On the basis of the SRAG score and despite all other clinical and observational data, the hospital staff at the new facility refused to allow the patient to leave the locked ward without the direct supervision of an escort. The treatment team took the position that there was no scientific evidence available that would allow them to assess whether his risk had reduced over the 14 years of his treatment. They noted that the actuarial guide for the SRAG does not allow for attenuation by such dynamic factors as a favourable response to treatment or the patient’s cooperation and good behaviour (all of which were documented without contradiction).

In 1999, counsel for the patient challenged the hospital’s position. After an independent assessment using more advanced techniques, evidence of significant frontal perfusion deficits was elicited on single photon emission computed tomography (SPECT). Magnetic resonance imaging (MRI) showed dilation of the frontal horns of the lateral ventricles of the brain, while computerized electoencephalography showed increased slow-wave activity in both the frontal and temporal areas of the brain. This clinical picture was clearly that of personality change due to neonatal asphyxia. At the same time, sexual sadism was ruled out as a factor. A clinical trial of a serotonin reuptake inhibitor was successful in modifying the clinical features of this condition.

The opportunity for a serious examination of the SRAG was also taken. The administration of the PCL-R, the most powerful variant of the SRAG, without an interview, despite the availability of the patient, raised serious concerns. The PCL-R manual cautions that “As an individual’s scores may have important consequences for his or her future, the absolute value is of critical importance. The potential for harm is considerable if the PCL is used incorrectly” (5). Counsel also questioned the participation of this patient without his knowledge or consent in a research project leading to the development of the SRAG—a clinical instrument that had a devastating effect on his life and liberty.

The preceding case highlights complex issues which arise in the interface between clinical management, legal disposition, and research with forensic patients. This paper reviews the historical development of research ethics with human subjects and discusses specific issues related to prisoners and psychiatric patients. Following this, we return to the case example and discuss the implications of research ethics for patients involuntarily detained because they pose a risk to society.

Historical Developments of Research Ethics

The first code of ethics for research with human subjects emanated from the famous Doctors’ Trial which took place in Nuremberg between 1947 and 1949. This trial focused on the Nazi doctors’ experiments on prisoners in concentration

camps—experiments that included exposure to extreme cold, high altitudes, mustard gas, sulfanilamide, sea water, and incendiary bombs (6). In referring to the trial, US Chief Prosecutor Justice Robert Jackson stated “The wrongs which we seek to condemn and punish have been so calculated, so malignant, and so devastating, that civilization cannot tolerate their being ignored because it cannot survive their being repeated” (7, p 30–1). In the end, 16 doctors were found guilty of crimes against humanity, and 7 were sentenced to death by hanging (6). The Trial resulted in the “Nuremberg Code,” a list of 10 principles for research with human subjects. These principles include directives that research should seek societal good and minimize harm, that researchers must be scientifically competent, and most important, that voluntary consent is absolutely essential (8).

The Nuremberg trial focused on the most heinous of crimes committed in the name of research and created the impression that they were committed by monsters under the control of a totalitarian regime. It has, however, been argued that although in the Allied countries no physician researchers sank to the depths of the experimenters in Dachau or Auschwitz, many did act in violation of the principles defined in the Nuremberg Code, both during World War II and long after it ended (6). Rothman chronicles the history of medical research in the US and cites numerous examples of flagrant abuses (9). The first of these came to light in 1966 when Henry Beecher, a Harvard Medical School professor, wrote an exposé in the New England Journal of Medicine (NEJM) (10). The 22 examples cited by Beecher included a study published in the NEJM in which live hepatitis virus was injected into residents of a state institution for the mentally retarded to allow researchers to study the etiology of the disease and attempt to create a vaccine (11). Another study involved injecting live cancer cells into elderly and senile hospitalized patients to study immune responses (12). Beecher’s conclusion was that unethical or questionably ethical procedures were not uncommon among researchers, and disregard for the rights of human subjects was widespread (9).

While we have, as Canadians, been for the most part immune from these exposés, many concerns about research in Canada have recently been raised as a result of the lawsuit of Dorothy Parker, one of 23 inmates involved with LSD experiments conducted between 1960 and 1963 at Kingston Prison for Women (13). Pursuant to this case, Ms Parker’s attorneys cited evidence that psychotropic drugs were also tested in Kingston Penitentiary in 1960, and in Collins Bay Prison in 1973. Moreover, they presented evidence of abuses elswhere, including a 1964 letter wherein the federal government permitted researchers to give nightly steroid enemas for up to 3 weeks to inmates at Collins Bay Prison to assess whether rectal irritation occurred. Other examples of abuse included permission granted in 1972 to test penicillin on inmates in Quebec and a 1967 study in which the federal government