Clear communication: Making sure patients understand stem cell research participation

iPS cells reprogrammed from skin (Kathrin Plath/UCLA)

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

A few weeks ago we held a meeting of our Standards Working Group to discuss medical and ethical standards relating to the recently approved proposal for creating a stem cell bank.

I admit that a discussion of medical and ethical standards doesn’t sound as exciting as cutting edge research and finding new cures. But that groundbreaking research can’t happen if we don’t have some clear standards in place to guide our grantees and ensure that patients understand what they are committing to when they agree to participate in research.

In the case of the new stem cell banking initiative, these standards are particularly important because we want to be sure patients fully understand how their cells will be used and can make an informed choice about whether or not to participate. For example, before agreeing to donate tissue those people must understand that the cell lines generated could survive indefinitely and be used for research for many decades to come.

The cell bank will rely on individuals with known diseases to donate tissue samples, which will be reprogrammed into embryonic-like cells, called iPS cells. The iPS cells can then be used by researchers to learn how a disease develops and help in the discovery of new therapies. (We’ve blogged about these awards here.)

At CIRM, the governing board turns to the Standards Working Group (SWG) – comprised of scientist, patient advocates, and medical ethicists – to advise them on ethical procedures for responsible research conduct. One goal of this meeting was for the SWG members to hear from researchers at the The Parkinson’s Institute who have already developed ways of protecting patients who donate for this kind of research.

A key part of the discussion centered around the process of obtaining permission from patients to use cells for reprogramming experiments and iPS cell creation. This process – called informed consent – is designed to explain the procedure for collecting tissue and the subsequent uses of their cells in research.

Birgitt Schuele of The Parkinson’s Institute described their informed consent process. One important point that came out of the discussion is the need to make clear to potential donors that their cells are not being collected to make personalized therapies. Instead, the reprogrammed cell lines will be deposited in a cell bank and then distributed to researchers.

The researchers will use the lines in experiments designed to understand the disease process and to discover therapies. This distinction between using the cells in the lab to understand the disease and to discover therapies – using it as a tool - rather than returning the cells as the treatment – like receiving a blood donation -- is a very important point. Schuele mentioned that despite a rigorous informed consent, some donors still ask about the personalized use of their cells. This highlights the need to develop an effective informed consent processes based on knowledge gained from prior experience.

As part of the meeting, SWG members discussed proposed language in a model consent form that could be used as a guide for grantees gathering tissue for iPS cell line creation. To address concerns about patient understanding of the cells’ use, the model contains the language, “Research is not designed to provide direct medical benefit to you and will not be restricted to a specific disease or condition.”

CIRM is fortunate to be able to draw on the experiences of our grantees, and to have a deliberative body such as the Standards Working Group to advise CIRM on approaches for advancing research under the highest standards. This combination of bringing knowledge gained from experience, into a deliberative setting with a diversity of viewpoints, defines CIRM’s approach to fulfilling its mission.

G.L.