Written with contributions from Geoff Lomax, CIRM’s Senior Officer for Medical and Ethical Standards and Rosario Isasi, Research Associate at McGill University and Academic Secretary for the International Stem Cell Forum Ethics Working Party. Portions of this post were previously published on the CIRM Research Blog and are included here with consent.
It’s not unusual for advances in technology to create new purpose for data or material that were created for entirely different reasons. Duct tape and Post-It notes are two examples many may already be familiar with, and from the pharmaceutical side, there is a rapidly growing list of old drugs that are being tested and/or used for conditions completely unrelated to their initial design.
In stem cell research, thanks to advances that now allow us to create patient and disease-specific induced pluripotent stem cells (iPSC), there is a renewed interest in biobanking and in the ability to use the large quantities of tissues and cells that are stored in one of many locations throughout the world.
These cell and tissue libraries have immense value for research. They represent an accessible and robust source of cellsthat could now be harnessed in efforts to understand disease and improve treatment options through disease modeling, target discovery and drug development. Collectively, they are representative of a large percentage of the global population and individually, they may represent a rare or “orphan” disease or track the progress of a patient’s disease over time.
However, not all of the biomaterials contained in these libraries were collected with today’s iPSC technologies in mind, which presents an ethical – if not a legal- problem (if the story of Henrietta Lacks teaches us anything, it’s that informed consent is vital to both research participants/patients and researchers, and should not be overlooked). New stem cell and tissue banking initiatives now include iPSC derivation as part of their informed consent process (for example, CIRM’s iPSC bank, which will eventually contain 9,000 stem cell lines along with other similar initiatives in Japan, the UK, Europe and other locations. Canada does not have an induced pluripotent stem cell registry, but does have a registry for human embryonic stem cells and a national public cord blood bank.), which provides donors with detailed information about how their cells will be used.
The obvious question for cells and tissues collected prior to the discovery of iPS cells is whether the existing donor consent will allow these cells to be used for iPSC derivation, research and banking?
In 2013, a number of organizations (CIRM, the National Institutes of Health, the Stem Cell Network and the International Stem Cell Forum) formed the DISCUSS Project (Deriving Induced Stem Cells Using Stored Specimens) to engage the broader research community on this issue. Given that investigators around the world are asking the same questions about the use of existing cell lines and tissue, DISCUSS began by publishing a paper on the subject. The paper included nine points to consider when answering the question of whether existing cell libraries can be used for iPSC research.
Following this, a series of meetings and workshops were convened to get reactions on the proposed points to consider. The process culminated with a workshop in March of this year, where researchers from around the world provided recommendations and comments to inform the development of a revised version of the points to consider, which are included in a Workshop Report released last week.
Highlights of the report are:
- Emphasis on the importance of having an effective management system in place to make sure cells are used in a way that is consistent with the donor consent.
- There are a number of specific mechanisms that should be used by the research community to mitigate risk and to ensure cells are used appropriately, including obtaining robust informed consent, material transfer agreements and ethics board oversight. They also include having effective governance systems in place to manage cells and iPSC lines in accordance with donors wishes in order to build trust.
- The recommendations of the DISCUSS project, though iPSC-specific, may be applicable to other contexts. For instance, the model proposed may inform research with cultured human tissue generally.
The DISCUSS team is now working on a final publication to capture their findings and recommendations.
Lomax G.P., J. Lowenthal, M. Rao & R. Isasi (2013). The DISCUSS Project: Induced Pluripotent Stem Cell Lines From Previously Collected Research Biospecimens and Informed Consent: Points to Consider, Stem Cells Translational Medicine, 2 (10) 727-730. DOI: http://dx.doi.org/10.5966/sctm.2013-0099
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