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Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding an Unethical Clinical Trial Involving Heart Attack Patients

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Public Citizen calls on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to immediately suspend the National Institutes of Health-funded Myocardial Ischemia and Transfusion (MINT) trial that is expected to involve 3,500 heart attack patients throughout the U.S. and Canada because of potentially serious ethical and regulatory violations.

View press release.

August 15, 2017, acknowledgment letter from the VA Office of Research Oversight.

View list of researchers who provided letters of support for the MINT trial.

View MINT trial protocol.

View MINT trial sample consent form.

June 7, 2018 response letter from the OHRP and ORO.

June 12, 2018, press release commenting on the OHRP and ORO letter.

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