Commentary on the Code of Medical Ethics and Deontology

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Chapter VI: Reproduction. Respect for life and dignity of the person.

This Chapter, one of the most doctrinally dense in the Code, is also one of the most contentious. It deals with a number of important issues that affect the very depths of a physician's being and acting and deals with situations in which men's differing self-images clash.

Medical respect for life imposes deontological condemnation of abortion and euthanasia. Many nations have decriminalised abortion. Some others are discussing the possibility of decriminalising euthanasia. The Hippocratic tradition, in which professional deontology has its roots, has always rejected with the utmost vigour the use of medicine to cause death.

The Code devotes special attention to medical interventions in the field of human reproduction because this is a highly ethical field, area , in which, in addition, new technical possibilities have been introduced that are highly charged with responsibility. The technical mastery of the transmission of human life offers the doctor great possibilities and no lesser risks, which must be subject to the ethics of respect for life and for persons.

The deontology of transplantation is also included in this Chapter. Although the medical profession and society have already accepted transplantation as a solution to certain clinical problems, the internship of organ or tissue transplantation always has very significant ethical nuances, which cannot be neglected. Moreover, this is a problem that is not only discussed between doctor and patient: the donor is at the heart of transplantation ethics.

The deontological rules of biomedical research are also included in this chapter to emphasise that man, as an experimental subject, remains worthy of respect for his unique dignity.

article 25.1. It is not deontological to admit the existence of a period in which human life has no value. Consequently, the physician is obliged to respect it from the beginning. However, a physician who, within the law, acts in a manner contrary to this principle shall not be penalised.

The Code does not accept the existence of worthless human beings. The duty not to discriminate among patients, imposed on physicians in article 4.2, does not exclude any human being: all human beings are equally worthy of respect. All periods of human life, every human life, including its first and last days, are deontologically equivalent in dignity and demand equal respect from physicians.

Having established this doctrine, article 25.1 imposes respect for life from its beginning. And, obviously conditioned by the law in force, it expresses, without naming abortion, an ethical condemnation of the destruction of prenatal life. There are two points to consider in this article: the perennial deontological obligation to respect prenatal human life is one. The other concerns the dissociation, created by decriminalising legislation, between deontology and legality, which results in the annulment of deontological action in the face of legalised abortion.

1. The obligation to respect human life from its beginning.

Conception marks the beginning of life for every human being. There are no pre-human or sub-human forms of human existence, no stages that do not deserve respect. No sane human being considers it innocent and unethical for another to deliberately kill him for any reason, at whatever point in his existence he chooses to do so.

Following the Hippocratic tradition, the World Medical Association ( association ), in its Declaration of Geneva in 1948, included among the promises of the physician that of "ensuring the utmost respect for human life from the moment of conception". The wording of this commitment was changed in 1983 at the Venice Assembly, which since then has read "from its beginning" instead of "from the moment of conception". This change, which is subtle, almost tautological in appearance, authorises each doctor to determine at his own discretion the moment at which, for him, human life begins. The relativisation of medical ethics is inevitable. Once the legalisation of abortion has been introduced, medical ethics lives under the slavery of the law.

To the decisive question of when each man begins his existence worthy of respect, each answers in his own way: when the sperm penetrates the plasma membrane of the oocyte, when syngamy of pronuclear chromosomes occurs, when the first DNA replication takes place, or when the embryo passes through the n-blastomere stage. Others postulate that there is no obligation to respect until nesting is complete, a biological phenomenon that symbolises the acceptance of the new being by the mother or society. Apart from these biological criteria, other simply conventional or legal criteria have been proposed: the 14th day post-fertilisation (report Warnock), the end of the third month of development, when the foetal brain is capable of capturing and processing sensory stimuli, the deadlines set by the different laws for the internship of abortion, the moment of birth or the moment when legal personality is acquired.

2. The rupture between ethics and legality and its deontological consequences.

The harmony between deontology and legality was broken in Spain with the passing of Organic Law 9/1985 of 5 July 1985, which reformed article 417bis of the Penal Code in the following terms:

"Abortion performed by or under the direction of a doctor in an accredited public or private health centre or establishment, with the consent of the pregnant woman, shall not be punishable when any of the following circumstances apply:

1st. That it is necessary to avoid a serious risk to the life or physical or psychological health of the pregnant woman and that this is stated in an opinion issued prior to the intervention by a physician of the corresponding specialization program , other than the one by whom or under whose direction the abortion is performed.

In urgent cases of vital risk to the pregnant woman, the opinion and express consent may be dispensed with.

2ª. That the pregnancy is the consequence of an act constituting the crime of rape of article 429, provided that the abortion is carried out within the first twelve weeks of gestation and that the aforementioned act has been denounced.

3ª. That it is presumed that the foetus will be born with serious physical or mental disabilities, provided that the abortion is carried out within the first twenty-two weeks of gestation and that the opinion, expressed prior to the abortion, is issued by two specialists from a public or private health centre or establishment, accredited for this purpose, and different from the one by whom or under whose direction the abortion is carried out.

2. In the cases foreseen in the previous issue , the conduct of the pregnant woman shall not be punishable even if the internship abortion is not performed in an accredited public or private centre or establishment, or if the required medical opinions have not been issued.

In the face of legislation, the Code continues to point out that the ethical duty to respect prenatal life is above the permissibility introduced by the law, as it does not depend on the criminal-legal grade of the actions. Any abortion, i.e. the deliberate destruction of a human being before birth, as medically disrespectful conduct, is ethically disqualified, irrespective of what legislators establish about the non-punishability of those who perform abortions in certain circumstances.

It should be noted, however, that, on paper and in spirit, Organic Law 9/1985 is a restrictive law. This must be understood in the light of the Constitutional Court's Ruling 53/1985 which, although ambiguous, established that prenatal life is a legal right that must be protected and that it can only give way in situations of proportionate gravity. If this law were honestly observed, the issue number of legal abortions in Spain would be very small. In fact, the number of abortions performed in public institutions of hospital rank constitutes a minimal percentage of those that are performed in private clinics for profit. In Spain, as in some other countries, the internship abortion is blatantly commercialised. It is therefore understandable that in September 1987, in order to put an end to these abuses, the Central Ethics Commission proposed that legal abortion should be free of charge in Spain, in the conviction that the vast majority of doctors who perform abortions do so, not for medical or legal reasons, but out of a clumsy desire for profit.

Finally, the article establishes that legal abortions will not be deontologically prosecuted: not because it is not maintained, as has already been said, that all abortions are deontologically condemnable, but because the deontological penalty for performing a decriminalised abortion would be annulled in the resource before the contentious jurisdictionmanagement assistant, which any doctor can bring against the decisions of the Colleges (article 76 of the EGOMC). The deontological prosecution of legal abortion would therefore be not only inoperative, but also ruinous for the WTO. The article states, however, that if an abortion does not fall under one of the conditions of decriminalisation, it automatically becomes a punishable misconduct.

article 25.2. Sick embryo-fetal human beings should be treated agreement with the same ethical guidelines, including informed parental consent, that guide diagnosis, prevention, therapy and research applied to other patients.

The Code regulates, in this article, the physician's relationship with his embryo-fetal patient. The doctor is the protector of the life that is beginning. For this reason, when treating a pregnant woman, he modulates his diagnostic manoeuvres and his treatments with due respect for the life that is born. He will guide his decisions with the entire maternal-fetal unit in mind, and will ensure that the mother's benefit is not achieved at the cost of inflicting harm on the foetus.

The ethical prerogatives that medicine recognises for all human beings are extended to the embryo and foetus. The continuity of human life imposes a continuity of ethical respect and of the medical attendance , with its diagnostic, preventive and therapeutic services. The nascent embryo-fetal medicine is a medical specialization program conditioned by the peculiar characteristics of biology and pathology in the different ages of man. It therefore has the same raison d'être as Neonatology, Paediatrics or Geriatrics, and obeys the ethical rules common to all medicine. Its interventions are guided by the same criteria of efficiency and tolerable risk. Just as in postnatal medicine a policy of eliminating worthless lives is not tolerable, in prenatal medicine genetic screening or the systematic destruction of sick or simply excessive embryos or foetuses is not tolerable at issue. If a human being is sick before birth, he or she should benefit from medical progress: many diseases can already be diagnosed and treated.

Embryofetal medicine is a genuinely medical and ethical product; abortion as a treatment for embryofetal disease is not. The first stems from the alliance between medical respect for the weak and the biomedical research . The second is based on the idea that there are worthless human beings who can be discarded.

Some have objected that embryo-fetal medicine puts the pregnant woman at risk of losing her "right to abortion" or of being reduced to the status of a mere container for the foetus, such as when she acts as an intermediary for submission drugs to the foetus or when she undergoes surgery to treat a foetal disease. The article states that the physician should apply for obtain the informed consent of the parents before treating the foetus medically. He or she must, at times, act as an advocate for the unborn child, to protect those who, because of their vulnerability and dependence, are most in need of financial aid. The vast majority of women know that suffering for their children is part of the human function of being a mother. Any mother-to-be will gladly submit to preventive, diagnostic and therapeutic measures to protect her child's health, or refrain from smoking, drinking alcohol or injecting drugs. In order to save her child, a mother is obliged to accept invasive treatments that she can bear without substantial risk to her life and health.

article 26. Physicians shall provide patients who request them with relevant information at subject on human reproduction in order to enable them to make a sufficiently informed and responsible decision knowledge .

Although not all doctors are, nor are they obliged to be, competent in matters of human reproduction, those who, because of the needs of the population they serve or because of the nature of their specialization program, are consulted and must advise on subject must be. This article 26 outlines the general lines of this duty to inform.

The physician will provide relevant information. In a topic so charged with human and moral values, honest and objective information about the procedures available to present-day medicine for influencing procreative processes should be considered as such. Such information should pay attention not only to biochemical or pathophysiological data , but also to psychological aspects, to the significance of human sexuality and the transmission of human life, and to its moral implications. Conflicts may arise in this subject due to differences of opinion between doctors and patients, who have differing convictions about, for example, the moral legality of certain birth control or assisted procreation techniques. These conflicts should be resolved on agreement as indicated on purpose of articles 8.1 and 10. There is a deontological way of respecting the consciences and moral autonomy of individuals, which consists of providing relevant medical information, clearly presenting the morally significant data , clarifying any doubts that may arise and, finally, respecting the individual's freedom of decision.

In order to enable patients to decide with sufficient knowledge and responsibility, physicians should not limit themselves to merely describing the contraceptive techniques available today and their biological advantages and disadvantages or their fees efficiency. He must also provide his patients with clear, objective and unbiased information about the mechanism of action of the various methods, and Degree in which they respect the moral values that patients profess. Respect for the individual and his or her convictions obliges, for example, to communicate faithfully to believers the judgement of the Catholic Church or of the corresponding religious denomination on the legality or illegality of each procedure. Providing this subject information is not an intrusion into the other's private sphere: on the contrary, it is an excellent way of respecting it. Withholding morally relevant information is a disregard for people's moral dignity: it is tantamount to treating them as beings incapable of deciding for themselves, to abusing their consciences.

article 27.1. It is in accordance with professional ethics for a physician, on the grounds of his ethical or scientific convictions, to abstain from internship abortion or in matters of human reproduction or organ transplantation. He shall promptly give reasons for his abstention and, if necessary, offer appropriate treatment for the problem for which he was consulted. He shall always respect the freedom of the persons concerned to seek the opinion of other physicians.

There are basically two issues to consider here: the first concerns the ethical dignity of conscientious objection, or scientific objection, to abortion or participation in matters of human reproduction (and, interestingly, to organ transplantation: see, at purpose, article 29.1). The second indicates the conduct to be followed by the physician when dealing with persons who request information or services to which he objects.

1. Deontology of objection to decriminalised abortion and participation in human reproductive issues.

The deontological congruence of refraining from performing abortions and counselling in matters of human reproduction is based on both ethical reasons and professional considerations: neither abortion is the scientific solution to any medical problem, nor are certain assisted reproductive techniques compatible with the respect due to human life and the dignity of procreation.

Of the legal indications for abortion, only those that are presented as medical indications require a medical-deontological analysis: the so-called therapeutic abortion, to save a woman who is supposedly in serious danger to her life or health caused by continuing the pregnancy; and the abortion of a foetus affected by malformations or illnesses that may induce serious physical or psychological deficiencies.

The decision to treat the woman's illness without resorting to the destruction of the unborn human being stems from a profoundly professional attitude, scientifically and ethically superior to its opposite. Today, given the formidable advances in the clinical management of diseases that can seriously endanger the life of the pregnant woman, no truly competent physician considers abortion to be the treatment of choice for any illness of the mother: abortion is not a superior solution to all other treatment alternatives. Therefore, the physician is morally obliged neither to propose it nor to perform it. Without the need to invoke conscientious objection, the physician, based on the medical art of the day, may refuse abortion on strictly scientific grounds instructions . It is not that he refuses on moral grounds to perform the abortion, but that he offers treatment alternatives that not only offer a solution to the medical problem of the pregnant woman, but also respect the life of the unborn child.

The doctor's refusal to abort foetuses with malformations or defects that seriously impair their further physical or mental development development is justified by the specifically medical respect for deficient life. The attitude of the doctor to the illness of the embryo and foetus has been described under article 25.2. Abortion is excluded as a treatment for the sick foetus, because the eugenicist idea of life free of imperfections, of the "tyranny of normality", is alien to medicine.

It should be added, finally, that medical refusal of abortion of the foetus conceived by the raped woman is ethically based on the obligation to respect all human life (art. 4.1) and on their duty not to discriminate "on the grounds of birth ... or any other circumstance ... or any other circumstance staff or social circumstance" (Art. 4.2). There is a widespread view that "ethical" abortion is morally justified. But the fact that such an abortion destroys an innocent human life cannot be ignored.

2. The conduct of the objecting doctor towards the pregnant woman.

The refusal of an abortion can never mean a moral insult to the person who has requested it. This article points out the deontological path that the doctor must follow: faithful to his ethical and scientific convictions, he will not limit himself to refusing the abortion, but will give the pregnant woman, calmly and clearly, the reasons for his decision. He will offer to treat her in accordance with scientific and professional criteria that respect equally the life and human dignity of the mother and the unborn child, showing the advantages and possible risks of this approach, while explaining the biological, professional and ethical basis for his refusal of the abortion requested.

The physician is repugnant to violence. If his or her offer is refused and the pregnant woman decides to seek another physician who will respond to her wishes, the objecting physician shall terminate his or her professional relationship with the patient. In respecting the woman's freedom, he/she will be guided by the criteria outlined in article 9, at purpose for termination of the physician-patient relationship. The physician is under no deontological obligation to tell the woman which colleagues or which facilities would not make it difficult for her to undergo the abortion operation, for that would be to go against his own conscience and to cooperate in an action that he considers morally unacceptable. It is unacceptable, in good ethics, to act against one's own conscience; it is also unacceptable to profess the moral duplicity of considering that it is morally permissible for others to carry out actions that one considers unethical. This relativistic view, in a more or less attenuated form, is widespread. It appears, for example, in point 6 of the Oslo Declaration on Therapeutic Abortion (1970) of the World Medical Association ( association ) ("If a physician considers that his convictions do not permit him to perform or advise on an abortion, he may withdraw from the case provided that he ensures continuity of care by a qualified colleague"), or article 17 of the Principles of European Medical Ethics ("It is ethical for a physician, on the basis of his or her personal convictions, to refuse to intervene in reproductive processes or in cases of termination of pregnancy or abortion, and shall invite those concerned to apply for to seek the advice of other colleagues").

Interestingly, article includes the possibility for the physician to object to organ transplantation. This issue is addressed in the commentary on article 29.1.

article 27.2. A physician must not be conditioned by actions or omissions outside his or her own freedom to declare conscientious objection. The Medical Associations shall, in any case, provide the necessary advice and assistance financial aid .

The protection of the freedom of those who claim conscientious objection is a matter required by the protection of professional independence (see article 22.1). Recent history, in other countries and, episodically, also in our own, sample that objecting physicians may be subject to discrimination by other colleagues or by those who run the health care institutions in which they work.

There is no moral life without freedom, and no professional responsibility without independence. The article encourages physicians to oppose any action that seeks to diminish their freedom or to discriminate against them because of their seriously matured and sincere ethical attitudes. It does so not only in the name of the rights to ideological freedom and freedom from discrimination enshrined in the Spanish Constitution (article 16: "The ideological freedom... of individuals and communities is guaranteed.... No one may be forced to declare their ideology, religion or beliefs"; article 14: "Spaniards are equal before the law, and no discrimination may prevail on the grounds of birth, race, sex, religion, opinion or any other condition or circumstance staff or social"). It also does so in order to fulfil the statutory duty to "defend the rights... of the members... if they are subjected to vexation, undermining, disregard or disregard in professional matters" (article 34, b, of the EGOMC) and to respond to the right of members "to be defended by the high school or by the committee General when they are vexed or persecuted on account of their professional practice" (Art. 42, b of the aforementioned EGOMC).

The most fearsome forms of discrimination are not, however, the blatant deprivations of rights, but the techniques that are often used to subtly and finely bend the moral resistance of those who do not bow to the wishes of those in power. There are legal channels to counteract serious unjust reprisals (dismissals, transfers, opening of files). But there are none to defend against these other forms of ideological torture by which the objector can be discriminated against.

The Medical Association undertakes to provide moral support and advice to members whose professional freedom is under attack. It will be able to do so effectively in cases where the directors of institutions or groups of work, intolerant of objection, are members of the medical profession.

article 28.1. A physician shall never intentionally cause the death of a patient either by his or her own decision, or at the request of the patient or the patient's relatives, or by any other requirement. Euthanasia or "mercy killing" is contrary to medical ethics.

This article condemns without extenuating circumstances or exceptions the internship of euthanasia: the doctor can never recognise any motive to justify it, since all euthanasia is an intrinsically unethical action: it is a homicide, even if subjectively it may have been carried out out out of compassion. This categorical medical condemnation of euthanasia contrasts with certain attitudes that seem to be widespread in society, result perhaps from the pro-euthanasia activism that, in recent years, has spread its message in favour of the decriminalisation of (medical) financial aid voluntary suicide and the right of individuals to decide the time and manner of their own death.

First of all, the confusion surrounding the term euthanasia should be dispelled as far as possible. In the deontological context, euthanasia is understood to mean the deliberate and painless killing of patients who claim to be victims of unbearable suffering or extreme incapacity, usually by gestures that appear to be medical, in order to relieve them of their suffering status and to relieve society of a useless burden. This definition highlights the general features - deliberate killing, for medical reasons and by medical means - of euthanasia and makes irrelevant the distinction between the active form of euthanasia (that caused by the application of a lethal and painless treatment) and the omissive form (that caused by the deliberate omission or suspension of care, necessary and effective, for cure or survival).

This is how the notion of euthanasia is to be understood today in the ethical-medical context. The Declaration on Euthanasia of the association World Medical Association (Madrid, October 1987) begins: "Euthanasia, i.e. the deliberate act of ending a patient's life, whether at the patient's own request or at the request of relatives, is unethical". And the conclusions of the group of work of the British Medical Association to review the association guidelines on euthanasia, made public in May 1988, read: "The law should not be changed. The deliberate killing of a human being must remain a criminal offence. This rejection of any change in the present law, so that doctors would be allowed to intervene to end a person's life, (...) is, above all, an affirmation of the supreme value of the individual, no matter how worthless or hopeless he or she may feel.

As necessary as an unambiguous definition of euthanasia is the use of the terms by which it is designated. Euthanasia activists use misleading terms such as neonatal triage, nursing care only, passive euthanasia, aid in dying, or dying with dignity. They use, in particular, the latter two expressions both to designate the mercy killing of unhappy or useless people, and to demand the right to be killed, painlessly and with the doctor's financial aid , in the place, time and manner of one's choice.

The ethical judgement of euthanasia committed by action does not seem to present many difficulties, nor that of gross forms of euthanasia by omission, as defined above. But there is some confusion about the ethical problem of not applying or fail medical care.

Indeed, not applying or fail medical care may sometimes be a form of euthanasic conduct (deliberately killing or allowing a patient to die), while at other times it is the correct way of fulfilling the ethical mandate, imposed by article 28.2, not to subject the incurable and terminally ill patient to futile and demonstrably ineffective treatment. Not applying or fail medical care is also an ethical way of respecting those patients who refuse to undergo certain treatments, for the physician may not, except in cases of obvious incapacity or loss of reason, violate the patient's wish not to be treated. The patient has an ethical duty to care for his or her health and life and to accept treatments to preserve them, if they offer a reasonable hope of benefit and can be obtained and applied without serious inconvenience, pain or expense. The patient may, therefore, refuse treatment that does not offer a reasonable hope of benefit and which cannot be received except at great suffering, or at great expense or inconvenience.

The old problem of life-shortening treatment, once known as indirect euthanasia, can now be considered to have been overcome. Recent advances in the treatment of pain and terminal illness have eliminated the risk of anticipating the real but involuntary death of certain patients: compassionate death can no longer be invoked today as the only resource against intractable pain. There is therefore no medical-professional need to legalise euthanasia or the medical financial aid suicide: there are medical resources to treat terminal illness, pain and depression. The deliberate death of patients is not a solution to any medical problem.

Legal tolerance of euthanasia, even the most restrictive, would inevitably lead to a brutalisation of medicine. For if doctors knew that they would go unpunished, whether they treat or kill certain patients, their vocation as caretakers of life would be extinguished. Moreover, permissive legislation is intrinsically expansive: the restrictions imposed in legal texts would fall away in the face of the unstoppable drive of the utilitarian demand to eliminate unproductive or inconvenient lives.

In addition, the medical profession would suffer serious damage to its scientific and ethical vocation. It would become progressively indifferent towards certain types of patients and its interest in vast areas of pathology would decline. For if, for example, it were possible to cleanse humanity of "rubbish Genetics" by means of low-cost neonatal euthanasia, the basic and applied research of hereditary diseases would lose all interest; and if Alzheimer's disease sufferers were given sweet death as their first option, there would no longer be any serious reason to study the causes and mechanisms of dementia.

article 28.2. In the case of incurable and terminal illness, the physician shall confine himself to alleviating the physical and moral pain of the patient, maintaining as far as possible the quality of a life that is coming to an end and avoiding taking or continuing hopeless, useless or obstinate therapeutic action. He shall assist the patient to the end, with the respect due to the dignity of man.

This article establishes, first of all, the physician's obligation to attend the incurable and dying patient and to care for him in the terminal phase of his illness, alleviating his pain and anguish. It goes on to condemn therapeutic overkill. It concludes with the proclamation that, in the terminal phase of life, medical care must continue to respect the dignity of the sick person.

1. The high professional value of palliative medicine, which requires as much science and experience as other medical specialties, cannot be overemphasised. In a Declaration on Euthanasia, issued by the Central Commission on Deontology in June 1986, it is stated that " attendance medical care of the dying is one of the most important and noble professional duties.... The physician is obliged to perform his genuine function of assisting and caring for the dying of his patients by competent treatment of pain and anguish. He shall endeavour to provide for the greatest material well-being; he shall, according to circumstances, promote the spiritual attendance and human comfort to the dying; he shall also lend his support to their relatives".

Thus, the doctor cannot remain oblivious to the needs of the patient and those close to him, and must know how to comfort them in this final trance. To this end, in addition to sufficient knowledge of palliative medicine, he or she must be sensitive to the physical and moral needs of the dying person and cooperate to ensure that he or she does not lack the human comfort and spiritual care that is usually the primary need of the patient and his or her family and friends.

2. On the other hand, this article condemns obstinacy or therapeutic stubbornness. All useless treatment is ineffective. data This is not because the physician practises a utilitarian ethic, but because demonstrably ineffective treatment, especially when it involves the use of expensive technology and separates the patient from attention with family and friends, is first of all an error of therapeutic indication: the physician ignores beyond what is tolerable the prognoses of the case he is treating and applies remedies incapable of opposing the already ineluctable course of the disease. The physician, for example, is obliged to judge objectively and conscientiously when a patient should be admitted to an intensive care unit because his condition is a critical episode from which he can be rescued; and when he should not, because his terminal illness no longer has a medical remedy. Physicians must have the moral rectitude not to offer or permit intensive care or any other aggressive intervention when, judged in the circumstances of the case, they conclude that it is inoperative. There is a need for knowledge and serious investigation of the constellations of prognostic factors, so that the decision to treat or not to treat is not the result of intuition or humour, but a prudent and informed action.

On other occasions, therapeutic incarceration is not result of medical incompetence, but result of a falsification, sometimes commercial, sometimes political, of the aims of medicine. In both cases, it is an ethical error with the aggravating factor that it provides euthanasia activists with their main argument for claiming the right to die with dignity.

The aforementioned Declaration of June 1986 stated that "the physician dignifies death when he refrains from painful and unjustified treatment and when he discontinues such treatment because it is no longer useful". Deontology imposes on physicians the duty to recognise the limits of medical action, even when aided by the most powerful technology, to be aware that technological abuse causes suffering, humiliation and indignity to the patient and the patient's relatives, so that medicine is branded as inhumane and haughty.

article 28.3. The decision to terminate artificial survival in case of brain death shall only be taken on the basis of the most rigorous scientific criteria and the guarantees required by law. Before fail care, two qualified doctors, independent of the team in charge of obtaining the organs for transplantation, shall sign a document authenticating status.

This article addresses the problem of fail the means of artificial survival in patients who appear to have already experienced death, clinically manifested as brain death, when the aim is to obtain, in the best possible conditions, organs for transplantation. The problem is not directly related to the circumstance, considered in the previous article , of avoiding the prolongation of care that is already inoperative: the criterion is the medical judgement of uselessness, of no therapeutic indication. It is now a question, in the event of organ donation for transplantation, of avoiding even the most distant risk of "killing" the donor.

attendance It is stipulated that the artificial support of vital functions (by means of assisted breathing machine, cardiac stimulation, pharmacological financial aid ) cannot be withdrawn until a diagnosis of brain death has been established according to the most reliable scientific criteria and as prescribed by law. These requirements will change as our knowledge improves: they are periodically reviewed by the bodies concerned with providing technical and ethical guidelines on the subject. In addition to the rigorous scientific criteria for the diagnosis of brain death, it is also important to bear in mind the legal regulations in force, which require certain guarantees in order to be able to make an objective diagnosis of death and to proceed, if necessary, to obtain organs for transplantation. These rules, contained in Royal Decree 426/1980, which develops Law 30/1979 on organ extraction and transplantation, are commented on in articles 29.1, 29.2 and 29.3.

article 29.1. Given the benefits of organ transplantation, it is the physician's obligation to encourage donation.

Although article 27.1 recognises the moral right of physicians to refrain, on the basis of their convictions, from participating in organ transplantation issues, it imposes a duty on physicians to encourage donation. Their success in this field will depend to a large extent on their ability to disseminate correct information and to echo social initiatives and professional bodies that promote this significant aspect of human solidarity among the public. In addition to playing an active role in creating a favourable environment for donation, physicians have a responsibility for which no one can take their place: that of being vigilant in seizing every opportunity to obtain organs for donation, so that none are lost. Many opportunities for donation are missed every year, and many lives are lost or condemned to a precarious existence, because doctors do not take a more active role in this field, especially since the availability of efficient computer systems at regional, national and even international level, which make it possible to assign the organs obtained to the most suitable recipient in each case.

To achieve the goal goal of encouraging donation, physicians must inform the public about the benefits of transplantation. The data that physicians should offer to the general public or to those who question them on the subject are of two kinds: legal and medical.

The basic legal texts that, in Spain, regulate organ removal and transplantation are Law 30/1979, of 27 October, Royal Decree 426/1980, of 22 February, which develops it, and others of lower rank that complement them (for example, the Order of 24 June 1987 on the obligation of HIV detection). The legal information to the public will deal with the skill of the medical centres that carry out these operations and the free and anonymous nature of the donation; the requirement, when it is a donation between living persons, that both the donor and the recipient grant, once informed of the advantages and risks of the operations to which they are subjected, their express, free and conscious consent; when the organ to be transplanted is obtained from a corpse, apart from the verification of death, it is required that the deceased had not declared in life his or her civil service examination to the donation. The article 428 of the Penal Code, which exempts from criminal liability the physician who, in accordance with the law and if average the free and express consent given by the living donor, removes an organ for transplantation, establishes, however, that liability is incurred if the consent has been obtained viciously or by means of price or reward, or when the donor is a minor or incapable, in which case the consent given by the donor himself or by his legal representatives will not be valid.

The medical information to be provided by the physician should include an objective and understandable description of the techniques and results. The physician should also educate the public and, in particular, prospective living donors about the immediate and long-term risks deadline, and about the conditions necessary to give informed consent and Exempt of coercion or other psychological conditioning that limits full freedom of decision. It will also inform the intended recipients of the risks and benefits of transplantation in terms of quality of life compared to alternative treatments; of the outcomes and expectations in relation to the donor's and recipient's age; and finally, of the ethical, religious, social and psychological considerations involved.

agreement Obviously, if, in accordance with the provisions of article 27.1, a doctor presents a conscientious objection to the internship of transplants, which is certainly an exceptional eventuality, he/she is not bound by this article.

article 29.2. For the removal of organs and tissues from cadavers, at least two physicians shall verify the death of the patient, agreement with the latest scientific data . These doctors shall be independent of the transplantation team manager and shall draw up their reports. The harvesting physicians shall verify by all possible means that the donor has not expressed, in writing or verbally, his refusal to donate.

The body of a dead person can be used for the procurement of organs for transplantation, including odd organs. This establishes the scientific, deontological and legal requirements that must be complied with in order to establish the diagnosis of death, which must be certified by two doctors knowledgeable of the subject, who must be independent of the team that will, if necessary, carry out the removal of the organs for transplantation.

It is neither lawful nor ethical to harvest odd human organs before death. Included in this prohibition are anencephalic neonates, who are to be treated not as packages of organs to be transplanted into other children, but as human beings, whose organs may only be removed after their death has been established.

This article also requires that it is proven that the deceased did not express in life, in writing or verbally, his or her civil service examination to the donation. Spanish law presumes that all have given their tacit consent, unless they have personally expressed their will to the contrary. And, although R. D. 426/1980 recognises as valid the civil service examination to organ removal expressed by relatives or guardians only in the case of minors or mentally handicapped patients, the Code chooses to impose on the doctor manager to remove the organ the deontological duty to seriously investigate whether the presumed donor had rejected the donation, logically asking those close to him and following their opinion. It is not ethically correct to disregard this formality and remove the organs stealthily from the family: this would be tantamount to giving an operation so full of ethical values a clandestine and inhumane character.

In his or her efforts to obtain free and informed consent, the physician may not reveal to either party the identity of the donor and recipient.

article 29.3. For organ transplants from living subjects, two doctors shall certify that the donor's general condition is not affected. The doctor manager shall ensure that the donor has given free consent, without any violence or emotional or financial pressure.

This article insists on the need to verify that the donation (of a double organ, part of an organ) will not cause foreseeable damage to the general physical and mental health of the donor. This must be verified by two doctors at certificate . It is their responsibility not only to exclude the possible risks for the recipient that could arise from any illness of the donor, but also to include in the certification the statement that, in their opinion and after making the appropriate checks, the removal of the organ will not cause harm to the donor's health.

It is up to the doctor who removes the organ or tissue to be transplanted to verify, beyond reasonable doubt, that the donor acts with plenary session of the Executive Council knowledge of the risks and possible consequences of the donation, and that his or her decision is free, voluntary and given without violence or price. It must exclude even more or less subtle forms of emotional or economic pressure. This discernment of the voluntary nature of the donation is also a legal requirement: article 429 of the Penal Code decriminalises the removal of an organ only under this condition, as it would otherwise be considered a criminal offence of mutilation.

This criterion of voluntariness provides the basis for ethically condemning the use of human embryos and foetuses as source of tissues or organs for transplantation when abortion is provoked for this purpose. This is also prohibited by Law 42/1988 on the donation and use of human embryos and foetuses or their cells, tissues or organs, which states in its article 3, 2 that "The termination of pregnancy shall never have as its purpose the donation and subsequent use of embryos or foetuses or their biological Structures ". The embryo and foetus, even when they are non-viable, must receive the same attention as other human beings: they may not be caused to die or be made victims of vivisection for the purpose of purpose to further the interests of other individuals. This is required by the respect that doctors must show towards all human beings, including the unborn (articles 25.1 and 25.2 of the Code).

article 30.1. Physicians must never participate in, support or condone acts of torture or ill-treatment, regardless of the grounds invoked. On the contrary, they are obliged to report them to the competent authority.

This article contains a strong condemnation of the use of medicine for inhumane purposes and, in particular, for torture in any form. The doctrine underlying this article is that of the Declaration adopted in Tokyo in 1975 by the World Medical Association ( association ) to define the ethical conduct of physicians with regard to torture and other cruel, inhuman or degrading treatment. For its part, the Permanent committee of the Physicians of the EC (Declaration of Madrid, 1989) has urged its member medical organisations to ratify the Declaration of Tokyo and to incorporate its essential content into their respective codes of professional conduct.

It is therefore appropriate to outline here the basics of the Declaration of Tokyo. It states, in its preamble, that the physician has a role exclusively in curing disease and protecting life and health; that it is the physician's constant purpose function to restore the patient to normality, without discrimination or personal prejudice. He may never deliberately harm those who come to him, nor weaken their health or impair their capacities, unless this is required by solid and strict therapeutic indications that seek the cure or relief of the patient, not their harm. It reiterates once again the clause, taken from the Declaration of Geneva, whereby the physician undertakes never to use, even under threat, his or her knowledge contrary to humanitarian laws.

The Declaration prohibits physicians from favouring, accepting or authorising torture internship . As a physician, he or she shall refrain from passing judgement on the convictions or ideologies that may motivate torturers or their victims, regardless of whether the events occur in times of peace or war. purpose Torture is defined as the deliberate infliction of physical or mental suffering on a human being, systematically or capriciously, by one or more persons acting alone or under the orders of any authority, for the purpose of extracting information from the victim, making him or her plead guilty or for any other reason. Physicians must resist any pressure, from whatever source, to witness or advise on acts of torture or to use their place of work, their instruments, or their knowledge to inflict punishment or to undermine the mental health, resistance to interrogation, or freedom of decision making of individuals. There are no legal, social or political reasons that can justify the misuse of medical techniques for unprofessional purposes. Finally, the association World Medical Association calls for support for physicians who may suffer reprisals or threats for their reluctance to cooperate in torture. (The Declaration refers, in one of its points, to the behaviour of physicians in dealing with prisoners who refuse to feed themselves, a problem discussed at purpose of article 32).

The obligation of physicians to report torture and ill-treatment to the competent authority is added to the standards of the Tokyo Declaration by article 30.1. This may, in certain circumstances, involve no small sacrifice or risk. When, because of socio-political circumstances, it is not possible to fulfil the duty to report to the competent authority practices of torture that the physician has learned of in the course of treating certain victims, or to report colleagues who have been involved in such practices, the physician should endeavour to report such incidents to colleagues abroad, to the leadership of the World Medical Association association , or to international human rights associations. It is important to remember that the complaint cannot have political overtones: its content is exclusively concerned with the misuse of the physician's knowledge and skills.

The World Medical Association ( association ) has also condemned the participation of physicians in the execution of the death penalty in a Resolution adopted in Lisbon in 1981.

article 30.2. A physician who becomes aware that any person, especially a minor or incapacitated person, for whose care he is required, is being subjected to ill-treatment, shall take the necessary steps to protect him by bringing him to the attention of the competent authority at knowledge .

This article imposes a particular obligation on physicians to protect those who are abused or ill-treated, especially children and the disabled. Although he or she must treat all patients equally, an exception to the principle of non-discrimination is established here (article 4.2): the duty to take special care of the weakest, to protect those who are unable to defend themselves against unfair assault, abuse or ill-treatment.

There appears to be a widespread epidemic of abuse of infants and young children, in the form of cruel physical assault, deprivation, moral harm or sexual abuse. Nor have the elderly been spared ill-treatment by their relatives and by staff of some institutions, public or private, that care for them position. For reasons of public health and humanity, physicians must combat this epidemic. In order to do so, mission statement , physicians must be able to recognise and detect typical injuries caused by ill-treatment and abuse of the skin, locomotor system or internal organs; they must learn to suspect and diagnose, through the psychological and anatomical manifestations of the victims, cases of sexual abuse perpetrated against minors.

When he has become convinced of the existence of cruel treatment of weak human beings, because he has gathered sufficient evidence or solid and well-founded suspicions, he is obliged to report the case to the competent authority. This is one of the universally accepted derogations from professional confidentiality, which may not be used to conceal or cover up injustice or wrongdoing. The physician should never allow himself to be led astray by light suspicions, which logical moral indignation tends to amplify. He or she must check them seriously, even if this sometimes requires removing the victim from his or her usual environment and admitting him or her to hospital.

The World Medical Association ( association ) has published Declarations on the Abuse and withdrawal of Children (Singapore, 1984; Hong Kong, 1989) and on the Abuse of the Elderly (Hong Kong, 1989; Jerusalem, 1990).

article 31. In no case shall a physician withhold care from a patient in need of care because of a suicide attempt, hunger strike or refusal of treatment. They shall respect the freedom of patients and shall try to persuade them to desist from their conduct, applying, in borderline situations, and subject to judicial authorisation, the indispensable medical attendance .

This regulates the doctor's conduct in three situations in which the patient attempts against his life or neglects his duty to preserve his health: attempted suicide, hunger strike and refusal of treatment. These three situations have, in addition to certain common features, some very different nuances. The doctor's conduct, however, is well defined: he cannot refuse his attendance to these patients.

1. attendance from the doctor to the person who has attempted suicide. The physician must cure the person who has attempted suicide of his or her injuries and then help him or her to return to the life he or she has regained and try to prevent further attempts. Those who argue that physicians should refrain from treating those who have decided to commit suicide are wrong, because their life-saving intervention runs counter to the autonomous decision of the victim who has decided to end his or her life are wrong. Experience indicates that the vast majority of those who have attempted suicide are grateful to those who rescued them from death. Apart from caring for the victims of attempted self-destruction, physicians should also contribute to the fight against this endemic evil in our society: they should know something of the epidemiology of suicide in order to detect the risk factors and intervene in them (the deontological condemnation of medical cooperation in voluntary suicide has already been commented on at purpose from article 28.1).

2. The attendance doctor to the hunger striker. In the event of a hunger strike, the doctor, regardless of his or her own judgement on the strike and its motivations, will respect the will of the hunger striker as long as possible, will help him or her by informing him or her of the consequences of his or her conduct, and will offer advice and appropriate treatment, trying to persuade the hunger striker to abandon his or her attitude. He shall warn the striker if prolonging the fast would seriously damage his health or endanger his life.

What the doctor should do at this critical moment is a matter of debate. It depends largely on one circumstance: whether the hunger striker is a free man or a prisoner. If the hunger striker is a free man, it is highly recommended that the physician, prior to the initiation of the hunger strike, agree with the hunger striker that he will stop fasting when the physician deems it necessary to preserve his life. In general, the free hunger striker never intends to carry his fast to death.

The imprisoned striker may radicalise his behaviour and decide to prolong his fast until death. The doctor will inform him of the biological effects of his behaviour and of his willingness to provide medical care at all times. This can lead to very complex situations, as the doctor cannot impose forced treatment on a person who voluntarily and consciously refuses it. The prison doctor, who is statutorily obliged to visit the striker every day, cannot break his professional relationship with him, although what is stated in article 43.3 of the Code could be applicable in this circumstance: the doctor, faced with the patient's refusal to be treated, withdraws and transfers to the prison doctor the responsibility to resolve the situation with the patient's consent. director the prison director the responsibility for resolving the conflict with the prisoner. However, the Code is restrictive: at the status limit, the doctor will apply the essential medical attendance , after requesting the authorisation of the judge, in order to protect himself from any judicial eventuality. The conduct envisaged in the Code deviates from the rule established in one of the points of the Tokyo Declaration, which states: "A prisoner who refuses to feed himself and whom the doctor considers capable of making a conscious and rational judgement about the consequences of his refusal of food shall not be artificially fed. The decision concerning the prisoner's ability to make such a judgement shall be independently confirmed by at least one other physician. The physician shall explain to the prisoner the possible consequences for his health of his decision not to be fed.

In Spain, the Constitutional Court has recently declared, in its judgement 121/1990, that the preservation of life is, in this status, a good that must prevail over respect for autonomy.

3. Refusal of necessary treatment. The ethical problems created for the physician by patients who refuse to follow the prescribed treatment vary widely. In many cases these are minor omissions in the treatment plan: sometimes, rather than a manifestation of rebellion, they are a veiled warning to the physician that his prescription has not been correct and that changes in treatment should be made. In such cases, the doctor's conduct must be guided by tolerance and acceptance of the patient's indications.

When the patient does not follow treatment guidelines or does not follow basic elements of the treatment plan, the physician will have to consider what Degree of energy can and should be used to bring the patient to his or her senses. Intelligent and sympathetic negotiation can solve many problems. A physician, having tried in vain to persuade his or her patient, may, if the patient insists on not complying with the proposed plan, consider that he or she has lost the patient's trust and may consider fail their relationship in accordance with article 10.

Reference should be made here to the physician's behaviour towards patients who, for cultural or religious reasons (see article 8.1), refuse life-saving treatment, such as Jehovah's Witnesses. They refuse transfusion of blood and red cell or platelet concentrates and have different attitudes towards the administration of blood products, haemodilution and transfusion of blood recovered from the operative field. The physician is, in principle, obliged to respect these attitudes as long as they do not interfere with acceptable medical care. He is even morally obliged, out of respect for individuals, to seek out-of-the-ordinary solutions to carry out his interventions (in surgery, in anti-tumour chemotherapy, in emergency medicine) without harming the convictions of his patients. He must inform his patients sincerely and honestly about the risks they run by reason of their refusal. And he must judge whether, in conscience, he can undertake the care of the case in a way that respects the patient's wishes. If the physician believes that, in certain circumstances, he cannot in good conscience assume the risk of foregoing transfusion or of applying a less satisfactory therapeutic alternative, he may fail the relationship with his patient. It does not seem in keeping with the ethics of respect to deceive a patient benignly by promising to follow a course of action and then breaking that promise.

When parents or guardians of Jehovah's Witnesses impose a prohibition on the transfusion of blood or blood products to minors or incapacitated persons, the physician, after obtaining judicial authorisation application , may administer such treatment even in contravention of the prohibition.

In case of urgency, see article 11.3.

article 32.1. Progress in medicine is based on research and therefore cannot, in many cases, do without experimentation on human beings, their health being a priority for researcher.

The necessity of research for the progress of medicine and the ethical value of this progress is proclaimed here. The immeasurable difference in scientific rigour and curative efficacy between today's medicine and that of years past is due to the astonishing achievements of biomedical research . And if nobody doubts the need for biomedical research , nobody doubts that it must be subject to certain rules: some, to make it correct and effective from a scientific perspective; others, to ensure that it respects certain ethical requirements. The former are self-justifying, since orthodox medicine is basically an application of natural science. The latter are imposed by the ethical dignity of man, the subject and object of research, whose health is its primary purpose.

The article states that experimentation on human beings is a moral duty, as the progress of medicine depends on it. There is a general ethical duty to contribute to it, should the occasion arise, out of an imperative of solidarity which, although voluntary, strongly appeals to the responsibility of all, healthy and sick. There is also a professional duty to carry out research, which is part of the medical vocation, in order to strive for the improvement of current medicine, making it more beneficial and effective.

article points out that experimentation on human beings is essential, as medicine is based on the natural-scientific method. Obtaining new knowledge is based on the construction of hypotheses that are not proven by logical reasoning or theoretical deduction, but by empirical demonstration (verification or falsification). Although always necessary, the data and results obtained in animal experimentation are not directly transferable to the human species. animal experimentation is a great financial aid. Moreover, it is an ethical and methodological prerequisite for research on human beings. But the physician, before applying a new remedy to his patients, has to answer honestly the question whether this procedure, which has shown a certain efficacy in the animal laboratory or in in vitro tests, is really effective and in what way Degree when applied to humans. This question cannot be answered without human experimentation.

The article ends with the statement that the health of the individual human subjects being tested is the primary interest of the physician researcher. The indication applies to all medical internship , as stated in article 4.3. But it is particularly demanding in the context of biomedical research , where the physician must weigh even minimal risks to the health of the human subjects, healthy or ill, who participate in the experiments. They cannot be harmed for the benefit of others. The subjects of research are patients for whose health the medical experimenter is responsible. On this point, see Articles 32.2, 32.3 and 32.4.

article 32.2. The protocol of any planned experimentation on human subjects must be submitted to an Ethics or Clinical Trials Committee for prior approval.

The tragic mistakes made by Nazi doctors, and not only by them, in design and conducting experiments on human beings, led to the promulgation of two documents that set out the fundamental ethical rules for biomedical research . The first, historically, was the Nuremberg Declaration (actually a part of the 1948 judgement against Nazi war criminals) which established that the free and informed consent of the subject undergoing experimentation on human beings is an absolute condition for experimentation on human beings research. research The second was the Declaration of Helsinki (1964, revised in 1975 and 1983), which, in addition to recapitulating the Nuremberg rules, establishes the obligation to submit project in advance to the approval of an ethics committee , which also assumes a supervisory function of the approved research .

This article requires the creation and maintenance of commissions to evaluate the ethical aspects of research projects. Firstly, the ethics committee of the institution in charge of carrying out the project or within which it is to be carried out. And, if this committee does not exist, it could be replaced, in the case of a clinical pharmacology work , by the Clinical Trials Committee provided for in Royal Decree 944/1978, whose functions and composition are set out in the Ministerial Order of 3 August 1982.

Such committees should examine whether the project of research is ethically and methodologically sound and whether the researcher team possesses the necessary technical and scientific skill . They may apply for, if necessary, the opinion of experts on subject.

The existence and function of these committees has been fully accepted by the academic community, which does not see them as an obstacle to the freedom of research, but as a financial aid. No one can reasonably object to having their projects evaluated, since, on the one hand, biomedical research can never be a clandestine or secret activity, and, on the other hand, it must be subject to the loyal judgement of peers, revealing the hypotheses on which it is based, and the Materials and methods used in it. It is advantageous for researcher to be open to constructive criticism from colleagues and to negotiate with them on the extremes of their project that they deem unsatisfactory.

The more specific role of the ethics committee of research is to analyse ethically the conditions under which informed consent is obtained from the subjects of research, the magnitude of the calculated risks and benefits, and the safety safeguards built into the project.

There is a danger that institutional ethics committees may routinely perform their work role and simply rubber stamp their nihil obstat on the projects sent to them. They may also succumb to pressure from their colleagues or from those who govern the institution (it should not be forgotten that the prestige of medical centres is partly built on their achievements at research and that research is one of the most profitable investments in prestige), as these colleagues or directors often have the power to appoint or dismiss members of committee at their discretion from research. What is really important is that researchers and committee members always bear in mind that the quality of their work comes as much from their respect for the intellectual and technical demands of science as from their respect for the human being, the subject of research.

article 32.3. Biomedical research on human subjects shall include the ethical safeguards required by the relevant Declarations of the association World Medical Association. Particular protection in this matter is required for biologically or legally weak or vulnerable human beings.

The standards (technical and scientificskill of group researcher , informed consent for experimentation, the role of the Ethics Commission in the assessment of biomedical research projects), the ethical guarantees required by the Declaration of Helsinki, referred to in the first part of the article, have already been described in the commentary to the two preceding articles.

In its second part, it states that weak or otherwise disadvantaged human beings also have the right to have their specific problems addressed by research, but that this must be surrounded by special precautions to prevent abuse or exploitation of their handicap. There are some shocking examples in the recent history of medicine of abuses perpetrated on members of racial minorities or institutionalised persons. Those charged with protecting them betrayed their duty and facilitated ethically unacceptable experiments.

Ethics Commissions should take special care to protect the weak. They will only authorise internship for research that may be of direct benefit to them and will refuse to approve any project that presents a risk of abuse or exploitation.

Human beings who are particularly vulnerable to experimentation are well identified, by degree scroll biological or legal means: embryos, foetuses, children, pregnant women, the elderly, the mentally handicapped, terminally ill patients, people in penitentiary or welfare institutions, the poor. It is said that also medical and nursing students may be unfairly pressured by their professors to participate in experiments as healthy subjects or as part of control groups. There is an export of human experimentation risks: there has been talk of scientific colonisation when patients from poor countries are subjected to experiments that could not be authorised in rich countries.

The members of the Ethics Committees must be guided by an ethical rule of great significance: the ratio of proportionality between weakness and deontological respect. This rule was formulated by the French National Consultative Ethics Committee for Life and Health Sciences, committee , in its opinion on the employment of human beings in a chronic vegetative state in experiments that did not benefit them, with these words: "They are human beings who are all the more entitled to the respect due to the human person the more fragile the state in which they find themselves. They can never be treated as a means of scientific progress, whatever the interest or importance of the experiment, if it is not aimed at improving their condition".

article 32.4. The free consent of the individual who is the subject of the experimentation, or of the person who has the duty of care in the case of a minor or incapacitated person, shall be obtained after adequate information has been given on the aims, methods and expected benefits, as well as on the potential risks and discomforts. They shall also be informed of their right not to participate in the experimentation and of their right to withdraw at any time without being harmed thereby.

This article describes the conditions for obtaining the free and informed consent of the experimental subject and the information that must be offered to him/her so that he/she can decide with due knowledge. An extensive legal and ethical doctrine has already developed on the necessary freedom to consent, which must be supported by the assurance that the presumed subject of the research, whether he/she accepts or refuses to participate in the essay, will not be the victim of any subject discrimination.

An overemphasis on free and informed consent for research has, in fact, a paradoxical effect: it goes from a protective resource to a distinct disadvantage, as it makes orphans of medical progress out of those human beings who cannot consent, because they are either incapable of understanding or lack freedom. The article solves the problem by transferring the responsibility of consent to those who have the duty to care for and protect the incapable. This is intended to prevent minors and handicapped people from being exploited as human guinea pigs, as the caregiver is supposed to be able to exercise a balanced judgement about the risks and benefits of experimentation.

The second part of article 32.4 contains a brief enumeration of the elements of the information necessary to obtain informed consent. The information is required to be comprehensible to the subject and to relate to the purposes of the research, a sufficient and concrete description of the procedures to which the subject will be subjected, the nature and intensity of the benefits sought by the project, the foreseeable discomforts and risks that the experiment may cause and how they will be avoided or dealt with to minimise their effects. Finally, the subject should be told that he/she remains free at all times to withdraw from the research, without any harm being done to him/her. The information must be truthful and authentic, which excludes deception and mental reservation . The researcher may be presented with difficult situations in order to make the truthfulness of the information compatible with the methodological need to eliminate any systematic bias in the subject's answers or reactions.

article 32.5. The risks or discomfort involved in the experimentation on the healthy person shall not be disproportionate or detrimental to his or her moral conscience or dignity.

This article summarises the gist of Section III (research biomedical non-therapeutic human subjects, research biomedical non-clinical) of the Declaration of Helsinki, which establishes the important difference between research clinical - that which may benefit the patient by seeking to diagnose or treat his or her disease - and research biomedical non-clinical, non-therapeutic, which is performed on voluntary subjects, whether healthy or ill, and who will not receive any immediate and direct benefit from it. The Declaration states that in this second, purely scientific subject of research, the physician cannot renounce his or her status as a physician: he or she remains the protector of the life and health of the individual who has volunteered to participate in research. The Hippocratic injunction to do no harm has a clear meaning here. The Declaration reiterates once again that in this subject of research the interests of science and society will never take precedence over the well-being of the individual.

The general rules relating to the functions of the Ethics Commission in approving the experimental project , in supervising its implementation on internship and in obtaining informed consent are even more strongly applicable to this experimentation subject . The committee will be particularly attentive to the appearance of harmful psychological and physical effects resulting from the experiment. The researcher or the committee shall not hesitate to fail the experiment, especially in cases of permanent injury or risk of death.

It is obvious that the subject who volunteers to undergo experimentation has the right to receive appropriate financial compensation. But those sponsoring or directing research should provide for financial compensation for any harm or incapacity that the subjects may have suffered as a result of the experiment. This should be set out in the informed consent document or in an accompanying document.

article 32.6. The physician is obliged to maintain a clear distinction between procedures in the process of essay and those that have already been accepted as valid for the internship correct medicine of the time. The clinical essay of new procedures should not deprive the patient of valid treatment.

There are two problems on which this article is judging: one concerns the need to distinguish between practices admitted in the lex artis and procedures that are still in the experimental phase; the other establishes the need not to leave patients who form the group witness of a clinical experiment in a therapeutic vacuum.

1. The ethical boundary between accepted practices and experimental procedures. The ethical background to the problem is clear: the nature of informed consent and the way it is obtained are different in each case. The structure and the internship of consent in the ordinary therapeutic context is relatively simple: the patient, by going to the doctor, gives implicit authorisation for remedies that have already passed their experimental phase and have been received at the ordinary medical internship . The doctor can provide information on their indications, efficacy and undesirable effects, since all this has already been determined and is well defined. It is much more ethically complex to obtain consent to include a patient in an experimental protocol , for which neither the efficacy nor the side effects are yet known. The physician must therefore be clear in his or her thinking about the experimental or accepted nature of each procedure. Such confusion arises in the minds of many physicians because articles are published which, without sufficient substantiation, claim that a new procedure looks very promising, which is often a subjective and voluntaristic conclusion. Occasionally, a new diagnostic procedure , drug or operation is excluded from the scientific process of objective validation and uses the shortcut of provisional results and premature propaganda to illegitimately sneak into the orthodox internship of medicine. They leap at a stroke from being a mere promise to becoming standard procedure without the decisive question of whether and to what extent they are really effective having been answered.

Faced with situations such as this subject, it is understandable that physicians have a moral obligation to critically read the articles on research in order to weigh the probative value of the data and the comments they contain.

2. The ethics of non-treatment or placebo treatment of the group witness. No clinical experiment, says article, may deprive the subject of a valid treatment for his or her illness. This commandment raises the question of the ethical correctness of certain ways of designing clinical trials, in which the patients of the group control either receive no treatment, a placebo or are randomly assigned to groups receiving a treatment of unknown efficacy. The researcher clinician is challenged by sometimes competing factors: neutrality in the design of the experiment and in the recording of his observations on the one hand, and on the other hand, his commitment to put the patient's interest first and foremost. It is unethical to apply experimental models vitiated by subjectivity, by preferences, by exceptions, as this runs the risk of invalidating the research. For the same reason, it is unethical to conduct trials for which rigid statistical support is not programmed in advance. The experimenting physician has a deontological duty to act as a rigorous scientist.

But in conducting his clinical experiments, the physician researcher remains a physician who must respect and seek the good of his patients. He cannot deprive any of his patients of a valid treatment.

The question arises here as to whether the use of placebos is ethical. Two types of situations must be distinguished when one wants to compare the action of a hypothetically active agent with that of a placebo. In some, the agent is tested to control a component of the disease that causes major complications, which may result in serious disability or even death. In these subject situations it is unethical to use placebos: the group control patients should receive the most effective treatment available, against which the efficacy of the agent will be measured at essay. Only if no validated treatment of any efficacy exists, would it be permissible to constitute a group placebo in that status. In the other subject situation, one wants to determine the effect of the active agent on symptoms that do not alter the incidence or development of lethal or disabling complications. It is then that placebos can be used as a comparator, as the risk involved is tolerable, particularly if none of the available agents have shown appreciable efficacy.