Research in the Interest of Prisoners
Historical Context
Since the release of a Report by the Institute of Medicine in 2006, a great deal has been written about the egregious exploitation of prisoners as subjects in human research projects during the mid – to late 20th century. There can be no question that the Nazi regime engaged in shocking, inhumane studies which often culminated in the death of prisoners. But these offenses against humanity were not limited to the 1930’s and 40’s.
The United States government has conducted research that was both unethical and unconscionable when, in 1942 a Harvard biochemist 64 Massachusetts prisoners with cow blood in a study sponsored by the U.S. Navy. Between 1944 and 1946, more than 400 Illinois prisoners were used as test subjects in malaria experiments conducted by University of Chicago Medical School researchers. In 1950, some 200 female prisoners were injected with viral hepatitis in a University of Pennsylvania experiment, and two years later, Sloan-Kettering Institute researchers were sponsored by the National Institute of Health to study the effects of live cancer cells injected into Ohio State Prison.
But the horrors do not end there. In the 1960’s, the U.S. Atomic Energy Commission commissioned radiation studies on the male reproductive system. The testing consisted of irradiating hundreds of prisoners testicles with large doses of radiation. And similar high-dose radiation experiments were conducted through the mid- 70’s by states who used uniformed prisoners as subjects whose participation caused severe burns, testicular inflammation, painful biopsies and bleeding into the scrotum.
Preliminary Remedial Measures
This shameful history of callous disregard for basic human rights and the exploitation of vulnerable prisoners led to a host of formal actions aimed at the prohibition and criminalization of research that so grossly abuses human subjects. For instance, shortly after the Second World War, the Nuremburg Code, which, among other subjects, addressed ethical parameters involving research on prisoners, essentially proscribing it altogether because no person deprived of liberty was capable of providing informed, voluntary consent to participate in human subject research. By 1964, the Declaration of Helsinki (developed by the World Medical Association) addressed ethical considerations related to human research. In the United Sates, the National Research Act of 1974 commissioned a group of experts to study the issue and to make recommendations regarding the involvement of prisoners in research. In response, the “Belmont Report,” was published some five years later and provided the basis for regulations promulgated at 45 C.F.R. 46, “Regulations for the Protection of Human Subjects in Biomedical and Behavioral Research.” In 1978, Subpart C was adopted to provide special protections for prisoners involved in human subject research. However, the regulations, which apply only to research conducted using federal monies, have been adopted only by three agencies of government: the National Institute of Health (NIH), Central Intelligence Agency and Social Security Administration. Private organizations may voluntarily indicate an intention to comply with the regulations by filing a document known as a “federal wide assurance.”
Notwithstanding these fairly rigorous safeguards, continuing abuses have been decried by Professor Allen Hornblum, author of a 1998 book (“Acres of Skin”) that reported on research abuses at Holmesburg prison in Pennsylvania. Professor Hornblum described horrendous experiments conducted on prisoners that caused serious, lastly health problems. Similar abuses have been documented in Andrew Goliszek’s 2003 book, “In the Name of Science.”
The Existing Regime
Today, there are no regulations that apply to all prisoner research in this country, which has been a serious concern to ethicists, researchers, prisoners, and prisoner advocates, especially since the identification of human immune deficiency (HIV) and acquired immune deficiency syndrome (AIDS) in the mid- to late ‘80’s. The reader will recall that at that time there was no known treatment that was effective against either condition, and one diagnosed with the condition was under a virtual sentence of death. For prisoners, that was particularly so because research involving prisoners was either prohibited or so circumscribed as to be impracticable. Thus, some prisoners advocates, researchers, and health care providers argued that new regulations should be developed. Support for a review of governing research standards was supported by those who found the regulations, difficult to understand, impractical, and virtually impossible to apply in a correctional setting. Indeed, existing regulations (45 CFR 46) are rife with deficiencies, including the narrow scope of their applicability and significant changes in the correctional and social context for which they were designed
The subject is of significant importance and deserves serious discussion if prisoners are to directly receive the benefits offered by medical science. Thus, a special committee of the Department of Health and Human Services gave preliminary consideration to the issue. The Secretary’s Advisory Committee on Human Research Protections (SACHRP) issued a report in April, 2005 recommending that the office responsible for monitoring compliance with regulations at 45 C.F.R. 46 examine the issues more closely.
Considering a New Ethical Framework
Thus, the Office of Human Research Protections (OHRP) commissioned the Institute of Medicine to study “Ethical Considerations for Revisions to DHHS Regulations for the Protection of Prisoners Involved in Research.” Chaired by Attorney and Law Professor Lawrence O. Gostin, the committee was comprised of 16 doctors, lawyers, ethicists, correctional professionals, and scholars, supported by IOM staff, consultants, and expert panels: one of which included former prisoners and prisoner advocates, and another made up of correctional professionals, scientists, and research practitioners. The Committee was specifically charged to:
(1) consider whether the ethical bases for research with prisoners differ from those for research with nonprisoners, (2) develop an ethical framework for the conduct of research with prisoners, (3) based on the ethical framework developed, indentify considerations or safeguards necessary to ensure that research with prisoners is conducted ethically, and (4) identify issues and needs for future consideration and study.
Ethical Considerations for Research Involving Prisoners, Preface (National Academies of Science, Institute of Medicine 2006).
To briefly summarize the outcome of the committee’s examination, its report recommends permitting some research involving prisoners after the adoption of safeguards and protections commensurate with the confinement setting and the level of risk involved in the proposed research, but only with the consent of the prisoner.
Methodology
The committee began its task with a fact-finding process: surveying all the identifiable scientific literature (some studies involving prisoners make little or no reference to that fact and could be located only on a hit-or-miss basis), reviewing the work of previous committees, attending presentations by and taking testimony from various interested individuals and organizations, and conducting site visits at two prisons where dozens of prisoners and correctional authorities were interviewed.
The committee learned much. The existing regulations apply only to a few federal agencies and those private institutions that voluntarily adopt them. To the extent feasible, the regulations are enforced nationally by a four-person cadre of OHRP’s staff. Beyond the reach of these regulations (for example, research conducted by private entities), ethical concerns are left to researchers, themselves. Many studies are not governed by any rules and receive no independent review to assess the ethical propriety of the research. In short, the existing regime provides prisoners precious little protection.
The committee also discovered that there has never been a national repository of all research involving prisoners, and thus, there is no reliable basis upon which to quantify how many research projects have been completed or are in process, how many prisoners have been involved, what adverse incidents resulted, or what knowledge was gained through that research.
Changed Circumstances
The committee found exponential growth of the prison population has implications for ethical research. The prison population has increased almost fivefold since the ‘70’s. That explosion has been accompanied by a proliferation of dissimilar correctional settings, including probation, house-arrest, community service, half-way houses, boot camps, and traditional correctional facilities (from pretrial detention, to minimum custody work-release facilities, to the highly restrictive “super-max” prisons). Of about 7.5 million people under the supervision of the criminal justice system, only about 2.3 million are incarcerated in prisons or jails. The extent of governmental control exerted over a prisoner is correlative to the potential for coercion. Restrictions on privacy, liberty, and autonomy all bear upon the capacity of a prisoner to give meaningful consent to participate in human research, but existing regulations take no account of these divergent circumstances.
An increasingly disproportionate part of the prison population is comprised of women, racial minorities, people who suffer from mental illness, and those who suffer from communicable diseases. Many of these people traditionally have been underserved by our health care system. And correctional health care is woefully under-funded and too often ill-equipped to provide the kind of specialized treatment these populations require. Nor do these prisoners enjoy many of the benefits of medical research, especially for medical conditions prevalent among women or people of color (sickle-cell anemia, for example).
Thus, there has been a changing societal perception of the value of research; it imposes not only burdens and risks upon participants. Responsible research can also confer benefits, including the potential to improve the health and well-being of prisoners. (For example, during the late 1980’s when there was no effective treatment for HIV, the condition was terminal. The only chance to prolong life – experimental drugs developed through research – was a treatment regimen generally foreclosed to prisoners. Participation in research would have brought hope to infected prisoners and may have contributed to progress in treating the disease.)
The closed or opaque correctional setting has for years contributed to the mistreatment of prisoners and the ignorance of the public regarding the challenges and needs of correctional professionals. By opening the otherwise closed institutions of prisons and jails to outside researchers, operational transparency can only be improved and mutual understanding, fostered.
Recommendations in the Interest of Prisoners
During almost 18 months of deliberations, the committee formulated recommendations in the interest of prisoners. These recommendations are intended to strengthen and extend protections in a number of ways. One of the most important is a recommendation to expand the class of people protected by the regulations by redefining the term “prisoner” to encompass everyone enmeshed in the criminal justice system, thereby extending human subject protections beyond the prison gates to many more people. The committee further recommended a broader application of protective regulations so that they would apply to all prisoner research irrespective of private or public sponsorship or funding. (The existing regulations circumscribe only research conducted with federal funding.)
The IOM committee also called on Congress to create a comprehensive national database that tracks all studies involving prisoners, and further urged Congress to create a robust system of national oversight and enforcement. (OHRP reportedly had only four employees who worked to enforce existing regulations. Obviously, vastly greater resources must be invested if any regulations are to produce the intended effects.)
Existing regulations rest on narrowly defined and ambiguous research categories that are subject to varying interpretations. They are far from simple and easily understood, as anyone who has served on an Institutional Review Board can attest. The committee recommended a paradigm shift from that “categorical approach” to a “risk/benefit” analysis. Ethically permissible research must offer potential benefits to prisoners that outweigh the risks. With regard to virtually all biomedical research, no more than half of the research subjects may be prisoners – the remainder must be recruited from the general citizenry. This framework makes clear that prisoners will not be included in studies that the general public views as unduly risky, and studies offering no potential benefit to subjects would be precluded entirely.
Of course, voluntary and meaningful consent will continue to be a cornerstone requirement of ethical research involving human subjects. In the context of correctional settings, consent can be meaningful only where prisoners have reasonably prompt access to decent health care services (including medical, mental, and dental services) and are not otherwise coerced to participate (as for example, by offering incentives that might seem insignificant in the free world but have high value in prison). But members of Institutional Review Boards, no matter how well intentioned, and even with the benefit of input from a prisoner representative, may not fully appreciate the value of any inducement, other aspects of a particular study, or conditions at any particular correctional environment.
Different types of studies in varying correctional settings require a range of participant protections. For studies that involve little or no risk and the potential for some benefit where the participants are recruited from the public, a person living in a half-way house may be perfectly capable of offering valid and informed consent, requiring no special protection. For more intrusive studies, as well as those involving greater risk, and for those living in more restrictive conditions (e.g., “supermax” facilities) the committee recommended a panoply of safeguards, including continuous monitoring by a “prison research subject advocate” (PRSA) who has familiarity with the local correctional setting (but who is not an employee of the facility) to provide protection and assurance of the study’s legitimacy to the prisoner-subjects by maintaining close scrutiny of, and independence from researchers, correctional authorities, funding sources, or other factors that might endanger the welfare of prisoner-subjects or the validity of the study.
Conclusion
For many reasons, we all should care deeply about issues involving the health and welfare of prisoners, implementing appropriate measures to protect them from harm. Prisoners are family members, friends, and former (and future) neighbors. Most prisoners (about 95% of the population) will eventually return to our communities. (Nationally, more than 600,000 prisoners are released every year.) Prisoners are afflicted in greater percentages than the general population with maladies such as HIV, tuberculosis, and Hepatitis. Access to adequate health care and beneficial research minimize the risk that untreated conditions may spread and threaten the public health.
Recognizing these and other moral and social imperatives, the committee’s recommendations were intended to extend and strengthen protections for prisoners who choose to participate in potentially beneficial research, and to improve correctional health care, generally.
The recommendations have yet to be acted upon by the United States Congress, the U. S. Department of Health and Human Services, or even the Office of Human Research Protections. Perhaps the complexity of the recommendations and the expense of implementation will present insurmountable obstacles to new regulation or even an outright ban on prisoner research. The far more desirable outcome would be to ensure that prisoner participants in research are fully protected from exploitation, but have the opportunity to benefit from the advances that sometimes result from medical research.
Since research involving prisoners is presently being conducted in correctional settings across the country with little or no oversight, and without regulatory constraint; and in the absence of any reliable information about those studies, their protocols, adverse incidents, or outcomes, the adoption of regulations that impose reasonable requirements to protect human subjects is mandatory if we hope to ensure that all such research is conducted in a safe and ethical manner. The haunting specter of the past should propel the initiative forward.
Michael S. Hamden has practiced law for 23 years, the first 10 as a staff attorney with NORTH CAROLINA PRISONER LEGAL SERVICES, INC., as the Executive Director of that organization for 12 years, and now, in private practice as a consultant on corrections law and policy. Hamden is co-editor of The Law and Policy of Sentencing and Corrections (Lynn S. Branham & Michael S. Hamden)(7th ed. 2005). Hamden has also authored many articles and publications and has delivered presentations to a host of organizations and associations. A long-standing member of the American Bar Association, Hamden co-chaired the ABA’s Corrections and Sentencing Committee and presently serves on the Criminal Justice Section Counsel. As the ABA’s liaison to the American Correctional Association, Hamden served on the Standards Committee, as a Commissioner on Accreditation, and is an ACA Certified Accreditation Auditor. From 1995 forward, Hamden has served on 3 institutional review boards as the prisoner representative. From 2005 through 2006, Hamden served as a member of the Committee on Ethical Considerations for Research Involving Prisoners (National Academies of Science, Institute of Medicine). For additional information or to contact Mr. Hamden, visit www.HamdenConsulting.com.
