- Describe the "Dual Loyalty" problem in patient care, illustrated by corrections medicine practice.
- Examine tensions between obligations to society versus to the individual patient, and Report formal professional organization positions on the obligation to the patient
- Identify external resources relevant to training for corrections medicine.
- Explicate the bias physicians can develop upon learning undesirable components of the patient's social history.
- Discuss ways physicians can navigate the emotional challenges of care of the "undesirable patient"
- Report the current and historical legal requirements regarding adequate medical care of imprisoned persons in the United States.
Section 1: Dual Loyalty: Physician's Duties to Patients and Society
Section 2: Useful Social History? Or Intrusive Voyeurism?
Section 3: Physician's Emotional Responses to Undesirable Patients
Section 4: Historical Perspective on the Medical Rights of Prisoners
SECTION 1: Dual Loyalty: Physician's Duties to Patients and Society
Jeremy Graham MA DO FACP, Internal Medicine Residency Spokane, and Washington State University-Spokane
- Bennett, the physician of the story intentionally delivers adverse drug effects upon his patient: What motivates his action?
- What guidance exists regarding physicians obligation to individual patients, as versus the protection of a larger society?
- Bennett departs from the patient-care obligation to discuss truthfully the harms and benefits of a therapy with Mr. Masterson. What is known of physicians' knowledge, acceptance, and adherence to ethical standards of prisoners' care, as they are encoded by specialty societies?
- The physician of the story acts in the exam room as if his primary responsibility was (at least his perception of) the protection of a larger community. What other forces might similarly cause a physician to face conflict between service to the individual patient, and another interest?
- Certain diseases and health problems have become accepted as reasons to limit an individual's rights and liberties, in service of the greater society's needs.
- What are examples of these?
- What differentiates these sanctioned limits on individual freedoms, which have been accepted socially and legally, from the actions the young physician of the story exerted upon Masterson?
- What training or guidance materials are available for physicians confronted with the care of prisoners, and the special circumstances which emerge in their care?
- Specific to Medical Education, discuss: Do participants perceive Bennet to be moonlighting in the prison, or is he working there for a sanctioned resident activity?
- What governance applies to resident physicians working in this context, or n any situation outside of their residency program support systems?
- In this story, Bennett's practice in the prison is not described with any relationship to accessible supervision or support or colleagues. Is it acceptable for him to practice in this setting? At this stage of his career and training? At any future stage of his career and training?
- Is the prison population sufficiently different from other practice, that it warrants its own special training or preparation?
- How accessible is adequate health care known to be, for imprisoned persons? Is poor access to healthcare a legitimate feature of imprisonment? What ethical obligations exist, for clinicians to ensure their care is not an element of punishment?
BACKGROUND MATERIALS AND EXPLORATORY QUESTIONS:
Discussants have noted that " Opposing and competing obligations to third parties, such as employers, governments and insurers, often test the devotion that health professionals are required to give to their patients. Such conflicts are generally identified as "dual loyalty" issues because the health professional is torn between two different players which often have different or competing aims and objectives." (from http://phrtoolkits.org/toolkits/asylum-detention/background/dual-loyalty/ accessed May 25 2012)
EBM and Population Based Medicine: The growth of evidence-based medicine, married to the advocacy for best practices, and diagnostic and therapeutic algorithms aims to deliver the most cost-effective care (with varying degrees of successes and failures). These efforts intrinsically apply concepts such as pre-test probability and number-needed-to-treat, which describe population health, to make decisions about treating the individual patient at the bedside. Consider whether you have seen a time when an individual patient's needs diverge from the available evidence-basis?
Military medicine: Physicians in service of governments have long dealt with the ambivalence of serving both their individual patient and a larger operational capacity, for instance of a military service. In this context, individuals' liberties and lives are socially-legitimized as ultimately expendable in the interests of a larger entity. In some instances, the best interests of the patients' wellness might be in conflict with the service imperative to return a patient to his or her role as a soldier. In what ways does this compare and contrast with the rights and protections afforded to the disenfranchised and disempowered imprisoned person?
Physician participation in coercive treatment of prisoners and in capital punishment: Major medical societies as well as the AMA, hold ethical policies which preclude physician participation in selecting injection sites, placing IV access, delivering injections, order the drugs intended to end the prisoner's life, prescribe tranquilizers to the prisoner before execution or to use medications to subdue resistance, supervise the execution, monitor the prisoner during death, pronounce the person dead. Most positions approximate that of the World Medical Association, which posits that only certifying the person dead (that is, signing a death certificate) is an acceptable ethical role for a physician in capital punishment.
However, a survey of 413 responding physicians from the AMA master file found that among U.S. physicians, 41% would be willing to perform at least one prohibited action, 25% would perform a majority of the prohibited actions. More than a third (36%) stated they were willing to pronounce the person dead, and nearly one in five (19%) were willing to actually inject a lethal dose. Importantly, a strong correlate of willingness to violate these ethical conventions was physicians' perception "of a duty to society." The authors concluded that the medical profession had much more to learn about the ethical issues surrounding physicians' participation in capital punishment. (Farber NJ, Aboff BM, Weiner J, Davis EB, Boyer EG, and Ubel PA. "Physicians' Willingness to Participate in the Process of Lethal Injection for Capital Punishment" Annals of Internal Medicine v135, pp 884-888, 20 Nov 2001.)
In 2008, Marc Stern, MD MPH, resigned from the directorship of the Washington State prison health system, having learned that drugs for executions were obtained from his department's pharmacy. State officials refused physicians' request that the drugs not be obtained from a department intended to serve the health of the imprisoned persons. Dr Stern's resignation and similar controversies in California, Missouri, Georgia, and North Carolina in the years immediately before engendered a renewed discussion and disagreement. Ethicists and policymakers re-examined the boundaries between prison physicians' care roles and their intrinsic connection to punishment operations.
PROFESSIONAL SOCIETY ETHICS STATEMENTS ON PRISON MEDICINE:
The American College of Physicians Ethics Manual 6th Edition, specifically addresses the care of prisoners as a component of Physician and Society. The Ethics guidelines acknowledges the tension of the Dual Loyalty, and emphasize that the physician's ultimate responsibility is to the individual patient:
Physicians must not be a party to and must speak out against torture or other abuses of human rights. Participation by physicians in the execution of prisoners except to certify death is unethical. Under no circumstances is it ethical for a physician to be used as an instrument of government to weaken the physical or mental resistance of a human being, nor should a physician participate in or tolerate cruel or unusual punishment or disciplinary activities beyond those permitted by the United Nations' Standard Minimum Rules for the Treatment of Prisoners.
Physicians must not conduct, participate in, monitor, or be present at interrogations (defined as a systematic effort to procure information useful to the purposes of the interrogator by direct questioning of a person under the control of the questioner; it is distinct from questioning to assess the medical condition or mental status of an individual) or participate in developing or evaluating interrogation strategies or techniques. A physician who becomes aware of abusive or coercive practices has a duty to report those practices to the appropriate authorities and advocate for necessary medical care. Exploiting, sharing, or using medical information from any source for interrogation purposes is unethical.
Limited access to health care is one of the most important characteristics of correctional systems in the United States. Physicians who treat prisoners as patients face special challenges in balancing the best interests of the patient with those of the correctional system. Despite these limitations, physicians should advocate for timely treatment and make independent medical judgments about what constitutes appropriate care for individual inmates.
TRAINING NEEDS AND RESIDENT PHYSICIANS AS PRISON PHYSICIANS:
Balance between resident physicians' autonomy and their supervisory and support needs has shifted over recent decades. Current ACGME guidelines mandate both limitations of hours, and appropriately-accessible attending faculty support, review of practice actions, and feedback
In past decades, resident physicians moonlighting outside of work was common; the hours spent were not accounted for or accommodated in residency programming. If moonlighting, Bennet's role at the prison would not necessarily supervised in the current era, but would be subject to hours limitations. Although indirectly, an outside work setting would be monitored by a residency program for the impact of outside work upon his fatigue, well-being and education progress.
Similarly, historical traditions of nearly-unsupervised resident practice have shifted in recent years to a wide recognition of greater need for academic support, personal support, and adequate supervision of medical actions and decision-making. If his care of Masterson is part of an official residency operation, Bennett's patient-care (and professionalism) in the prison setting would be reviewed by attending faculty, through this supervision would not necessarily be physically on-site during all patient visits.
In the current story, there's no evidence reported of any collegial or supervisory presence in Bennett's prison work, and the isolation and lack of support is perhaps an ingredient in his delivery of problematic medical care and the ethical difficulties he faces.
Further Discussion: Resident physicians treating the general population receive both support and supervision; these are regarded as necessary elements to provide quality care. Is practice upon prison populations (or other vulnerable groups) by not -yet-trained physicians appropriate?
SELECTED / ANNOTATED BIBLIOGRAPHY
Br Med J (Clin Res Ed). 1984 March 10; 288(6419): 781–783.PMCID: PMC1444628 Prison doctors: ethics, invisibility, and quality R Smith. An older but lucid discussion of the longstanding ethical conflicts encountered by physicians who care for imprisoned persons.
When Law and Ethics Collide- Why Physicians Participate in Executions Atul Gawande, M.D., M.P.H. N Engl J Med 2006; 354:1221-1229 March 23, 2006 A physician-journalist's brief history and the current status of physicians' role in capital punishment, with narrative interviews of some involved physicians.
United Nations. First Congress on the Prevention of Crime and the Treatment of Offenders. Standard Minimum Rules for the Treatment of Prisoners. 1955. Accessed at www2.ohchr.org/english/law/pdf/treatmentprisoners.pdf on May 15 2012
The foundational global standards for the treatment of imprisoned persons. National Commission on Correctional Health Care. Charging inmates a fee for health care services. 1996; reaffirmed 2005. Accessed at www.ncchc.org/resources/statements/healthfees.html on May 15 2012. A review and discussion of the widespread inadequacy to access to care for the imprisoned, the ethical imperatives to provide fundamental medical care to the imprisoned person, and the limits on requiring the disempowered to facilitate their own medical care.
Farber NJ, Aboff BM, Weiner J, Davis EB, Boyer EG, and Ubel PA. Physicians' Willingness to Participate in the Process of Lethal Injection for Capital Punishment. Annals of Internal Medicine v135, pp 884-888, 20 Nov 2001. Article cited in discussion above regarding US physician's perspectives on participation in capital punishment, as is prohibited by major professional organization standards.
Thorburn, Kim. May;134(5):457-61.Croaker's dilemma--should prison physicians serve prisons or prisoners? PMID:7257360. An early and robust discussion of whether prison medical care is to be regarded as a part of the punishment process or as care of individual persons.
http://www.ama-assn.org/amednews/2009/02/09/prsc0209.htm A medical news review of the 2008 resignation of Washington State's chief of prison medicine and the ensuing and related controversies regarding physician participation in delivering punishment as contrasted with delivering care. Access June 20, 2012
http://www.acpinternist.org/archives/1999/07/prisonmed.htm "Once the practice of last resort, prison medicine rebuilds it image". A medical news discussion of the changing role of prison practice into a more recognized and supported practice area. An interview with an ACP fellow working in a large prison highlights improvements in the practice life of prison physicians, as well as concerns for future developments in the commercial relationships in both medical care and corrections operations.
INTERNET AND WEB EDUCATION RESOURCES FOR CLINICIANS WORKING IN CORRECTIONS MEDICINE
http://www.wma.net/en/20activities/20humanrights/30doctorsprison/ The World Medical Associations' accredited course on the ethical work of physicians in prison settings. Delivered in conjunction with the Norwegian Medical Association.
http://phrtoolkits.org/toolkits/asylum-detention/background/dual-loyalty/ A human-rights oriented discussion and resource set regarding the "Dual Loyalty" problem physicians may face in serving both a social agency, and their individual patient. Examines the problem physicians may encounter from a perspective of serving the primary goal of individual rights
http://www.unodc.org/documents/balticstates/EventsPresentations/FinalConf_24-25Mar11/Pont_25_March.pdf A current presentation from The United Nations Organization on Drugs and Crime on the global standards for ethics in the medical care of prisoners, as delivered by Jorg Pont in Vienna.
RELATED HUMANITIES RESOURCES
Vettese, TE. Judgment. [On Being a Doctor] Annals of Internal Medicine 21 August 2012;157(4):296-29. (Audio)
A teaching physician confronts the inner dilemmas and social burdens of caring for prisoners, in personal essay published 15 years after "The Prison Patient."
Prison Terminal. [FILM] Online at: http://www.prisonterminal.com/resources.html . A 2012 documentary film about a single one of the 3000 persons annually who die in US prisons, and an end-of-life hospice care program in a maximum-seciurity prison. Educational resources and discussion guides are made available at the film-makers'
SECTION 2 : USEFUL SOCIAL HISTORY? OR INTRUSIVE VOYEURISM?
Darryl Potyk MD FACP, Internal Medicine Residency Spokane
Should the prison physician have known or had access to the events that lead to his patient's incarceration?
Rephrasing the question; should this be part of the social history for incarcerated patients?
Some prisons forbid the medical staff from knowing the crimes that their patients have been accused of. (Mental health providers in the referenced facility are exempted from this restriction)
Was Bennett's reaction to his patient a result of a flawed individual reacting on an emotional level?
Was this an abuse of the power? Was it right to try to further frighten the patient?
Was Bennett being misleading? Were Bennett's actions noble and was he acting to protect others?
Framing the arguments:
Physicians in prisons should not have access to this information.
Not having access to this information simplifies the ethical dilemma. Not knowing the allegations or crimes their patients are accused of allows the medical provider to offer nonbiased care to the patient. Implicit in this position is that physicians cannot or should not be trusted with certain information. If we have this information will we be capable of providing the care that each individual deserves, that is the best care possible? We are human and prone to making human errors and judgments, having this knowledge will put us at risk of making judgments about our patients that could compromise their care or influence the way they are treated as was the case in the story presented. To say that we should have access to this information and that we are well enough trained to avoid making judgments is a tremendous ideal for our profession. At the same time, it fails to acknowledge that we are all prone to our individual flaws and that our views can become contaminated. It is easy to say that as physicians we will not make these judgments, but a parallel example with good data already exists, that is the influence of pharmaceutical representatives on the prescribing habits of physicians. Even those who state that they are not influenced have been shown to have altered their prescribing habits. Not only do we all have subconscious biases that affect our behavior, at times these biases are not recognized and acknowledged.
Another concern about having access to the reasons for a prisoners' incarceration pertains to how good this information is. While we want to have faith in our justice system, there have been an increasing number of highly publicized cases in which it was revealed either through DNA evidence or recanting of stories that someone has been wrongly imprisoned. In these highly publicized cases, the prisoner has been exonerated and released. If we acknowledge our inherent, that is our human, susceptibility to biases and the untoward effects these biases can have on patient care, we should not risk compromising the care of our patients based upon data that may be unreliable.
For these reasons, prison physicians should not have access to or seek to find out the crimes their patients have been accused of. Some may argue that this approach is too simplistic and that it simply represents "putting our heads in the sand." On the contrary, such an approach acknowledges our own human flaws and allows physicians to serve those whose care they have been entrusted with and to care for those individuals without judgment regarding the circumstances that lead them to be incarcerated. This approach focuses on solely what is best for the patient and the physician is not in a position of making societal value judgments. This is not the role of the physician but is for the legal system and the courts to decide. Our job is to offer the patient in front of us the best possible care.
Note that his argument is predicated upon the provision of adequate safety for the health care team. Much like universal precautions for blood borne pathogens, safety precautions in the prison infirmary should be universally applied.
Physicians in prisons need to have access to this information.
Having access to this information allows the provider to put the care in the broader context – what is best for the patient and best for society at the same time. At times there can be a tension between population medicine and individual care – balancing the needs of the individual in front of us in the examination room with those of a larger sphere. This is part of our daily work and we are all familiar with these decisions. Examples include antibiotic stewardship and prudent prescribing in order to minimize antibiotic resistance in the community, denying driving privileges to those with dementia or a seizure disorder and even mandated directly observed therapy for patients infected with mycobacterium tuberculosis who are deemed to be unreliable. In each of these instances, we are advocating both for our patient and the society in which we practice and reside to the benefit of both.
In order to truly care for these individuals and ensure that we offer comprehensive primary care, we need to know the context in which our care is being delivered. Having comprehensive knowledge about the patient enables the physician to make better decisions about diagnostic and therapeutic interventions. Only by knowing our patients can we truly care for them and tailor our care to their needs.
Some patients may try to exploit the prison's medical staff and infirmary with a multitude of complaints, requests for specific medications and dietary issues. It is important to know the context in which these requests are being made – both in terms of the patient's medical problems, the social situation and conditions within the prison all of which are contingent upon the reason for incarceration. Without this knowledge, prison physicians risk practicing medicine in a vacuum. The consequences of practicing in a vacuum range from non-adherence to taking advantage of the medical system. There is a distinct hierarchy and culture within our prison system. Subcultures exist along the lines of gangs, race, crimes – and knowing about these issues, all of which can affect the healthcare we deliver, can be viewed as providing culturally competent care.
Lastly, only with full knowledge of the reason for incarceration can the medical providers take necessary precautions in order to ensure their own safety when caring for prisoners.
The importance of the social history.
Another way to reframe this question is how relevant the social history is or should be. Generally we think of social history as being important in helping us not only getting to know our patients but helping to deliver relevant care. As we shift towards patient centered care, we need to know about them but also know them. But is it possible to know too much? This question is increasingly being asked in our world of information overload and ready access to computerized information of all types. Yet we rarely if ever think that we know too much about our patient. Are there other instances in which we choose to not know certain information? There is some information that may be irrelevant but rarely do we choose to ignore information.
SECTION 3 : PHYSICIANS' EMOTIONAL RESPONSES TO UNDESIRABLE PATIENTS
Judy Swanson, MD; Internal Medicine Residency Spokane Faculty Group
- When a physician has a negative emotional response to a patient, whether it is a patient who engages in socially offensive interactions, criminal behaviors or is just a "difficult" patient, the consequences can affect both the patient and the physician. What are some of the behaviors which can arise out of this situation?
- Considerations as a Physician:
Stepping back into the role of the professional and failure to achieve empathy in the patient-doctor relationship. This is a self-protective strategy on the part of the physician which allows for the cognitive care of the patient's disease process. However, it fails to recognize that each patient is an individual. One needs to treat the whole person, and try to understand what led to the label as a difficult patient in the first place. Can you truly achieve a physician-patient relationship if you close off your emotions? Do we deprive ourselves and our patients of a depth of experience if we disengage emotions, and does this disengagement with one patient start affecting other relationship?
- Considerations as a patient:
The patient is morally judged by the physician, which can negatively impact the patient's care. How can the patient break out of behavioral patterns, knowing they are being looked down on? The disease can be seen as "their own fault" by physicians, and that they don't deserve the same level of care that would be given to a patient of a loving and supportive middle class family. The physician's attitude can affect the staff that is also caring for the patient. The organization's attitude can also affect the care of the patient. If a patient feels that he might be judged, he may not seek medical care.
- How much does scarcity of time affect the physician's response to an undesirable patient? The undesirable patient is typically seen as a "time hog" and to be avoided in a busy day. If Bennett had more time to talk with the patient, and develop an understanding of the forces behind the patient's criminal behavior (suppose the patient had a history of being molested that had come up in previous encounters?), could that have influenced his reaction? Does one need time in order to build empathy?
- It is easy to understand the emotional response brought on by the patient's history of being a child rapist; disgust, anger and horror being common reactions. One of the categories of undesirable patients that can elicit similar but less intense responses is that of the obese patient, where the failure to lose weight is perceived by both physician and patient as a moral failure. If you examine your reaction to the patient i.e. the physician is self aware of their reaction, does it make it easier to treat the patient or does it not matter?
- Bennett had an obvious physical and emotional reaction to the patient. Is there such a thing as PTSD for a physician after being involved in encounters with undesirable patients? You have just spent an hour with a drug-seeking patient and the encounter has gone badly. You dread working with your next drug-seeking patient and start trying to avoid encounters with them. This can lead to easy way outs such as giving in and prescribing them medicine, not return phone calls and cursory appointments where your hand is on the door the entire time. What might be some coping strategies for you when encountering this situation?
Further discussion: perhaps looking at why the situation is so painful might help. Physicians can be perfectionists and a patient that continually fails to get better with can lead to emotional avoidance of the situation. Perhaps changing your expectations of the patient might improve your encounter.
- Undesirable patients are those who do not live up to our expectations of the physician patient relationship. We expect the patient to trust us, but it is a two way street and we also build up expectations that the patient will respond in a certain way to our attempts to help them. In order to achieve the ideal relationship, do we need to give up our expectations of trusting our undesirable patients to respond in a certain way?
NAVIGATING EMOTIONAL BURDENS OF PATIENT CARE:
RESOURCES FOR STUDENTS, RESIDENT PHYSICIANS, AND IN PRACTICE:
Anger or judgmental response toward a patient can be a sign of burnout or compassion fatigue. Trying to overcome these reactions alone can lead to a circular path with no improvement for either you or the patient.
"In no relationship is the physician more often derelict than in his duty to himself."
-Wm. Osler, in Dr Johnston as a Physician, Washington Med Ann 1902;1:158-61.
Well-being and self care are themselves legitimate professional needs. It is frequently appropriate to utilize supportive resources. Specific resources vary by institution. However JCAHO has mandated that each hospital have an ongoing wellbeing program for physicians which include residents.
For residents, the residency office and your faculty advisor should be a source of support information. The medical staff office at your hospital provide resources to you. County or state medical associations maintain physician well-being committees and resources.
Teaching physicians and administrative physicians should familiarize themselves with their community and program resources to facilitate referral and access for colleagues and trainees .
Find a mentor or colleague with whom to talk is invaluable in medicine. Sometimes, your peers and colleagues already have informal discussion groups set up that help address these situations.
Knowing that you one's feelings towards a patient or problem are a human fact, and can be steps towards improving the physician-patient relationship.
Hill, Terry. How clinicians make (or avoid) moral judgments of patients: implications of the evidence for relationships and research. Philos Ethics Humanit Med. 2010; 5: 11.
Groves, James E. Taking Care of the Hateful Patient. NEngl J med 1978;298:883-887
Gorlin, R. Physicians' reactions to patients. A key to teaching humanistic medicine. NEngl J med 1983; 308: 1059 – 1063.
ADDITIONAL HUMANITIES RESOURCES
Hugo, V. Les Misérables (1862)
SECTION 4: HISTORICAL PERSPECTIVES ON THE MEDICAL RIGHTS OF PRISONERS
Rachel P Safran MD, Internal Medicine Residency Spokane
- The provider-patient power dynamic can change based on many variables and is often taken for granted –Bennett was "impressed by his own unexpected power and by the transparency of Masterson's soul." What practices inform a unique power differential, when treating prisoners?
- knowledge of the crime committed
- societal designation of inmates as "undesirable" (discussed elsewhere)
- limited choice of provider, particularly given movement restrictions
- presence of custody officials and restrictive clothing/cuffs
- Although the physician in the story is undoubtedly providing medical care to Masterson, does his conduct meet the legal standard of care?
There is substantial case law supporting prisoners' rights to access adequate health care while incarcerated, unfortunately there is little consensus as to what qualifies as "adequate" or if providing what some consider a bare minimum is truly ethical regardless of being legal. One could argue that the patient in this story's complaints about erectile dysfunction do not qualify as "serious" health concerns, and, therefore, the physician is excused from any negligence. It is not uncommon for physicians to feel the benefits outweigh the risks of a given treatment and use their position of authority to persuade a patient to comply without thoroughly considering the patient's preferences. Unfortunately, the dynamic between provider and patient in this story is particularly concerning given the physician's personal feelings towards the patient's sexuality.
Thirty Years After Estelle v. Gamble: A Legal Retrospective J Correct Health Care January 2008 14: 11-20
- The Supreme Court held Estelle v. Gamble held that the 8th Amendment required the federal government, and through the 14th Amendment the states, to provide medical care to prisoners. The court established a two-pronged test to determine an "adequate" standard of care. The test holds that a prisoners' right is violated if: 1) prison officials manifest "deliberate indifference" to prisoners' medical needs and 2) those medical needs are "serious". Accordingly, the test excludes negligence and "deliberate indifference" to medical needs that fall short of being "serious".
- Plata vs. Scharzenegger was the largest ever prison class action civil rights lawsuit where prisoners alleged that the California Department of Corrections and Rehabilitation (CDCR) inflicted cruel and unusual punishment by being deliberately indifferent to serious medical needs. The plaintiffs and defendants negotiated a stipulation for injunctive relief, which the court approved requiring defendants to provide "only the minimum level of medical care required under the 8th Amendment." An evidentiary hearing revealed the persistence of sub-adequate and "appalling" conditions. The CDCR was ultimately held in civil contempt and the medical health care system was placed in receivership.
- As the field of medicine evolves, so does the practice of how medical research is performed. The story presented in "The Prison Patient" asks us to think about the struggle to provide high quality health care for prisoners, but it is important not to forget about the possibility of providing intentionally poor quality care in the name of intellectual curiosity. What is the history of medical research in prisons?
From 1913 to 1951, Dr. Leo Stanley, performed a wide variety of experiments on hundreds of prisoners at San Quentin. Many of the experiments involved testicular implants, including attempts to implant the testicles of rams, goats, and boars into living prisoners. In the 1940s, hundreds of Illinois prisoners were submitted to experimental cases of malaria as medical researchers attempted to find more effective means to prevent and cure tropical diseases that ravaged Allied troops in the Pacific after WWII. Researchers employed prisoners as subjects in a multitude of experiments that ranged in purpose from a discovering the cause of cancer to testing the effects of a new cosmetic. After the FDA's restructuring of drug-testing regulations in 1962, prisoners became almost the exclusive subjects in non-federally funded Phase I pharmaceutical trials designed to test the toxicity of new drugs. By 1972, FDA officials estimated that more than 90 percent of all investigational drugs were first tested on prisoners. In 1950, Dr. Joseph Stokes of the University of Pennsylvania deliberately infected 200 female prisoners with viral hepatitis. And the abuses were not limited to US soil as evidenced by experiments where US government doctors intentionally infected prisoners in Guatemala with syphilis in the 1940s for research purposes.
"Procedures Used at Stateville Penitentiary for the Testing of Potential Antimalarial Agents," Journal of Clinical Investigation 27, no. 3 (part 2) (1948): 2-5
Aileen Adams and Geoffrey Cowan, "The Human Guinea Pig: How We Test New Drugs," World (5 December 1971): 20.
"Guatemala syphilis experiments in 1940s called 'chillingly egregious'";.
Hornblum, Allen. "Acres of Skin: Human Experiments at Holmesburg Prison : a True Story of Abuse and Exploitation in the Name of Medical Science." Psychology Press, 1999.
Washington, Harriet. "Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present." Random House Digital, Inc., 2006.
Ethical Considerations for Research Involving Prisoners. Washington (DC): National Academies Press (US); 2007. (Ch. 2: Today's Prisoners: Changing Demographics, Health Issues, and the Current Research Environment).
- How have medical research regulations changed to protect incarcerated patients?
Prisoners are considered vulnerable research subjects, because of the restrictive institutional environment. Because they have little opportunity to making meaningful choices, their autonomy is deemed limited. According to current Human Health and Services guidelines prisoners may only participate in certain categories of research. Additionally, special precautions are mandated to ensure that their consent to participate in said research is "genuinely knowing and voluntary."
Permissible categories for research involving prisoners:
- the exemptions that generally apply to certain types of research involving human subjects do not apply to research involving prisoners;
- in order to approve research involving prisoners, the IRB must find that the proposed research falls into one of the permissible categories of research;
- the institution must certify to the Office for Human Research Protections that an IRB has reviewed the proposal;
- the IRB must include a prisoner or prisoner representative, and meet a membership requirement concerning the number of IRB members not associated with a prison involved in the research; and
- Secretarial waiver of informed consent in certain emergency research is not applicable to research involving prisoners.
- If the study presents no more than minimal risk and no more than inconvenience to the subjects:
- Research on conditions particularly affecting prisoners as a class (e.g. Hepatitis vaccine trials)
- Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.
- Study of prisons as institutional structures or of prisoners as incarcerated persons.
- Research on practices which have the intent and reasonable probability of improving the health or well-being of the subject
An IRB must make seven additional findings in order to approve research involving prisoners:
- The research under review represents one of the categories of research permissible mentioned above;
- Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of receiving such advantages in the limited-choice prison environment is impaired;
- The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
- Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners;
- The information is presented in language that is understandable to the subject population;
- Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and
- Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.