Wednesday, September 4, 2013

Informing patients about tissue donation for stem cell banking

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

CIRM is creating a stem cell bank designed to make high-quality patient stem cell lines available to scientists who need them (here's more about that banking initiative). Before embarking on this initiative, CIRM’s Medical and Ethical Standards Working Group, along with other funding organizations, put considerable thought into the best ways of informing patients about how the cells they donate to create stem cell lines will be used. The crux of these recommendations, which were published last year in Stem Cells Translational Medicine, is embodied in the informed consent process, which is designed to describe the nature and purpose of research involving donated cells.
Our efforts to develop consensus about what constitutes effective informed consent have so far focused on obtaining consent from patients providing fresh skin and blood to create new stem cell lines. From a consent perspective, new donations are ideal because researchers can provide patients with the latest information about stem cell research.

However, older donations of skin, tissue and blood also exist. Many of these donations were provided by patients who were eager for the tissues to be used by scientists to understand, cure or prevent a particular disease. No one knows the precise number of research specimens, but as we reported in 2012 the figure is in the hundreds of millions. Existing collections often have intrinsic scientific value because they represent a particular disease at its various stages of progression.

Lately, CIRM, NIH and our international partners have been considering how existing research specimens can be responsibly (i.e. ethically and scientifically) used for stem cell line creation and distribution. We created the DISCUSS (Deriving Induced Stem Cells Using Stored Specimens) Project to advance dialogue. We also published a paper in last week’s Stem Cells Translational Medicine detailing points to consider regarding the use of human cells to derive and distribute stem cell lines. These Points to Consider are specifically intended to assist researchers, ethics review bodies, and funding agencies in designing policies to allow repurposing of previously collected research specimens.

You can read all our points here, but I thought it would be informative to highlight a few points in this post, so you get a flavor for our thinking. Here are two statements from our publication.
  • Statement 2: Stem cell derivation and use should be considered a standard method for modeling disease and developing therapies. In cases where the original biospecimen collection is designed to study a particular disease condition, stem cell derivation and use (i.e., as a tool for research on that particular disease) should be considered consistent with this purpose.
  • Statement 3: A reference to the possibility of sharing biospecimens with other researchers in the original consent form is sufficient for distributing material via a stem cell repository. Obtaining consent to share biospecimens with other researchers has become common practice and is consistent with broad data sharing goals that have been articulated in order to maximize the public benefits of funded research.
Statement 2 is intended to recognize that some donors may have provided cells to study their particular disease before modern stem cell research methods were developed, but such methods may be an excellent way to fulfill the intent of their donation. Statement 3 points out that donors often approve of cells being shared but the consent process did not specify a clearing house method of distribution, like our cell bank.

We believe our recommendations are consistent with international consensus for ethical research. However, we are putting this proposition to the test by asking for feedback on our recommendations. Comments should be sent to discuss@cirm.ca.gov.

In 2014, we will be revising our recommendations in response to feedback.

Geoff Lomax

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