What did the OHRP determine in their investigation of ARDSNet studies?
On July 3, 2003 the Office of Human Research Protections (OHRP) published its determinations from an inquiry into the safety and design of completed and ongoing ARDS Network studies. In its most important finding, OHRP said “… almost all of the consultants engaged by OHRP opined that risks to subjects in the ARMA [tidal volume] trial were minimized and reasonable in relation to anticipated benefits to the subjects and the importance of the knowledge that was expected to result.” The OHRP consultants expressed the same opinion regarding the ARDS Network fluids and catheters treatment trial (FACTT). The OHRP consultants’ findings were consistent with those of the 5 independent consultants engaged by the NHLBI who, on August 30, 2002 concluded unanimously that the ARDS Network trials were safe and appropriately designed. The OHRP determination letter requests that all IRBs review additional background materials pertinent to the FACTT study, examine their practices, and requested changes
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