Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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Since 1998, the volume of research being conducted using hES cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Although privately funded hES cell research is currently subject to many of the same oversight requirements as other biomedical research, given restricted federal involvement and the absence of federal regulations specifically designed for hES cell research, there is a perception that the field is unregulated.
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Research using chimeras will be valuable in understanding the etiology and progression of human disease and in testing new drugs, and will be necessary in preclinical testing of hES cells and their derivatives. Because there is widespread agreement in the international scientific community about the potential value of hES cell research, the volume of this research has expanded since 1998, despite restrictions in the United States.
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STATEMENT OF COMMITTEE TASK The National Academies initiated this project to develop guidelines for hES cell research to advance the science in a responsible manner. The Committee on Guidelines for Human Embryonic Stem Cell Research was asked to develop guidelines to encourage responsible practices in hES cell research -- regardless of source of funding -- including the use and derivation of new stem cell lines derived from surplus blastocysts, from blastocysts produced with donated gametes, or from blastocysts produced using NT.
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In addition, many but not all of the guidelines and concerns addressed in this report are common to other areas of human stem cell research, such as research with adult stem cells, fetal stem cells, or embryonic germ cells derived from fetal tissue. Institutions and investigators conducting research with such materials should consider which indi vidual provisions of the guidelines set forth in this report are relevant to their research.
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To provide local oversight of all issues related to derivation and research use of hES cell lines and to facilitate education of investigators involved in hES cell research, all institutions conducting hES cell research should establish an Em bryonic Stem Cell Research Oversight (ESCRO) committee.
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Through its Embryonic Stem Cell Research Oversight committee, each research institution should ensure that the provenance of hES cells is documented. Docu mentation should include evidence that the procurement process was approved by an Institutional Review Board to ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality.
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Research that is permissible after notification of the research institution's ESCRO committee and completion of the reviews mandated by current require ments. Purely in vitro hES cell research with pre-existing coded or anonymous hES cell lines in general is permissible provided that notice of the research, documentation of the provenance of the cell lines, and evidence of compliance with any required Institutional Review Board, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, or other mandated reviews, is provided to the ESCRO committee or other body designated by the investigator's institution.
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Review of the Procurement Process Research involving hES cells will require access to human oocytes and embryos, necessitating some interaction between oocyte and blastocyst donors and people or institutions seeking to procure these materials for use in hES cell research. Individu als and couples who voluntarily and with full information donate somatic cells, gametes, or blastocysts for hES cell research should be assured that their donation is made for meritorious research and that all efforts will be made by those responsible for handling, storing, and using cell lines to protect donor confidentiality.
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Institutional Review Boards may not waive the requirement for obtaining in formed consent from any person whose somatic cells, gametes, or blastocysts are used in hES cell research. When donor gametes have been used in the in vitro fertilization process, result ing blastocysts may not be used for research without consent of all gamete donors.
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This recommendation should not be interpreted as a commentary on commer cial IVF practices, but as a narrow policy position specifically with respect to hES cell research. Furthermore, as with all the policies recommended by the com mittee, this policy should be regularly reviewed and reconsidered as the field ma tures and the experiences under other policies can be evaluated.
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Investigators, institutions, Institutional Review Boards, and privacy boards should ensure that authorizations are received from donors, as appropriate and required by federal human subjects protections and the Health Insurance Port ability and Accountability Act, for the confidential transmission of personal health information to repositories or to investigators who are using hES cell lines derived from donated materials. As the level of hES cell research in the United States increases, it is essential that
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When FDA requires that a link be maintained to the donor source, investigators and institutions must ensure that the confidentiality of the donor is protected, that the donor understands that a link will be maintained and that, where appli cable, federal human subjects protections and the Health Insurance Portability and Accountability Act or other privacy protections are followed. Banking of hES Cell Lines As hES cell research advances, it will be increasingly important for institutions that obtain, store, and use cell lines to have confidence in the value of stored cells, that is, confidence that they were obtained ethically and with informed consent of donors, that they are well characterized and screened for safety, and that their maintenance and storage meet the highest scientific standards.
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They provide an oversight process that will help to ensure that hES cell research is conducted in a responsible and ethically sensitive manner and in compliance with all regulatory requirements pertaining to biomedical research in general. Although the committee hesitates to recommend another bureaucratic entity to oversee biomedical research, in this case it believes the burden to be justified because of the special issues involved in hES cell research and because of the diverse entities that might have a role in the review process in a research institution.
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To help ensure that these guidelines are taken seriously, stakeholders in hES cell research -- sponsors, funding sources, research institutions, relevant oversight com mittees, professional societies, and scientific journals, as well as investigators -- should develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, professional societies, journals, and institu tional review panels can provide valuable community pressure and impose appro priate sanctions to ensure compliance.
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