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n engl j med 356;18 www.nejm.org may 3, 20071806

subjects or objects? prisoners and human experimentation

Subjects or Objects? Prisoners and Human Experimentation Barron H. Lerner, M.D., Ph.D.

During the 1950s, inmates at what was then called Holmes-

burg Prison, in Philadelphia, were inoculated with condyloma acu- minatum, cutaneous moniliasis, and viruses causing warts, herpes simplex, and herpes zoster.1 For participating in this research, and in studies exposing them to diox- in and agents of chemical warfare, they were paid up to $1,500 a month. Between 1963 and 1971, researchers in Oregon and Wash- ington irradiated and repeatedly took biopsy specimens from the testicles of healthy prisoners; the men subsequently reported rash- es, peeling, and blisters on the scrotum as well as sexual diffi- culties.2 Hundreds of such exper- iments induced the federal govern- ment to essentially ban research involving prisoners in 1978. The message: such research is funda- mentally exploitative and thus un- ethical.

Yet a recent report by the Insti- tute of Medicine (IOM) has opened the closed door, arguing not only that such research can be per- formed appropriately but that pris- oners deserve to be included in investigative studies — at least those who might benefit directly. Examination of the explanations behind U.S. restrictions on prison research and their current appli- cability can provide guidance for today’s policy debates.

The vulnerability of prisoners to exploitation has long been known. As early as 1906, for in- stance, critics noted how difficult it would have been for prisoners to refuse to participate in a cholera experiment that ultimately killed 13 men.3 Still, investigators pe- riodically sought out “volunteers” among such captive populations,

whose institutionalization offered researchers accessible subjects un- likely to be lost to follow-up.

Most such research did not seek to benefit participants. In 1915, for example, Public Health Service researcher Joseph Goldberger in- duced pellagra in healthy Missis- sippi prisoners, who were offered

parole in exchange for participa- tion. Those who signed up experi- enced the very severe symptoms of the disease, including diarrhea, rash, and mental confusion.3 Gold- berger, however, proved his hy- pothesis that pellagra was a vita- min-deficiency disease that could be cured by ingestion of the B vita- min now known as niacin. Thanks to this work, as well as the discov- ery of insulin and the first antimi- crobial agents, the years between World War I and World War II were heady times for scientific re- search.

World War II turned question- able experimentation on prisoners into a cottage industry. As other Americans risked their lives on the battlefield, prisoners did their part by participating in studies that exposed them to gonorrhea, gas gangrene, dengue fever, and malaria.1 Any consideration of meaningful consent was sub- sumed by the war imperative.

Ironically, the biggest boost to such experimentation came as a result of the postwar Nuremberg

trial of 20 Nazi doctors, which gave rise to the Nuremberg Code, a set of principles intended to prohibit human experimentation without subjects’ consent. When defense lawyers implied that American scientists had conduct- ed wartime research analogous to that of the Nazis, one prosecu- tion witness, Andrew C. Ivy, cited malaria experiments involving Il- linois prisoners as an example of “ideal,” noncoercive research. Ivy’s 1948 publication of his con- clusions helped to institutional- ize prison experimentation for the next quarter-century.4

It was an experiment involving another vulnerable population that halted the prison research enter- prise. In 1972, an Associated Press reporter broke the story that poor southern black men with syphilis had been deliberately left untreated for 40 years so researchers could study the natural course of the dis- ease. In the environment created by the civil rights movement and pro- tests against the Vietnam War, such research was condemned. The scandal led to the formation of the National Commission for the Pro- tection of Human Subjects of Bio- medical and Behavioral Research and eventually the Belmont Report, which recommended revamping human experimentation using the principles of respect for persons, nonmaleficence, and justice.

In the case of prison research, the new atmosphere proved espe- cially restrictive. In 1978, the De- partment of Health and Human Services (DHHS) passed regula- tions that limited federally funded research involving prisoners in several ways, stipulating, for ex- ample, that experiments could pose no more than minimal risk

The New England Journal of Medicine Downloaded from nejm.org at COLUMBIA UNIV HEALTH SCIENCES LIB on March 23, 2011. For personal use only. No other uses without permission.

n engl j med 356;18 www.nejm.org may 3, 2007

PERSPECTIVE

1807

to the subjects. The overarching concern was that prisons were in- herently coercive environments in which informed consent could never be obtained. The fact that research offered financial rewards, alleviation of boredom, and the prospect of earlier parole made it even more dicey.

This was the prevailing view until 2004, when the DHHS asked the IOM to revisit the matter. In August 2006 the IOM published its report, which acknowledged that it might make sense to leave the situation alone. For example, the U.S. prison population in- cludes disproportionate numbers of vulnerable people: members of minority groups, the mentally ill, and persons with HIV infection and other serious infectious dis- eases. Prisons are generally over- crowded and have inadequate health care services. All these fac- tors suggested that any easing of restrictions might lead to the rep- etition of previous errors.

Nonetheless, the IOM panel, although sensitive to past “uncon- scionable abuses,” recommended that experiments carrying more than minimal risk be allowed, with the caveat that studies in- volving drugs or other biomedical interventions be required to have potential benefits for prisoners. The panel also recommended several safeguards, such as creat- ing a public database of prison experiments, limiting research to interventions with some demon- strated safety and efficacy, ensur- ing that studies include a major- ity of nonprisoner subjects, and requiring that proposals be vetted by institutional review boards that would include prisoner represen- tatives.

The panel’s decision makes sense for several reasons. The first might be termed historical. For most of the 20th century, despite

the findings at Nuremberg and occasional other warnings, hu- man experimentation was largely seen as a “good,” something that would advance science and bene- fit health. The backlash against experimentation in prisons oc- curred during the 1970s, when authority was being questioned throughout society. No mecha- nisms were in place to ensure the rights of vulnerable subjects. It thus made sense to ban any risky research in prisons.

It is often said that those who ignore history are condemned to repeat it. But a decision to retain current restrictions because of past abuses would ignore several im- portant developments. Since 1978, a network of institutional review boards has been established at the National Institutes of Health, other governmental agencies, and re- search universities throughout the country. With “informed consent” now common parlance, study sub- jects are more aware of their rights. And, largely owing to the work of AIDS activists and breast cancer activists, sick and at-risk persons, even those from poten- tially vulnerable populations, now actively pursue participation in re- search protocols. Even though not all these developments are unam- biguously positive, to ignore them and the opportunities they may af- ford prisoners would be to regress. As the IOM report said, “Respect for prisoners also requires recog- nition of their autonomy.”

Another argument in favor of relaxing restrictions is that the re- flexive assumption that all prison research is problematic may not be accurate. In light of the abuses, critics have understandably ar- gued that human experimentation in prison has failed because it takes place in a coercive environ- ment that vitiates any possibility of informed consent. But that is a

theory that can and should be in- vestigated empirically through formal studies of the consent pro- cess in prisons. Moreover, as phi- losopher Carl Cohen has argued, research outside of prisons often has coercive elements as well — so to the degree that coercion is involved, it may have little to do with imprisonment.5

Finally, reinstituting and then monitoring prison research would afford society an opportunity for ongoing scrutiny and reassess- ment. Indeed, the IOM panel found that much unregulated prison re- search was being conducted despite the 1978 guidelines. Many of the notorious prison experiments in- volved the active deception of study participants — an abuse more eas- ily avoided if the whole enterprise is aboveboard. It is even possible that research studies, by providing a window into prison life, would focus needed attention on deficien- cies in prison health care.

Still, the new regulations must be approached with trepidation. As sociologist Erving Goffman showed in his 1961 book Asylums, “total institutions” such as prisons may run roughshod over the rights of their inhabitants. Perhaps this book should be required reading for any investigator who embarks on research within prison walls.

Dr. Lerner is an associate professor of med- icine and public health at Columbia Univer- sity, New York.

Hornblum AM. They were cheap and avail- able: prisoners as research subjects in twenti- eth century America. BMJ 1997;315:1437-41.

Welsome E. The plutonium files: Ameri- ca’s secret medical experiments in the Cold War. New York: Delta, 1999:362-82.

Lederer SE. Subjected to science: human experimentation in America before the Sec- ond World War. Baltimore: Johns Hopkins University Press, 1995.

Harkness JM. Nuremberg and the issue of wartime experiments on US prisoners: the Green Committee. JAMA 1996;276:1672-5.

Subjects or Objects? Prisoners and Human Experimentation

The New England Journal of Medicine Downloaded from nejm.org at COLUMBIA UNIV HEALTH SCIENCES LIB on March 23, 2011. For personal use only. No other uses without permission.