Guidelines for use of embryos, fetal tissue
Guidelines for use of embryos, fetal tissue
(Editor’s note: The following is excerpted from Draft NIH Guidelines for Research Involving Pluripo tent Stem Cell Research by the Working Group to the Advisory Committee of the Director, National Institutes of Health, Office of Science Policy, April 8, 1999. This is NOT a final version. A final draft will appear in the Federal Register for public comment.)
Unlike pluripotent stem cells derived from human embryos, federal funds may be used to support research to derive pluripotent stem cells (PSC) from fetal tissue. However the following rules should be followed:
Restrictions governing fetal tissue research
Public Health Service Act sections 498A and 498B govern the use and transfer of human fetal tissue for research and transplantation. PHS Act section 498A specifies that fetal tissue means tissue or cells obtained from a dead human fetus "after a spontaneous abortion or induced abortion, or after a stillbirth." The Act also states the following:
The timing, methods and procedures used to terminate the pregnancy may not be altered for the purposes of obtaining the tissue. The tissue may not be acquired, received, or otherwise transferred for profit.
The woman providing the fetal tissue may receive no money for the costs associated with pregnancy termination.
Informed consent:
Informed consent must be obtained from all donors. Informed consent requires that prospective donors of fetal tissue appreciate the nature and purpose of the application of human stem cells for research and give their consent to it. Derivers, therefore, should disclose to potential donors information that a reasonable individual would consider pertinent in making the decision whether or not to donate their fetal tissue for research purposes.
The informed consent should contain information that the fetal tissue will be used to derive PSC; information regarding the general type of PSC research that will likely be done; statement that the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantation of the tissue and the woman has not been informed of the identity of such individuals; the deriver should disclose the possibility that commercial products might be developed from these cells and who would own the products or patents; and information on the extent to which privacy and confidentiality will be maintained.
The possibility of obtaining and ensuring full and informed consent lies with the deriver. The burden of demonstrating that the consent process was voluntary and free of coercion also rests with the deriver. To avoid potential conflicts of interest, the physician and the individual deriving the cells should never be one and the same.
Utilization of pluripotent stem cells that were derived from human embryos
Studies utilizing human embryo-derived pluripotent stem cells may be conducted using federal funds, if the cells were derived from human embryos that were in excess of clinical need and if the derivation is not carried out with federal funding.
Considerations for research utilizing PSC derived from human embryos:
The derivation of pluripotent stem cells from human embryos currently can be done only in laboratories that do not receive HHS funding. To be eligible for federal funding of research utilizing human PSC derived from human embryos, an investigator should obtain the cells from suppliers who follow these practices:
Human pluripotent stem cells can be derived only from embryos that were created specifically for infertility treatment and are in excess of clinical need. Investigators using pluripotent stem cells derived in the private sector from human embryos should obtain documentation from the deriver that the embryos were created for infertility treatment.
When embryos are donated by women/couples in infertility programs, the laboratory must have written practices in place to ensure there is no undue, or even subtle, pressure to donate. The voluntary nature of such donations is essential, and under no circumstances should individuals who do not wish to donate their embryos ever feel pressured to do so.
The woman/couple should not be approached about donation until the issue of how to handle excess embryos is discussed; then, donation, storage, or immediate discarding should be presented without showing favor to the option to donate for research.
Investigators using pluripotent stem cells derived in the private sector from human embryos should obtain documentation from the individual who derived the cells that the couple was approached in this way.
Human PSC cannot be derived from embryos created for research purposes (such as the purpose of deriving PSC). Investigators using PSC derived in the private sector from human embryos should obtain documentation from the deriver that the embryos were not created for research purposes.
Informed consent:
Investigators using PSC derived in the private sector from human embryos should obtain documentation from the individual who derived the cells that informed consent was obtained from all donors. The burden of demonstrating that the consent process was voluntary and free of coercion rests with the individual deriving the PSC. To avoid possible conflicts of interest, the physician and the individual deriving the cells should never be one and the same.
Derivers, therefore, should disclose to potential donors information that a reasonable individual would consider pertinent in making the decision whether to donate embryos for research purposes. Informed consent should contain: information that the embryo will be used to derive PSC; information regarding the general type of PSC research that will likely be done; the deriver should disclose the possibility that commercial products might be developed from these cells and who would own the products or patents; information on the extent to which privacy and confidentiality will be maintained.
Laboratories from which derived stem cells are obtained should have written policies in place regarding the protection of privacy and confidentiality. Investigators utilizing pluripotent stem cells derived from human embryos also should document that donors were assured the embryos would not, under any circumstances, be transferred to any woman’s uterus.
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