University must tell patients that they were research “guinea pigs”

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 …