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NIH Blood Transfusion Trial’s Ethics Questioned – MedPage Today (Larry Husten | August 2017)

Posted by saviorteam in Human Research Ethics on September 3, 2017
Keywords: Beneficence, Bioethics, Biomedical, Clinical trial, Consent, Controversy/Scandal, Ethical review, Human research ethics, Medical research, Merit and integrity, Methodology, Protection for participants, Researcher responsibilities
Folded newspaper, isolated on a white background, with the headline BAD NEWS! Above the fold.

Public Citizen demands halt to study comparing transfusion strategies after MI

Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy group in a letter sent to the Office for Human Research Protections and the VA’s Office of Research Oversight.

The MINT trial started earlier this year in April and is expected to be completed in 2021. The trial plan calls for 3,500 hospital patients with acute MI who have blood counts below 10 g/dL to be randomized to either a liberal or restrictive transfusion strategy with red blood cells. The primary endpoint is the composite outcome of all-cause mortality or nonfatal MI at 30 days.

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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