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. Following the section on children is the section on adult prisoners, which covers definitions, additional provisions for IRBs, and avoidance of coercion.
Finally, there will be an analysis of biomedical and behavioral research on juvenile inmates and the specific problems that are entailed. This section covers reasons why this is a particularly vulnerable population to research, with problems of informed consent and coerced choices. There is also an examination of the juvenile inmates' constitutional rights when participating in research. Then the two additional provisions on children and prisoners are combined to see how they may apply to juvenile inmates. This section will conclude with the various troubles created by the regulations when applied to juvenile inmates.
II. WHAT IS BIOMEDICAL AND BEHAVIORAL RESEARCH?
Biomedical and behavioral research involves many types of research. Research, for purposes of the federal regulations, is broadly defined by 45 C.F.R. [section] 46.102 as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." (13) Research may also be classified as a clinical investigation. (14) A clinical investigation is defined by 21 C.F.R. [section] 50.3 as "any experiment that involves a test article and one or more human subjects and ... is subject to ... the Food and Drug Administration." (15) The definitions of research and clinical investigation, when combined, subject almost every type of research to the authority of the federal regulations. (16)
Biomedical and behavioral research is conducted for many purposes. An argument could be made that such research is too necessary for any sort of regulation. Human experimentation has had many successes that are widely recognized. (17) It has enabled scientists to further "medical understanding" and "unlock knowledge that may profoundly change the nature of our existence." (18)
Despite these accomplishments, various arguments have been made against the use of human subjects for biomedical and behavioral research. These arguments directly conflict with the goals and objectives of the researchers conducting the experiments. Researchers argue that research or human experimentation is useful, or for the "common good." (19) There is a difference between the interests promoted by research (the researcher's motivations) and interests that are at stake due to the research (the interests of the human subject). The researcher is interested in discovery, accomplishment and recognition. By contrast, the human subject is interested in rewards for participating, taking part in improving medicine, and avoiding physical harm or pain and suffering. Whose interests are being looked out for in research where human subjects undergo pain and suffering in exchange for biomedical advances in medicine?
III. DEVELOPMENT OF THE FEDERAL REGULATIONS
There is a long history of biomedical and behavioral research conducted on human subjects worldwide. However, only in the twentieth century has concern developed over the abuse of research on human subjects. (20) In 1932, Japan
began to experiment on thousands of people in China, including American prisoners of war, to test germ warfare. (21) Also, in 1946, several Nazi German officials were tried in Nuremberg, Germany for conducting "medical experiments on men, women, and children in concentration camps." (22) From 1932 to 1972, over 400 black men were exposed to syphilis in an experiment, referred to as the Tuskegee Syphilis Experiment, sponsored by the U.S. Public Health Service. (23) Following these twentieth century abuses of experimentation, there arose a demand for regulation of experimentation involving human subjects. The federal regulations were created in 1974 and have been amended several times since. (24)
The federal regulations that have been adopted come from the Food and Drug Administration [hereinafter "FDA"] and the Department of Health and Human Services [hereinafter "DHHS"], titles 21 and 45 of the Code of Federal Regulations, respectively. (25) Many other departments and agencies that experiment or conduct research on human subjects have adopted these regulations as the "Common Rule." (26) Some state laws have even begun to model the federal regulations. From 1975 to 1990, the New York State Department of Mental Hygiene has issued regulations that match those of the federal regulations. (27) These federal regulations are, themselves, a model of a body of law, the Nuremberg Code.
The FDA and the DHHS have borrowed some of the main principles of the Nuremberg Code, and have included them in the federal regulations. (28) The Nuremberg Code is the "first known attempt to establish international legal guidelines for regulating research on humans." (29) The general principle emphasized by the Code was that the importance of research and the gathering of scientific knowledge could not outweigh the individual rights of subjects. (30) The most important idea borrowed from the Nuremberg Code is that "voluntary consent of the human subject is absolutely essential." (31) In addition to the FDA and the DHHS regulations, the Nuremberg Code is binding upon researchers in the United States. (32)
The federal regulations have the force of law and are binding on all researchers. (33) Title 21, part 50 only applies to clinical investigations regulated by the FDA, as defined above. (34) Title 45, part 46 covers "all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency...." (35) This coverage, however, is limited only to federally funded or supported research. (36) There are also certain situations in which the regulations will not apply at all. (37) The majority of these exempted types of research deal with research held in educational settings or involving cognitive tests. (38) Furthermore, "department or agency heads may waive the applicability of some or all of the provisions" set forth in these regulations for research activities, as they deem necessary. (39) Thus, it is questionable as to how much coverage the regulations actually have over biomedical and behavioral research.
Title 42, section 289 of the United States Code requires that there be a regulation in force which in turn will require an IRB for the purpose of reviewing "biomedical and behavioral research involving human subjects." (40) The IRB has the "authority to approve, require modifications in, or disapprove all research activities" covered by the regulations. (41) The IRB fulfills its duties by: (i) ensuring that risks to subjects are minimal, (ii) reviewing informed consent documents and the procedures used to obtain consent, (iii) reviewing the selection of subjects, (iv) balancing the risks with the benefits derived from the research, and (v) providing that the subjects' privacy is protected. (42) If all of these criteria are satisfied then the research is approved by the IRB. The IRB must also meet member requirements, according to 45 C.F.R. [section] 46. Every IRB must have five members who are diversified by gender and race. (43) One member must be a person with scientific concerns, another must have concerns in a nonscientific area, and there must be at least one member who is not affiliated with the institution conducting the research. (44)
There are three main interests that an IRB must consider when deciding whether to approve a specific research experiment. (45) They are the interests off (1) the researchers or investigators, (2) the institution supporting the research, and (3) the research subjects. (46) As to the latter, "the subject's own health and well-being, which are directly and foreseeably affected by the research, make the subject the most vulnerable of the three parties." (47) In all, the IRB has the challenge of taking all three interests into consideration and balancing them so that the private rights involved are never underestimated.
As stated, the FDA and DHHS have borrowed from the …
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Publication information: Article title: Biomedical and Behavioral Research on Juvenile Inmates: Uninformed Choices and Coerced Participation. Contributors: Wyman, Brian Paul - Author. Journal title: Journal of Law and Health. Volume: 15. Issue: 1 Publication date: Spring 2000. Page number: 77+. © 1997 Cleveland Marshall College of Law. COPYRIGHT 2000 Gale Group.
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