Specimen Collection for Induced Pluripotent Stem Cell Research: Harmonizing the Approach to Informed Consent

• Published in: Stem cells translational medicine Vol. 1; no. 5; pp. 409 - 421
• Main Authors: Lowenthal, Justin, Lipnick, Scott, Rao, Mahendra, Hull, Sara Chandros
• Format: Journal Article
• Language: English
• Published: United States AlphaMed Press 01.05.2012; Oxford University Press
• Subjects: Administrative support; Clinical translation; Ethics; Human subjects; Humans; Induced pluripotent stem cells; Induced Pluripotent Stem Cells - cytology; Informed Consent; iPS; Medical research; Original and Reviews; Pluripotency; Practice Guidelines as Topic; Regenerative medicine; Regenerative Medicine - ethics; Regenerative Medicine - legislation & jurisprudence; Researchers; Specimen Handling - standards; Stem Cell Research - ethics; Stem Cell Research - legislation & jurisprudence; Stem cells; Transplants & implants
• ISSN: 2157-6564; 2157-6580
• DOI: 10.5966/sctm.2012-0029

Prospective donation of tissue specimens for induced pluripotent stem cell (iPSC) research requires an approach to informed consent that is constructed for this context. 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. This analysis addresses this need by providing concrete recommendations for informed consent that balance the goals of iPSC and regenerative medicine researchers with the interests of individual research participants. 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.