Obtaining Consent for Future Research with Induced Pluripotent Cells: Opportunities and Challenges

The recent development of human induced pluripotent stem (iPS) cells [1–5] has reshaped the scientific and political landscape of stem cell biology. iPS cells provide an unprecedented opportunity to study the pathophysiology of diseases, understand stem cell biology, identify new therapeutic targets, and test new therapies. Furthermore, they offer the possibility of transplanting therapeutic cells that are genetically identical to their recipient. iPS cells are not included in the heated debates over the ethics of embryonic stem cell research because embryos or oocytes are not used. The President’s Council on Bioethics called iPS cells “ethically unproblematic and acceptable for use in humans” [6]. Currently, there are no restrictions on federal funding of iPS cell research, and iPS cells are not subject to the special regulations in place for embryonic stem cells [7]. While neither the donation of materials to derive iPS cells nor their derivation raises special ethical issues, some potential downstream uses of iPS derivatives may be so sensitive as to call into question whether the original somatic cell donors would have agreed to such uses. In light of the enormous scientific and public interest in iPS cells and claims about their lack of ethical problems, it is important to consider these downstream issues now. Although these concerns also apply to other types of stem cell and genomics research, they are particularly salient to iPS research for two reasons. First, if the perception that iPS research poses no ethical concerns is not corrected, there could be a backlash against iPS cells later. Second, the virtual genetic identity between iPS cells and donor cells raises particular concerns regarding respect for donors. Because human biological materials are precious and iPS cells can be propagated indefinitely, it is advisable to design the consent process for donating somatic cells for iPS derivation to facilitate a broad range of future research, beyond what the initial investigators may have in mind. The US National Academy of Sciences recently revised its guidelines for stem cell research [7]. In this paper, we go beyond the National Academy of Sciences report to recommend how the consent process for the donation of somatic cells to derive iPS cell lines should foster their future scientific uses, particularly in fundamental research to study the properties of stem cells, derive specialized cells, and carry out preclinical studies of transplantation.