26 HASTINGS CENTER REPORT January-February 2006 ment’s ability to require centralized review of stem cell transplantation studies. Alternatives to federal oversight should therefore be contemplated. One possibility would be the creation of an interstate review committee by states funding stem cell research; such a body would emulate the original Recombinant DNA Advisory Committee’s system for reviewing gene transfer protocols. Short of such concerted state efforts, professional societies with an interest in stem cells might devise a system for the voluntary review and public reporting of transplantation protocols. ! 2. A Mandatory International Registry of Studies Should Be Established. We recommend another salutary practice well established for gene transfer: the establishment of an international registry of human studies. (See http://www.wiley.co.uk/genmed/clinical/ for a registry of gene transfer studies.) We also recommend that editors of journals likely to publish stem cell transplantation reports require preregistration of protocols as a condition for publication. (Journal statements on preregistration presently would not apply to initial stem cell transplantation trials, since they exempt phase I studies.) Trial registration would provide a means for scientists, policy-makers, ethicists, and the public to remain abreast of ongoing work on stem cell transplantation. !3. A National Panel Should Be Created to Set Guidelines for Studies. Stem cell transplantation studies raise ethical and scientific questions not routinely encountered in clinical research. For example, transplantation investigators may need to devise consent language to convey “moral” risk related to stem cell derivation. Stem cell researchers might also develop a set of standards and guidelines intended to maximize the value of information sought in human studies. Given the politically sensitive nature of stem cell tissues, transplantation researchers might also wish to discourage members of their field from pursuing studies aimed at medical enhancements. Although the NAS guidelines for the responsible practice of stem cell research offer very little comment on transplantation trial ethics, they do call for the establishment of a national body to “assess periodically the adequacy of the guidelines proposed . . . and to provide a forum for a continuing discussion of issues involved in [stem] cell research.” The mandate of this body could usefully be expanded to explicitly refer to stem cell transplantation research. Consistent with the NAS recommendation, we recommend that a high-level national panel of scientists and ethicists be convened to devise national ethical guidelines for stem cell transplantation studies. The need for such measures may be heightened by one way stem cell research is significantly different from gene transfer research. Whereas the latter is now regarded as a natural extension of practices likes bone marrow transplantation, stem cell research raises some special ethical and political issues, including the moral status of embryos, informed consent from egg/embryo donors, and the acceptability of treating embryonic tissues as mere commodities. The politicization of debates over these issues may cause some investigators to bristle at what they consider to be ethical roadblocks to transplantation research, but the penalties for failing to appreciate the complex ethical terrain are likely to be greater than has been the case for gene transfer research. As the curtain rises on stem cell transplantation trials, the field will at least have enjoyed a luxury available only to understudies: extra time to review its script and learn from its predecessors’ missteps.1 Acknowledgement This work was funded in part by the Canadian Stem Cell Network (a member of the Network of Centres of Excellence program). Special thanks are owed to Natalie Ram for able research assistance. 1. A version of this essay containing references is available at http://www.mcgill.ca/biomedicalethicsunit/about/kimmelman/. It has been nearly a year since the groundbreaking passageof Proposition 71, the law that created the California In-stitute for Regenerative Medicine (CIRM) and authorized bonds that would provide $3 billion in funding for stem cell research. As the first anniversary approaches, what is the state of human embryonic stem cell research? At this point, CIRM has yet to produce any...