani- FDA requirements before clinical applications. nal editors could require written assurance of
mal care committees. Institutions should also Chimeras can involve transfer of human stem compliance by authors before accepting papers
establish (severally or collectively) stem cell cells and their derivatives into postnatal animals for publication.
banks that keep careful records of all aspects or into developing embryos. The guidelines We encourage all those who may participate
of cell culture and source and assure that all state that an ESCRO committee should review in work involving hES cells to familiarize them-
donor consent and confidentiality rules have any proposals to place hES cells into an animal. selves with the guidelines and to commit them-
been satisfied. Uniform, industry-wide stan- Particular consideration and oversight will be selves to the standards they contain. This will
dards should be adopted by each bank. required when it is possible that hES cells could establish a consistent set of rules for the ethi-
The report recommends that ESCRO com- contribute in a major, organized way to brain cal conduct of this important area of scientific
mittees review all proposals for research involv- structures. This is perhaps more likely in the research and provide both a stable scientific
ing hES cells from all sources. These sources case of transfer into early stages such as blasto- environment and assurance to the public that
include unused blastocysts stored at in vitro cysts, and such experiments will require more the research is being conducted with appropri-
fertilization clinics, blastocysts generated careful oversight. Chimeras should not be cre- ate oversight. Failure to implement a common
explicitly for the purpose of generating hES ated if there are alternatives for achieving the standard would not only make interinstitu-
cells (not eligible for federal funding but legal same scientific goal. No hES cells should be put tional cooperation more difficult but would
in several states) and blastocysts created by into nonhuman primate blastocysts, and no ani- also undermine public confidence that the
nuclear transfer (again not eligible for federal mal into which hES cells have been introduced scientific community is proceeding with care
funding but legal in several states). should be allowed to breed, to avoid the unlikely in this sensitive field.