The ethics of research involving prisoners

A recent article in Medical News Today about whether Canadian prisoners should be paid to participate in research started me thinking about whether prisoners should be research subjects at all. One of the basic requirements for ethical research on human subjects is the freely given informed consent of the participants. Being a prisoner puts a person in conditions that make it very difficult to assure that the prisoner is able to make a truly voluntary and uncoerced decision about being a research subject. Adding a financial incentive as is discussed in the article could make it more difficult to be sure that a free and uncoerced decision was being made.

To help in thinking about whether any research with prisoners are subject should be allowed, I decided to look into the current US regulations regarding the use of prisoners as research subjects. The regulations of the National Institutes of Health and the Department of Health and Human Services are quite clear on what type of research is allowed when prisoners are the research subjects. The biggest concern is that prisoners might be coerced into being subjects in research that those who were not prisoners would not agree to participate in. The US federal regulations have addressed this by restricting research involving prisoners to include only research from which prisoners will benefit. This avoids prisoners being exploited for the benefit of others in society. The types of research that are allowed include research on the causes and effects of incarceration, studies of prisons as institutional structures and how that affects prisoners, research on conditions particularly affecting prisoners as a class, and research which has the intent of improving the health of the individual subject. The first two categories involve research on the penal system itself which could not be done without involving prisoners and should lead to benefits to prisoners from improvements in the penal system. The third seeks to improve the health of prisoners as a group, and the fourth seeks to improve the health of the individual prisoner who is a participant. Limiting research on prisoners to these categories greatly reduces the concern about exploiting prisoners for the benefit of others.

When we return back to the issue of paying prisoners to participate in research it makes a significant difference what type of research is being considered. The biggest problem with financial compensation of research subjects is the use of that compensation to coerce prisoners into agreeing to be subjects in research they will not benefit from and which others would not agree to participate in. Restriction of the research on prisoners to the categories currently allowed in the US eliminates that problem to a very large degree. Compensation of prisoners who volunteered to participate in research about the penal system would be appropriate to be compensated on an equal level with other activities that prisoners do which benefit the prison system as a whole. Compensation for participation in research designed to improve the health of the prison population as a whole can be seen to be appropriate as long as the risks are adequately controlled. Compensation would not be expected to be needed when the research was being done to benefit the individual prisoner. I do not know whether Canada has the same restrictions on what research can be done using prisoners as subjects, but if the restrictions are similar to those in the US it would seem that compensation of prisoners for participation in those limited types of research would not pose a significant ethical problem.

What the German Medical Association declaration has to teach us about codes of medical ethics


“The human rights violations perpetrated in the name of medicine under the Nazi regime continue to have repercussions to this day and raise questions concerning the way in which physicians perceive themselves, their professional behavior, and medical ethics.”  – The Nuremberg Declaration of the German Medical Association 2012


65 years ago this month the Doctors Trial concluded in Nuremberg, Germany. Sixteen Nazi physicians were found guilty of organizing and participating in crimes against humanity, including ghastly experiments performed on concentration camp prisoners without their consent. Earlier this summer, the German Medical Association (GMA) admitted that not just the doctors on trial but the whole German medical establishment, its leadership, and its most renowned researchers were responsible for the atrocities committed. “In contrast to still widely accepted views, the initiative for the most serious human rights violations did not originate from the political authorities at the time, but rather from physicians themselves,” according to the GMA statement.

Most sobering is that the German doctors thought that they were practicing ethical, Hippocratic medicine.  Their perception of themselves — doctors of the Nazi state rather than individual patients — coupled with their perception that  certain people contributed to the poor health of the state — Jews, Roma, the disabled — led them to do terrible things in the name of Hippocratic medicine.

The apparent breakdown in the millenia-old Hippocratic ethos led to the elaboration of the Declaration of Geneva to reinforce the humanitarian goals of medicine, and the Nuremberg code to protect human subjects of research. But if the example of the Nazi physicians teaches us anything, it is that neither Hippocrates, Nuremberg, Geneva, nor any other code of medical ethics can protect us if we do not acknowledge the basic human dignity inherent in all human beings. As witness, the original Declaration of Geneva reads, “I will maintain the utmost respect for human life, from the time of its conception . . .” The current version has been shortened to, “I will maintain the utmost respect for human life.” It is not difficult to see which class of humans has been quietly removed from the protections of the Declaration.

Is the AMA in danger of committing the same crimes as those for which the GMA has recently admitted responsibility? Are there some humans whose human dignity we have decided not to acknowledge? No, we don’t practice eugenic sterilization; but we do practice prenatal genetic screening and perform eugenic abortion. No, we don’t declare a “Life not worth living,” but we implicitly (and explicitly) use the calculus of “Quality of Life” as we make ethical decisions. No, we don’t do horrific experiments on prisoners; but we do experiment on the youngest and weakest of our species, our own embryos. And we do it all in the name of practicing good, ethical, humanitarian, Hippocratic medicine.

Some have declared in recent years that the concept of “human dignity” is useless in medical ethics. The GMA declaration shows us that, to the contrary, codes of medical ethics are useless without a robust concept of human dignity.

ICDs: Autonomy vs. Beneficence

Implantable cardioverter-defibrillators (ICDs) are like the automatic external defibrillators (AEDs) that you see everywhere these days. They deliver a shock to a heart in a lethal rhythm in order to try to restore the heart to a normal rhythm. Unlike AEDs, however, ICDs are implanted directly on a patient’s heart, are constantly monitoring it, and automatically deliver life-saving shocks whenever needed. The statistics are quite clear for patients with symptomatic heart failure in certain conditions: ICDs prevent mortality from sudden cardiac death (SCD), and are the sole effective therapy for prevention and treatment of lethal heart rhythms. And in a recent study in the Archives of Internal Medicine, more than half of doctors were so convinced by the statistical mortality benefit of ICDs that they valued the statistics more than patient preferences in making decisions about ICD placement.

On the one hand, this could be a good thing: here are a bunch of doctors who want to do what is best for their patients (the principle of beneficence). And if there were no downsides to ICDs, maybe it would be less problematic. But for many patients, the tradeoff for decreased mortality from SCD is dying instead from progressively increasing symptoms of heart failure. There are perfectly reasonable patients who, given the choice between the increased chance of a sudden death and the increased chance of a protracted death from heart failure, would choose the former (exercising the principle of autonomy); but if physicians are so enchanted by their gizmos and their ability to postpone mortality that they don’t elicit patients’ preferences — or don’t inform them of the options — then a lot of patients may be getting procedures that they would not want if they knew the full risks and benefits.

Medical technique and technology have come in the last century to wield great power. That power must be exercised with the utmost care, and with the utmost respect for persons and their inherent dignity. Our love for gizmos and all things high-tech blinds us to the fact that all techniques and technologies have unintended and unforeseen side effects. And our love for empirical, statistical data blinds us to the fact that statistics tell us exactly nothing about the person in front of us. Careful exercise of medical power requires that medical practitioners treat their patients not as part of a statistical herd but as individuals, eliciting their individual values and preferences. In many instances in modern American medicine, autonomy has been elevated too highly and led to questionable practices or to medical practitioners abdicating their duties as moral decision-makers; but the remedy for runaway autonomy does not lie in a return to a paternalism in which a doctor makes all of the decisions for a passive patient.

The Virtue of Human Development

New York University bioethicist S. Matthew Liao has recently proposed giving people drugs to predispose them to make decisions in favor of programs working toward climate change:

Yes. It’s certainly ethically problematic to insert beliefs into people, and so we want to be clear that’s not something we’re proposing. What we have in mind has more to do with weakness of will. For example, I might know that I ought to send a check to Oxfam, but because of a weakness of will I might never write that check. But if we increase my empathetic capacities with drugs, then maybe I might overcome my weakness of will and write that check. (1)

What Liao is talking about is something still closely tied to beliefs: the will.  Jonathan Edwards spent a good bit of his time writing about the close relationship between these two aspects of human character.  If all that was needed was a little perk-me-up to help out a sleepy donor, then we would prescribe a cup of coffee.  However, beliefs and the will are both components of human character and therefore are changed and molded by the process of maturation.  And the maturing of a person takes place in relationship with other persons, in relationship to God and in relationship to other human beings.  This is the heart and soul (literally) of the human experience.  Theologians oftentimes use the term sanctification to describe this change within the person as a result of the action of God.  This process is ultimately directed toward Jesus, the Mediator who opens the door for making the human heart living and the One who is the New Adam—the One who is human in the truest sense.  Pharmacological manipulation of human behavior seeks to short-circuit the process of human development, thereby essentially taking away that which is truly human.  Just think: if the literature describing the story of human struggle and development were eliminated, our libraries would be largely empty.  A person no longer growing in relationship with God and with others would be less human.  The manipulative means would have done great harm in pursuit of the end behavior.

The renewed interest in virtue ethics in recent years may serve to steer us away from further attempts at manipulation in favor of choosing a path of maturity.

I have always marveled at how Meda Pharmeceuticals markets their version of the muscle relaxant carisoprodol as Soma because of the name’s negative connotations.   Maybe it has no negative connotations at all.

By this time the soma had begun to work. Eyes shone, cheeks were flushed, the inner light of universal benevolence broke out on every face in happy, friendly smiles. (2)

1.  Anderson, Ross.  “How Engineering the Human Body Could Combat Climate Change.” The Atlantic,  March 12, 2012.

2.  Huxley, Aldous. Brave New World.  HarperCollins, 1932 (2006).

Species priority

I admit that I am a speciesist. In fact I would say that it is morally proper to be a speciesist. Members of the species Homo sapiens ought to be treated as having higher moral value than animals of other species. The primary reason that human beings have a level of moral value that nonhuman animals do not have is because we have been made in the image of God.

That does not mean that we have no obligation to treat other species responsibly. A Christian understanding of our relationship with all the rest of creation includes the understanding that God called all of his creation good. As human beings we have been given the role of being stewards of what he created which gives us the responsibility of caring well for God’s good creation. That means we should act on an understanding that nonhuman animals have significant value, but a value that is not at the same level as human beings.

These thoughts were precipitated by a recent article in the Washington Post about animal rights groups in Britain that have pressured British transportation companies to stop transporting animals such as mice, rats and rabbits into Britain for use in research. They claim that the use of animals in research inflicts pain and suffering on the animals that is not justified by the results of the research. It is reasonable to expect animals used in research to be treated well and for their suffering to be minimized, but to say that there is no justification for using animals in research is to put the suffering of animals above the suffering of human beings that can be alleviated by the research. To say that human beings who are unable to consent to being research subjects should not be participants in research from which they will not personally benefit is reasonable. To say that animals should not is unreasonable.

It is interesting that this is happening in Britain where research on human embryos has been a focus. A proper understanding of the moral value of human beings and other species would prohibit destructive research on human embryos, but allow properly conducted research using nonhuman animals.

CPR: Autonomy vs. nonmaleficence


The medical procedure that is one of the most invasive and violent imaginable is also the one medical procedure that does not require the informed consent of the patient.

I am speaking of course of cardiopulmonary resuscitation, or CPR. Anywhere and everywhere in this country, if your heart were to stop or threaten stopping, you would automatically have people pounding on your chest, putting tubes down your throat, and giving you electric shocks. CPR is the default mode; it does not require you to have ever given consent. This is unique in medicine; there is virtually nothing else that a doctor can do to you without your consent.

That no consent is required is often a good and necessary thing; once your heart has stopped is no time to ask if you would like the doctor to do something to help you. But CPR by its brutal nature is often a very injurious thing; and there are many patients for whom CPR is virtually certain to have no beneficial effect whatsoever, but only great harms. Doctors realize that sometimes CPR is not only futile but harmful; but if the doctor were to make a decision in advance not to do CPR on a patient he might be considered not only paternalistic (and paternalism is one of the dirty four-letter-words in modern medical ethics), but potentially Kevorkian-esque, intending the death of the patient. With every other medical decision, from whether or not to prescribe a particular medicine to whether or not to go ahead with surgery, potential benefits are weighed against potential harms and decisions made accordingly. Not so for CPR: unless the patient makes an explicit request to the contrary, CPR will happen, regardless of likely benefit or harm.

In this week’s JAMA is a sensible Viewpoint article by Blinderman et al. entitled “Time to Revise the Approach to Determining Cardiopulmonary Resuscitation Status.” The authors recommend that instead of the current de facto status of CPR, physicians approach CPR in one of three ways: when the relative benefits and harms of CPR are uncertain, present CPR as a “plausible option”; when there is a low likelihood of benefit and a high likelihood of harm from CPR, recommend against CPR; and when a patient’s death is imminent or the patient has no chance of surviving CPR, do not offer CPR as an option.

In many cases this would represent a radical departure from current practice, because in many cases the doctor rather than the patient would be making the decision whether to perform CPR. But it is also a necessary corrective to the painfully inappropriate care that too many receive, as anybody who has ever served on a hospital ethics committee can attest. As the article authors write, “While promotion of patient autonomy is a fundamental responsibility of physicians, protecting the patient from harm becomes increasingly important as the patient becomes more vulnerable. Sometimes, it should be preeminent.”

(JAMA, March 7, 2012 — Vol 307, No. 9, pp. 917-918)

Gattaca Revisted

I teach ethics, bioethics and other philosophy-related courses at a Christian college. So I was not shocked, but nonetheless mildly surprised, when a student recently handed in a paper supporting human genetic enhancement. Actually, the paper was a critical response to an article by Michael J. Sandel, “The Case Against Perfection: What’s Wrong With Designer Children, Bionic Athletes, And Genetic Engineering?” Sandel maintains that genetically enhanced children would “never be fully free” because the improvements are imposed upon them without their consent. Moreover, genetically altered children will excel above normal children; this creates an unfair gap between the enhanced and the unenhanced.

To the argument that genetically enhanced children aren’t truly free, the student responded that no one is completely free, regardless of whether he has been enhanced or not. All humans are unavoidably saddled with the genes they have been given at birth. So why not improve the odds, so to speak, and do what can be done to overcome human limitations? In the student’s words, “It is not a sin to excel, and one should strive in lifting themselves above the norm; there is nothing admirable to be in the norm. We are not created to live in the mediocrity of the norm, but rather to reach above it, and to work on becoming the best possible person one can be.” And, “There is no blessing in being at the mercy of nature; blessing is being in control… Responsibility is what I strive for, not what I avoid at any price, because my goal in life is to become the best person that I can be…”

As I reflect on the argument for enhancement, several thoughts come to mind. First, I agree with the sentiment that we should not live in mediocrity but strive for excellence. I too want to become the best person I can be. But is genetic enhancement a better path to excellence?

Two situations come to mind. Currently, I am halfway through an 8-week program to lose some weight and improve my BMI (body mass index). I’m less than 10 lbs. “overweight,” but I am determined to get down to a healthier BMI. But suppose I could have been genetically engineered so that I would never become overweight no matter what I ate? Think of the benefits – fewer health-related problems due to excess fat in the body (not to mention my unrestrained enjoyment of food). Would this really be to my advantage? Indeed, perhaps I would be physically fit, but there is something to be said about the continuous discipline (those seemingly endless reps, crunches, pushups, etc.) it takes to maintain a healthy BMI. I feel better about myself as a person if I have worked diligently to stay in shape. Without the effort, I would not appreciate what it takes to achieve my goals.

The same could be said about academic achievements. Suppose it was possible to genetically enhance human intelligence? Again, I’m not convinced that this is a better option. I look back on the many hours of intense research it took to earn academic credentials. I come away from that experience with a deep sense of satisfaction, accomplishment and the virtue of perseverance. Moreover, I can echo David’s words – I praise you because I am fearfully and wonderfully made; your works are wonderful…” (Ps. 139:14).

Exaggerated response to a limited clinical study

A preliminary report was published online on 1/23/12 in Lancet about the first two patients in safety studies of injecting retinal pigment epithelium cells derived from human embryonic stem cells into the eyes of patients with different kinds of retinal blindness. What can be concluded from the studies is that no tumor formation or rejection was noted in these two patients four months after the injections. That is not enough information to make any conclusions about the safety of this treatment and safety is the only thing these studies are designed to assess. There are some who have questioned why such limited data would even be published, but the headlines in the press were amazing. They ranged from “Early Success in a Human Embryonic Stem Cell Trial to Treat Blindness” (Time) and “Blindness eased by historic stem cell treatment” (New Scientist) to “Embryonic stem cells: can we make the blind see?” (Forbes).

Why would very limited initial results from preliminary safety studies have such an exaggerated response? Part of it undoubtedly has to do with our culture’s desire to find miraculous cures in science. In fact the Forbes article says “Restoring sight to the blind is, literally, a miracle…when the cells inside the eye are damaged, there is nothing we can do. Until now.” Another part may be due to economics. These studies are being funded by a private company, Advanced Cell Technologies, which stands to benefit from any positive publicity. The company’s Chief Scientific Officer, Robert Lanza, was quoted in the New Scientist article emphasizing the improvement in the vision of one of the patients. The studies are not designed to assess the effectiveness of the treatments to improve vision and vision was only measured to look for deterioration as a possible side effect. One of the other researchers involved noted that the other patient was found to have some slight improvement in vision in both of her eyes, even though only one was treated, suggesting any improvement was due to the immunosuppressant drugs used or a placebo effect.

Scientific discoveries can at times be very beneficial, but we need to take very preliminary studies such as this one as what it is – preliminary. We should not induce false hopes in people with retinal blindness that they are going to be cured. We should not forget that there may be some studies and treatments that should not be done, such as those which require the destruction of human embryos when other methods for deriving retinal pigment epithelial cells could have been used.

The procurement of organs for transplantation: China vs. the WMA

Can a convict sentenced to death give truly free and informed consent to the harvesting of his or her organs after execution?

There is great difficulty obtaining organs for transplant in China. Much of this is blamed on cultural factors, although suspicion of corruption in the medical profession is also a significant reason. Whatever the reasons, between 2003 and 2009 there were only 130 voluntary organ donations in all of China. Yet in 2006, there were 11,000 organ transplants performed.

So where are all of these organs that are not voluntary donations coming from? Answer: executed prisoners. To its credit, China does try to make sure that prisoners give informed consent. According to Bing-Yo Shi MD and Li-Ping Chen PhD, writing in Wednesday’s JAMA, “If a sentenced convict [in China] would like to donate his organs, the convict and his family must submit an official application and sign an informed consent statement with a lawyer present. Before execution, the convict is asked to confirm his organ donation again, and if consent is reneged, organ procurement is explicitly prohibited.”

However, the World Medical Association (WMA) in its Statement on Human Organ Donation and Transplantation explicitly states that “Because prisoners and other individuals in custody are not in a position to give consent freely and can be subject to coercion, their organs must not be used for transplantation except for members of their immediate family.” (Section F par. 4) In a 2005 resolution the WMA addressed China specifically, stating unequivocally that “The WMA demands that China immediately cease the practice of using prisoners as organ donors.”

In a society such as China’s with such strong biases against organ donation, what are we to make of this large number of sentenced convicts apparently consenting to donation? Are they simply the most altruistic segment of the Chinese population? In the absence of another explanation, one must wonder whether the fact of imminent execution itself is somehow a form of coercion, an external constraint on behavior. In the absence of another explanation, one must wonder whether China or the WMA is right:

Can a convict sentenced to death give truly free and informed consent to the harvesting of his or her organs after execution?


(Information for this post came from the letters, “Organ Transplantation and Regulation in China,” and its reply, published on pages 1863-4 of the November 2nd issue of JAMA: The Journal of the American Medical Association, which were in response to the article “Regulation of Organ Transplantation in China: Difficult Exploration and Slow Advance,” by Shi and Chen, published on pages 434-5 of the July 27th issue.)

Managing Patients

Many people remember C.S. Lewis not only as a gifted thinker but also as someone who was very funny.  Funny in a typically British, understated, often-profound way.  When reading That Hideous Strength, the last book of his Space Trilogy, I laughed again and again at his many references to the National Institute of Co-ordinated Experiments.  Yes, you got that right: the N.I.C.E.  This vast array of committees and investigators would finally bring a “really scientific era” to managing society, and eventually all the ills of the country would be deciphered and cured.   And of course building this grand enterprise meant bulldozing a large part of a quiet university town—all for the sake of noble, or at least “nice,” goals.  True, one might have to keep the citizenry in the dark on what actually was going on inside the N.I.C.E., but of course this would be for their benefit.  (“You musn’t experiment on children; but offer the dear little kiddies free education in an experimental school attached to the N.I.C.E. and it’s all correct!”)  The book is great commentary on misguided human endeavors and is prescient on many of the bioethics matters of today.  But what is most entertaining is that the N.I.C.E. is indeed alive and well in the United Kingdom: the National Institute for Health Clinical Excellence, a.k.a. NICE.  More on this in a moment.

Christ and the Canaanite Woman by Germain-Jean Drouais (1784)

During the past five weeks of my Psychiatry Clerkship, I’ve seen that we are often in a position to simply do the best for patients with the little we have.  Many of our patients suffer from life-long substance abuse, others are being monitored because of signs they might harm someone, and others are there at the request of the courts.  It’s easy to fall into a “managing patients” mode of just keeping things from getting out of hand but never really helping the patient recover from his illness.  (Especially when the patio re-modeling keeps some patients from being able to go outside for two weeks.)

One of the populations that figure prominently into “patient management” is that group diagnosed with antisocial personality disorder.  NICE has dual concerns of managing resources as well as managing antisocial patients who may cause harm to society in the form of criminal activity, for instance.  NICE working groups have to come up with guidelines for handling these patients.  For instance:

Pharmacological interventions should not be routinely used for the treatment of antisocial personality disorder or associated behaviours of aggression, anger, and impulsivity.  Pharmacological interventions for comorbid mental disorders, in particular depression and anxiety, should be in line with recommendations in the relevant NICE clinical guideline.

Psychological interventions such as Cognitive Behavioral Therapy, on the other hand, were found to be wise uses of funds in working with these patients.

It is easy to click through a patient roster quickly in order to carry out management guidelines and lose a sense of the human being who is at dis-ease because of an illness.  This is why I think Christian hospitals and places of rest for the mentally ill offer something that our modern health care systems do not: their reason for being is first the healing ministry of Jesus, seeing that the ill become whole.

For more information