Biomedical and Behavioral Research on Juvenile Inmates: Uninformed Choices and Coerced Participation
Wyman, Brian Paul, Journal of Law and Health
In 1997, Stanford University and the California Youth Authority [hereinafter "CYA"] conducted a biomedical research experiment on sixty-one male inmates from ages fourteen to eighteen. (1) All of the subjects were given a drug named Depakote, used primarily for treating seizures and mania. (2) The drug was tested to see if it would reduce the amount of aggressiveness in juvenile inmates. (3) The possible side effects to such a drug include "drowsiness, nausea, indigestion and vomiting ... hair loss, anxiety, depression, and a decrease in white blood cells." (4) These particular juveniles were selected as a target population because they had been convicted of violent crimes. (5) While Stanford attempted to obtain consent from parents of the juvenile inmates, not all parents responded. (6) Where parents did not respond or could not be found, the CYA consented for the juveniles. (7) This experiment presents various issues in biomedical and behavioral research on human subjects in vulnerable populations. The Stanford study led to such serious concerns, that the Governor of California asked the attorney general and inspector general to investigate the study's "legal implications." (8)
The most important issue presented by the Stanford study is whether children who are incarcerated can give voluntary, informed consent to such experiments. (9) Federal regulations govern biomedical and behavioral research on human subjects. (10) These regulations give separate additional protections to both children and prisoners. (11) However, there are no regulations specifically covering the area of biomedical and behavioral research on juvenile prisoners or inmates. This is an especially vulnerable class of individuals to target for conducting biomedical and behavioral research. Voluntary informed consent is an essential element to any type of research, and when dealing with juvenile inmates as subjects, that consent is more difficult to obtain. Yet biomedical and behavioral research is still conducted on this population, as evidenced by the 1997 Stanford University study. (12)
The question that will be addressed here is whether juvenile inmates can voluntarily give informed consent to participate in biomedical and behavioral research. Further, can juvenile inmates act voluntarily in the midst of coercion used by researchers to persuade the subjects to participate, and coercion that is inherent in the nature of being a juvenile inmate? Can consent be informed when a juvenile inmate's comprehension and understanding of what biomedical and behavioral research entails is limited by age and maturity level? Finally, even if juvenile inmates are deemed capable to give voluntary informed consent to biomedical and behavioral research, is simply participating in such research violative of their constitutional rights?
This note begins briefly by defining biomedical and behavioral research according to the federal regulations. Then, the development and history behind the federal regulations is highlighted to show the origin of the current form of the regulations. This development includes an examination of the current form of the regulations, which illustrates the general provisions and their application to biomedical and behavioral research on human subjects. This section on the general provisions covers what is termed an Institutional Review Board [hereinafter "IRB"], informed consent standards, and possible sanctions for noncompliance.
Following the section on general provisions is an analysis of two specific provisions that add protections for vulnerable classes of persons as research subjects. These two additional protections are for children and prisoners. Before there can be an investigation into research on juvenile inmates, there must first be a description of the additional protections provided for children and prisoners. The provision that relates to children is examined first, and covers definitions, minimal risk standards, and parental consent attached to informed consent standards. …