Informed, Free and Voluntary Consent
Where does your medicine come from? The easy answer, and the one pharmaceutical companies, anxious to justify their bloated profit margins, want you to remember, is that your medicine comes from research and development scientists and programs supported by these corporations. However, what is the nature of this research? How are new pharmaceutical products and new therapies developed? How does medical research, apart from its few successes, impact the people recruited, with varying degrees of knowledge and consent, as research subjects? What justifies the use of these men, women, and children in such roles? Who is likely to be taken into a research project, and why? These questions and their answers have significant moral implications that touch on social norms, the structure of communities and economies, and the nature of ethics in science as a human pursuit.
The accepted narrative of science, and therefore the popular biography of scientists, especially research scientists, is one of heroic progress. To some extent, this narrative holds. Significant advances have been made, and continue to be made, in the struggle against disease, chronic illness, and our scientific understanding of toxins and health. Public health, despite crises like the HIV/AIDS epidemic, has improved, and future advances appear to be on the horizon for chronic illnesses like diabetes with the possibilities promised in stem-cell research and technological improvements in mechanical treatment options. However, in very important and troubling ways the narrative fails, for the truths it leaves covered in silence. The sunlit science has its shadow, and within that shadow lie the difficult questions of justice, equity, abuse and power that are also part of the scientific narrative, or should be.
When the subject of unethical medical research is discussed, two bodies of action are prominently discussed and analyzed: the Nazi experiments in concentration and death camps, and, in the USA, the Tuskegee Syphilis Study that ran from 1932 to 1972. The stress on these two programs alone makes it seem that unethical research is anomalous, and both end on the ostensibly positive note of regulation, on avowals that the anomalous will not, and can not, be repeated. The past and present of medical research practices, however, do not support such a happy conclusion.
Regulations do not in themselves prevent anything. Along with regulation, a system of sanctions must be established and maintained with personnel possessing the will and the real ability to apply them. Without such infrastructure and institutional presence, regulations may be readily agreed to and endorsed without affecting reality at all. The Nuremberg code largely falls into this category of regulation. Scientists readily accepted its application to the Nazis and their experiments, but were less ready to accept it as a rule governing their own pursuits. Furthermore, regulations invite evasion, as the firm definition of what can and cannot be done includes a language of compliance that those willing to breach the intent of the regulations master and use to their own benefit. For example, it is widely accepted that coercion is a bad thing, and that people should not be coerced into participating in an experiment, especially one with significant dangers to the subjects of the study. However, it is less clear in the public and in the scientific community what coercion actually is and what behaviors, inducements, and pressures might constitute coercion.
Clearly, threatening a person with imprisonment should they fail to participate in research is coercion; but, is it coercion to use public officials to "invite" a young African American mother with one child in juvenile detention to deliver her child for tests and interviews at Columbia University, as was done in New York City? The mother felt threatened; she thought that the people inviting her to offer her son for tests had access to her detained son, and that with this power they were capable of acting against him while he was in confinement. This, in fact, is the major problem with judging the coercive nature of a given interaction: coercion, beyond the physically threatening and certainly inappropriate verbal threats of immediate violence, relies on a perception of threat. I feel myself to be coerced, and so I act in a way I would not freely choose if I did not believe a threat exists. The party to whom I contribute the ability and will to achieve the harm I fear does not by virtue of my perception know what I believe the situation to be. Nor are all threats, even very real threats that are certainly coercive, easily contained in a record of consent forms and official transcriptions. Coercive situations can be maintained and created by unspoken understandings embedded in the surrounding community and culture: a Jew did not have to be told that a swastika was bad news in 1942, nor did a black American in the south require detailed instruction in what keeping to one's place meant.
The base line of medical ethics, medical ethics in their simplest form, center on the concept of informed, free and voluntary consent. A research subject should know what the experiment is, what the associated risks are, and as conditions change the subject should be kept up to date with those changes. The research subject should not be forced to participate in the study, nor retained if at any time he/she changes his/her mind. The research subject should be free to leave the study and cease participation at any time. There are other rules attached to research studies in the United States, but this principle lies at the core of it all. Among the additional rules are those which require accurate record keeping, disallow any forfeit by the subject of their right to seek redress should they suffer injury or harm in the course of the study, define the limits of acceptable risk for different categories of participant, and place research protocols under review, primarily through Institutional Review Boards.
Informed, voluntary consent appears to be a rather simple, clear standard, but it is as troubled in practice as any other feature of medical research. First, there is the question of "informed". Research subjects are often informed in a manner that leaves them in complete ignorance. Very few research subjects are fluent in medical and scientific jargon, but consent forms are largely written in such terms and rarely do researchers attempt to clarify the terms or ensure through discussion and explication that the subject does in fact understand the nature of what they are consenting to. Research subjects may believe they are being offered guaranteed treatment when they are, in fact, participating in a randomized blind trial, and may end up receiving only a placebo. They may be more reliant on what they are told--that they are doing good for the community, that they will benefit from the experience, or that the test is harmless--than on what the consent form contains, especially if, as is true of many experimental subjects, they are uneducated or uncomfortable with their level of education in comparison with that of the researchers. There is little effort given to ensuring that every research subject is fully aware of the nature of the experiment and its risks. Researchers are looking for a requisite number of people, of subjects or research material, and tend to be unwilling to risk a subject on the hook slipping off if the risks are made clear.
Second, the voluntary nature of research subject participants is routinely breached, by private doctors, pharmaceutical companies, and the government. Children, for example, are unable to consent to research projects, but their proxies can, and in many studies, these proxies may not be the child's parents at all, but state institutions or other such authorities. Even where the child's parents are the ones providing consent, the problem of 'informed' reappears, inducements such as financial and emotional relief may prove to be very tempting to parents in difficult circumstances, and agencies associated with researchers, sometimes including municipal authorities, might apply pressures the parents do not know how to resist. Some research subjects do not believe that leaving a study once they have begun it is permitted. Some parents have been led to believe that denying their child the "care" contained in a research protocol is tantamount to child abuse, and that by refusing they risk custody of their child.
In the most egregious violations of the voluntary principle of research participation, people do not so much participate in a study, as data is collected from them and actions taken affecting their health and welfare without their knowledge or consent. For example, the US government in its efforts to discover new and better ways to fight the Soviet Union, supported studies of disease-bearing mosquitoes as vectors of infection for use against enemy troops. Without enemy troops available, they settled for black residents of Florida in 1951 and 1955, resulting in a tripling of the whooping cough rate in the state of Florida. In one of the research sites, Carver Village, 1,080 cases of whooping cough occurred, 8% in children 9 years old or younger. Dengue fever and yellow fever were also released into the community. In an effort to eliminate associated records after the media storm accompanying revelations concerning the Tuskegee Syphilis Study, Dr. Sidney Gottlieb, director of the CIAs MK-ULTRA program, under whose auspices the Carver Village and other community scale experiments in bioweaponry possibilities had taken place, destroyed most of the evidence related to these actions. The program was revealed in the 1980s due to the efforts of the Church of Scientology's American Citizens for Honesty in Government, who collated those documents which survived CIA destruction with events in Florida and other source material to recreate events insofar as they could be determined with so much of the record destroyed. Despite the Church of Scientology's record in other matters, independent statisticians, researchers, and journalists agree that their work in this case was superb.
Science would like to be pure, removed from the irrational prejudices and superstitions of the society in which it is practiced, to which it contributes, and whose men and women form its practitioners and its subjects. It would like to be, but it is not. If Josef Mengele's experiments, supported at the time by 'respectable' scientists outside the camps and 'respectable' institutions which insisted they were following the laws of science, seem ridiculous and ill-conceived, as well as sadistic and criminal, they were experiments which were shaped by the concerns and goals of the society in which he acted, by which he was funded, and to which he reported. Even Mengele's madness was not science in a vacuum, science as conceived by one lone wolf; it was the science of Nazi Germany, and it could be no other way. Another Nazi scientist, this one a careful researcher pursuing a treatment for phosgene gas exposure, experimented on horses. He thought his research sure enough to require no further proof, but was instructed by Himmler to repeat the tests with concentration camp inmates. The use of concentration camp inmates was central to scientific research in the Nazi era. The existence of and access to these inmates was fundamental to the way experiments were conceived, framed, and performed.
We are not Nazis. Our experiments are conceived, framed, and performed following different premises and within a different social context, but this does not free us from questioning the purity of science. In the nineteenth century, it suited slave-owners to claim that Africans were not susceptible to physical and emotional distress to the same degree that whites were. It suited several scientists to claim this as well, sometimes scientists who filled the role of both slave-owner and slave doctor. Since slaves did not feel pain as others felt pain, and yet fell prey to diseases whites also experienced, they were the perfect guinea pigs for the development of new treatments and surgical techniques. James Marion Sims of Hanging Rock, South Carolina, established the first women's hospital in New York City and is widely hailed as the father of American gynecology. However, the surgery which made him famous and wealthy was developed in Alabama, where he developed it on slave women before transferring it, once perfected, to a white clientele. His slave subjects were given no anesthesia, though anesthesia was provided his white patients. Another slave owner, Dr. Thomas Hamilton of Clinton, Georgia, investigated heat stroke by experimenting on slaves in his control, and also blistered them to see how deep 'black' went, as reported by his escaped slave-subject, James 'Fed' Brown in 1855.
These are atrocities from the distant days of slavery, but social preconceptions still affect the way research is conducted and the choice of topics to study. For example, research into black violence is well-funded, as society equates violence, especially urban violence, with black males, and, instead of searching for social causes and cures, turns to a medicalization of the problem, largely in the language of mental health syndromes and genetic tendencies. Despite repeated failures to identify genetic causes of violence or the existence of any specific mental health condition that creates urban violence, including the fall of the XYY thesis of the 'mean gene', these research directions still occupy a large amount of money and effort. Meanwhile, meaningful directives addressed to the problems of poverty, police presence, and community relations remain unaddressed as too expensive, and can be attacked as "gifts" to a community which has not earned that support.
Lead paint is a huge problem, especially in older cities, and the efforts to remove lead from public housing blocks can be very expensive. In the mid-1990s, Baltimore's Kennedy Krieger Institute began a "Repair and Maintenance Study" to evaluate the effectiveness of a new, cheaper method of lead removal. In order to evaluate its effectiveness, the Kennedy Krieger Institute arranged with landlords to bring families with young children into contaminated units. The goal of this program was not to prevent or treat lead exposure in the children involved, but to measure it. The children's parents were not aware of the danger their children faced by living in those units. They were data points for a study, not patients.
Prisoners, an ever-expanding pool of possible research subjects, form a perfect population for various research projects. It is easier to control their behavior--whether they take the medications they are given on time and consistently, whether they return for evaluations on time and consistently--than it is to control members of a free population, who may move away or end their participation without notice. Their participation is relatively cheap to purchase, and one does not have to apply additional coercion when their very situation and placement in the institution is coercive. Additionally, prisoners form a pariah population for which the rest of society feels little direct responsibility and with which it has little contact. Those with whom prisoners have contact are often without social or political power to affect the prisoner's situation. Society feels that prisoners owe them, that they are coddled on the public dollar for crimes against the public, and therefore the fact that they are being used, without regard for their welfare and person, is right and just. Cases of notorious, criminal abuse of inmates may end their use as research subjects for a time, but not forever. The habitual attitude of society towards them remains, and with it, given time to forget, researcher's access to prison populations returns.
Do these problems of accountability, responsibility, and morality mean that human participation in research studies is always wrong, unethical, and unjustifiable? No. Nor are all studies involving human participants criminal or unnecessary. In fact, human research is vital to progress in medical science. We have found in the past that what works on a rat does not work on a man, or works in dangerous, even deadly, ways that were not foreseen during animal testing. However, all research involving human subjects faces significant moral perils, for it is easy to justify almost anything we desire to do, and scientists are merely human in this quality and capacity. The poor, the powerless, the uneducated, and those dependent on institutions are at significant risk as research subjects, for they are easily abused and usually are unaware of their rights, or feel unable to exercise them. It is not in the researcher's interest to fully explain the subject's rights and ensure that he/she has been understood, but it is the researcher and his/her subordinates who are supposed to do this. The researcher wants to get the work done, receive the results, and either adjust them to say what is desired or report them honestly and continue work with a new set of subjects and new questions. It is, I think, unreasonable to believe that ethical considerations which might put his/her project at risk of failure will be prominent in the researcher's mind.
Human subject studies will continue. The poor, the uneducated, and the incarcerated will continue to be key subjects in these studies. It is unavoidable. The middle class and the wealthy are not storming the bastions of research institutes to take part in drug trials, lead paint studies, and environmental toxin studies. In addition to the regulations we have in place, largely regulations that have been written in response to significant ethical and moral failures on the part of researchers, and the will to see those regulations diligently followed, there needs to be a body of persons concerned only with the research subjects as individuals, as persons with all the rights, dignities, and concerns of human beings. This body should be educated in the language of science, of medicine, in the jargon it will be their job to translate for their clients, the research subjects. They must be educated in the laws that govern research, researchers, and those legal options to which their clients may have recourse if they should require legal redress for their treatment. This body should receive no funding from any body concerned in medical research, pharmaceuticals, medical therapy, or any other associated agency that might have an interest in the researchers' work and/or success.
Even should such a body come into being, and in reality prove effective, there would remain the problem of the Third World. Increasingly, the Third World, especially Africa, is becoming prime hunting grounds for experimental protocols. There, the poor, the uneducated, and the desperate are everywhere, providing a cheap, available resource for researchers and the companies that fund them. Regulation, where it exists, is lax and easily avoided. Experimental health care may very well be the only health care available. Institutional structures to protect the people from abuse are lacking. As a result, in areas where sleeping sickness and other debilitating tropical diseases are rampant, are testing grounds for therapies of First World illnesses and medical issues. Should these therapies reach the market, the people on whom they were tested will not receive them. The diseases which threaten them remain untreated, or treated by toxic measures unacceptably outdated in the West, as further research or distribution of new medications in the area is seen as unprofitable.
The problem with scientific research is not that it is immoral, but that it is amoral. It has only the morality its practitioners bring with them. All too often, the morality they bring with them is based on greed, ambition, and the pure joy of data, unconsciously colored by the prejudices and blindnesses built into the society they share with their fellow citizens.