lished 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 national bodies have been established in most other countries where hES cell research has been debated and approved—such as Australia, Canada, Israel, Singapore, and the United Kingdom (see Chapter 4)—usually under government auspices. Some of those bodies also have responsibility for reviewing individual research proposals, and such centralized review entities may serve well in smaller jurisdictions where public funds are being used in the research. However, in line with the longstanding practice in the United States of using local review boards for human subjects research, animal research, and biohazards, the committee believes that local review of individual research proposals by ESCRO committees (with involvement of IRBs, IACUCs, IBCs, and other panels as described above) will be the best mechanism of oversight of hES cell research. Nonetheless, there will be a need for continuing consideration of new issues that arise from scientific advances, clinical applications, or public policy concerns that will need to be discussed in a central forum. Such a forum should from time to time review the adequacy of the guidelines proposed in this report (Chapter 6) in light of changes in science and the emergence of new issues of public interest. New policies and standards may be appropriate for issues that cannot currently be foreseen.
The organization that sponsors the public forum should be one that is respected in the lay and scientific communities, is politically independent without conflicts of interest, and is able to call on suitable expertise to support the effort. Its membership should include nationally and internationally recognized authorities in the scientific, medical, ethical, and legal issues associated with hES cell research, and representatives of the public. The proposed national body must pay careful attention to evidence and argumentation in its deliberations, as well as taking into account the diverse views of the public on these sensitive and evolving issues.
To help ensure that these guidelines are taken seriously, the various 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 these guidelines and adhere to the recommendations of the national panel. Funding agencies, professional societies, journals, and institutional review panels can provide valuable community pressure and 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.
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.