Bioethics

Bioethics is an activity of reflection designed to find concrete solutions, rules of conduct, to conflicting problems arising from developments in the life sciences.

More generally, ethics is the doctrine of human happiness and the means to achieve it through a set of rules of conduct. It is part of morality. Morality, for its part, can be defined as a set of rules for action and values that function as norms in a society, a theory of the ends of human actions.

Fundamental principles of healthcare ethics

• Beneficence: helping, relieving, healing
• Refusal to harm: balance between health benefits and risks to patients
• Justice: all patients are entitled to the same quality of care
• Respect for human dignity and autonomy: the right to decide on one's own actions and to take responsibility for them → duty to inform, to check that information is understood, to advise, to make suggestions

Consent

Foundations of consent: right to integrity, to free disposal of one's body, to autonomy, general obligation of prudence and foresight, good faith performance of agreements

Free" and "informed" consent: ensuring that the patient is in a position to express his or her decision, duty to inform so that the decision is taken in full knowledge of the facts.

This is not a transfer of responsibility from the doctor to the patient, as the patient-physician relationship (contract of trust) still requires the decision to be made by the caregivers within their competence, and therefore their responsibility and autonomy.

This consent is one of the foundations of the physician's immunity (see above).

Consent does not have to be given in writing, except in the case of sterilization, abortion, organ removal from a living donor, clinical drug trials, etc., but there is a tendency to ask for written agreement for more and more procedures, to protect oneself from possible legal proceedings. In 1999, the Conseil National de l'Ordre issued an opinion to the effect that, in order to avoid an atmosphere of mistrust between patients and doctors, it was not in favor of drawing up an informed consent form, which should remain the exception when there is a real risk of litigation.

Exceptions to free and informed consent:

• right not to know
• emergency situations
• therapeutic exceptions (if the doctor thinks the information will harm the patient), requires the opinion of a colleague (who must leave a note)
• vaccinations required by law

Failure to provide information constitutes a legal fault. Although there is some debate about the scope of this information (it is impossible in practice to explain all aspects of a disease or all the risks and side-effects of a treatment, information sometimes conflicts with the principle of beneficence, the "right not to know" is a rather vague concept in certain situations, etc.).

Bioethics practice and decision-making

Recognize situations requiring ethical reflection: "is it right?", difficult therapeutic choices, conflicts of values, etc :

• caregivers' psychological signs: feelings of stress or uncertainty, anxiety, irritability, indecision.
• social signs from the care team: lack of communication or avoidance of the patient's situation.
• tensions and discord within the team, reduced efficiency and quality of care, absenteeism, requests for transfer.

Develop a decision-making procedure:

• identify the person(s) in charge of the decision
• gather data, diagnoses, prognosis, risks
• assess the patient's psychology, scale of values and quality of life
• multi-disciplinary reflection, allowing everyone to express themselves (reinforces the weight of decisions, identifies unperceived information and ethical issues, minimizes the risk of error, provides training, etc.).
• explain and justify the decision taken to the rest of the team, to the patient and to the patient's family.

Bioethics structures

The Bioethics Advisory Committee

Established in 1995 with 2 missions:

• to give an opinion on problems raised by research and its applications in biology, medicine and health, with regard to man, groups or society.
• inform the public and political bodies

It has 35 members from civil society: 16 academics (8 from the "exact sciences" and 8 from the "human sciences"), 10 members of professional bodies (6 proposed by the Order of Physicians, 2 lawyers chosen by the National Council of the Order, 2 magistrates), 9 members chosen by federal and community governments. Linguistic balance and gender parity.

It can be referred to by:

• the presidents of the various legislative assemblies (national or community), on their own initiative or at the request of 10 senators/deputies/community councillors)
• a member of an executive (national or community)
• a research organization, healthcare institution or higher education establishment
• a local ethics committee attached to a healthcare establishment or university.

It may also refer any matter to itself

It issues advisory opinions within 6 months of a referral, maintains a documentation center, and organizes a bi-annual conference on bioethical issues.

Local hospital ethics committees (1987 law)

Must be present in every Belgian hospital, with 2 missions:

• support and advice on the ethical aspects of hospital care practice
• advice on all human experimentation protocols

Comprising 8 to 15 members, the majority of whom are hospital physicians, with at least 1 non-hospital GP, at least 1 nurse and at least 1 legal expert. It gives advisory opinions. Any member of staff or doctor may question it.

Local ethics committees

Since 1985, the French Medical Association has been registering and approving local ethics committees, which are informal structures within universities or other groups.

Informal structures

Various groups that have taken the initiative.

Human experimentation: legal bases

In Belgium, there is no real legal basis "stricto sensu" codifying experimentation. However, Belgian law does require experimentation procedures before drugs can be marketed (1964). In addition, an article in the law on hospitals assigns responsibility for human experimentation to local ethics committees. A European directive sets out the principles governing drug registration. In addition, numerous international references to which Belgium is a signatory codify experimentation (e.g. the Declaration of Helsinki, most recently revised in 2000, the European Convention on Human Rights and Biomedicine, etc.). Background: the Nuremberg Code, drawn up in 1947 as a response to Nazi experimentation, defines ten criteria that must be respected in human experimentation.

In addition, the NOC's code of medical ethics, in line with national and international legislation, imposes various principles and the opinion of an independent ethics committee.

In 2001, the Bioethics Advisory Committee issued an opinion on human experimentation:

• experimentation is an ethical duty
• it is a vector for dynamism and the evolution of medical practices
• it has an impact on the quality of care
• it gives patients rapid access to new possibilities
• declaration of the experiment to the hospital is essential, and is the responsibility of the experimenter (medico-legal, professional insurance, contribution to costs, transparency, no interference with the organization of continuity of care).
• the opinion of the Local Ethics Committee:
  • Is crucial to the protection of subjects and the quality of research.
  • Obligation to request an opinion = safeguard
  • It must include :
    • Ethical legitimacy of purpose
      • Scientific interest (justify the contribution to knowledge, "no scientific interest, no ethical legitimacy!")
      • Elaboration of an appropriate protocol (likely to answer the questions posed, having the means and skills to do so)
      • Existence of prerequisites (prior knowledge legitimizing the project, all available data collected, sufficient for the experiment...)
    • Proportionality of means (risk versus expected benefit, very difficult evaluation, 0.04% of very serious ES and 0.55% moderate in the UK, "cognitive" or "therapeutic" benefit), pre-eminence of the interest of the healthy patient/volunteer over the interest of the community... but all experimentation involves a risk...
      • The potential risk may be physical, psychological or socio-economic.
      • Consideration of severity, probability of occurrence, reversibility and possibility of counteracting the risk.
    • Qualification of experimenters and experimental environment (skills, equipment, availability, competition between different protocols)
    • Free, informed, personal and prior consent
      • Prior information, essential for informed consent (data on liability and insurance, limits on confidentiality, remarks from the ethics board, method, duration, expected benefits, risks, constraints, etc.)
      • Prior collection of consent, free of any moral or financial pressure (?) → no remuneration but compensation for expenses and lost working time
      • It must be possible to withdraw it at any time without justification
      • Various problems arise: submission to authority, experimentation on healthy volunteers/pregnant women/psychiatric patients or minors/prisoners/..., specific situations.

End-of-life issues

Main medical decisions concerning the end of life: 38% consist of decisions on non-treatment, pain and symptom relief, euthanasia and equivalents.

The main reasons given by patients requesting euthanasia are :

• loss of dignity 57%
• pain 46% (single reason: 10%)
• "agony not worth the effort" 46%
• "dependence on others" 33%
• "tired of living" 23

In Belgium, 54% of doctors (62% of general practitioners and 44% of specialists) have performed euthanasia. 12% of doctors say they would refuse to perform one, of whom 8% are prepared to refer the patient to a colleague. Requests for euthanasia are on the increase, as is the number of doctors declaring themselves ready to perform it.

Author(s)

Dr Shanan Khairi, MD