Letter to OHRP Calling for Additional Agency Actions to Address Alarming Ethical and Regulatory Lapses in NIH-Funded Sepsis Clinical Trial
In a letter to the Office for Human Research Protections (OHRP), Public Citizen criticized the agency for putting hundreds of seriously ill sepsis patients at risk by not suspending enrollment in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial, which was funded by the National Institutes of Health (NIH), while much needed changes were made to the trial’s design and consent form to address alarming ethical and regulatory lapses.
See Public Citizen’s other work on CLOVERS.
See Public Citizen’s other work on ethics and clinical trials.