OTTAWA (March 4, 2002) - Dr. Alan Bernstein, President of the Canadian Institutes of Health Research (CIHR) today released guidelines for funding for stem cell research.

Under the guidelines, human embryonic stem cell research will now be eligible for funding under the following conditions:

• when using pre-existing human embryonic stem cell lines;

• when using embryos created for reproductive purposes which are no longer required;

• where the persons for whom the embryos were created have given free and informed consent for their use in research; and,

• when there were no commercial transactions involved in the creation and use of the embryos.

Research using stem cells from fetal tissue or adult stem cells would also be eligible for funding under specific conditions.

Under the guidelines, the funding for the following types of research would be banned:

• research leading to human cloning, reproductive and therapeutic cloning;

• research involving the creation of embryos strictly for research purposes; and,

• research combining non-human stem cells with a human embryo or fetus and human stem cells with a non-human embryo or fetus.

"Stem cell research holds tremendous potential for advances to improve human health," said Dr. Bernstein. "CIHR's guidelines for Canadian researchers strike a delicate balance between advancing research in this important area while carefully considering the ethical issues inherent in such research."

CIHR will also establish a Stem Cell Oversight Committee to ensure that human stem cell research eligible for CIHR funding is reviewed at the national level and conforms to the highest ethical and scientific standards. The Committee will include members from the general public, as well as those with expertise in stem cell biology and therapeutics, medicine and health care, ethics, law, and social sciences.

As well, CIHR will create a national registry of human embryonic stem cell lines generated in Canada with participation in the registry as a prerequisite for obtaining funding.

The guidelines, effective immediately, follow recommendations developed by an ad hoc Working Group created by CIHR and chaired by Dr. Janet Rossant of Mount Sinai Hospital's Samuel Lunenfeld Research Institute and the University of Toronto, in their report to the CIHR Governing Council, titled Human Pluripotent Stem Cell Research: Recommendations for CIHR-Funded Research. The Working Group initially released recommendations in a discussion paper in March 2001 for public input.

The Working Group's final report can be accessed electronically at http://www.cihr.gc.ca/.

CIHR is Canada's premier agency for health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened health care system.

Stem cells are immature, or undifferentiated, cells that have the ability to either develop into a variety of human tissues or organs or to renew themselves. They hold great promise in achieving a greater understanding of human development and treating degenerative diseases such as Parkinson=s disease, Alzheimer's disease, and multiple sclerosis.

Stem cells for research can be derived from three major sources:

• very early embryos where stem cells exist in their most flexible form and can develop into any type of cell in the body (called pluripotent);

• fetal reproductive organs, which also contain pluripotent stem cells which can be grown indefinitely in a culture environment; and

• adult tissues, such as skin and muscle, where stem cells with more restricted potential reside.

Research using these cells is governed by the same ethical framework as all research involving humans, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. While the ethical principles governing research involving humans, including tissues, biological fluids, embryos, and fetuses, are laid out in this statement, it does not deal directly with the issue of stem cells.

The Canadian Institutes of Health Research (CIHR) created the ad hoc Working Group on Stem Cell Research, comprising scientists, clinicians, philosophers, and a lawyer with national and international expertise in human reproductive technologies and stem cell research, to provide guidance as to whether human embryonic stem cell research should be eligible for CIHR funding and under what conditions. Initial recommendations were released as a Discussion Paper in March 2001, and were the subject of a three-month consultation period. The Working Group Report, submitted to the Governing Council of CIHR in January, 2002 reflects the input received during this process. CIHR guidelines, based on the final recommendations of the Working Group will now provide funding in the following kinds of stem cell research:

• Research to derive and study cells from embryos, human fetal tissue, amniotic fluid, umbilical cords, and placentas, provided that embryos are created for reproductive purposes and no longer required; there is free and informed consent from all parties; and there is no impact on a pregnant woman's decision to continue the pregnancy.

• Research to derive and study stem cells would be eligible for funding, given free and informed consent from the prospective research participant or, in the case of legal incompetence or death, by a legally competent third party.

• Research on cells lines that have been created in Canada or elsewhere, if they were created in accordance with CIHR guidelines.

• Research involving grafting human stem cells into non-human adult animals, if the research is designed to reconstitute a specific tissue or organ to derive a preclinical model and there is no possibility of reproduction.

• Research involving grafting human stem cells into legally competent humans, provided that there is overwhelming evidence of safety and efficacy, and the research is carried out in well-designed clinical trials with free and informed consent from all participants.

The following kinds of research would not be eligible for CIHR funding:

• Research involving the creation of human embryos specifically for deriving stem cells.

• Research involving somatic cell nuclear transfer into a human oocyte that has had its nucleus removed, to develop human stem cell lines (cloning).

• Research involving the directed donation of stem cell lines to particular individuals other than autologous donation.

• Research in which human or non-human stem cells are combined with a human embryo, grafted to a human fetus, or combined with a non-human embryo or fetus.

Because of the complex ethical issues around stem cell research and the public concern in this area, CIHR will establish of a Stem Cell Oversight Committee, with membership from the general public, as well as those with expertise in stem cell biology and therapeutics, medicine and health care, ethics, law, and social sciences, to provide ethical review of research proposals involving stems cells.

CIHR will also create a national registry of human embryonic stem cell lines generated in Canada, with participation in the registry a prerequisite for obtaining CIHR funding. Such a registry would minimize the need to create new stem cell lines from donated embryos.

Finally, CIHR will review the field of human stem cell research on an ongoing basis to respond to changing circumstances, narrowing or broadening the scope of eligible research as justified.

The guidelines apply to all stem-cell research proposals submitted to CIHR, effective immediately.

CIHR was established by the Government of Canada in 2000 as the premier funding agency for health research in Canada. CIHR funds a broad spectrum of health research, including biomedical, clinical, health systems and services, and population health research. The full text of Human Pluripotent Stem Cell Research: Recommendations for CIHR-Funded Research can be found at http://www.cihr.gc.ca/