The letter acknowledges that the SUPPORT study itself was complicated, but that “the question of whether the consent forms were adequate is not.”  The consent documents clearly failed to meet the standards set forth in the federal regulations governing research.   The letter also challenges the idea that there was no predictable increase in risk to participating in the study.  Although “the outcomes were not known ahead of time . . . a potential differential in the risks that were being tracked (death, retinopathy of prematurity, and neurologic impairment) was reasonably foreseeable, since determining differential risk was the very purpose of the study.”

Some of the signers of the letter defending the investigators and criticizing OHRP seem to agree with us that the consent forms were lacking important information about risks.  For example, Joel Frader is quoted in a New York Times article as saying, “It’s the obligation of investigators to say, ‘Here’s the debate, here’s how we’re trying to answer the question, and that involves the possibility that there is an additional risk with being a research subject.’”   He acknowledges that the SUPPORT investigators failed in this regard.  Even John Lantos, one of the most ardent defenders of the study’s consent process, has written that the goals of the study should have been disclosed and weren’t.   In explaining what he says should have been disclosed about the “goals,” he includes information about risk.  The consent forms consistently failed to adequately describe either.

While much can be learned by reading the substantial commentary about this controversy, nothing can take the place of reading the original documents—in particular, the protocol, the consent forms, and the clinicaltrials.gov page describing the study.  On August 28, OHRP will be holding a public meeting to discuss how the regulations “should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.”  It will be important to hear from those who believe that appeals to “standard of care” cloud rather than clarify the issues relating to consent.   Information about how to register for the meeting or submit written comments can be found here.

Lois Shepherd, J.D., is the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia.