Coming Full Circle: Getting Research Results to Patients

Geoff Lomax is CIRM’s Senior Officer to the Standards Working Group 

Altruistic cell and tissue donors are my heroes. Without them there would be no “cell” in stem cell research. Individuals have voluntarily donated skin, blood, bone marrow and embryos remaining after infertility treatment to CIRM-funded researchers. Researchers have transformed these donations into stem cell lines. A stem cell line is a group of identical cells that can be grown and multiplied in a lab dish. Stem cell lines derived from patient donors are enabling scientists to better understand how their particular diseases develops and help identify potential drug and cell therapies.

To accelerate disease research and therapy development, CIRM is creating a clearinghouse designed to make high-quality patient stem cell lines available to scientists who need them (here’s more about that banking initiative). This stem cell repository will distribute the lines to researchers around the world. 
Before embarking on this initiative, CIRM’s Medical and Ethical Standards Working Group, which I oversee, put considerable thought into procedures for obtaining cells and tissue and how best to keep patient donors appraised of research developments. The crux of their recommendations is embodied in a model informed consent document, which is the topic of a recent paper I recently wrote with my colleague Kelly Sheppard.
This informed consent document is what we’re encouraging the people who collect cells from patients to use to inform donors about the nature and purpose of research and describe any risk or benefit to the participant. One consideration for donor informed consent is the potential for research to result in findings that are medically relevant to the donor. For example, the CIRM repository is designed to support the development of drug therapies for diseases affecting patient donors. If that research results in a possible medical benefit, we argue that those findings should be available to the donor and ideally the population with the disease.

Given the potential for iPS cells to support translational research, one should not preclude the ability to recontact donors. Based on this reasoning, the consent form does disclose that the identification of significant new findings may be the basis for recontact. CIRM intends to evaluate the efficacy of this approach to inform ongoing research efforts.

However, the Standards Working Group recognized that there is a delicate balance that must be struck between keeping lines of communication open without creating expectations that cannot be met. Suggesting to donors that beneficial results may emerge can contribute to a “therapeutic misconception” – the belief that research is designed to directly help the patient.
The working group endorsed an approach that very explicitly tells donors that the research is not designed to help them directly, but simultaneously acknowledges that cells will be used in research intended to develop potential commercial therapies.
Thus far, researchers have been receptive to this approach, but questions remain as to the most effective ways to compile and disseminate research findings. As with may challenges at CIRM, this is a work in progress, but one we are firmly committed to finding effective solutions for.

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