Letter to the OHRP Regarding Major Ethical and Regulatory Lapses in the Conduct of the SUPPORT Trial

June 14, 2017

Public Citizen requests that the Office for Human Research Protections (OHRP) immediately expand its ongoing compliance oversight investigation of the Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT) trial to evaluate newly uncovered information — recently obtained by Public Citizen under the Freedom of Information Act — that reveals additional major ethical lapses and failures to materially comply with key requirements of federal regulations for the protection of human subjects.

View letter as PDF

View our press release

View a chart of key events and players

List of SUPPORT trial institutions

View SUPPORT trial consent forms

View Public Citizen’s recent work on the SUPPORT trial

Dr Carome speaks about the trials and how they could have endangered the lives of 1316 premature babies.