NCJ Number
53122
Date Published
1978
Length
8 pages
Annotation
A DISCUSSION IS UNDERTAKEN OF THE INFORMED CONSENT ISSUES WHICH AFFECTED A STUDY OF THE CAUSES OF INCARCERATION AND WHETHER ANTICONVULSANT MEDICATION MIGHT BENEFIT THE INDIVIDUAL PRISONER.
Abstract
IN GENERAL, THE PROBLEMS OF UTILIZING PRISONERS AS RESEARCH SUBJECTS REVOLVE AROUND THEIR POTENTIAL FOR GIVING INFORMED CONSENT. GUIDELINES PROPOSED BY THE U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PROHIBIT INVESTIGATION ON PRISON POPULATIONS UNLESS IT INVOLVES RESEARCH ON THE POSSIBLE CAUSES AND EFFECTS OF INCARCERATION, PRESENT MINIMAL OR NO RISK TO THE INMATES, DEALS WITH PRISONS AS INSTITUTIONS OR PRISONERS AS INCARCERATED INDIVIDUALS, OR CONCERNS INNOVATIVE OR ACCEPTED PRACTICES INTENT ON IMPROVING THE HEALTH AND WELL-BEING OF THE SUBJECT. UNLIKE RESEARCH WHERE NEW DRUGS ARE TESTED FOR TOXICITY OR WHERE INMATES ARE GIVEN INFECTIOUS AGENTS TO TEST THE VIRULENCE OF NEW VACCINES, THIS STUDY AT MARYLAND'S PATUXENT INSTITUTION WAS DESIGNED TO ISOLATE, UNDERSTAND, AN POSSIBLY TREAT AGGRESSIVE PRISONERS WHO WANTED HELP WITH IMPULSE CONTROL. DESPITE THESE AIMS, THE RESEARCHERS WERE UNABLE TO ASSURE THE SUBJECT OF ANY BENEFIT FROM THE EXPERIMENT; SUBJECTS WERE TOLD THAT, AT BEST, ONE-QUARTER TO ONE-THIRD OF THE VOLUNTEERS MIGHT BE HELPED. WHILE THE SUBJECTS WERE TOLD THAT THE DRUG UNDER STUDY, PRIMIDONE, WAS AVAILABLE TO ANY INDIVIDUAL ON A PRESCRIPTION BASIS FOR THE TREATMENT OF EPILEPSY, THEY WERE ALSO INFORMED THAT ITS USE TO TREAT IMPLUSIVE DISORDERS OR INDIVIDUALS IN A PRISON SETTING WAS CONSIDERED EXPERIMENTAL. BECAUSE THE RESEARCH DESIGN WAS COMPLICATED, SO, TOO, WAS THE PROCEDURE FOR OBTAINING INFORMED CONSENT, AND IT IS LIKELY THAT ONLY A FEW OF THE 93 VOLUNTEERS FULLY COMPREHENDED THE STUDY DETAILS. THE USE OF THE ALPHA CHLORALOSE TO ACTIVATE THE ELECTROENCEPHALOGRAPHS--A TECHNIQUE EMPLOYED TO MEASURE THE INSTABILITY OF THE CENTRAL NERVOUS SYSTEM--REPRESENTED A FURTHER COMPLICATION BECAUSE THE DRUG IS NOT APPROVED FOR USE IN THE U.S. BY THE U.S. FOOD AND DRUG ADMINISTRATION; A SPECIAL EXEMPTION HAD TO BE SECURED. ALSO, A PRISONER RIOT BROKE OUT DURING THE EXPERIMENT, AND ALTHOUGH THE RIOTERS PROTESTED (AMONG OTHER THINGS) THE USE OF THE INMATES IN PRISON RESEARCH, NONE OF THE STUDY SUBJECTS PARTICIPATED IN THE RIOT AND NONE COMPLAINED ABOUT THEIR ROLE IN THE EXPERIMENT. IN FACT, FOLLOWUP INTERVIEWS AFTER THE EXPERIMENT REVEALED NO SUBSTANTIAL CRITICISM OF THE PROJECT, EVEN FROM THOSE INMATES WHO DROPPED OUT IN THE COURSE OF THE STUDY. TABULAR DATA AND REFERENCES ARE PROVIDED. (KBL)