Wednesday, January 16, 2013

CIRM Supporting a Remarkable Experiment in Research Ethics

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

The American Journal of Bioethics dedicated its 100th issue, published this month, to the topic of stem cell research. Editor David Magnus noted, “the explosion of research in this area created an experiment in research ethics oversight—the Embryonic Stem Cell Research Oversight (ESCRO) committee.”

ESCROs are committees of scientists, ethicists, patients and public members that oversee stem cell research. CIRM requires ESCRO committees to oversee the research we fund.

In this issue, Stanford Professor Hank Greely authored a major target article looking at the history of what he calls “the great ESCRO experiment.” He describes the ESCRO experiment as “a truly remarkable experiment in applied research ethics.” Greely describes the history of ESCROs and then focuses on two questions (1) have they been successful and (2) what it their future. Greely points out that research centers across the country have invested considerable resources to establish and operate ESCRO committees. He suspects that committees have been successful in preventing abuses and making sure research is conducted in accordance with existing guidelines and regulations.

Perhaps the most provocative aspect of the article is Greely’s question about the future of ESCROs. He suggests that the day-to-day responsibility for research oversight might be moved to existing review boards and committees.
“It may be time to thank ESCROs for their valuable past services and to begin moving toward a world without ESCROs, at least as we have know them."
The journal invited CIRM and others to author commentaries on Professor Greely’s article – eight were published. I found his article to be a cogent historical analysis that provided a robust framework for continued assessment of the great ESCRO experiment. I do, however, argue that ESCROs still play a valuable role in supporting research and provided a number of examples from CIRM experience where ESCRO committees have taken actions to ensure research was performed according to our regulations.

In the more distant future, when stem cell research becomes commonplace, there may no longer be the need for the specialized expertise offered by ESCRO committees. Ideally, this future includes the routine treatment of patients with effective cell-based therapies. We are not quite there yet, but along the way we should heed Greely's counsel and explore, rigorously, the results of the great ESCRO experiment.

A number of other commentaries were also supportive of keeping ESCRO committees or ensuring that their expertise is maintained. Audrey Chapman of the University of Connecticut argues that trying to transfer the responsibilities to existing review boards “is likely to be met with agreement of those bodies.” She concludes, “it seems preferable to continue the great ESCRO experiment.” Julie Aultman from Northeast Ohio Medical University offers the following perspective:
“The downside to not having an ESCRO, or future IRB that would absorb some of the responsibilities of the ESCRO at a small university, is the inability to support the development of promising new programs with appropriate ethical guidance and oversight.”
Mary Devereaux and Michael Kalichman of the University of California, San Diego suggest there is still a need for ESCRO oversght:
“The fact that past problems have been solved does not mean that we have already anticipated, or are prepared to address, future challenges in this rapidly evolving field. Our choices about how to move forward should thus not be based on the assumption that we have settled or can avoid future ethical and/or policy issues.”
For now CIRM continues to see value in ESCRO committees, and we applaud our grantees’ efforts to establish effective oversight programs. As Sherry Lansing (ICOC and Standards Working Group members) reminds us, CIRM is a “work in progress.” As we move forward, we continually discuss and evaluate the best approaches to research and oversight. As evidenced by the American Journal of Bioethics series we are in good company.

G.L.

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