Department of Bioethics, Clinical Center.
Stem Cells Transl Med. 2012 May;1(5):409-21. doi: 10.5966/sctm.2012-0029. Epub 2012 May 8.
Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants.
诱导多能干细胞（iPSCs）因其在推进基础和转化研究方面的潜力，在科学界和伦理界都引起了极大的关注。它们被称赞为胚胎衍生的替代品，为研究和治疗应用提供了几乎无限的多能干细胞来源。然而，iPSC 的研究在伦理上非常复杂，独特地包含了与基因组学、永生化细胞系、移植、人类生殖和生物库相关的问题。因此，为 iPSC 研究提供组织标本需要一种针对这种情况的知情同意方法。即使在这个领域的早期阶段，知情同意的方法也存在差异，这威胁到保护供体和保护未来研究和转化的目标，调查人员正在寻求指导。我们通过提供具体的知情同意建议来满足这一需求，这些建议平衡了各种利益相关者的观点。我们的工作结合了对来自世界各地的研究人员的同意书语言的分析，以及对规范伦理问题、政策先例和科学现实的概念平衡。我们的框架要求人们前瞻性地同意一个广泛的可预见的研究范围，包括未来的治疗应用，在有限的情况下可以重新联系。我们认为，再生医学的长期目标、对共享 iPSC 系的兴趣以及未来研究的不确定格局都将通过与供体进行持续沟通的框架得到满足。我们的方法平衡了 iPSC 和再生医学研究人员的目标与单个研究参与者的利益。
