dr. Nindya Aryanty, M. Med. Ed Ethics and Bioethics dr. Nindya Aryanty, M. Med. Ed

Learning Objectives Students should be able to recognize and distinguish an ethical issues from other issues Students should be able to reason about ethical issues Students should be able to explain the differences between medical ethics and bioethics Students should be able to explain the principles of bioethics and how to balance these principles in practice

What is ethics? Judgments : Fact judgment = descriptive statement ex. Peter is tall (Peter is a person of more than the average height) Value judgment = evaluative statement ex. Tia is beautiful Moral judgment = prescriptive statement ex. We must do no harm to others

What is ethics? Ethics  from ethicos (Greek) meaning good or bad, right or wrong Ethics is the philosophy behind moral or the theoretical basis for moral (moral derived from the Latin word moris meaning manners) The goal of ethics is to take the right decisions  An ethical method of reasoning

An ethical method of reasoning Fact deliberation The case Begins with the presentation of a problem or a case  difficult from the moral point of view = moral conflict  in all possible actions, important values are at stake, and selecting one implies the infringement of other compelling values

An ethical method of reasoning Deliberation about the fact Carefully analyze the facts  to know the situation  individual or collective deliberation Our perception of facts is influenced by our education, cultural background, personal expertise and experience ex. Clinical rounds, ethics committee

An ethical method of reasoning 2. Value Deliberation Identification of the moral problems problems  concrete, specific moral problems ~ conflict of values Choice of the main problem The value at stake

An ethical method of reasoning 3. Duty Deliberation  Identify the different possible course of action of the case  Find the best course of action, that which promotes best the fulfillment of values, or that infringes upon them less

An ethical method of reasoning 4. Test of consistency Test of legality  compare our choice with relevant law Test of publicity Secret decision ~ not ethical Test of time “would we take the same decision if we had the possibility of waiting some hours or some days? “

An ethical method of reasoning 5. Final Decision  Take wise decision = take well-thought decision

What is Bioethics? Bioethics  bios = life ethicos = good or bad, right or wrong Ethics deals with values and bioethics should therefore deal with values related to life and life processes

What is bioethics? Medical ethics is only one of its branches The field of bioethics is as wide as the facts of life. Its study is divided in many branches. Ecological or environmental bioethics Medical bioethics Clinical bioethics

The UNESCO Universal Declaration on Bioethics and Human Rights

The 33rd session of the General Conference of UNESCO 19 October 2005 Universal declaration on bioethics and human rights Agreed by 191 member states of UNESCO  a set of bioethical principles  provides a common global platform by which bioethics can be introduced & strengthened within each member state

Learning objective Student should be able to explain the principles of bioethics and how to balance these principles in practice

Principles of bioethics Physicians and other health care professionals have to make health care decisions  principles of bioethics The UNESCO Universal Declaration on Bioethics and Human Rights identifies 15 bioethical principles

15 bioethical principles 1. Human dignity and human rights 2. Benefit and harm 3. Autonomy and individual responsibility 4. Consent 5. Persons without the capacity to consent 6. Respect for human vulnerability and personal integrity 7. Privacy and confidentiality 8. Equality, justice and equity 9. Non-discrimination and non-stigmatization 10. Respect for cultural diversity and pluralism 11. Solidarity and cooperation 12. Social responsibility and health 13. Sharing of benefits 14. Protecting future generations 15. Protection of the environment, the biosphere and biodiversity

1. Human dignity and human rights Human dignity, human rights and fundamental freedoms are to be fully respected The interest and welfare of the individual should have priority over the sole interest of science or society

1. Human dignity and human rights The notion of human dignity expresses the intrinsic value of the person  capable of reflection, sensitivity, verbal communication, free choice, self-determination in conduct and creativity All human being are equal in dignity irrespective of gender, age, social status or ethnicity Recognition of a person’s dignity  active respect for one’s human rights, self-esteem and self-determination, one’s privacy, protecting one from illegitimate intrusions and preserving one’s valid public space

1. Human dignity and human rights The person’s dignity and rights are proved by others’ obligation to treat a person respectfully, that is : to cause no harm not to abuse to be fair not to impose unwelcome models of personal good and happiness not to treat one merely as a means not to consider the interest and welfare of the individual as subordinate to others’ interest and welfare, to ‘the sole interest of science and society’

2. Benefit and harm In applying and advancing scientific knowledge, medical practice and associated technologies, direct and indirect benefits to patients, research participants and other affected individuals should be maximized and any possible harm to such individuals should be minimized

2. Benefit and harm Health (WHO definition) : a state of complete physical, mental and social well being and not merely the absence of disease or infirmity Health benefit  relief of suffering; care; prevention of disease, illness, disability; enhancement, psychological benefit, etc.

2. Benefit and harm Harm : Physical harm Psychological harm Moral harm (harm to interest, harm as unfairness, harm as disrespect) Social/economic harm (consequences for social role, stigmatization)

2. Benefit and harm Health care decisions : Assessment has to be made between risk of harm and potential benefits Where the risk of harm outweighs possible benefit  the treatment is not indicated Two or more patients  focusing on patients who are most in need because of the harm they are suffering or on patients for whom treatment will produce the greatest benefit

3. Autonomy and individual responsibility The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests

3. Autonomy and individual responsibility Autonomy  as individual capacity for self- determinations and evaluations Responsibility  is one’s awareness of one’s obligation to make decisions and to act appropriately on the basis of certain commitments (for example, toward an external authority, oneself, one’s status, engagement, or agreements, respected others, accepted principles and rules)

3. Autonomy and individual responsibility Patient autonomy and responsibilities in health care A. Responsibility for consequences of freely taken decisions B. Responsibility to avoid infringement of another person’s autonomy ex. One is free to decide to smoke and endanger his own health, but he can’t endanger the health of others

4. consent Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

4. consent 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.

4. consent 3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual’s informed consent.

5. Persons without capacity to consent In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent: authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;

5. Persons without capacity to consent b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual’s human rights. Refusal of such persons to take part in research should be respected.

6. Respect for human vulnerability and personal integrity In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected

6. Respect for human vulnerability and personal integrity Several aspect of vulnerability : Biological or corporeal vulnerability - natural threats are coming from our biology, ageing, susceptibility to illness and disease, and death - environment and other natural and man-made threats : pollutions, earthquake, etc 2. Social vulnerability : war and crime, prejudice and discrimination, etc 3. Cultural vulnerability

6. Respect for human vulnerability and personal integrity Respect for personal integrity  respect for the patient’s understanding of his or her own life and illness, for his/her interests and free will.

7. Privacy and confidentiality The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law

8. equality, justice and equity The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.

8. equality, justice and equity Equality : the right of different groups of people to have a similar social position and receive the same treatment Justice : fairness in the way people are dealt with Equity : when everyone is treated fairly and equally

9. Non-discrimination and non-stigmatization No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms

10. Respect for cultural diversity and pluralism The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope

10. Respect for cultural diversity and pluralism The value of cultural diversity may be in conflict with other human rights values  it is necessary to analyze and balance wisely the values in conflict

11. Solidarity and cooperation Solidarity among human beings and international cooperation towards that end are to be encouraged

11. Solidarity and cooperation Example: in Europe, everyone is obliged to make a fair financial contribution to a collectively organized insurance system that guarantees equal access to health and social care for all members of society

12. Social responsibility and health The promotion of health and social development for their people is a central purpose of governments that all sectors of society share Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance: (a) access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good; (b) access to adequate nutrition and water; (c) improvement of living conditions and the environment; (d) elimination of the marginalization and the exclusion of persons on the basis of any grounds; (e) reduction of poverty and illiteracy.

13. Sharing of benefits Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, benefits may take any of the following forms: (a) special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research; (b) access to quality health care; (c) provision of new diagnostic and therapeutic modalities or products stemming from research; (d) support for health services; (e) access to scientific and technological knowledge; (f) capacity-building facilities for research purposes; (g) other forms of benefit consistent with the principles set out in this Declaration. Benefits should not constitute improper inducements to participate in research

14. Protecting future generations The impact of life sciences on future generations, including on their genetic constitution, should be given due regard Ex : - prescription of medication without any rationale is a threat to future generation - genetically modified food

15. Protection of the environment, the biosphere and biodiversity Due regard is to be given to the interconnection between human beings and other forms of life, to the importance of appropriate access and utilization of biological and genetic resources, to respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity