The
National Academies' Guidelines for Human Embryonic Stem
Cell Research called for the establishment of an institutional Embryonic Stem
Cell Research Oversight (ESCRO) committee to oversee activities related to human
embryonic stem cell research.
Section 2.0 of the
guidelines describes the composition
and function of these ESCRO committees:
2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRYONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE
To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate
education of investigators involved in hES cell research, each institution should have activities involving
hES cells overseen by an Embryonic Stem Cell Research Oversight (ESCRO) committee. This committee could be
internal to a single institution or established jointly with one or more other institutions. Alternatively,
an institution may have its proposals reviewed by an ESCRO committee of another institution, or by an
independent ESCRO committee. An ESCRO committee should include independent representatives of the lay public
as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted
reproduction, and ethical and legal issues in hES cell research. It must have suitable scientific, medical,
and ethical expertise to conduct its own review and should have the resources needed to coordinate the
management of the various other reviews required for a particular protocol. A preexisting committee could
serve the functions of the ESCRO committee provided that it has the expertise recommended here and representation
to perform the various roles described in this report. For example, an institution might elect to constitute
an ESCRO committee from among some members of an IRB. But the ESCRO committee should not be a subcommittee
of the IRB, as its responsibilities extend beyond human subject protections. Furthermore, much hES cell
research does not require IRB review. The ESCRO committee should
(a) Provide oversight over all issues related to derivation and use of hES cell lines,
(b) Review and approve the scientific merit of research protocols,
(c) Review compliance of all in-house hES cell research with all relevant regulations and these guidelines,
(d) Maintain registries of hES cell research conducted at the institution and hES cell lines derived or imported
by institutional investigators. An institution conducting stem cell research should make information from the
registries (including, but not necessarily limited to, project abstracts and sources of funding) available to
the public and the media through the institution's Web site.
(e) Facilitate education of investigators involved in hES cell research.
An institution that maintains its own ESCRO committee should conduct periodic audits of the committee to
verify that it is carrying out its responsibilities appropriately. Auditable records include documentation
of decisions regarding the acceptability of research proposals and verification that cell lines in use at
the institution were acceptably derived (see Section 1.6). Institutions should make th eresults of the
audits available to the public.
An institution that uses an external ESCRO committee should nevertheless ensure that the registry and educational
functions of an internal ESCRO committee are carried out by the external ESCRO committee on its behalf or internally
by other administrative units. Those institute that use external ESCRO committees are also responsible for
ensuring that these committees are likewise carrying out their responsibilities appropriately.
2.1 For projects that involve more than one institution, review of the scientific merit, justification, and
compliance status of the research may be carried out by a single ESCRO committee if all participating institutions
agree to accept the results of the review.
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Members of ESCRO committees may wish to join the
ESCRO committee listserv or
consult the
ESCRO committee advice provided by the National Academies.
ESCRO committees are also encouraged to
submit comments to the National Academies'
advisory committee on the workability of the guidelines, problems experienced by your
institution, or aspects of the guidelines that you believe require clarification or updating in light of new
scientific, ethical, legal, policy, or other information.
