10
Jun2013

by Elisa Hurley, PRIM&R Education Director

Since our post last Thursday, there have been some additional, noteworthy developments around the SUPPORT trial and the Office for Human Research Protections’ (OHRPs’) latest actions that we thought were worth sharing. One day after the publication of OHRP’s letter stating it was putting on hold all compliance actions against the lead SUPPORT site, the New England Journal of Medicine (NEJM) posted a letter to the editor, signed by nearly 50 prominent bioethicists, calling for OHRP to retract its determination that the institutions involved in SUPPORT failed to meet regulatory informed-consent requirements. "We believe this conclusion was a substantive error and will have adverse implications for future research," the letter authors write. Not only is OHRP’s conclusion that the study exposed subjects to additional risk "not supported by the evidence," but, the letter continues, "the conclusion of the OHRP that the SUPPORT investigators violated federal regulations in failing to include specific information elements regarding risks of the study interventions in the parental permission documents is without substantive merit and overreaches."

The criticism of OHRP did not end there, however. That same day, NEJM also posted a “Perspective” piece from the National Institutes of Health (NIH), which is housed, as is OHRP, within the Department of Health Human Services. Authored by NIH Director Francis Collins, NIH Deputy Director for Science, Outreach, and Policy Kathy Hudson, and National Institute of Child Health and Human Development Director Alan Guttmacher, the piece makes clear that NIH "respectfully disagree[s] with the conclusions of the OHRP," and suggests that OHRP’s conclusions resulted from a "fundamental difference in interpretations of how the regulations should apply to the state of scientific understanding when the SUPPORT study commenced." The letter laments that the controversy swirling around the SUPPORT study over the last several months has alarmed parents and confused the biomedical research and oversight communities, but goes on to suggest the debate has "set the stage for a substantive national dialogue with the research, advocacy, and ethics communities on how best to respect and protect participation in research studies conducted within the standard of care and how to define 'reasonably foreseeable risks' within this setting." Finally, the letter calls for OHRP to be more transparent regarding the process it follows for investigating complaints of noncompliance.

Has your IRB or HRPP been following the SUPPORT study controversy? If so, what is your take on these latest developments? Share your thoughts with the community!


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