OIG Review of Allegations of Interference in OHRP Compliance Determination for SUPPORT

This report provides the results of our review of allegations that officials of the National Institutes of Health (NIH), the Immediate Office of the Secretary, the Office of the General Counsel, and others improperly intervened in the compliance oversight deliberations of the Office of Human Research Protections (OHRP) with respect to the NIH-funded study, Surfactant Positive Airway Pressure and Pulse Oximetry Trial (also called SUPPORT). The review was conducted at the request of a Member of Congress, a consumer advocacy group, and a member of the public. This report does not contain recommendations. Our review found no indication that NIH or other Department of Health and Human Services (HHS) officials sought to intervene in OHRP's initial determination letter regarding SUPPORT. Our review did confirm that after the initial letter was issued, NIH encouraged OHRP to reverse its determination and that NIH and others in HHS provided input on OHRP's later clarification letter. The emails contained no directive or order to OHRP from NIH or any other official to take a particular policy or scientific position; instead, the NIH emails contained arguments in support of a conclusion different from that reached by OHRP. Our research disclosed no law, regulation, or written policy that prohibits or restricts the kind of consultation that occurred here or would make such consultations improper. That is, no law establishes OHRP's organizational independence (indeed, no statute mentions OHRP by title at all) or prohibits the HHS Secretary from seeking input from other HHS components on OHRP determinations.

---