University must tell patients that they were research "guinea pigs"

British Medical Journal, Dec 16, 2000 by Deborah Josefson

Deborah Josefson New York

Federal regulators have ordered officials at the University of Missouri at Columbia Medical Center to inform 78 patients who underwent heart surgery there that they were unwitting research subjects.

The US Office of Human Research Protections ordered the university to notify patients that they were subjects of a randomised trial that compared one method of cardioplegia (stilling the heart during open heart surgery) with a more standard method.

The research was conducted by Dr Jack Curtis, chief of the hospital's division of cardiothoracic surgery, between June 1991 and March 1992. It resulted in a publication in the International Journal of Angiology (1996; 5:212-8).

The agency found that Dr Curtis randomised patients to receive either warm cardioplegia or the more standard cold cardioplegia depending on whether the patient's hospital medical record number was odd or even. The patients were unaware that they were participants in such a trial and therefore did not give consent.

The ruling from the Office of Human Research Protections grew out of an investigation of the case performed in 1998 by the University of Missouri's own institutional review board (IRB). The board found, by a vote of 12 to 2, that Dr Curtis should have obtained consent from his patients before surgery and recommended that patients be contacted and informed that they had been research subjects.

The review board voluntarily reported the results of that inquiry to the Office of Human Research Protections. Despite the board's 1998 recommendation, university administrators opted not to inform patients at that time, arguing that no harm was done to them, appropriate medical procedures were followed, the study was completed seven years ago, and such information could only cause psychological problems for the involved patients.

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