The New England Journal of Medicine has two new commentaries out on the SUPPORT study and arguing that OHRP has things all wrong – in a dangerous way.
From the editors:
“[OHRP’s] response is disappointing, because it does not take into account either the extent of clinical equipoise at the time the study was initiated and conducted or that the consent form, when viewed in its entirety, addressed the prevalent knowledge fairly and reasonably. At the time, as explained in the principal investigator’s response to the allegations and in a related letter to the editor in the Journal, there was no evidence to suggest an increased risk of death with oxygen levels in the lower end of a range viewed by experts as acceptable, and thus there was not a failure on the part of investigators to obtain appropriately informed consent from parents of participating infants. Through hindsight (and essentially faulting investigators for not informing parents up front of a risk later uncovered by the trial itself), the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice. . . . The OHRP has a duty to investigate questions of research impropriety, but we strongly disagree with their determination of inadequate informed consent in this case.”
And from Art Caplan and David Magnus:
“With regard to SUPPORT, the OHRP is asking that research be described as riskier than it really is and is suggesting that the parents were duped into enrolling their frail infants in dangerous research. Not only is that not true, but it also poses substantial risk to the conduct of valuable comparative effectiveness research both for premature infants and for the general public who continue to face too many treatments where uncertainty prevails about what is best.”
There is also a letter to the editor from the SUPPORT study group themselves.
What do you think – is this OHRP’s latest version of its checklist debacle, or are they right here?