Biological Ethics
Table of contents
Chapter 17. Scientific experimentation on man
G. Herranz
a) Man as a subject of biomedical experimentation
The topic of human experimentation for scientific purposes is highly topical and controversial. As I pointed out earlier1 , "on some occasions, and for some researchers, the temptation of knowledge is so strong that it makes them lose their reason. There are in the distant and recent history of scientific research some black pages. It is not that simple miscalculations have fortuitously led to adverse, sometimes catastrophic, results. On the contrary, they are episodes caused by scientists who are insensitive to the ethical requirements of the research, according to which the dignity of the person is not a higher value to which all experimental studies must be subordinated (...).
Undoubtedly the most sinister chapter in the history of research is the shocking array of experiments on defenceless human beings carried out by Nazi SS doctors during the Second World War2. When, at the end of the Second World War, the protocols of many of these atrocious investigations were discovered, public opinion was deeply shocked.
These have not been the only crimes committed in the name of research. Some have been widely publicised advertising; others go virtually unnoticed or are condoned by the permissive and pragmatic contemporary public opinion. It is not easy, for example, to understand the ethical "reasons" that may have informed the Tuskegee experiment3 4 . In this Alabama population, a group of more than 400 poor blacks, suffering from a contagious disease, were kept without treatment from 1932 onwards, in order to obtain a more accurate knowledge of the course of the disease and thus have a group control to evaluate the effectiveness of the treatments.
From time to time, society is moved by scandalous news headlines: that geriatric patients in a hospital are injected with cancer cells to study the immune response to tumours (which happened at the Jewish Hospital and Medical Cancer in Brooklyn), or that children in an institution for the handicapped in the same state of New York were inoculated with hepatitis virus in order to have a comparative data for a vaccine essay .5 6; or that the resources of a particular prison have been used, etc.
At other times, information on research "field", comparing different mass contraceptive procedures (pharmacological, outpatient surgery, etc.) or abortion techniques, is withheld. Or the little information that is disseminated goes unchallenged and uncriticised, despite not only its basic moral malignity, but also the immoral procedures for obtaining informed consent7. It is unethical to use ignorant populations, easily duped by modest economic incentives, as a bank of test for new procedures that are then applied to more advanced societies8.
On another note, it should be pointed out that in many experiments with human beings there is not an attitude of aggressive contempt towards them, but a blatant carelessness and lack of moral finesse, which is not Exempt of a risk of progressive deterioration. source Pappworth's well-documented and unbiased book is an indispensable source of information9 .
In the genesis of the great aberrations there is usually, in the initial phase, a disregard for the small ethical rules that must be observed in the scientific research .
There are scientists who think, quite simply, that minor ethical requirements are an inconvenient distraction from which they dispense with their own compliance. What is the reason for this marginalisation of ethics in the task of scientific creation? Probably the blame for this deterioration lies in the conversion of scientific reductionism, a methodological necessity, into scientistic reductionism, a deformed version of the world.
The effectiveness that the tactic of isolating a problem has brought to the experimental method, of drastically reducing it to its most essential elements and then studying the correlations between two or more well-defined variables, without parasitic interference, is undeniable. This attitude carries the risk of a certain intellectual arrogance. The method derives its astonishing effectiveness from simplification, from the deliberate abstention from taking into account a large issue number of factors that are deliberately ignored. It is only a step from there to considering certain moral aspects as insignificant from a scientific point of view.
At other times, the scientist lives with the fallacy internship that it is totally tolerable to commit slight ethical faults, because he thinks that the higher interest of the research must dispense with everything that is not experimental science. The latter then, by extrapolation, attains the status of a magic formula for the solution of all human problems: Science has become the supreme value.
Commenting on the origin and evolution of Nazi medical crimes, Alexander (2) states: "Whatever dimensions these crimes may have reached in their initial phase," he says, "it is evident (...) that they had small beginnings. The beginning consisted simply in a subtle shift in the emphasis of what the basic attitude of the physician to human life should be..... It began with making acceptable the concept that there are lives that are not worth living". He then traces the pathway that this concept went through: from the very seriously and chronically ill, the sphere gradually expanded to the socially unproductive, to the ideologically undesirable, and ended up encompassing dissidents from the political system. But it is important to realise," Alexander insists, "that the barely perceptible lever with which this mental attitude was given impetus was the theoretical and remote Admissions Office that there are sick people who cannot be rehabilitated, whose existence is not worth living".
b) Ethical criteria and rules and regulations
The ethics of the scientific researcher is the common ethics. It is bound by the same precepts, the same prohibitions as other rational beings. He enjoys no privilege or exemption. His beneficial activity does not exempt him from the golden rule of doing good and avoiding evil. He can never, in order to achieve a good purpose, use unworthy means.
But it is logical that an attempt has been made to specify the common ethical rules in more concrete terms, so that the scientist can apply them more easily to the problems he is confronted with. It is also logical that these rules or codes of conduct are more necessary and richer in content when research is carried out on man and on those more deeply personal aspects of man, such as the mind and sexuality, which, because they form the core of his highest dignity, are protected by a particular inviolability. Consequently, it is explainable that the ethics of biomedical research has received the most attention, compared to other provinces of research (Science of subject or Zoology, for example).
There is a wide area of contact between these ethical precepts and the legal norms that in some countries regulate research on human subjects. The risks of litigation for malpractice internship, breach of trust, etc., have in some cases resulted in undue complication of legal procedures for obtaining consent and have hindered the conduct of otherwise ethically sound research. But, on the whole and without doubt, the revitalisation of ethical principles in human experimentation is a priceless benefit.
Pope John Paul II reminded the Nobel Laureates on 22 December 1980: "Technical science, aimed at transforming the world, is justified on the basis of the service it renders to man and humanity (...). This is the decisive criterion: the criterion of serving the whole man, in the totality of his spiritual and bodily subjectivity.... Many believe that the fact of being technically capable of producing certain results is reason enough to no longer question the legitimacy of result in itself. It is clear that such a way of thinking leaves no room for a supreme ethical value or even for the very notion of truth".
The Regulations
With the Nuremberg trial, the crimes of the Nazi doctors became known, who had made their research by means of human vivisection, direct observation of the death of the heart, etc.; to make programs of study of adaptation they had experimented at great heights, with the consequent death by asphyxiation. At that time the Nuremberg Code was established. The principles of this Code can be summarised as follows:
1) The voluntary consent of the subject is necessary for human experimentation.
2) The experiment should be conducted with the aim of obtaining accurate results and should not be a randomly chosen experiment.
(3) The experiment must be conducted in such a way as to avoid any mental or physical impairment to the person being treated.
These ethical principles were expanded and refined in "The Helsinki Declaration" (Annex I), and can be summarised in the following five:
1) The experiment must have a sufficient scientific basis, and a prior experimental basis. It can be carried out on humans only after having experimented on animals.
2) The experimenter must have an adequate human and scientific training .
3) The subject to be subjected to the experiment must be well informed and give free consent; he/she must understand the purpose of the experiment.
4) The risk to life, health, discomfort, must be proportionate to the benefit directly gained by the patient, or the benefit gained by the community, with the good of the individual being paramount.
5) Not everything can be researched, in the sense that the research of certain aspects of science can be detrimental to the whole of humanity.
Thus, basic aspects of a rules and regulations for scientific experimentation on humans can be focused as follows:
Regarding the person
Consent must be express, plenary session of the Executive Council and free. topic of consent has, in addition to the ethical aspect, a legal repercussion. Logically, a researcher can be denounced for the abuse of power involved in carrying out this research without the full approval of the subject or going beyond what had been authorised.
Consent must be different from that given simply for ordinary medical performance; it must be expressly given after all necessary information about the experimentation has been made known.
Consent plenary session of the Executive Council requires that the person with capacity to consent is fully informed of the risks, dangers, content, purpose, etc. of the research programme. If the person is unable to give consent because of lack of capacity, there must be a manager tutor , a "guardian", someone who protects and defends the person from undue risks. This function has to be assumed by parents, guardians, family. However, a rather difficult problem is beginning to arise in "advanced" countries where it is beginning, in some cases, to be unrealistic for parents, the family, to be the natural protectors of sick children. Recently, in England, there has been a strong controversy because of the case of a mongoloid girl who needed surgery and whose parents decided to let her die. The doctors have appealed to the last legal written request , and, in view of the authority's decision, the operation was carried out. The child is alive and, in view of the fact that the parents abandoned her, she is under the guardianship of the court. These things would raise the serious problem of making the state somehow "owner" of the lives of citizens. In the same vein, with the socialisation of medicine, institutions - the public health administration - sometimes acquire an omnipotent power that leads them to not ask for people's authorisation or consent for anything.
In any case, such consent for minor inconvenience and damage must be sought very honestly. It is not possible to avoid the fact that people have a low level of education and are therefore unjustifiably suspicious, or to take advantage of the fact that they are physically, mentally or financially weak, etc., which makes them feel less free. The benefits of research never excuse asking for consent.
Risks: Ethical issues concerning possible risks or harm must be considered in all experimentation. Only those experiments in which there is certainty that no harm will be caused and which are useful for increasing scientific knowledge are lawful; or, in the case of such harm being caused, the experiment is not really such, but an uncertain treatment in the absence of a certain means of cure. Experiments in which there is a serious danger of harm and which are of no use for the bodily well-being of the person concerned would be unlawful; and it would also be unlawful to yield one's own body for dangerous experiments in exchange for a sum of money.
Nor can disproportionate or simply unwanted damage be inflicted on the subject. Logically, there are things that carry hardly any harm and therefore do not require special consent, but it must also be seen whether there is an accumulation of "small harms". An illustrative anecdote is what happened to an American author, director of an intellectual magazine, who fell ill; he went to a hospital and as he was an important and well-known person, people went out of their way to take blood samples in order to determine a whole series of constants, but when he had already been pricked five or six times in one morning, he started to become alarmed. As it continued the next day, he put a sign on the door of his room saying: "I will not give another drop of blood for research, because I will die of anaemia".
It is assumed that everyone, in principle, is in favour of voluntary blood donation, but there may be people who are not, and therefore scrupulous care should be taken to ask. However, it is also true that there is a certain moral obligation to collaborate in a research from which a great benefit could be derived.
Damages: Fame, private life, etc. cannot be harmed. Respect for people, respect for the human person during the research is core topic. Anything that diminishes the respect, the moral condition, anything that subjects, for example, children to situations of "stress", psychological terror or that can do them harm, must be rejected. Science must have a great ambition to know, but knowledge is not man's ultimate reason and there are things that are ethically illicit and should not be practised for the simple fact that they harm others deeply at the core of their personality. Thus, psychological experiments would only be lawful for very serious reasons.
With regard to the researcher
The researcher should not fail to carry out a project from which he foresees important consequences for the health and good life of other people, however arduous and demanding it may be project. Research should also be encouraged and supported.
On the other hand, whenever a research involves a risk, it is necessary, in the course of the research, to do everything possible to reduce it, and one way of reducing the risks of a research is to plan it very well and to devote the necessary efforts to the preparation of the protocol . If the approach to a given experiment saves 20 experimental subjects, they must be saved; it is obligatory not to subject people to risks or simply to inconvenience due to negligence in the experimental approach. Therefore, the phase prior to the research in which biologists are involved is very important; very important because it involves these great possibilities. And prior animal testing is always obligatory.
There are currently centres to consider whether or not experiments can be carried out because, as mentioned at the beginning, experiments have been carried out which are clearly contrary to the dignity of the human person and therefore morally inadmissible. The researcher should not circumvent this control. Currently in the United States, special permissions are required in order to be approved to carry out a research of this subject. Thus, there is a committee of consent that advocates for all those weaker beings, such as children, the handicapped, prisoners, etc.; the National Health high school that is in charge of giving ethical committee to different societies that promote the research. And there is a National Commission for the protection of persons undergoing biomedical research.
Notes
(1) HERRANZ, G. "Los límites éticos de la research científica". Nuestro Tiempo, 339, 112-123, 1982.
(2) ALEXANDER, L. "Medical Science under dictatorship". New England Journal of Medicine, 241, 39, 1949.
(3) INGELFINGER, F.J. "The Unethical in Medical Ethics". Annals of Internal Medicine, 33, 264, 1975.
(4) BEECHER, H.K. "Ethics and Clinical Research". New England Journal of Medicine, 274, 1354, 1966.
(5) BEECHER, H.K. 'Research and the individual. Human studies". Little Brown. Boston, 1970.
(6) JONES, J.H. "Bad Blood: The Tuskegee Syphilis Experiment. Free Press. New York, 1981.
(7) publishing house. "Fraud in Research. Nature, 290, 437, 1981.
(8) For association of ideas, the scandal of the "exploitation" of hazardous industries in the third world comes to mind. "Hazard export: a case for international concern'. Nature, 273, 415, 1978.
(9) PAPPWORTH, M.H. "Human Guinea-pigs: Experimentation on Man". London. Routledge and Kegan Paul. London, 1967.
Annex I: Declaration of Helsinki
Recommendations to guide clinicians on biomedical human subjects research
Adopted by the World Medical Assembly, Helsinki, Finland, June 1964. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975, by the 35th World Medical Assembly, Venice, Italy, October 1983, and the 41st World Medical Assembly, Hong Kong, September 1989.
Introduction
The physician's mission statement is to watch over the health of mankind. He fulfils this mission statement when he develops his knowledge and conscience to the full.
The Declaration of Geneva of the World Medical Association association states this duty of the physician in these words: "To have the health of my patient first and foremost at my heart". And the International Code of Medical Ethics states that "a physician, when administering professional care which may weaken the physical or mental condition of his patient, shall do so only for the benefit of the patient".
The purpose of the biomedical research in humans should be the improvement of diagnostic, therapeutic and prophylactic procedures and the elucidation of the aetiology and pathogenesis of disease.
On the real internship of medicine, most diagnostic, therapeutic and prophylactic procedures carry risks. This is also true of the biomedical research .
The progress of medicine is based on research which ultimately has to rely on human experimentation.
In the field of biomedical research there is a fundamental distinction to be made between those whose purpose is essentially to diagnose and treat the patient, and those whose purpose is purely scientific and which have no direct diagnostic or therapeutic benefit for the person undergoing the treatment research.
Particular care should be taken in the conduct of research that may affect the environment. Attention should also be paid to the welfare of the animals used on research.
Since it is essential for the advancement of scientific knowledge and the alleviation of human suffering that the results of experiments at laboratory be applied to human subjects, the World Medical Association association has prepared the following recommendations for guide for physicians in their biomedical research involving human subjects, subject to future revision. It should be emphasised that the criteria outlined here are simply guide for physicians worldwide. Physicians are not thereby relieved of their criminal, civil or ethical responsibilities under the laws of their own country.
I. Basic principles
1. The biomedical research in humans shall be in accordance with commonly accepted scientific standards and shall be based on previous, properly conducted experiments on laboratory and on animals, and on a thorough knowledge of the relevant scientific bibliography .
2. The design and the method of each experimental procedure on human subjects shall be clearly formulated in a protocol which shall be submitted for study, observations and committee to a specially appointed committee . This committee, independent of the researcher and the sponsor of the research, shall comply with the laws and regulations of the country in which the experimental research is carried out.
3. Biomedical research on human subjects may only be carried out by scientifically qualified persons under the supervision of a clinically competent medical doctor manager . Responsibility for the test subject shall always rest with a medical doctor graduate; never with the test subject himself/herself research, even if he/she has given his/her consent.
4. Biomedical research cannot legitimately be carried out on human subjects unless the importance of its objectives is proportionate to the risk to the subjects. research .
5. Any project biomedical research in human subjects must be preceded by a careful calculation of the foreseeable risks and their comparison with the benefits that may accrue to the subject of the research and to other individuals. Concern for the interests of the subject of the research should always prevail over the interests of science and society.
6. The right of the subject of research to protect his or her integrity should always be respected. Every precaution should be taken to preserve their privacy and to minimise the effect of the study on their physical and mental integrity and personality.
7. Physicians should refrain from participating in human research projects unless they are convinced that the inherent risks are predictable. They should discontinue any research if they find that the risks outweigh the calculated benefits.
8. In publishing the results of his or her research, the physician is obliged to ensure the accuracy of the results. Articles from research that do not adhere to the principles of this Declaration should not be accepted for publication.
9. In any research on human subjects, every potential subject should be adequately informed of the aims, methods, estimated benefits and possible risks of the study and of any discomfort that may be involved. He/she should also be informed that he/she is free to participate or not in the experiment and to withdraw consent at any time. The physician shall then obtain the subject's freely given informed consent, preferably in writing.
10. In obtaining informed consent for project from research, the physician should exercise particular caution if he or she is in a position of authority over the subject, in order to avoid the intervention of any subject of coercion. In such a case, consent should be obtained by another physician who is not involved in the research and who is completely independent of that relationship of authority.
11. In the absence of a legal skill , informed consent shall be requested from the legal tutor of agreement in accordance with the legislation of the country. When physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, the permission of the family member manager substitutes for that of the subject, agreement in accordance with the legislation of the country.
Provided that the minor is in fact capable of giving his or her consent, consent shall be obtained in addition to the consent given by the minor's legal tutor .
12. The protocol of research should always contain a accredited specialization of the ethical considerations given to the case and indicate that it conforms to the principles set out in this Declaration.
II. research medical combined with professional care (research clinical)
1. In treating his patient, a physician must be free to use new diagnostic and therapeutic procedures if in his judgement they offer hope of saving life, restoring health or alleviating suffering.
2. The potential benefits, risks and inconvenience of a new method should be evaluated against the advantages of the best diagnostic and therapeutic methods available at the time.
3. In any medical research , all patients - including those in the group control, if any - should be guaranteed to receive the best available diagnostic and therapeutic methods.
4. A patient's refusal to participate in a research shall not undermine the doctor-patient relationship.
5. If the physician considers that it is essential not to obtain informed consent, he/she should record the specific reasons for this decision on protocol of the experiment for the independent committee referred to in paragraph I-2.
6. The physician may combine medical research with professional care in order to obtain new medical knowledge only to the extent that medical research is justified by its potential diagnostic or therapeutic value to the patient.
III. research biomedical non-therapeutic human subjects (research biomedical non-clinical)
1. When medical research on human subjects is applied for purely scientific purposes, the physician has an obligation to remain the protector of the life and health of the person on whom the research is performed.
2. The subjects, whether healthy individuals or patients in whom the experiment is unrelated to their disease, shall always be volunteers.
3. The researcher or the research team should fail the experience if, in their opinion, continuing the experience could cause harm to the subject.
4. In the research on man, the interests of science and society can never prevail over the well-being of the subject.
Annex II: Articles of the Spanish Medical Code of Ethics on human experimentation
Art. 106.- Experimentation on man with new drugs and new techniques is scientifically necessary; however, such tests may only be carried out after serious animal experimentation has been carried out for a sufficient period of time, and if the results of these experiments, scientifically assessed, demonstrate the likelihood of success.
Art. 107.- Experimentation on healthy human subjects may only be allowed when the subject is of legal age, is at status able to freely give written consent, has been fully informed of the nature of the research, is guaranteed the right to interrupt the essay at any time, and the conditions of medical supervision can cope with any complications.
Art. 108.- The sick expect relief and cure from the doctor. degree scroll Under no circumstances may they be used for the purposes of observation and research without their consent, or if they are incapable, without that of their legal representatives. They may not be subjected to interventions or practices that may cause them the slightest inconvenience or be directly useful to them.
Art. 109.- The essay of new medicines and particularly the double-blinding method cannot deliberately deprive the patient of a valid therapy.
Art. 110.- Any experimentation in medical or surgical therapeutics must be surrounded by moral guarantees appreciated by the provincial Deontological Commission directly or by the Delegation, and scientific solvency, controlled by a competent group , independently of the experimenter. The data must be collected with rigour and protocol.
Art. 111. - In cases of incurable diseases, in the current state of medical knowledge and in the terminal phases of these conditions, the essay of new therapeutics or new surgical techniques must present reasonable possibilities of being useful and take into account, above all, the moral and physical well-being of the patient. Suffering, or even discomfort, must never be imposed on the patient.
Art. 112.- The doctor or the group of doctors who carry out an experiment or a therapeutic test on humans must have total financial independence with respect to any organisation that has commercial interests or promotes a new treatment or a new research.
Art. 113.- Medical ethics prohibits any research that may impair or undermine the moral conscience of the subject or violate his or her dignity.
gradeRegarding the ethics of pharmacological research and clinical trials, the Royal Decree 944/1978 elaborated by the National Centre of Pharmacobiology and the Order of 3.VIII.82 (B.O.E. of 12.VIII.82) regulating the clinical trials of pharmaceutical products and medicinal preparations are of interest.