Geoff Lomax is CIRM’s Senior Officer to the Standards Working Group
CIRM recently posted a request for applications to form a stem cell repository or bank that would enable us to store and supply researchers with high quality stem cell lines. (We blogged about that initiative here.) As part of our work in setting up that bank we put forward rigorous standards for informing potential donors to the bank of how their cells will be used.
This issue of how best to inform people about tissue donation – a process called informed consent – has been widely debated recently in the literature. That debate centers around whether it’s necessary for donors to consent to each and every type of experiment in which their cells could one day be used.
One unique opportunity we have at CIRM is the ability to talk with researchers, patients and the public to better understand their perspectives on tissue donation as the field of stem cell research evolves. Over the years we have received a number of inquires involving the donation of cells and tissue, including embryos, for the purpose of creating human cell lines. I typically respond to these inquiries and am frequently able to talk with interested individuals about their motivations for donating to research.
These discussions reveal a lot about individuals’ values and motivations for getting involved in research. They also provide insight into the amount of uncertainty some people are willing to accept in the process of informed consent.
In the case of donating unused IVF embryos, the knowledge and sophistication of prospective donors is remarkable. It is compelling and moving to understand why certain individuals believe research donation is the best choice for them, as opposed to, for instance, simply discarding the unused embryos. Individuals and families touched by disease are another example. A number of families have donated cells and tissue to help researchers better understand the disease process and inform the development of therapies.
I am also struck by a sense that donors understand that “we don’t know what we don’t know” and are willing to take an “informed leap of faith.” Individuals donate even though we cannot guarantee the successful creation of a cell line. Donors hope their contribution will alleviate disease even though we have limited ability to describe how cures will come about or the specific types of experiments that might be involved.
In this month’s issue of the Journal Nature, Chris Hempel, Steve Peckman and I commented on the informed consent process for cell line creation (published here). The issue has received considerable attention in the academic literature with some suggesting the inability to describe each specific study for which donated cells will be used makes “informed” consent impossible. For example, when a person donates tissue, the scientists might not yet know about experiments that will become possible a few years in the future. We have suggested previously (published here) that study-specific consent is not essential for ethical and responsible research. Further, such a process may be inconsistent with the hopes and aspirations of donors by impeding research.
With our perspectives in patient advocacy or at research centers aimed at bringing new regenerative therapies to patients, we have consistently emphasized the value of research donors’ perspectives. In the context of protocols for creating immortalized cell lines for banking and distribution, we have also witnessed support for broad consent. Indeed, enthusiasm is even more pronounced among those touched by disease, and patient donors actually express concern that study-specific consent can be burdensome and impede research.
A recent review of studies designed to gauge public preferences reports broad consent is favored by 34 to 79% of respondents. These findings are reassuring and suggest there are ample numbers of donors willing to take an informed leap of faith.