Obtaining Consent for Future Research with Induced Pluripotent Cells Opportunities and Challenges 英文参考文献.docVIP

Perspective Obtaining Consent for Future Research with Induced Pluripotent Cells: Opportunities and Challenges Katriina Aalto-Set?l?, Bruce R. Conklin*, Bernard Lo T he 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. 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. and in stem-cell-specific standards from the International Society for Stem Cell Research, the US National Academy of Sciences, and the California Institute for Regenerative Medicine [15–17]. Under US regulations for research on humans, an exception to consent allows existing biological materials to be used for research without consent if they are de-identified. The rationale for this exception is that there is no risk of physical harm to donors, and de-identifying materials greatly reduces the risk of breaches of confidentiality. How