Public Citizen Health Research Group v. HHS

Public Citizen’s Health Research Group has drawn attention to the ethical consent standards of two NIH-supported clinical trials testing experimental treatments in extremely premature babies: the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (“SUPPORT”) and the Transfusion of Prematures (“TOP”) trial.  HRG has raised concerns about the SUPPORT study because it exposed over 1,300 premature infants to increased risk of blindness and death without adequately informing parents of the risks involved and the nature of the research. HRG has raised similar concerns about the ethical consent standards for TOP.

HRG submitted five FOIA requests to NIH seeking documents related to these studies and filed suit under FOIA to compel the agency to release the documents in full. After HRG filed the lawsuit, the agency released many records, and HRG dismissed the case.