A man in a medical experiment

Limits of control

Elena Bryzgalina, Head of the Department of Philosophy of Education, Faculty of Philosophy, Moscow State University
Forbes, 01.09.2016

Biomedical experiments deal with the most precious thing that a person has – human life and health. Natural science experiment as the main method of cognition was considered ethically neutral in Modern times. But with the development of knowledge about human physicality, with the development of biomedicine, an increasing number of people become participants in biomedical experiments. Most biomedical experiments deal not with saving lives, but with obtaining or improving knowledge that can be applied not only for the treatment of this particular patient, but also for the good of humanity in general, the good associated with the progress of biomedicine as a tool for the development of society.

Attention was drawn to the need for bioethical and legal regulation of experimentation after World War II, when facts about inhumane experiments carried out by Nazi doctors in concentration camps on prisoners, including women and children, became known as part of the Nuremberg Trials.

Humanity was faced with the fact that at the time of the Nuremberg trials there were no national or supranational legal acts that would regulate medical experiments.

The Nazi doctors who ended up in the dock had fairly qualified lawyers. They argued that conducting experiments was an attempt to extract at least some benefit in the form of knowledge from the evil that did not depend on doctors. Of course, when comparing such arguments with the indisputable harm that was inflicted, up to the killing of a significant number of people (according to official data, this is more than 275,000 people who died as a result of experiments from 33 countries), the task of regulating experiments strongly asserted itself.

The first international document of this kind was the so–called Nuremberg Code - a set of rules on conducting experiments on humans, the main provisions of which are reduced to several points.

The first, absolutely necessary condition for conducting experiments, which was justified in the Nuremberg Code, is the voluntary consent of the subject. It was precisely this kind of consent that the Nazi doctors did not receive in the experiments.

Voluntary consent means that the person involved in the experiment has the legal right to give such consent and has freedom of choice without any element of violence, deception, fraud, cunning or other hidden forms of coercion. In modern bioethics, the concept of "voluntary informed consent" is used, that is, it is required that a potential participant in the experiment has sufficient knowledge to understand the essence of the experiment and make an informed decision about whether or not to agree to become a participant in the experiment. In order to provide consent, the subject was informed about its nature, duration and purpose; the method and methods by which it will be conducted; about all possible inconveniences and risks; about the consequences for his health and moral well-being that may arise as a result of participation in the experiments.

Further, the Nuremberg Code proclaimed that the experiment should bring fruitful results that are unattainable with the help of other methods and means. Such an experiment should be organized and based on the basis of preliminary experiments on animals. The experiment should be constructed in such a way as to exclude any unnecessary physical and mental suffering or damage. No experiment should be conducted where there is a priori reason to believe that death or crippling injury may occur. It is impossible to take risks where the problem under study is not too important for humanity. Appropriate precautions are needed to protect the person participating in the experiment from the possibility of injury, death and incapacity. The experiment should be carried out only by qualified specialists. During the experiment, the subject must have the right to terminate the experiment at any time. During the experiment, the researcher should be ready to stop the experiment at any time if, in his opinion, the continuation of the latter may lead to damage, incapacity or death of the subject.

Interestingly, the text of the Nuremberg Code, even in the countries of the anti-Hitler coalition, was not published in full for a long time. For example, in our country the full text of the document was published only in 1993. In many ways, this is no coincidence, because the regulation of biomedical experiments naturally has as a consequence a restriction on attracting the number of subjects.

Since many biomedical experiments have a dual purpose – both civil and military, there are cases when, unfortunately, in our country, in the USA and in other countries, despite the norms established by the Nuremberg Code, experiments on an involuntary basis continued.

Currently, four types of experiments in biomedicine are evaluated from the point of view of bioethical justification and legal regulation. The first type is the experimentation of doctors on themselves. From an ethical point of view, doctors who have full knowledge of the essence of the experiment, about the consequences, conducting experiments on themselves, have the opportunity to give voluntary informed consent. There are many examples in the history of medicine when doctors conducted experiments on themselves. For example, Ilya Ilyich Mechnikov's experiment almost cost him his life when he tested a typhus vaccine on himself. The second type of experiments is experiments on healthy people. In such experiments, which are a mandatory stage of pharmacological research, the maximum dose and side effects are checked.

The third type is experiments on patients, during which the benefit is expected for the subject himself. This type is called therapeutic experiments. The fourth type is experiments on sick people, during which no therapeutic effect is expected. The purpose of such an experiment is to gain knowledge. This is a non-therapeutic experiment. Just as an experiment on healthy people can be called non-therapeutic.

In medicine today it is quite difficult to draw a line between therapeutic and experimental intervention.

One of the reasons is the complexity of the most modern medical care. Another reason is that paternalism is an acceptable model of communication with a doctor for a significant part of the population. Paternalism is a model of a doctor–patient relationship where the patient delegates to the doctor the right to make decisions regarding medical interventions in full. Within the framework of paternalism, just as a child does not expect evil from the father and obeys his will, the patient follows the doctor's orders. And many patients, without separating therapy and experiments, do not delve into the essence of the experimental procedures and manipulations proposed by the doctor.

The bioethical question is related to how complete the patient's information should be in order for his consent to be interpreted as ethically correct. To what extent can such consent be obtained from certain categories of citizens whose lives, for example, are controlled? These are residents of state institutions, such as psychiatric clinics, orphanages, and nursing homes. The lives of those who are in such institutions depend, often absolutely, on the actions of the staff. The question arises: do these people have at least some opportunity to give informed consent? According to international norms of law, developed after the publication of some facts of conducting ethically questionable experiments, the use of institutionally imprisoned persons, except for therapeutic research purposes (when the latter receive certain assistance), is prohibited.

Until recently, prisoners and military personnel made up the largest reserve of potential test subjects, especially when testing the effects of drugs. Many countries of the world have refused to involve such large groups of the population as military personnel and prisoners in experiments on healthy people. The fact that the alleged subject is in controlled conditions makes his consent to participate in the experiment very doubtful. It is extremely difficult to assess whether the consent to participate in the experiment given to military personnel or prisoners deprived of any overt or covert violence is extremely difficult. In addition, studies involving military personnel or the military are not subject to close public control, which creates opportunities for abuse: if a negative reaction from the public is expected, such abuse is easy to hide.

How is consent achieved? The immediate answer is that you can simply ask for consent to participate in the experiment. However, a detailed discussion of this question shows that the answer is not so simple.

For example, the correct condition for conducting a medical experiment is the presence of a control group that receives a placebo – a "dummy" instead of a drug. The word "placebo" comes from a Latin phrase meaning "I would like to be liked." This is necessary in order to distinguish the psychosomatic effects of taking medication associated with a person's belief that an experimental drug can help him from a real therapeutic effect. What should be done if the participant of the experiment should not be informed about whether he receives a real drug or a dummy? How to ensure informed consent in this case? In some experiments, not only the participant of the experiment should be uninformed, but also the experimenter conducting it. This is a so-called double-blind experiment. Considering such cases, bioethics assumes special forms of obtaining voluntary informed consent, where the patient receives information about the probability with which he falls into the control group receiving a placebo.

For certain categories of patients, for example children, participation in the experiment needs special regulation that strictly distinguishes therapeutic and non-therapeutic experiment. As a rule, the involvement of children in non-therapeutic experiments under the age of 14 is prohibited. International legal acts indicate that parents can consent to participate in the experiment for the child if the treatment is carried out for the benefit and benefit of the latter, that is, for therapeutic purposes. Only those decisions can be made that do not lead to a violation of the physical or mental state of the child. However, neither morally nor legally, parents cannot make a decision for a child when medical intervention leads to a serious risk. One of the difficulties is that ideas about the good and the good can be interpreted extremely broadly.

If the experiment is not carried out for therapeutic purposes, then the practice adopted in most countries sets conditions: the child must be at least 14 years old, he must think independently and be mature enough to understand the nature of the upcoming procedure, including potential dangers, and there should be no violence or appeal to a sense of duty. If these conditions are satisfied, the consent of the child – with the consent of the parents or guardians – complies with the norms of international law. In some types of risky experimental interventions, this age can be changed at the national state level for both non-therapeutic and therapeutic experiments. Thus, according to French law, if it is a question that a child needs a transplant of a donor organ, for example a kidney, the age from which consent should be sought from a potential recipient is reduced to 6 years. And this is also a problem. Is it only calendar age that determines the understanding of the information provided by the doctor?

The question also arises as to how voluntary a child's consent can be, given under the influence of information received from parents or doctors. The concept of "voluntary informed consent" implies that no arguments related to intimidation were used, with a call for altruistic donation (if we are talking about the use of paired donor organs, for example, about taking a donor kidney from a healthy person).

Currently, transplantology as a type of medical care is generally considered experimental, and all the rules governing medical experiments apply to it.

The scope of experiments in biomedicine will increase. The further science develops, the more people will become participants in experiments, the more tasks bioethics will have. Bioethics draws attention to the need to develop state mechanisms for informing people about the rules of medical experiments. Currently, the main European document that regulates experiments in biomedicine is the Convention on Human Rights and Biomedicine. Its official name is the Convention on the Protection of Human Rights and Dignity in Connection with the Application of Biology and Medicine. This document was adopted in 1996, there were several additional protocols to it, for example, in 1997 there was an annex to it concerning the prohibition of experiments in the field of human cloning. This convention has been signed by most European countries in order to prevent the possibility of negative consequences of the use of new medical technologies, to protect the rights and dignity of a person who finds himself in the role of a patient or a test subject.

Currently, experiments with the participation of volunteers are necessarily evaluated by bioethical commissions or committees before they begin. They exist today from the state level to the level of a separate scientific and educational institution that conducts experiments. During the submission of the application, the experimenter is obliged to describe in detail the scientific base that currently exists in this subject area in order to prevent repeated experiments if they have already been conducted somewhere in the world and the data has been published. It is mandatory to indicate the number of participants in the experiment, the duration of its conduct. The Ethics Commission evaluates the informed consent form, including information on how thoroughly the potential participant of the experiment will be informed by the organizers of the experiment about the essence of the experiment, risks, side effects, and so on.

Portal "Eternal youth" http://vechnayamolodost.ru  01.09.2016