Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS)

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.

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