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

Abstract

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.

Towards guidelines for informed consent for prospective stem cell research

“…The narrow approach to IC can be considered to lie on the other end of the spectrum, where participants give consent for their material to be used for a very specific purpose. Lowenthal et al [13] suggest that an IC 'middle ground' can be reached, which allows for broad aims, but with clear boundaries with regard to future research. This approach relies on a constant dialogue with participants, and re-consenting may be required in some cases.…”

“…However, it is impossible to anticipate the full range of their future application. Therefore, regarding prospective collection of biological material for future research of this nature, we propose that the consent form should be used prudently to assure participants of the ethical use and governance of their specimens in SA, as was proposed by Lowenthal et al [13] Some guidelines should be formulated for an ethical approach to obtaining comprehensive IC for the collection of biological material for the generation of iPSCs for prospective research purposes. Broadly, the recommended issues to be addressed in IC forms, incorporating requirements for stem cell research, are given in Table 1.…”

“…Issues to address when compiling informed consent forms for stem cell related research (based on recommendations by Lowenthal et al [13] 2012)…”

Ethics and Policy Issues for Stem Cell Research and Pulmonary Medicine

“…Given expectations for consent in most research settings as well as concerns about immortalization of cell lines, their distribution and commercialization, and uncertainty regarding their potential future uses, the general consensus is that explicit consent should be obtained for the collection of biologic materials. 35,36 For example, such concerns must be taken into account when researchers obtain consent for blood draws, lung biopsies, lavages, or bronchoscopies to collect samples, as may be necessary for stem cell-based research on cardiopulmonary disorders.…”

Stem cells on South African shores: Proposed guidelines for comprehensive informed consent

“…2 The HDI undertook a major project to assess the needs of these children (physical, including dental). Among other findings, the survey identified service gaps for this population, and made suggestions as to how they could be bridged.…”