Wednesday, July 12, 2006

International Stem Cell Research Guidelines

The International Society for Stem Cell Research has published (.pdf file, here) the proposed guidelines for stem cell research. Unfortunately, like the National Academies guidelines (available, here. You may have to do a search on "stem cell guidelines" if the link doesn't work), they assume that cloning and embryonic stem cell research is a given. Fortunately, the guidelines do recommend a moratorium on "reproductive cloning," although defining "reproductive cloning" as implantation for the production of a baby. In reality, of course, all cloning is asexual reproduction of the donor of the nuclear DNA.

The Scope of the Guidelines are given as:

4.1) Well-established guidelines and regulations governing the use of human subjects are already in place throughout the world. These principles have been articulated in internationally recognized research ethics guidelines including, but not limited to, the Nuremburg Code of 1947, the Declaration of Helsinki of 1964 and 1975, the Belmont Report of 1979, the Council for International Organizations of Medical Sciences (CIOMS), the International Ethical Guidelines for Biomedical Research Involving Human Subjects of 2002, and the UNESCO Universal Declaration on Bioethics and Human Rights of 2005. Regulations for use of animals and hazardous materials in research have also well established and in wide use. This Guidelines document focuses on issues unique to stem cell research that involve pre-implantation stages of human development, and
research on the derivation or use of human pluripotent stem cell lines, and on the range of experiments whereby such cells might be incorporated into animal hosts.

4.2) These Guidelines pertain to the procurement, derivation, banking,distribution, and use of cells and tissues taken from pre-implantation stages of human development; to procurements of gametes and somatic tissues for research; and to the use of human totipotent cells or human pluripotent stem cell lines.

4.3) These Guidelines assign criteria for defining categories of research that arenon-permissible, that are permissible under currently mandated review processes, and research that is permissible yet should be subjected to an added level of oversight. These Guidelines prescribe the nature of regulatory review and
oversight for each of the permissible research categories.


I was right about the overlap of the two committees, btw. The International Committee is much larger, but the two committees have several members in common. More importantly, Appendix C of the National Academies' document is the "Workshop Agenda and Speakers' Biographies." The agenda reveals that, as the International guidelines acknowledge, the same set of men and women were called on to inform one another and to draw up both sets of guidelines. I wish there were some inclusion of scientists and ethicists who are not proponents of cloning and destructive embryo research, perhaps someone like Dr. James Sherley of MIT.

The glossary at the end of the ISSC document defines the embryo as beginning with the first cleavage of the "fertilized ovum," while noting that some sources define the embryo as beginning at the implantation stage. There are definitions of "parthenogenic embryos," "nuclear transfer embryos," "altered nucleus embryos," "chimeras," and "hybrids." The definitions of "totipotent" and "pleuripotent" are:


Terminology relating to developmental potential
Totipotent: capacity to support full organismal development in utero
Pluripotent: capacity to support development of all tissue of an organism,not alone capable of sustaining full organismal development in utero.

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