Abstract
Amid much controversy, the National Institutes of Health (NIH) released its guidelines for stem cell research in the Federal Register on August 25, 2000. According to the NIH, these guidelines were developed to ensure the ethical and legal use of human pluripotent stem cells by researchers who receive NIH funding. Although the NIH solicited comments from the public, reportedly receiving close to 50,000 responses, and incorporated them into the guidelines, opponents of the research believe that this NIH document does not adequately address concerns related to how the stem cells will be obtained and used.
The guidelines explain exactly what documentation is required in an application for funding for research that involves stem cells, the conditions of how the stem cells may be obtained, what types of stem cell-related research may not be funded, and how the evaluation of applications will be overseen by the NIH.
Besides proof of Institutional Review Board (IRB) approval, materials required for funding application include statements from the author assuring that the stem cells were obtained in accordance with the guidelines, that the type of research to be conducted is eligible for funding, and that no monetary or other incentive, beyond reasonable expenses related to obtaining the cells, was provided in exchange for the stem cells.
To allay fears that research involving stem cells derived from human embryos will promote the creation of embryos specifically for research, the guidelines state that only cells from fetal tissue or frozen “embryos that are a result of in vitro fertilization, are in excess of clinical need, and have not reached the stage at which the mesoderm is formed” may be used in research funded by the NIH. Furthermore, there must be a “clear separation between the decision to create embryos for fertility treatment and the decision to donate human embryos in excess of clinical need for research purposes.” To this end, the physician overseeing the fertility treatment and the researcher receiving the embryos for stem cell research may not be the same person.
Informed consent must be obtained, with the following statements, among others, being disclosed to the donor: that the cells derived from the fetal tissue or embryo will be used for research, possibly including transplantation, that cells may be stored for many years before use, that the donor is not entitled to any financial profit resulting from the research, and that donated embryos will not be implanted in a woman or survive derivation.
Types of research that may not receive NIH funding include the actual derivation of the stem cells from embryos, the creation of embryos, research that uses cells from embryos purposely created for research, research involving somatic cell nuclear transfer, the combining of human and animal embryos, and cloning.
Regarding NIH oversight, all applications for funding for research involving stem cells will be reviewed by the newly established Human Pluripotent Stem Cell Review Group and the NIH will produce an annual report indicating the number of applications from and awards granted to investigators conducting stem cell-related research.
Meanwhile, proposed legislation sponsored by Senators Arlen Specter (R-PA) and Tom Harkin (D-IA), the Stem Cell Research Act of 2000, would legally authorize the NIH to fund research based on stem cells derived from human embryos. The Senate Labor, Health and Human Services, Education, and Related Agencies Subcommittee, which is chaired by Specter, held hearings on stem cell research in September.