Letter to the Vanderbilt University Medical Center IRB Chairs Regarding Sepsis Clinical Trial Funded by NIH

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Public Citizen called on the Vanderbilt University Medical Center institutional review board (IRB) that approved the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) to (a) immediately review our letter to the Office for Human Research Protections in which we identified serious ethical and regulatory lapses related to the design and sample consent form of CLOVERS and (b) suspend the IRB’s approval of CLOVERS and direct the CLOVERS investigators to cease enrolling subjects in the trial.

See Public Citizen’s other work on CLOVERS.

See Public Citizen’s other work on ethics and clinical trials.