January 2, 2012
In a comment to what I posted earlier about the decision of the Swedish Data Inspection Board to stop LifeGene, Åke Thörn asks what I mean by saying that
- “LifeGene represents a new reality in the making.”
Since the question has deep interest, I want to answer it here, in a new post. I will use a simile to explain my intended meaning.
Suppose that rather than discussing biobank ethics, we were playing a form of chess with the strange feature that the chessboard sometimes changes. Squares turn into circles. Or the entire chessboard turns into a rhomb.
These changes of the chessboard make the old rules obsolete. What is “straight” and what is “diagonal” on a chessboard with the shape of a rhomb? The rules need to be reconsidered!
Research ethics and ethical review can be compared to games played on chessboards that sometimes change and require that rules and basic notions are reconsidered. What I meant in my previous post was that LifeGene represents such a basic change of the research ethical chessboard.
How should the “aim” of biobank infrastructure be described, given that infrastructure is not a research project with the aims of individual biobank projects? Do people turn into “research participants” when their ten-year old blood samples are used in new studies?
We cannot always cherish old ethical notions – as if there were no such things as TIME and CHANGE. We sometimes need to rethink rules and basic notions.
I hope these considerations explain my understanding of ethics as sensitive to changing times, and my notion of LifeGene as a “new reality.”
December 16, 2011
The company Geron recently decided to stop its unique clinical trial concerning treatment of spinal cord injury with neural cells derived from human embryonic stem cells.
In a previous post on this blog, I used the company’s decision to illustrate a possible consequence of the European ban on stem cell patents requiring the destruction of human embryos. The same day I posted my consideration, Francoise Baylis published a wholly different perspective on Geron’s decision…
Geron claims that the decision to stop the trial was made for business reasons. They wanted to concentrate their limited resources to their oncology drugs. However, the decision left the four research participants that had been enrolled in the trial in a vacuum.
Geron says it will continue to study these participants and report findings. But the trial was originally meant to include ten participants. Will results with only four participants be scientifically valid, Baylis asks. If the results are valid, then using ten participants, as originally planned, would have meant using more patients than required for producing valid results. If results with four participants are not valid, four patients are exposed to risk without any prospects of countervailing new knowledge.
– Which conclusions can be drawn from this example? Should the practices of ethical review be changed for applications from the private sector? Should financial resources and business strategies be included in the issues to consider? That seems to be Baylis’ response to Geron’s decision to quit stem cell research.
For my own part, I think we need more than one example before we consider making ethical review practices even more complex. A more time-consuming process of ethical review has a cost that we need to acknowledge…
As Simon Whitney summarized his views on the expansion of ethical regulation of medical research, “since biomedical research saves lives, it is unsurprising that the regulation of research costs lives.” – It may be unethical to make the process of ethical review even more cumbersome. Patients die when life-saving research is delayed. That cost must be brought into the equation when we consider single examples of ethically problematic conduct that we may wish to regulate against.