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ASRM BULLETIN
Volume 3, Number 43
November 19,
2001
NIH AND HEALTH AND HUMAN SERVICES ISSUE FURTHER INFORMATION FOR STEM CELL RESEARCHERS
The Office for Human Research Protections of the Department of Health
and Human Services has published some guidelines for Institutional Review
Boards (IRBs), investigators and sponsors considering research activities
involving human embryonic stem cells, materials derived from them, human
embryonic germ cells from fetal tissue, or materials derived from them.
See http://ohrp.osophs.dhhs.gov/references/HESCGuidance.pdf
Also
available is a list of frequently asked questions on federal funding for
embryonic stem cell research. The questions (and their answers) are about
how to apply for funding under the extended deadline, what to do if you
can't make it by the extended deadline, prohibited areas of research, the
requirement to identify the stem cell line to be used, IRB review, and
regulations on importing cells from other countries. The FAQs are found at
http://grants.nih.gov/grants/stem_cell_faqs.htm
Many
of the embryonic stem cell lines approved for federal research funding
were developed outside the United States. Researchers who want to work
with them may be required to get permission to import them. At http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-103.html
the NIH explains some of the policies U.S. federal government agencies
have in place for the importation of biological specimens. Details and
contact information are given for USDA, CDC, and FDA.
SINGAPORE BIOETHICS PANEL OK'S HUMAN EMBRYONIC STEM CELL RESEARCH
Over the weekend, Singapore's government-appointed Bioethics Advisory
Committee, comprised of scientists, a judge, a philosophy professor and a
newspaper editor, issued a report approving the use of "early embryos, not
more than 14 days old for serious research which may benefit others." The
committee advised policy makers not to permit human cloning for
reproductive purposes, stating that, "With reproductive cloning, a human
being may be brought into existence for a utilitarian purpose. The primary
purpose of existence is demeaned, and there is a loss of human
dignity."
Suffering from recession, the small, yet wealthy,
Southeast Asian city-state hopes to maintain a political environment
hospitable to the promising field of biomedical research. Singapore
officials do not foresee tightening restrictions on human embryonic stem
cells.
UK COURT RULES THAT DRAFTING OF LAW LEAVES HUMAN CLONING LOOPHOLE OPEN
Last week, in a suit brought by the Pro-Life Alliance, the High Court
of Justice handed down a ruling that current law does not cover, and
therefore cannot permit, the research use of somatic cell nuclear
transfer-derived human embryonic stem cells. The court reasoned that the
1990 Human Fertilization and Embryology Act pertains only to embryos
derived from an egg fertilized by a sperm and is inapplicable to SCNT. The
ruling would require the legislature to state specifically that SCNT
cannot be used for reproductive cloning in order to allow for its use in
research.
In the meantime, the United Kingdom has no
regulations governing human cloning- for purposes of research or
reproduction. The Department of Health may appeal the High Court ruling
and the House of Commons is considering emergency legislation to close the
loophole.
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