Nature Medicine | Spoonful of Medicine

Bioethicists renew calls for additional oversight of translational research

The current controversy over the publishing of H5N1 research is good news for one unlikely group: bioethicists. Controversy in medicine breeds conversation about ethical questions, and the more people are talking, the more likely researchers are to go looking for ethical guidance as they design studies. Some bioethicists think the best way to address such questions is via ethics consultation services that act independently of institutional review boards (IRBs) so that formal regulatory and informal consulting functions are kept separate.

One of those bioethicists is David Magnus, director of Stanford University Center for Bioethics in California. Writing today in Science Translational Medicine, Magnus and his colleagues argue that IRBs are ill-equipped to provide consultation to researchers on thorny protocol design issues in translational areas such as DNA banking and stem cell therapies because IRBs are already overseeing protocols as regulators..

“There are pitfalls to having a regulatory body in a consulting role,” Magnus told Nature Medicine. “It can lead to slowdowns in the oversight system.”

Such arguments are not exactly new territory, however. Since the creation of the Clinical and Translational Science Awards (CTSA) by the now-defunct US National Center for Research Resources (NCRR) in 2006, bioethicists have been considering such a proposal. In the intervening years, they have published countless reports calling for institutions to fund ethics consultation services for their researchers.

But other than a few select institutions, such as Stanford, most academic centers have not bothered with ethics consultation services, and, in fact, many bioethicists today don’t see the need for additional ethics groups. Tom Murray, president of the Hastings Center, a bioethics think tank in Washington, DC, thinks that the overall goal should be to help institutions come up with clear, consistent and detailed policies for translational research. But, as Murray points out, “That doesn’t necessitate on-the-fly consulting so much as it requires a sounding board for researchers to communicate with their IRB.” So, perhaps it’s time to reinvest in the infrastructure already in place at most academic institutions rather than adding more administrative burdens to cash-strapped research hospitals.

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