Ethics

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Dr Umesh Kawalkar

OVERVIEW
What is mean by Ethics ? History of Medical Ethics and Bioethics Principle of Medical Ethics Institutional Ethical Committee Conflicts of interest What is Public Health Ethics ? Principles of the ethical practice of public health Issues in public health ethics

WHAT IS MEANT BY ETHICS ?


a set of principles of right conduct. According to Last (1989) Ethics is branch of philosophy dealing with the distinction between right and wrong , with moral consequences of our action. According to World Medical Association ...ethics is the study of morality careful and systematic reflection on and analysis of moral decisions and behaviour whether past, present or future.

BIOETHICS (BIOMEDICAL ETHICS).


Concerned with the moral issues raised by developments in the biological sciences more generally. Four major subdivisions: Clinical ethics, (issues in patient) Research ethics Professional ethics, (duties of physicians& HCW)
(medical ethics is one type of professional ethics);

Public policy ethics,

SYSTEMS GOVERNING HUMAN SOCIAL BEHAVIOUR


CUSTOM Mores ETIQUETTE ETHICS Professional Professional Etiquette Values Courtesy Competence Integrity Fairness Goodwill Truth LAW MORALITY State, Statutes Spirituality Legislature Enforcement Compulsion Judiciary Punishment Justice Religious Good vs Evil Right vs Wrong

Tradition

Ethics > knowing whereas Morality > doing.

Ethics prescribes higher standards of behaviour than does the law.

Public Health, Experimentation and the Slippery Slope


1920s-1930s: Era of Eugenics 1930s-1940s: Mass sterilization of "defectives" in the USA and Sweden. Mass euthanasia of defectives in Germany 1940s: Quarantining epidemic disease as pretext for ghettos by Nazis Concentration camp human experimentation The Holocaust of jews

HISTORY OF MEDICAL ETHICS AND BIOETHICS


Hippocratic oath as the first articulation of the moral duties of

physician Human experimentation has been a subject of great concern since the Nazi and Imperial Japanese armed forces experiments on prisoners and concentration camp victims during World War II . The Nuremberg Code was formulated in 1947 highlighted the essentiality of voluntariness of the consent.

In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed concern about rights of human beings being subjected to involuntary maltreatment. Article 25. Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services etc.

In 1964

In Helsinki efforts of the Council for International Organizations of Medical Sciences (CIOMS) & the World Medical Association formulated general principles and specific guidelines on use of human subjects in medical research, known as the Helsinki Declaration, which was revised from time to time. The World Medical Association has prepared the recommendations as a guide to each doctor in clinical research. Doctors are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries. .

In February 1980, The Indian Council of Medical Research released a 'Policy Statement on Ethical Considerations involved in Research on Human Subjects for the benefit of all those involved in clinical research in India .

World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) issued the In 1991 International Guidelines for Ethical Review in Epidemiological studies and In 1993 International Ethical Guidelines for Biomedical Research involving Human Subjects.

The Declaration of Geneva of The World Medical Association

binds the doctor with the words : The health of my patient will be my first consideration And International Code of Medical Ethics declares that Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest.

The most recent documents on ethics are those of UNESCOs 1997 The Universal Declaration on Human Genome and Human Rights 2003 The International Declaration on Human Gene Data and 2005 Universal Declaration on Bioethics and Human Rights

BASIC PRINCIPLES OF MEDICAL ETHICS

Respect for autonomy, non-maleficence, beneficence, and

justice

Respect for autonomy


right to information and self determination
free and informed consent respect and dignity maintained of indiviuals to tell the truth (veracity) and to be faithful to ones commitments (fidelity).

Non-maleficence
first do no harm
sanctity of life calculated risk or risk benefit

beneficence
ones intended actions to do good,
do only that which benefits the patient patients welfare as the first consideration care consideration competence

Justice and Social Responsibility


Actions are consistent, accountable and transparent
not to discriminate on age, sex, religion, race, position or rank greater good of society respect of the Law equity and distribution of burden & benefits

Components of Medical Ethics


The Physician -- Patient Relationship
The Physician -- Physician Relationship The relationship of the Physician to the System of Healthcare The Relationship of the Physician to Society

Principles of Ethics in Epidemiology and Medical Research


Four major principles
Informed consent Confidentiality

Respect for human rights


Scientific integrity

0thers.
No. 1 No human being should be exposed to any form of intervention which is likely to be hazardous to human health, safety or well being, just because epidemiological or research principles dictate so. No. 2 : No human being should be denied a treatment or such other intervention which is known to be effective for that particular disease, just because epidemiological or research principles dictate so.

No. 3 : Confidentiality of participants and of the information given by them should be protected there could be occasions when the epidemiologist may be required by law to divulge the information. At times this divulgence may itself be an ethical requirement, if not legal. No. 4 : (principle of informed consent). Any human being should participate in an epidemiological or medical research study only after he / she has been clearly informed of the scope of the research, and having been so informed, the subjects should consent to participate, of their own free will, without any force, coercion or undue motivation

Informed consent
The process consists of transfer of

information and understanding of its significance to all participants in medical interventions of all kinds, followed by explicit consent of the person (or responsible proxies) to take part in the intervention

Consent may be active, agreement to take part; passive personal physician ,a village headman, tribal elder, or religious leader have responsibility. Evidence of consent Explicit Consent is given orally or in writing. Implicit Consent a willingness to undergo a certain procedure or treatment by his or her own behavior.

No. 5 : No incentives or pressure should be there to force or lure the subjects into the study. No. 6 : In case of any harm resulting due to the research, on the health of a subject, there should be adequate treatment and compensation.

No. 7 : The people who are doing the research should be adequately qualified / competent to undertake the same and the research should be executed using sound research methods. This aspect should also be considered by the IEC and Institutional Review Boards (IRBs).

No. 8 : (The principle of justice). This says that the benefits and burdens or research and epidemiology should be distributed fairly. No 9 : The participants should be informed of the information which has resulted from the research, about themselves, as well as provided guidance regarding the future course of action they should undertake.

No. 10 : Research on animals should be undertaken only when it is absolutely essential and the animals should be treated/sacrificed in humane manner. It is advisable that any research involving animals should be deliberated upon & cleared by Institutional ethical committee on animal research

Institutional Ethical Committee (IEC)


Every institution where health research is taking place should have an IEC, which should review and clear research proposals before they are actually launched. The chairperson:- eminent person with a well documented record in health research, and should be from outside the institution to give independence of judgment. The secretary: within the institution and should be a person with well documented track record in academics and health research.

Members : 1) The professor or advisor in one of the basic medical sciences, 2) And from the departments of surgery, medicine, pathology, community medicine and pharmacology 3) One member from legal field. 4) One independent member representative from the community, with track record in community work. 5)Officer in charge of animal house. 6)Any other member(s) depending on the type of research may be co - opted for particular meetings. The IEC should develop detailed Standard Operative Procedures (SOPs) which should be circulated to all members. All research proposals should be scrutinized by the IEC,

Conflicts of Interest
Researchers may have conflicting interests that may impair their objectivity or make them biased towards or against a research work Reasons Financial conflicts of interest : Conflicts of interest because the investigator is also the care provider:

Methods to Resolve Conflicts of Interest


Mandatory registration and reporting of all research results are

important to ensure the integrity of medical research. Financial interests should be evaluated by a sufficiently independent and publicly accountable research ethics committee It should be obligatory on the researchers to declare any conflict, especially the possible sources of funding. Ensuring rigorous randomization, blinding and placebo control during the trial. An independent data safety monitoring board that regularly review the interim data.

What is Public Health Ethics..

Public health ethics focuses on the design and implementation of measures to monitor and improve the health of populations.
Divided into Field of study Field of practice.

As a field of study,

public health ethics seeks to understand and clarify principles and values which guide public health actions.
As a field of practice,

public health ethics is the application of relevant principles and values to public health decision making.

In applying an ethics framework, public health ethics inquiry carries out three core functions : 1) Identifying and clarifying the ethical dilemma posed. 2) Analyzing it in terms of alternative courses of action and their consequences. 3)Resolving the dilemma by deciding which course of action best incorporates and balances the guiding principles and values.

Medical Ethics vs. Public Health Ethics

Medical ethics emphasizes individuals: Autonomy


right to decline care

Public Health ethics emphasizes populations: Interdependence


individual actions effect others

Non maleficence
do no harm

Participation
public health decisions should include input from the public

Beneficence
seek benefit of patients

Justice
providing equal care to all

Scientific Evidence
reasoned interventions based on facts, not beliefs or conjecture

Ethical Theories and Values


Public Health Ethics entails multiple ethical theories and values: Consequentialism
focus on the outcomes of actions

Deontology
focus on rights, duties, or other intrinsic moral features of actions

Casuistical Reasoning
examining the relevant similarities and differences between cases

Utilitarianism
do the greatest good for the greatest number of people

Egalitarianism
fair procedure and distribution of benefits and burdens

Code of Ethics: Principles of the Ethical Practice of Public Health


Promulgated by the Public Health

Leadership Society (PHLS) in 2002


12 Principles to guide public health Intended to be a living document Available at: http://www.phls.org

Code of Ethics:
1. 2. 3.

4.

5. 6.

Public health should address principally the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes. Public health should achieve community health in a way that respects the rights of individuals in the community. Public health policies, programs, and priorities should be developed and evaluated through processes that ensure an opportunity for input from community members. Public health should advocate for, or work for the empowerment of, disenfranchised community members, ensuring that the basic resources and conditions necessary for health are accessible to all people in the community Public health should seek the information needed to implement effective policies and programs that protect and promote health Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the communitys consent for their implementation.

Code of Ethics :
Public health institutions should act in a timely manner on the information they have within the resources and the mandate given to them by the public 8. Public health programs and policies should incorporate a variety of approaches that anticipate and respect diverse values, beliefs, and cultures in the community. 9. Public health programs and policies should be implemented in a manner that most enhances the physical and social environment. 10. Public health institutions should protect the confidentiality of information that can bring harm to an individual or community if made public. Exceptions must be justified on the basis of the high likelihood of significant harm to the individual or others. 11. Public health institutions should ensure the professional competence of their employees. 12. Public health institutions and their employees should engage in collaboration and affiliations in ways that build the publics trust and the institutions effectiveness.
7.

Ethical issues raised by public health research

Providing intervention at level of community means that everyone in community automatically is exposed to intervention . When individual cannot refuse their participation in study & harm due to study is less. then public health benefits resulting from study outweighs then intervention should imposed. e.g. fortification n of salt with iodine & health education intervention at community level social stigma or stereotyping of identifiable group. (IDU,MSM)

Issues in Public Health Ethics


Who is Responsible for Health? The wide spectrum of views has at one end the view, that it could be purely a matter of individual choice. & On the other extreme, responsibility for health could be completely delegated to government. The central dilemma, therefore In public health is to balance respect for individual freedom and liberty with the responsibility of governments to provide their citizens with some degree of protection in relation to health.

In public health policy, some measures might constitute minor infringements of a persons freedom but bring about significant benefit for a large number of people. Tobacco smoking lends itself easily as an example. By banning advertisements by tobacco companies and restricting the availability to children, the governments are discharging their role in harm reduction to vulnerable citizens while still permitting their citizens their right to smoke tobacco.

EQUITY AND JUSTICE IN RESOURCE ALLOCATION


The fair and equitable distribution of scarce resources to

protect, preserve, and restore health is the domain of public health. Resource allocation depends in part on value judgments about the relative importance of small improvements in quality of life for a large portion of the population as compared with a lifesaving intervention that would benefit only a few people. Funds sometimes are allocated for expensive equipment and devices, perhaps on dubious grounds, while badly needed public health services such as water purification plants in need of renovation, or logistic support for immunization programs, go without funds

Disparities in Health Status in Different Parts of the World


Most of the developing countries have very poor state of health

of their citizens. They look towards the affluent nations and philanthropic agencies for economic and technological aid to alleviate the sufferings of their citizens Most inter governmental economic aid is however conditional to the use of services provided through companies of the donor country, which may exploit the situation for economic gain rather than philanthropy. The astronomical and unjustifiable gains of some pharmaceutical companies, from sale of life saving drugs, are well documented. Governmental health policies may become dictated by the donor of funds rather than from perceived need.

Disparities in Access to Quality Health Care and the Benefits of Medical Research
Many of the clinical researches being conducted in the world

have used subjects who may have nothing to gain from the research. The Global Forum for Health Research has pointed out that less than 10% of the worlds research resources are earmarked for 90% of the health problems.

The Tuskegee Experiment

Communicable Disease Control : Rights And Needs


Stigmatizing by notifying and restricting freedom infringes

individual autonomy, but these practices are generally held to be necessary restrictions whose purpose is to benefit society as a whole. When smallpox, cholera, poliomyelitis, diphtheria were prevalent, few people questioned the actions of public health authorities who notified and isolated cases, quarantined contacts, sometimes severely infringing the freedom and dignity of entire families.

Some diseases, for example, tuberculosis, carried

considerable social stigmawhich was worst of all in cases of syphilis. These features of communicable disease control have been tolerated because they were believed to be necessary for effective control.

HIV And Bioethics


The first wave of the AIDS epidemic in the hit hardest at an

already stigmatized group, male homosexuals. Widely publicized instances of victimization of AIDS patients homosexual men hounded out of their jobs, men and hemophiliac children rejected by schools, Combined with the rising demand for equity and justice in dealing with minority groups in society, it heightened awareness of the need to provide health-care services with justice and equity for all. Ethics and Public Health Policy only recently been able to break free from age-old prejudices to minority group

A second wave of the epidemic affected intravenous drug users

who shared needles, and this group did not attract so much sympathy, Although, infants infected with HIV have generally been recognized as innocent victims of the epidemic. The social reactions to AIDS and HIV infection have led to much discussion about ethical aspects of management. Public health workers need to know and understand the behavior patterns associated with the transmission of HIV; without this understanding it is impossible to prepare effective strategies and tactics to control the HIV epidemic.

A diagnosis of HIV infection even to this day carries a grave

burden of not only cost, but also of both stigma and concern for ones life. The diagnosis, thus, must not be lightly made, nor the test for HIV antibody lightly undertaken: both voluntary testing and communicating the results of a positive test must be accompanied by careful counseling of all persons concerned, and their sexual or otherwise intimate partners. Health workers have a particular obligation not to discriminate against persons who are HIV antibody positive or who suffer from AIDS.

For epidemiologic surveillance, public health authorities need

data on the prevalence of HIV infection. The World Health Organization and many national authorities agree that unlinked anonymous HIV testing is the best way to generate prevalence data. In the United Kingdom and in the Netherlands, it was held for a time that anonymous unlinked testing is unethical, because identifying and counseling cases and their sexual partners was regarded as a higher moral responsibility than determining community-wide prevalence trends.

Stigmatization and the threat of stigmatization can serve to

cause great public health harm simply by virtue of pushing behaviors underground and not allowing access for controlling the spread of HIV infection. Ultimately, consideration of the four principles will require that we do more good than harm. Supportive and compassionate environments likely always result in better control than do oppression and stigmatization.

ENVIRONMENTAL HEALTH : INDIVIDUAL RIGHTS AND COMMUNITY NEEDS


Sometimes health is adversely affected by environmental

conditions, but correcting these conditions may have unpleasant economic repercussions, such as massive unemployment, poverty, economic loss. It is difficult to decide the best course of action in such situations, but a useful guideline is to consider the ethical principles of justice and non-maleficence: What is the fairest way to deal with the situation? Which of the competing priorities will harm the fewest people over the longest period?

Transnational corporations, with support from some national

governments and the World Trade Organization, have often attempted to weaken or emasculate aspects of public health laws and regulations aimed at protecting the population from unnecessary occupational and environmental health risks. Such actions are motivated by desire for greater profits
In such circumstances, it is the ethical duty of all public health

scientists to uphold the public good and to avoid doing the bidding of corporations whose primary intention of making profits for their shareholders

Risk and Benefit


Risk-to-benefit ratios have to be calculated for every immunizing

agent. Consider measles: there is a risk somewhere between one in a million and one in five million of subacute sclerosing pan encephalitis (SSPE) as an adverse effect of measles vaccination. This fact, and the cost of measles vaccination in face of competing claims for other uses of the same funds, is an incentive to stop using measles vaccine; but the risk of stopping will be the return at some later date of epidemic measles, perhaps not until there is a large population of virgin susceptible. Argument based on the principle of justice or equity: all infants deserve the protection of vaccines, even though a small proportion of infants may be harmed.

Acceptable risk Health administrators and hospital staff members also accept the small risk of malignant disease among radiographers and other health workers occupationally exposed to x-rays, and the risk of fetal loss among operating room staff exposed to waste anesthetic gasesbut not all the occupationally exposed individuals are informed of this admittedly small risk, as they ought to be by those in positions of responsibility.

Is There a Right to Health?


Health is a generic term includes both medicine and health. However, governments, doctors and many others use the term health incorrectly, talking of drugs, hospitals, medical technology, surgery and other aspects in health care services. The medical profession unethically uses the phrase ' health' to describe medical circumstances and conditions, thus colluding in the misrepresentation and the denial of basic primary health care to villages.

The ethical issues in discussing 'Health for All' are equity,

justice, equality and human rights. These ideals should continue to be of primary importance in providing primary health care. health education, adequate food, safe and adequate drinking water, care of mothers and children, immunisation, prevention and control of local endemic diseases, treatment of common diseases and injuries, and provision of essential drugs are the nine elements of primary health care. There are no priorities in these, and they must be offered as a complete package.

Is it ethical to neglect the medical and health problems of people who are unable to even approach a doctor? In this situation, the government cannot think of privatising health services. It is highly unethical to keep people ignorant about the causes, control and prevention of diseases, about the social and community responsibilities of the people. Yet this is exactly what happens in the absence of public health education. It is not correct to borrow and spend crores of rupees from public funds to pay for cardiovascular surgery or neurological surgery, when the government is not able to provide basic health needs.

Educating and Socializing Students in Public Health

Our professional educational system has failed to promote the development of moral values. Subjects like public health, preventive and social medicine and epidemiology receive a low priority in medical education. The medical and allied professions have failed to regulate themselves, and society has failed to make amends. Can societal efforts be coordinated and integrated to promote ethical values in health care?

Reference
Textbook of public health and community medicine first edition 2009 Ethical Issues

in Epidemiology & Medical Research RajVir Bhalwar 205 Oxford Textbook of Public Health 5th Edition ethical principles & ethical issue in public health Nancy Kass 383 Textbook of public health and community medicine first edition 2009 Ethics in Public Health, ; Health and Human RightsAmitava Datta 364 Wallace/Maxcy-Rosenau-Last public Health & Preventive Medicine 15 th edition Mc Graw Hill Publications 2008 Ethics and Public Health policy p.n. 29-31 The New Public Health Second Edition Theodore H. Tulchinsky, John Last Elsevier Academic Press publications Health Technology, Quality, Law, and Ethics Ethical Principles for medical research involving human subjects. World Medical Association Declaration of Helsinki. JAMA 2000; 2841 : 3043 - 9. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Subjects. ICMR, New Delhi, 2000. Research ethics committees Basic concepts for capacity-building www.who.int/ethics/publications/en/

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