2151-805X/12/$35.00 © 2013 by Begell House, Inc. 1 Ethics in Biology, Engineering & Medicine - An International Journal, 4(1): 1–14 (2013) Framing the “Right to Withdraw” in the Use of Biospecimens for iPSC Research Justin Lowenthal 1 & Sara Chandros Hull 1,2, * 1 Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland; 2 Ofice of the Clinical Director, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland *Address all correspondence to: Sara Chandros Hull, Ofice of the Clinical Director, National Human Genome Research Institute, National Institutes of Health, 10 Center Drive, Bldg. 10, Rm. 1C118, Bethesda, MD 20892-1156; Tel.: (301) 435-8712; Fax: (301) 496-0760; Email: shull@nih.gov ABSTRACT: A “right to withdraw” from research participation is an important mechanism for ensuring voluntariness and respecting participant autonomy throughout a study. This right often is expressed as an absolute, dictating that a participant can withdraw from research at any time for any reason. However, it is more challenging to deine a right to withdraw when the interactions between a researcher and participant have ended but the researcher is continuing to use biospecimens provided by the research participant. This issue is becoming particularly complicated as researchers are generating induced pluripotent stem cell (iPSC) lines for a broad spectrum of research applications, banking, distribution, commercial product development, drug screening, and preclinical testing for cell-based therapies. The generation of iPSCs from biospecimens presents particular challenges for informed consent and the right to withdraw as researchers develop informed consent documents and as projects undergo eth- ics review. Here we consider the reasons why a participant may want to withdraw donated biospecimens from research, especially when considering the ethical landscape of withdrawal from iPSC research in particular. We then suggest guidance to help policy makers and ethics review bodies evaluate the issue of withdrawal in relation to iPSC research. KEY WORDS: informed consent, induced pluripotent stem cells, iPS, iPSC, bioethics, regenerative medi- cine, withdrawal, biobanking, biospecimens, ethics, right to withdraw I. INTRODUCTION Voluntary participation is a fundamental ethical requirement for most research with hu- man subjects and is achieved through a robust process of informed consent. 1–3 Voluntari- ness applies not only at the stage of initial decision-making but throughout the course of research participation, meaning that participants should be free to change their minds. The “right to withdraw”—the idea that research participants are permitted to discontinue their involvement in the research—is an important mechanism for ensuring voluntari- ness and respecting participant autonomy throughout the conduct of a study. 4 This right is often expressed as an absolute: that a participant can withdraw from research at any time for any reason, although limits on this right also have been articulated as both philosophical arguments against the right’s inalienability and practical limitations (e.g., related to concerns for the safety of the participant). 5–7 Several cases have in some sense