On August 28, 2018, Public Citizen called on the Office for Human Research Protections to immediately direct the National Heart, Lung, and Blood Institute to terminate enrollment in CLOVERS and launch a compliance oversight investigation of the trial and its review and approval by the responsible institutional review board(s). Based on Public Citizen’s review of the most recent version of the protocol, sample consent form, and relevant background scientific literature, the trial, as proposed and currently conducted, fails to (a) materially comply with key requirements of Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 C.F.R. Part 46 and (b) satisfy the basic ethical principles upon which those regulations are founded. In particular, the design of CLOVERS is deeply flawed and exposes subjects to unacceptable dangers, included increased risks of organ failure and death.
More information on CLOVERS
- Letter to the OHRP Calling for a Halt to Unethical NIH-Funded Sepsis Clinical Trial Until NIH Stops Interfering in OHRP’s Evaluation of the Trial, May 1, 2019
- Letter to the HHS Office of Inspector General Calling for an Investigation of NIH Leadership’s Obstruction of OHRP Probe of Unethical, Reckless Sepsis Clinical Trial, April 29, 2019
- Letter to the Vanderbilt University Medical Center IRB Chairs Regarding Sepsis Clinical Trial Funded by NIH, August 29, 2018
- Letter to OHRP Calling for a Halt to Unethical, Reckless Sepsis Clinical Trial Funded by NIH, August 28, 2018
- Press Release: Federal Regulators Must Halt Unethical, Reckless Sepsis Trial Funded by NIH, August 28, 2018
- List of study locations for CLOVERS