NIH Center for Regenerative Medicine and NIH Clinical Center join forces in an effort to harmonize informed consent for iPS cell-based research and therapies
The NIH Center for Regenerative Medicine has collaborated with the NIH Clinical Center Department of Bioethics on a manuscript
that considers the challenges to obtaining informed consent to derive induced pluripotent stem (iPS) cells from donated tissue samples for research and therapeutic purposes. The manuscript provides concrete recommendations, along with a model consent form, in an effort to broadly harmonize informed consent, which currently varies considerably between tissue collection sites.
The promise of iPS cells in clinical therapies to replace damaged or diseased tissues, and as a resource for understanding a wide range of diseases and discovering candidate therapeutic drugs, is huge. However, to maximize their utility while safeguarding the donors that provide the starting material (e.g. skin) that the iPS cells are derived from, it is critical that informed consent is carefully considered now while the field is still nascent. This is particularly challenging when all the potential downstream uses of iPS cells are not yet know and can result in narrowly restricting the informed consent to a specific application at hand. Conversely, re-contacting donors/study participants indefinitely to re-consent to additional uses of the iPS cells, or to collect additional samples or information on their health, is not ideal either. This manuscript makes a cogent argument for a middle ground that balances the perspectives of a variety of stakeholders and arrives at a model consent form for the prospective collection of fresh specimens from which to derive iPS cells. Some important features include:
- Research purposes are “open-ended” within the boundaries of all applicable laws and policies and may include transplanting cells or tissues made from iPS cells in to another patient to treat a disease
- The iPS cells and participant’s medical information will be shared with other researchers to benefit medical research and society
- Donors may be re-contacted for additional samples, medical information, or to consent to additional iPS cell uses not originally anticipated, but they do not need to oblige
- A provision is included for donors to opt out of being re-contacted by researchers for any reason
- Pediatric re-consent is incorporated to allow children to be informed upon reaching adulthood of the ability to review the previous consent and continue to participate in the study or not
- Explicit language is included indicating that direct medical benefits for the donor are unlikely and no financial benefits will result from any commercial products developed from the iPS cells
- Withdrawal at different stages of the research process is allowed. A request can be made to destroy any leftover original samples; however, any iPS cells already derived cannot be destroyed and any shared with other researchers cannot be retrieved, though the codes that link the sample to the donor can be removed
The implementation of a consistent approach to informed consent for iPS cell derivation and use across research/medical institutions in these early days as proposed in this manuscript could potentially be invaluable to providing stem cell researchers with crucial access to high-quality, thoroughly documented materials and resources.
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Lowenthal J, Lipnick S, Rao M, Hull SC. Specimen collection for induced pluripotent stem cell research: Harmonizing the approach to informed consent. Stem Cells Translational Medicine. Published online May 8, 2012; doi: 10.5966/sctm.2012-0029.