Summary

This report provides guidelines for the responsible practice of human embryonic stem (hES) cell research. 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. More accurately, there is a patchwork of existing regulations that are applicable to hES cell research, many of which were not designed with this research specifically in mind, and there are gaps in how well they cover hES cell research. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. The guidelines, which are set forth in the final chapter of the report, are intended to enhance the integrity of privately funded hES cell research both in the public’s perception and in actuality by encouraging responsible practices in the conduct of that research. The body of the report provides the background and rationale for the choices involved in formulating the guidelines.

In 1998, James Thomson and co-workers became the first scientists to derive and successfully culture human embryonic stem cells (hES cells) from a human blastocyst, an early human embryo of approximately 200 cells, donated by a couple who had completed infertility treatments. Although ES cells had been derived from mouse blastocysts since 1981, this achievement with human cells was significant because of its implications for improved health. The dual capacity of hES cells for self-renewal and for differentiation into repair cells offers great potential for under-



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Guidelines for Human Embryonic Stem Cell Research Summary This report provides guidelines for the responsible practice of human embryonic stem (hES) cell research. 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. More accurately, there is a patchwork of existing regulations that are applicable to hES cell research, many of which were not designed with this research specifically in mind, and there are gaps in how well they cover hES cell research. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. The guidelines, which are set forth in the final chapter of the report, are intended to enhance the integrity of privately funded hES cell research both in the public’s perception and in actuality by encouraging responsible practices in the conduct of that research. The body of the report provides the background and rationale for the choices involved in formulating the guidelines. In 1998, James Thomson and co-workers became the first scientists to derive and successfully culture human embryonic stem cells (hES cells) from a human blastocyst, an early human embryo of approximately 200 cells, donated by a couple who had completed infertility treatments. Although ES cells had been derived from mouse blastocysts since 1981, this achievement with human cells was significant because of its implications for improved health. The dual capacity of hES cells for self-renewal and for differentiation into repair cells offers great potential for under-

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Guidelines for Human Embryonic Stem Cell Research standing disease development and progression, for regenerative medicine, and for targeted drug development. In addition to that research accomplishment, the cloning of Dolly the sheep in 1997 using a technique called somatic cell nuclear transfer (SCNT) or, more simply, nuclear transfer (NT) provided a means of generating ES cells with defined genetic makeup. hES cell preparations could potentially be produced by using NT to replace the nucleus of a human oocyte, trigger development, and then isolate hES cells at the blastocyst stage. The advantage of using NT to derive hES cells is that the nuclear genomes of the resulting hES cells would be identical with those of the donors of the somatic cells. One obvious benefit is that this would avoid the problem of rejection if cells generated from the hES cells were to be transplanted into the donor. A more immediate benefit would be facilitation of a wide array of experiments to explore the underpinnings of genetic disease and possible forms of amelioration and cure. Some such experiments will not be possible using hES cells derived from blastocysts generated by in vitro fertilization (IVF), in which the nuclear genomes are not defined. Although the promise of using NT for such research is as yet unrealized, most researchers believe that it will be a critical source of both important knowledge and clinical resources. Use of NT for biomedical research, as distinct from its use to create a human being, has been considered by several advisory groups to be ethically acceptable provided that such research is conducted according to established safeguards against misuse and has undergone proper prior review. However, there is nearly universal agreement that use of NT to attempt to produce a child should not be allowed at present. The medical risks are unacceptable, and many people have additional objections to using this procedure for attempts at human procreation. hES cells currently can be derived from three sources: blastocysts remaining after infertility treatments and donated for research, blastocysts produced from donated gametes (oocytes and sperm), and the products of NT. Ethical concerns about those sources of hES cells—combined with fears that the use of NT for research could lead to its use to produce a child—have fostered much public discussion and debate. In addition, concern has been expressed about whether and how to restrict the production of human/nonhuman chimeras in hES cell research. 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. First, federal legislation forbids the use of federal monies for any research that destroys an embryo; this effectively prevents any use of federal funds to derive hES cells from blastocysts. Second, research with established hES cell lines is limited by a policy announced by President George W. Bush in 2001 that restricts federal funding to research con-

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Guidelines for Human Embryonic Stem Cell Research ducted with specific federally approved hES cell lines already in existence before August 9, 2001. Despite the restricted use of federal funds for research of this kind, the derivation of new cell lines is proceeding legally in the private sector and in academic settings with private funds except in those states where such research has been partially or totally banned. Privately funded hES cell research is subject to some regulation or other constraints primarily through human subjects protections regulations, limits placed on licensees by the holders of NT and hES cell patents, animal care and use regulations, state laws, and self-imposed institutional guidelines at companies and universities that are now doing or contemplating this research. Those aiming to produce biological therapies are also subject to Food and Drug Administration (FDA) regulation. However, because of the absence of federal funding for most current hES cell research, some standard protections may be lacking, and the implementation of protections is not uniform across the country. Moreover, the techniques for deriving the cells do not yet amount to fully developed standard research tools, and the development of any therapeutic application remains some years away. The best way to move forward with hES cell research in pursuit of scientific goals and new therapies is with a set of guidelines to which the U.S. scientific community will adhere. Heightened oversight also is essential to assure the public that such research is being conducted in an ethical manner. Established criteria for deriving hES cell lines and reviewing research will help to ensure that the derivation, storage, and maintenance of cells meet a standard set of requirements for provenance and ethical review. Because not all scientists want or have the resources to derive new hES cell lines, the ability to share cell lines will create greater access for qualified scientists to participate in stem cell research. The tradition of sharing materials and results with colleagues speeds scientific progress and symbolizes to the nonscientific world that the goals of science are to expand knowledge and to improve the human condition. One key reason for the remarkable success of science since its emergence in modern form—besides the application of the scientific method itself—is the communal nature of scientific activity. 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. The guidelines take ethical and legal concerns into account and encompass the basic science and health science policy issues related to the development and use of hES cells for research and eventual therapeutic purposes, such as

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Guidelines for Human Embryonic Stem Cell Research Recruitment of donors of blastocysts, gametes, or somatic cells including medical exclusion criteria, informed consent, the use of financial incentives, risks associated with oocyte retrieval, confidentiality, and the interpretation of genetic information that is developed from studies with these materials and that might have importance to the donors. The characterization of stem cells for purposes of standardization and for validation of results. The safe handling and storage of blastocysts and stem cell material and conditions for transfer of such material among laboratories. Prerequisites to hES cell research (such as examination of alternative approaches), appropriate uses of hES cells in research or therapy and limitations on the use of hES cells. Safeguards against misuse. To conduct its work, the committee surveyed the current state of science in this field and probable pending developments, reviewed the policy and ethical issues posed by the research, examined professional and international regulations and guidelines that relate to hES cell research, and conducted a 2-day workshop to hear representatives of many scientific, ethical, and public policy perspectives. The committee did not revisit the debate about whether hES cell research should be pursued; it assumed that both hES cell and adult stem cell research would continue in parallel with federal and nonfederal funding. WHAT THE GUIDELINES COVER The guidelines are intended for the use of the scientific community, including researchers in university, industry, or other private-sector organizations. They cover all derivations of hES cell lines and all research using hES cells derived from Blastocysts made for reproductive purposes and later obtained for research from IVF clinics. Blastocysts made specifically for research using IVF. Somatic cell nuclear transfer (NT) into oocytes. The guidelines do not cover research with nonhuman stem cells. 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 individual provisions of the guidelines set forth in this report are relevant to their research. The guidelines do not apply to reproductive uses of NT, which are addressed in the 2002 report Scientific and Medical Aspects of Human Reproductive Cloning, in

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Guidelines for Human Embryonic Stem Cell Research which the National Academies stated that “Human reproductive cloning should not now be practiced. It is dangerous and likely to fail.” Although these guidelines do not specifically address attempts to use NT for reproductive purposes, it continues to be the view of the National Academies that such attempts should not be conducted at this time. MAJOR RECOMMENDATIONS This summary provides the major recommendations made by the committee, each of which supports an operational aspect of the guidelines presented in Chapter 6. Central to the recommendations is a dual system of oversight at the institutional and national levels. This system of oversight will ensure that the highest ethical, legal, and scientific standards are met in the derivation, storage, and use of hES cells in research. Institutional Oversight of hES Cell Research The ethical and legal concerns involved in hES cell research make increased local oversight by research institutions appropriate. Because of the complexity and novelty of many of the issues involved in hES cell research, the committee believes that all research institutions conducting hES cell research should create special review bodies to oversee this emerging field of research. Such committees will be responsible for ensuring that all applicable regulatory requirements are met and that hES cell research is conducted in accordance with the guidelines set forth in this report. 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 Embryonic Stem Cell Research Oversight (ESCRO) committee. The committee should include representatives of the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research. The committee will not substitute for an Institutional Review Board but rather will provide an additional level of review and scrutiny warranted by the complex issues raised by hES cell research. The committee will also review basic hES cell research using preexisting anonymous cell lines that does not require consideration by an Institutional Review Board. The ESCRO committee will assist investigators in assessing which regulations might apply to proposed research activities. The committee could serve as a clearinghouse for hES cell research proposals and could assist investigators in identifying the types and levels of review required for a given protocol. For example, the

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Guidelines for Human Embryonic Stem Cell Research creation of a chimera might involve both an Institutional Review Board (IRB), if cells are to be obtained from human donors for research, and an Institutional Animal Care and Use Committee (IACUC), if animals are to be used in the research. In some instances, Institutional Biosafety Committees (IBCs) and radiation safety committees might also have roles to play in research review. If hES cell research involves potential clinical applications (such as development of products to be tested in humans), FDA regulations will apply. However, care should be taken that the ESCRO committee does not duplicate or interfere with the proper functions of an IRB or other existing institutional committee. The functions of IRBs and ESCRO committees are distinct and should not be confused. One particularly important aspect of regulatory compliance for hES cell research deals with protection of donors of blastocysts and gametes. Laboratory research that uses hES cells is generally not subject to federal regulations governing research with human subjects unless it involves personally identifiable information about the cell line’s progenitors. In general, research institutions are likely already to have rules in place for research involving other biological tissues, and hES cell research, like any other form of biological or biomedical research, would be covered by these rules and in many cases will not require further review. In the case of hES cell research, however, it will be critically important for investigators and institutions to know the provenance of hES cell lines, particularly if the cell lines are imported from another institution. That would include obtaining an assurance that the process by which the cells were obtained was approved by an IRB to ensure that donors provided voluntary informed consent and that risks were minimized. Through its Embryonic Stem Cell Research Oversight committee, each research institution should ensure that the provenance of hES cells is documented. Documentation 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. The second role of ESCRO committees is to review research proposals that involve particularly sensitive kinds of research, including all proposals to generate additional hES cell lines by any means. The vast majority of in vitro experiments using already derived hES cell lines are unlikely to raise serious ethical issues, and will require minimal review. Some research with hES cells, such as the creation of human/nonhuman chimeras, will need more extensive review. Other types of studies should not be permitted at this time (such as implantation of embryos or cells into a human uterus or breeding of any interspecies chimera). Still others warrant careful consideration, including research in which identifying information about the donors is available or becomes known to the investigator and experiments involving implantation of hES cells or human neural progenitor cells into nonhuman animals. Because of the sensitive nature of some aspects of hES cell research, it is critical that the scientific community propose and

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Guidelines for Human Embryonic Stem Cell Research implement limits on what is to be allowed and provide clear guidance on which research activities require greater scrutiny (as discussed in the full report). Thus, a primary activity of ESCRO committees will be to ensure that inappropriate research is not conducted and that sensitive research is well justified (as explained in the full report) and subject to appropriate additional oversight. Oversight will in many instances conform to a higher standard than required by existing laws or regulations. ESCRO committees should have suitable scientific and ethical expertise to conduct their own reviews and should have the resources to coordinate the various other reviews that may be required for a particular protocol. A pre-existing committee could serve the functions of the ESCRO committee provided that it has the recommended expertise to perform the various roles described in this report. Embryonic Stem Cell Research Oversight (ESCRO) committees or their equivalents should divide research proposals into three categories in setting limits on research and determining the requisite level of oversight: (a) Research that is permissible after notification of the research institution’s ESCRO committee and completion of the reviews mandated by current requirements. 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. (b) Research that is permissible only after additional review and approval by an ESCRO committee or other equivalent body designated by the investigator’s institution. The ESCRO committee should evaluate all requests for permission to attempt derivation of new hES cell lines from donated blastocysts, from in vitro fertilized oocytes, or by nuclear transfer. The scientific rationale for the need to generate new hES cell lines, by whatever means, should be clearly presented, and the basis for the numbers of blastocysts or oocytes needed should be justified. Such requests should be accompanied by evidence of Institutional Review Board approval of the procurement process. All research involving the introduction of hES cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development should be reviewed by the ESCRO committee. Particular attention should be paid to the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues. Research in which personally identifiable information about the donors of the blastocysts, gametes, or somatic cells from which the hES cells were

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Guidelines for Human Embryonic Stem Cell Research derived is readily ascertainable by the investigator also requires ESCRO committee review and approval. (c) Research that should not be permitted at this time. Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first. Research in which hES cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts. No animal into which hES cells have been introduced at any stage of development should be allowed to breed. Because stem cell research is subject to a greater degree of public interest and scrutiny than most other kinds of laboratory research, the committee recommends that each institution should maintain through its ESCRO committee a registry of hES cell lines in use and of investigators working in this field and descriptive information on the types of hES cell research in which they are engaged. The purposes of such a registry include facilitating distribution of educational information in light of evolving ethical, legal, or regulatory issues and enabling the institution to respond to public inquiry about the extent of its involvement in hES cell research. ADDITIONAL RECOMMENDATIONS The committee makes several additional recommendations pertaining to the need for IRB review of procurement procedures, the need for voluntary informed consent free of inducements, adherence to standards of clinical care, and compliance with all applicable federal regulations. Those recommendations are summarized here. 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. Individuals 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. IRB review of the procurement process, combined with a full informed consent process before donation, will facilitate the ethical conduct of this research.

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Guidelines for Human Embryonic Stem Cell Research Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines through nuclear transfer. Informed Consent of Donors The donors of sperm, oocytes, or somatic cells used to make blastocysts for research are themselves rarely the subject of the research. Nevertheless, the physical interaction needed to obtain the materials brings them under the purview of the human subjects protections system, and IRB review is required. Thus, their fully informed and voluntary consent is required before such research use. Institutional Review Boards may not waive the requirement for obtaining informed 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, resulting blastocysts may not be used for research without consent of all gamete donors. In addition to ensuring voluntary informed consent of all donors, there should be no financial incentives in the solicitation or donation of blastocysts, gametes, or somatic cells for research purposes. Nonfinancial incentives also should be avoided. For example, a donor’s decision should not be influenced by anticipated personal medical benefits or by concerns about the quality of later care. Thus, a potential donor should be informed that there is no obligation to make such a donation, that no personal benefit will accrue as a result of the decision to donate (except in cases of autologous transplantation), and that no penalty will result from a decision to refuse to donate. To facilitate autonomous choice, decisions related to the production of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research. Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person. No cash or in kind payments may be provided for donating blastocysts in excess of clinical need for research purposes.

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Guidelines for Human Embryonic Stem Cell Research Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for nuclear transfer) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board. No cash or in kind payments should be provided for donating oocytes for research purposes. Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in nuclear transfer. This recommendation should not be interpreted as a commentary on commercial IVF practices, but as a narrow policy position specifically with respect to hES cell research. Furthermore, as with all the policies recommended by the committee, this policy should be regularly reviewed and reconsidered as the field matures and the experiences under other policies can be evaluated. It is widely accepted that, whenever possible, donors’ decisions to dispose of their blastocysts should be made separately from their decisions to donate them for research. Potential donors should be allowed to provide blastocysts for research only if they have decided to have those blastocysts discarded instead of donating them to another couple or storing them. Consent for blastocyst donation should be obtained from each donor at the time of donation. Even people who have given prior indication of their intent to donate to research any blastocysts that remain after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the blastocysts are actually used in cell line derivation. The current regulatory system specifies basic elements of information that must be provided to prospective participants during the informed consent process. In the context of donation for research, disclosure should ensure that potential donors understand the risks involved, if any. Potential donors should be told of all options concerning the handling and disposition of their blastocysts, including freezing for later use, donation to others for reproductive use, research use, or disposing of them in accordance with the facility’s policies and practices. To the extent possible, potential donors should be informed of the array of future research uses before giving consent to donate blastocysts for research. Comprehensive information should be provided to all donors that is readily accessible and at a level that will facilitate an informed decision. Written informed consent should be obtained from all those who elect to donate blastocysts or gametes. Adherence to Standards of Clinical Care Clinical facilities that provide assisted reproductive technology services are obligated to protect the rights and safety of their patients and to behave in an ethical

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Guidelines for Human Embryonic Stem Cell Research manner. Researchers should not pressure members of the fertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An IVF clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material it obtains, except for specifically defined cost-based reimbursements. Such restrictions on payment to those who obtain the embryos discourage the production during routine infertility procedures of excess oocytes that might later be used for research purposes. No member of the clinical staff should be required to participate in providing donor information or securing donor consent for research use of gametes or blastocysts if he or she has a conscientious objection to hES cell research. However, that privilege should not extend to the appropriate clinical care of a donor or recipient. Consenting or refusing to donate gametes or blastocysts for research should not affect or alter in any way the quality of care provided to prospective donors. That is, clinical staff must provide appropriate care to patients without prejudice regarding their decisions about disposition of their embryos. Researchers may not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An infertility clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services). Compliance with All Relevant Regulations If hES cell research involves transmission of personal health information about the donors, which will increasingly be the case as cell lines approach clinical application, it will be important for investigators, institutions, and IRBs to be aware of any privacy requirements that apply through the Health Insurance Portability and Accountability Act (HIPAA). Authorization should be obtained from donors for the transmission of specific health information, which should be secured to protect donor confidentiality. 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 Portability 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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Guidelines for Human Embryonic Stem Cell Research institutions and investigators adhere to applicable regulatory requirements and, given the increasing frequency of international collaboration in hES cell research, it will be important to monitor regulatory developments in other countries. The ESCRO committees will be charged with ensuring that U.S. investigators follow standards and procedures consistent with current regulations and with the guidelines recommended in this report. FDA’s Good Laboratory Practice regulations pertain to the management of laboratories that are developing products that might eventually be introduced into humans (for example, in a clinical trial). Those regulations do not cover basic exploratory studies conducted to determine whether a test article has any potential utility or to determine its physical or chemical characteristics, but they do encompass in vivo or in vitro experiments to determine their safety—an activity that would be characteristic of the preclinical phase of hES cell research. Failure to conform to FDA regulations, although not itself a violation of law, would render any hES cell lines less useful if they are considered for tissue transplantation or other cell-based therapies. Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care. hES cell research leading to potential clinical application must be in compliance with all applicable Food and Drug Administration (FDA) regulations. 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 applicable, 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. Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, and that meticulous records are maintained about all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells should be established.

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Guidelines for Human Embryonic Stem Cell Research The full report lays out recommended standards for any facility engaged in obtaining and storing hES cell lines (see Chapter 5). National Policy Review As individual states and private entities move into hES cell research, it is important to initiate a national effort to provide a formal context in which the complex moral and oversight questions associated with this work can be addressed. The state of hES cell research and clinical practice and public policy surrounding these topics are in a state of flux and are likely to be so for several years. Therefore, the committee believes that some body should be established to review the policies and guidelines covering appropriate practices in this field, but not to review and approve specific research protocols, an activity that will best occur at the local institutional level. Such a body should periodically review the adequacy of the guidelines proposed in this report in light of changes in the science and emergence of new issues of public interest. New policies and standards may be appropriate for issues that cannot now be foreseen. The organization that sponsors this body should be politically independent and without conflicts of interest, should be respected in the lay and scientific communities, and able to call on suitable expertise to support this effort. A national body should be established to assess periodically the adequacy of the guidelines proposed in this document and to provide a forum for a continuing discussion of issues involved in hES cell research. CONCLUSION Research using hES cells offers great promise for future improvements in health care. To realize those benefits, further research will be required, including derivation of additional hES cell lines and testing of their potential. Such research is already in progress in many institutions and there is a need for a common set of standards. The guidelines provided in this report focus on the derivation, banking, and use of hES cell lines. 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. The success of hES cell research rests with those conducting and supporting it. All scientific investigators and their institutions, regardless of their fields, bear the

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Guidelines for Human Embryonic Stem Cell Research ultimate responsibility for ensuring that they conduct themselves in accordance with professional standards and with integrity. In particular, people whose research involves hES cells should work closely with oversight bodies, demonstrate respect for the autonomy and privacy of those who may donate gametes and embryos, and be sensitive to public concerns about research involving human embryos. To help ensure that these guidelines are taken seriously, stakeholders in hES cell research—sponsors, funding sources, research institutions, relevant oversight committees, 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 institutional review panels can provide valuable community pressure and impose appropriate sanctions to ensure compliance. For example, ESCRO committees and IRBs should require evidence of compliance when protocols are reviewed for renewal, funding agencies should assess compliance when reviewing applications for support, and journals should require that evidence of compliance accompanies publication of results.