Part II is the third of five files creating a single report entitled: Research involving prisoners.General history, nature, and extent of research involving prisoners in the United States is discussed in Part II.Supported by the Department of Health, Education, and Welfare (DHEW)

United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

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PART II. BACKGROUNDChapter 3. Nature of Research Involving PrisonersResearch activities involving prisoners may be divided into four broadcategories: biomedical research not related to the health or well-being ofthe subject, biomedical research on practices intended to improve the healthor well-being of the subject, social research, and behavioral research onpractices intended to improve the health or well-being of the subject. Thefirst category of research using prisoners mainly involves phase 1 testingof new drugs and testing of vaccines as to efficacy. Biomedical and behavioralresearch related to the health or well-being of the prisoner-participantsgenerally involves the study of conditions associated with prisoners or prisons.In addition, innovative practices in prisons, intended to rehabilitate or treatprisoners, often have many attributes of behavioral research but are seldomintroduced as such. The major controversy over participation of prisonerssurrounds their use as subjects of biomedical research not related to theirhealth or well-being and their unwilling involvement in experimental treatmentor rehabilitative programs.Biomedical research unrelated to the health or well-being of prisoner-participants was conducted in the United States only in isolated instancesprior to the establishment in 1934 of a program at Leavenworth Prison to assessthe abuse potential of narcotic analgesics; such research is now conducted atthe Addiction Research Center in Lexington, Kentucky, although it was announcedrecently that the program will be terminated by the end of 1976. The currentinvolvement of prisoners in biomedical research unrelated to their health or23well-being can be traced to three sources. First, during World War II, pris-oners volunteered in large numbers for studies, such as those to developeffective anti-malarial drugs, which were viewed as contributing to the nationalinterest. Reviews of these prison research activities by several state commis-sions resulted in their endorsement. In fact, prisoner participation in re-search was felt to be such a salutary experience that the American MedicalAssociation formally opposed allowing persons convicted of particularly seriouscrimes to have the privilege of participating in scientific experiments. Second,the enthusiastic support of biomedical research by the government and the publicfollowing the war brought an enormous growth to research enterprises, and pris-oners served as subjects in many of these new endeavors. Third, the thalidomideexperience was followed by passage in 1962 of the Kefauver-Harris amendments tothe Food and Drug Act, which established additional requirements for testing thesafety and efficacy of all drugs to be sold in interstate commerce and therebyencouraged the continued use of prisoners in research. The phase 1 testingrequirements established under these amendments required evaluation of thesafety of new drugs in normal volunteers under controlled conditions, and pris-oners became the population on which much of this testing was performed.Innovative prison practices are often difficult to distinguish from whatmight be termed behavioral research on practices intended to improve the healthor well-being of prisoner-participants. Since the early 1900's, innovationssuch as flexible sentences, indeterminate sentences, behavioral therapiesduring imprisonment, and parole and probation based on evidence of rehabili-tation have been introduced into the prison system. These innovations havenot generally included provisions for design, review and evaluation as research.24Frequently, though, the behavioral programs have had many characteristics ofbehavior modification research. Examples range from use of "therapeuticcommunity" and reinforcement techniques in prison, to use of aversive condi-tioning (employing electric shock or drugs with unpleasant effects) in treatingsex offenders or uncontrollably violent prisoners, to use of a structured tiersystem (token economy) in which a prisoner progresses from living conditionsof severe deprivation to relative freedom and comfort as a reward for sociallyacceptable behavior. At the extreme of research or treatment designed to changebehavior were castration for sexual offenders and psychosurgery for uncontrollableviolence.The peak of enthusiasm for the application of behavior modificationtechniques in the prison system was marked by the establishment of the SpecialTreatment and Rehabilitation Training (START) program in the Federal Bureauof Prisons, and the planning of a new federal prison at Butner, North Carolina,with research in applying behavioral modification throughout a prison as itsprimary purpose. The START program was abandoned, after 1 1/2 years of operation,under considerable criticism and after some challenges in court. Similar acti-vities led to a re-evaluation of the programs planned for Butner, which openedin May 1976. It now offers a variety of vocational and academic courses aswell as general counseling. Participation in these programs is voluntary,and changes in the program content will be introduced only with the approvalof both the inmates and the staff.Social research and psychological testing are also conducted in pris-ons. Projects include studies of the factors which may contribute to criminal25behavior (such as cytogenetic anomalies or socioeconomic and psychologicalstress), comparison of effectiveness of various rehabilitative programs inreducing recidivism, psychological assessment of criminals as compared withnoncriminal counterparts, tracking the outcome of judgments concerning "dangerousness, " and evaluating standards for determining competency to standtrial.Examples of biomedical research on practices intended to improve thehealth or well-being of subjects in prisons are studies to reduce the spreadof infections in crowded environments or to develop new methods of treatingdrug addiction. Other research, which may or may not be intended to bene-fit subjects, includes investigations to increase understanding of the natureand causes of narcotic or alcohol abuse and addiction.Research conducted or supported by DHEW. Information was made availableto the Commission by the Public Health Service (PHS) regarding all biomedicalresearch projects involving prisoners that were conducted or supported sinceJanuary 1, 1970. In addition, the National Institute of Mental Health (NIMH)provided information on all behavioral research with prisoners that was con-ducted or supported since July 1, 1971. A summary of this information follows.Biomedical research with prisoners was conducted or supported by five ofthe six PHS agencies, the exception being the Health Resources Administration.The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) reportedconducting over 40 intramural research projects in its testing facility atthe Addiction Research Center in Lexington, Kentucky. These studies involveda wide range of activities, such as developing methods for detecting drugs of26abuse through urinalysis, studies of various properties of morphine and othernarcotics, evaluations of methadone, studies of the effects of amphetamines,analysis of interactions of various drugs with narcotics, and assessment ofthe addictive or abuse potential and psychoactive effects of new drugs. ADAMHAalso supported nine extramural studies involving prisoners, including studiesof the XYY chromosome anomaly, assessment of clinical methods to predict epi-sodic violence, study of the use of narcotic antagonists to treat addict in-mates in a prison and in a work release program, and study of behavioral andbiological correlates of alcoholism.The Center for Disease Control reported three studies with prisoners;these involved vaccines and skin test studies for a parasitic disease. FDAconducted five studies with prisoners, all of which involved oral administra-tion of a standard dose of a commercially available antibiotic (Penicillin orTetracycline). FDA also supported three studies with prisoners (two evaluatingskin sensitization by irritants and one studying cyclamates). In the HealthServices Administration, research involving prisoners was conducted by physi-cians at one PHS hospital (13 studies of metabolic responses to prolonged bedrest) and by physicians and behavioral scientists at the Research Division,Bureau of Prisons (33 studies involving a wide range of activities, such asdental care, weight reduction and tattoo removal; many were behavioral andrehabilitative rather than biomedical in focus). Seven institutes of theNational Institutes of Health reported support of a total of 19 research pro-grams involving prisoners. This research included studies of vaccines (rubella,rubeola, cholera toxoid, influenza and other respiratory viruses, streptococcus)testicular cell function, treatment of sun-induced skin conditions, responses27to infectious diseases (colds, cholera), pathogenesis of acne, and the effectof diet on blood pressure and lipids.Behavioral research with prisoners conducted or supported by NIMH in-cluded psychological and social research studies of crime and delinquency,individual violence, institutionalization, and law-mental health interactions.Participation of prisoners as subjects in these studies was essential due tothe nature of the inquiries. A small number of intramural studies conductedat St. Elizabeths Hospital were related to analysis of procedures used todetermine competency to stand trial or assess dangerousness of criminallyinsane patients. Support was provided for 19 extramural studies, some ofwhich had biomedical as well as behavioral components. This research includedstudies (1) to identify sources and patterns of criminal and delinquent be-havior (the XYY syndrome, attitudes toward criminal behavior); (2) to develop,test or evaluate models for the prevention, treatment or remediation of crimi-nal behaviors (prediction of violence, lithium treatment for aggressive behavior,impact of imprisonment on the families of black prisoners, perceptions of theminority prison community, effects of prison environment stress on physicaland mental health of inmates and staff); and (3) to define and analyze criticalissues in law and mental health interactions (due process in determination ofcriminal insanity, assessment of adequacy of treatment for offenders committedto mental institutions, release of dangerous mental patients, the impact of a"dangerousness" standard as the sole criterion for involuntary commitment).In addition, NIMH has been directed by Congress to study the factors contri-buting to homosexual rape in prisons.28Chapter 4. Extent of Research Involving PrisonersThe Commission obtained information from all fifty states and theFederal Bureau of Prisons on the policies of each toward research involvingprisoners and whether or not research, if permitted, is being conducted.Also, the Pharmaceutical Manufacturers Association surveyed its members toassess the extent of pharmaceutical research involving prisoners. Thesesurveys do not document what is generally considered to be a significantamount of social and behavioral research conducted by scholars and by theprison system itself.Research in state and federal prisons. To ascertain the status ofstate laws, regulations and policies governing research involving prisoners,and to determine where such research is being conducted, state correctionalagencies and the Federal Bureau of Prisons were surveyed during the summerof 1975. The following information is based on the reports received at thetime from the state-wide agencies and the Bureau of Prisons. It should benoted that the policies and research activities of county and municipaljails were not surveyed.1. Of the 21 states that permit biomedical research and the 23states that permit behavioral research in prisons, studies are being con-ducted in the state prisons of only seven and five states, respectively.2. Of the seven states in which biomedical research is conducted,all of the programs are unrelated to the health or well-being of the subjectsand primarily involve drug and cosmetic testing.293. Of the five states in which behavioral research is conducted, allof the programs are characterized as therapeutic in four states, and both thera-peutic and nontherapeutic research (so characterized) in one state. No statereported conducting research programs involving behavior modification.4. Eight states prohibit biomedical research: one by legislation, sixby departmental policy, and one by moratorium; twenty-two have no specific policy.5. Five states prohibit behavioral research: one by legislation,three by departmental policy, and one by moratorium; twenty-three have no specificpolicy.6. Research is being conducted only in states that have specificlegislation or departmental policies permitting and regulating it.7. Information provided by the Federal Bureau of Prisons indicatedthat both biomedical and behavioral research are permitted by departmentalpolicy. Biomedical research (limited to addiction research at Lexington)and behavioral research projects are being conducted. *Participation of prisoners in pharmaceutical testing. The PharmaceuticalManufacturers Association conducted a survey of its members to ascertain theextent to which they used prisoner volunteers as subjects for drug testing in1975, with the focus primarily on phase 1 studies. Fifty-one companies, repre-senting three-fourths of the members' annual expenditures for research anddevelopment, responded to the survey. Sixteen of the 51 used prisoners as sub-jects.* In March 1976, the Director of the Federal Bureau of Prisons announced thatall biomedical research in federal prisons would be discontinued.30Of these 16 companies, 14 conducted phase 1 drug research with pris-oners, employing a total of nearly 3600 prisoners in 100 protocols studying71 substances. For nine companies, phase 1 testing represented their onlyuse of prisoners as subjects. The percentage of phase 1 testing subjectswho were prisoners ranged from 100% (one company) to 2%, with a median of50% (an average could not be calculated from the data given). The companieslisted a total of eight state and six county or municipal prisons as researchsites. Ten companies used only minimum security prisons. No companies useddetainees in their research. Other categories of volunteer subjects whichthe companies reported using in phase 1 studies included college students,medical students, company employees, residents of foreign countries, mili-tary personnel, members of fraternal organizations, medical personnel, andthe general population.Thirty-three of the 51 companies indicated that they had insurancepolicies or other mechanisms for compensating subjects who might be injuredin research. (There was no determination of the extent to which such poli-cies or other mechanisms would provide compensation in the absence of legalliability. )31

Report and recommendations: Research involving prisoners -- Part II

Part IV is the fifth of five files creating a single report entitled: Research involving prisoners.Part IV of this report contains philosophical reports describing various perspectives on prison research as well as alternatives and foreign practices.Supported by the Department of Health, Education, and Welfare (DHEW)

Report and recommendations: Research involving prisoners -- Part IV

https://scholarworks.iupui.edu/bitstream/1805/574/1/part2.pdf

Report and recommendations: Research involving prisoners -- Part II

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