HIV Clinical Trials in Correctional Settings: Right or Retrogression?

Anne S. De Groot, MD; Joe Bick, MD; David Thomas, MD; Elizabeth Stubblefield

Disclosures

AIDS Read. 2001;11(1) 

In This Article

Abstract and Introduction

The right of incarcerated prison and jail inmates to health care is protected by the 8th and the 14th amendments of the Constitution, respectively. Does the right to health care include access to clinical trials? At the time of this writing, clinical trials have become part of the fabric of HIV/AIDS care, allowing patients to participate in studies of new and often lifesaving treatments. Participation in trials can also be dangerous, as illustrated by the recent death of a subject in a gene therapy trial. This danger is compounded by ethical dilemmas that can arise from the large amount of financial support for clinical trials (greater than 75%) that is derived from for-profit corporations. Indeed, clinical trials are the subject of grave concern on the part of the United States Government, which has recently taken steps to shore up human subject safeguards. Following a conference on the conduct of clinical trials in correctional settings, the Office for Human Research Protections suspended prison research conducted by 4 prestigious academic institutions.

Inmates and pretrial detainees residing in correctional institutions in the United States are protected from deliberate indifference to their health care needs by the 8th and 14th amendments of the Constitution. Paraphrased, these amendments state that the denial of liberty is sufficient punishment for a crime, and correctional institutions and their employees are prohibited from denying prisoners (and detainees who have not been sentenced) access to health care. Although access to health care is ensured, the courts continue to debate how much health care inmates are entitled to. In recent years, clinical research trials have become part of the fabric of medical care, allowing patients to participate in studies of new and often lifesaving treatments. This is especially so for HIV infection, a disease that disproportionately affects inmates as a class.[1] Some inmates and correctional health care advocates are eager to affirm prisoners' rights to participate in clinical trials. They point to studies that have demonstrated that participation in clinical trials has been associated with improved health care, and prolongation of health, for some participants depending on their disease.[2,3] Clinical trial researchers (trialists) based in academic institutions and pharmaceutical companies may also wish to gain access to this population of potential study subjects for less altruistic reasons. Prisoners typically have a closely regimented schedule and, by virtue of direct administration of medications, have demonstrated a degree of medication adherence far higher than that documented in the "outside world."[4,5] Others have voiced concern, citing the Nuremberg trials, the Tuskegee study, the Belmont report, and the Helsinki declaration in their efforts to protect inmates from potential abuse by clinical trialists.[6,7]

Certain facts are inescapable. As a result of changes in sentencing, the number of incarcerated persons with histories of injection drug use has increased in the past 2 decades, leading to a dramatic change in the types of illnesses affecting prison inmates. On average, 2 of every 100 inmates in the United States are living with HIV infection.[8] The prevalence of HIV infection is even higher among inmates of prisons and jails in the Northeastern United States, ranging between 1 in 10 to 1 in 4 incarcerated persons. The prevalence of hepatitis C virus (HCV) infection is also very high among incarcerated persons, reaching 40% of the inmates in some states[9,10] (S. Ostrawski, personal communication, May 1999). Recent analyses suggest that almost one quarter of this nation's population of HIV-infected persons and one third of the nation's population of HCV-infected persons pass through prisons and jails (Figures 1 and 2).[11] Prisoners are now disproportionately affected by HIV (as well as HCV infection and tuberculosis) as a class, satisfying at least 1 of the requirements for the conduct of clinical trials in a correctional setting (Table 1).

Medical conditions that disproportionately affect inmates as a class. Data shown for number of infected jail and prison releasees in 1997. From Hammett et al. 1999.[11] Prepared for the National Commission on Correctional Health Care-National Institute of Justice "Health Status of Soon-to-Be-Released Inmates" Project.

Number of releasees with HIV infection or AIDS in 1997, compared with total number of patients living with HIV in the United States. Data from Hammett et al. 1999.[11] Prepared for the National Commission on Correctional Health Care-National Institute of Justice "Health Status of Soon-to-Be-Released Inmates" Project.

Physicians, nurses, and health professionals who provide care to inmates work in a health care environment unlike any other. Disparity between the conflicting missions of medicine (to help and heal) and security (to confine and correct) is characteristic of clinical practice in prisons and jails.[12,13] Health care providers must endeavor to treat illness, console the afflicted, and advocate for access to health care in a setting that by design restricts autonomy and acts to reduce access to health care options that exceed the minimal standard of care. Biomedical research that takes place in correctional settings must do so within this context.[14]

The presence of so many HIV-infected prisoners in US correctional systems requires researchers and clinicians to reconsider how research regulations, originally intended to protect prisoners, might negatively affect access to new life-sustaining AIDS treatments in prisons.[15,16,17] These regulations should inhibit the introduction of clinical trials in settings where study subjects do not have sufficient autonomy or have limited ability to make a fully informed choice or where deprivations associated with the setting may introduce an element of coercion if a trial is initiated. Specifically, the Nuremberg consent clause states that a research subject "should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion."[18] However, setting the barrier to clinical trials in correctional facilities too high could impair inmate access to new HIV/AIDS treatments, arguably denying inmates their right to a constitutionally protected level of health care. It is, therefore, essential to establish a legal and moral framework for the ethical conduct of clinical research in some correctional settings.

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