Updated guidelines for stem cell research released

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Updated guidelines for stem cell research released

http://www.eurekalert.org/pub_releases/2008-09/naos-ugf090508.php

The National Academies today released amended guidelines for research

involving human embryonic stem cells, revising those that were issued

in 2005 and updated in 2007. The Academies originally produced the

guidelines to offer a common set of ethical standards for the

responsible conduct of research using human stem cells, an area that,

due to an absence of comprehensive federal funding, was lacking

national standards. Since their initial release, the guidelines have

served effectively as the basis for oversight of this research in the

United States. In addition, a standing advisory committee -- a joint

project between the Academies' National Research Council and

Institute of Medicine -- was established to monitor and review

scientific advances and determine any need for revisions.

Embryonic stem cells have the potential to produce all of the body's

cell types. Researchers are working to harness stem cells' ability

both to regenerate themselves and produce specialized cells that may

lead to medical treatments that replace certain types of cells

damaged or lost to debilitating illness and injury, such as nerve

cells.

One reason for the 2008 modifications is to provide guidance on the

derivation and use of new human stem cells that were first developed

last year. These cells -- called " induced pluripotent cells " -- are

made by reprogramming nonembryonic adult cells into a stem-cell-like

state, in which they can be manipulated to form a wide array of

specialized body cells. Although induced pluripotent stem cells can

be derived without using embryos, the ethical and policy concerns

related to their potential uses are similar to those pertaining to

human embryonic stem cells. For example, issues arising from mixing

human and animal cells in a single organism are relevant for stem

cells from both embryonic and nonembryonic sources. However,

derivation of induced pluripotent stem cells does not require special

stem cell expertise and is adequately covered by current

Institutional Review Board regulations, the report says.

At this time it is still undetermined which stem cell types will

prove the most useful for regenerative medicine, as most likely each

will have some utility, noted the committee that wrote the report.

Therefore, the need for research with human embryonic stem cells

still exists despite the availability of new cell sources.

The amended guidelines also clarify that " direct expenses " for

reimbursement to women donating their eggs for use in stem cell

research may include costs associated with travel, housing, child

care, medical care, health insurance, and actual lost wages. This

language extends the 2005 guidelines, which stated that women who

undergo hormonal induction to generate eggs specifically for research

purposes should be reimbursed only for " direct expenses " incurred as

a result of the procedure, although they did not specify which

expenses qualified as direct. The committee stressed that

reimbursement for lost wages is not a payment for eggs; the intent is

to leave all donors neither better off nor worse off financially.

To instill a high level of confidence that institutions and their

researchers are conducting stem cell research responsibly, the

guidelines recommend that the public be informed about the types of

stem cell research under way and how the research conforms to the

institution's established procedures. Moreover, the committee

strongly suggested as a good management practice that institutions

conducting human embryonic stem cell research carry out periodic

audits of their embryonic stem cell research oversight (ESCRO)

committees to ensure proper performance and make the findings of the

audits available to the public. The audits should document decisions

regarding the acceptance of research proposals and verify that cell

lines in use were acceptably derived.

Additionally, the new guidelines clarify that an institutional ESCRO

committee may conduct expedited review for research done exclusively

in a laboratory dish or test tube that does not create new lines of

stem cells but uses previously derived human embryonic stem cell

lines. The original guidelines stated that research is " permissible

after currently mandated review and proper notification of the

relevant research institution. " However the word " notification " led

some experts to question if the requirement could be fulfilled by

merely informing ESCRO committees that the research would occur.

Although allowing for expedited review, the guidelines still require

an ESCRO committee to determine if the human embryonic stem cells

have been acceptably derived.

Future committee deliberations will consider items for which

additional information-gathering and more extensive debate and

discussion may be necessary. For example, the National Institutes of

Health determined that the human embryonic stem cell lines declared

in 2001 by President W. Bush to be eligible for federally

funded research were derived from embryos donated with informed

consent and without financial inducement. Based on this

determination, the Academies' 2007 guidelines had deemed those lines

to have been acceptably derived. However, questions about their

derivation were raised when this report was near completion. In

addition, a breakthrough in the ability to " reprogram " adult cells

from one type to another in a living animal was recently announced.

The committee will continue to monitor developments in stem cell

research to decide whether any future changes to the guidelines are

warranted.

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The report was sponsored by the Ellison Medical Foundation, the

Greenwall Foundation, and the Medical Institute. The

National Academy of Sciences, National Academy of Engineering,

Institute of Medicine, and National Research Council make up the

National Academies. They are private, nonprofit institutions that

provide science, technology, and health policy advice under a

congressional charter. The Research Council is the principal

operating agency of the National Academy of Sciences and the National

Academy of Engineering. A committee roster follows.

Copies of 2008 AMENDMENTS TO THE NATIONAL ACADEMIES' GUIDELINES FOR

HUMAN EMBRYONIC STEM CELL RESEARCH are available from the National

Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the

Internet at HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the

Office of News and Public Information (contacts listed above).