Ethics in Medicine

• Ethics –Greek term “ethikos” (i.e.customary).

• Moral obligations which govern actions in biological sciences – medicine,

environmental and philosophical sciences.

Equity (i.e.Fairness principles of justice used to correct or supplement the law)

constitutes the basis of all ethics in the modern society .

Partly social and professional guidelines

Partly legal (Case law / Statute law)

 Medico-Legal Issues

Medical Jurisprudence- Science or Philosophy of Law (related to Medicine)

Medical Negligence
• Lack of proper care and attention

• Culpable carelessness (Culpable-deserving blame)

Medical Ethics
• Professional practice (clinical indications/Commerce)

• Research and Technology

• Publications
 Medical Negligence

• Disease-diagnosis / Tests

• Medical Expertise Disease – information

• Standards of care

• Treatment – Drugs / Interventions

• Emergency Management

• Costs/Referrals

• Complications

• Violation of Acts
 How to Avoid Problems?

1. Follow standard procedures – in place.

2. Consult others / seniors

3. Communicate well with patients / attendants

4. Good record-keeping

5. Adequacy of care (as per standards / Guidelines in place)

 Why should doctors learn about ethics?

• Unusual influence over patients’ lives

• Balance the rights and interests of society with that of patients

• Civil rights movement

• Avoid ethical conflicts and think through ethical dilemmas

• Avoid judicial oversight with legal and regulatory systems – Personal and
Institutional
 BASIC ETHICAL PRINCIPLES
• Autonomy – an individual’s right to self -determination
• Beneficence –to do good
• Nonmaleficence -do no harm
• Distributive Justice - the just and equitable provision of finite health
care resources
 Evolution of Medical Ethics

Hippocratic tradition

Philosophical inquiries
(Principle based moral theories)

Antiprinciplism
(Competing moral theories)

Crisis
(Conceptual conflicts – Skepticism of morality)

(Pellegrino, 1993)
 Beneficence
• Has roots in the Hippocratic doctrine of fostering the patient’s well-being

• Moral obligation to promote goodness or benefit to the patient and family,

to provide care that maintains or improves health, reduces disability, and
alleviates physical, and existential pain and suffering.
• Little quarrel regarding nobility of these goals

• Few conflicts nevertheless

 Nonmaleficence

• Embodied in the Hippocratic dictum primum non nocere ( first, do no

harm)
• Typically is seen as a more strict requirement than beneficence

• Disagreement about the proper balance between beneficence and

nonmaleficence
 Ethics Determinants
• Cultural-social, religious and ethnic values and customs

• Economic and commercial issues

• Legal system

• International codes

• Political power

• Individual biases, beliefs and rights

 Autonomy

• Patients autonomy and the right to self-determination are well established

ethical principles and legal rights in medicine.

• Many patients are incapable of making their own decisions, often causing
ambiguity and uncertainty, which can lead to conflicts among health care
providers and families.
 Distributive Justice
• This is, perhaps the most difficult to interpret and implement

• Personal justice: physicians must treat each and every patient with respect
and fairness
• Social justice: which dovetails with medical futility; in a world with
limited resources, ineffective treatments for a particular individual may
waste resources better spent on appropriate therapies for others
 Autonomy – Issues & Concepts

• Capacity
• Informed consent
• Surrogate decision making
• The best argument
• Paternalism
• Resuscitation status
 Capacity
Presumption that adults have the ability to make decisions for themselves
and able to participate in the process of informed consent

“Incompetent” individuals
• Children

• Prisoners

• Mentally challenged

• Dependents
 Informed consent
*Disclosure *Understanding *Voluntariness

Exceptions
•Life threatening emergencies in which delay will result in harm to the patient

•Patient waives the right to informed consent

Informed refusal
•Important in ICUs when considering withdrawing or withholding life
support.
 Surrogate Decision Making

• Patient loses capacity

• Most commonly a family member: “ surrogate” or “proxy” for the

patient
• It is the surrogate’s responsibility to represent the personal values of
the patient
• Difficulties when value set is not well defined or disagreement among
family members
 Best Interest Argument
• When a patient’s wishes are unknown by the family members and there is
no designated proxy for health care decisions , the “best interest” standard
prevails
• Doctors are morally obligated to overrule a surrogate if there is clear
evidence that decisions are based on surrogate’s personal values than the
patient.
 Advanced directives…

• Now increasingly used for End-of-Life & Critical care

• Enable a patient to maintain a degree of control over his or her life, even
after the capacity to make decisions is lost.
• The card carried by many Jehovah’s Witnesses, detailing their refusal to
accept blood or blood products.
• Legal status: Changing and is now becoming part of UK law for the first
time. Not yet accepted in Indian Law.
 Medical Ethics: Domains

1. Clinical practice

2. Medical Research- Human

- Animal

- Laboratory

3. Epidemiological

4. Economical issues

5. Medical teaching

6. Biotechnology

7. Management
 CLINICAL PRACICE

Physicians are like kings ; they brook no contradiction

John Webster, 1580-

1625
 CLINICAL PRACTICE ISSUES
1. End-of Life Care & Dignity of death:
Palliative Care and “Allowing to die”
(Euthanasia – “assisted” and “mercy killing”)
2. Organ transplantation
Live-donor
Cadaver – Brain stem death
3. Sex selection – Abortion
4. Assisted Reproduction:
Ovum donation
Surrogate motherhood…
5. Genetic Engineering
6. Cloning
END-OF-LIFE (TERMINAL) CARE
 TRAJECTORIES of Death
1. Sudden Death 2. Progressive Illness
Health Status

Health Status
Death Death
Time
Time
 3. Slow decline and Crises
Health Status

Decline

Death

Time
 Problems of the Terminally Sick Patients
1. Fear of death

2. Symptoms and suffering

3. Social isolation

4. Financial pressures

5. Medical disinterest

6. Nihilistic approaches

7. Denial of death
 Important Issues for Doctors

• Palliative care – relief of symptoms vs. Life prolonging treatments

• Hospice versus hospitalization
• Telling the obvious
• Management in the last hours of living
• Patient’s obligations: Family, financial, social, spiritual, religious
• After death handling
• Bereavement
 Acts and Omissions
• Treatment withheld/withdrawn even if allows disease progression to natural
death
• Important distinction between allowing the patient to die a natural death
(allowing illness progression normally) and actively doing it (intentional
killing)
• Decision based on inability of patient to benefit from the treatment

(Read “Guidelines for Withdrawal of Treatment of Irreversibly Critically Ill

patients on Assisted Respiratory Supports” www.pgimer.nic.in)
 Euthanasia and physician –assisted
suicide
• Active euthanasia is illegal - The Netherlands and Belgium permit
voluntary active euthanasia by lethal injections
• Physician- assisted suicide is legal in some countries and states of North
America, such as Switzerland and Oregon
• Indian Courts do not accept the concepts
 Do not resuscitate (DNR) orders
• CPR is highly effective in ventricular fibrillation

• Not successful as a routine to all dying patients (critically ill patients with
multi organ failure or overwhelming sepsis)
• DNR orders has lead to conflict b/w doctors and patient’s families

• No sanction for DNR in India

• Good communication, why CPR will be commenced resolves many such

issues. CPR may not be wise or necessary in known, end-stage disease in
the absence of a reversible factor
 Rule of double effect (RDE)
• In terminal care, there is an obligation to maximize the patient’s comfort
and minimize the pain & distress
• Drugs such as opioids and benzodiazepine are often required more
liberally
• The harmful effects of drugs may appear to hasten a patient’s death( i.e.
double effect)
• The US Supreme Court has given RDE legitimacy
 Medical Commerce
“We cannot expect to see much action until enough policy makers lose their
fascination with the view that hospitals are basically businesses”.

Arnol Relman, NEJM 1985

A hospital is both alike and fundamentally different from a factory, public

school or corporate headquarters.

Chasles Rosenberg, 1987

 A CODE OF MEDICAL ETHICS
For information of the Registered Medical Practitioners on the Punjab Medical
Register

Part I: A code of Medical Ethics

General Advice

Part II: Warning notice

Some matters of forensic importance

 Health-Research: Ethical Issues
1. Subversion of research

Entrepreneurship

Conflicts of interest

Growing alliance

2. Dangers : Unknown risks vs promise of benefits

3. Patent protection

4. Citation & Publication

 BIOETHICS in Health-Research

• Restrictive / prohibitive to growth ?

WHY NEEDED?
• Preventing misguidance

• Warning future misuse

• Protecting the public interest

Bioethics promote a disciplined approach

 Specific Areas of Concern
1. Objectives of Research: Methodology & Safety; Costs of investigations;
Sponsorships

2. Animal Research: Numbers, Up-keep, Animal rights

3. New drug development - DNA and genetic technology

4. Genetically modified foods and plant based drugs

5. Use of living cells; cell-lines

6. Assisted reproduction techniques

7. Chimera technology

8. Biobanks, human gene patents, stem cell research, human cloning

9. Bio informatics and biological weapons

10. Plagiarism & False claims

 ICMR Guidelines - I

• Essentiality
• Voluntariness – informed consent and community agreement
• Non-exploitation
• Privacy and confidentiality
• Precautions and risk minimization
 ICMR Guidelines - II

• Professional competence
• Accountability and transparency
• Maximization of the public interest and of distributive justice
• Institutional arrangements
• Public domain
• Totality of responsibility
• Compliance
 Publication & Authorship
For “intellectual works”: Papers, Project reports, images, electronic (etc.)

I. Citation and Copy-right issues

II. Plagiarism (Pass off another person’s thoughts, writings as one’s own).

III. Authorship issues: It involves -

i. Accountability: Intellectual ,Professional, Moral, Social, Legal

ii. Responsibility for Contents Errors & Omissions

 Fundamental principals for authorship

All three

1. Substantial, intellectual contribution

2. Participation in writing, reviewing of the drafts and approval of the

final version

3. Precise contribution should be identifiable and justifiable.

Authorship is not a charity – should be earned as above.

 What is intellectual contribution?
1. Conceptualization

2. Performance of experiments and data collection

3. Conducting analysis and interpreting data

4. Reviewing literature, assessing accuracy & relevancy, writing

significant part of paper

5. Involvement in data collection, verification, supervision and guidance,

analysis and writing (throughout or for most of the study period).
 Framing Ethics: Difficult Issues

• Impervious vs Responsive
• Fusion of theory and practice
• Conceptual framework of

Right or wrong

Good or bad

Conflicts of morality

Other conflicts: Personal/Social/Cultural/Legal/Professional/

Commercial/Political
 Ethical Management Guidelines for
Leaders of Academic Medical Centres
• Threats (fiscal / others) to AHCs

• Power concentration in leaders –

“Ethical concepts of professionalism and justice required”

“Voluntary cooperation of all stake holders”

“Fostering financial viability”

Chervenak et al, Acad Med

2002
 Value system vs. Decision making

It is not only that value systems inevitably creep in to bias decision-making,

although they do. It is rather that policy making logically requires a
system of values. In large part those values are determined by culture.

Robert Veatch
 Handling Ethical Concerns

New discovery / vision

Social / Political /
Professional criticism / concerns

Commissions

Guidelines

Laws / Legislation
 Part I
A Code of Medical Ethics (Pb. Med. Council)
1. Dignity of Profession of medicine maintained on all occasions…following and similar
practices avoided.

a. Soliciting pvt. Practice…advts.

b. Deriving pecuniary profit from sale of any secret remedy

c. Share in profits

d. Publishing or sanctioning publication of reports of cases, operations, letters of thanks…

e. Covering persons not regd. Under Medical Acts

f. Keeping an open shop…

g. Talking to or association with the profession unconnected…

h. Agreeing to treat patient on the terms “no cure no payment” basis

i. Giving certificates under their own names to manufacturers of secret remedies.

 Not Necessarily a Right to Authorship 1

• Mere provision of funds, facilities or administrative supports.

• Mere participation in data collection.
• Work done by an employee in course of his/her employment for a
specific purpose.
• Being Head of a Department, does not quality to be author. Scientific
contribution is required for authorship.
• Authorship distribution should not be a charity –it should be earned.
• Preservation of raw data is the responsibility of the primary author in the
department.
 Terminal sedation

• The US Supreme Court has sanctioned the practice of terminal sedation,

in which the patients are rendered comatose and then may have nutrition
and hydration withdrawn
• Though the issue is contentious, the Courts allow this practice if based on
informed consent
• No such sanction in India.
 Not Necessarily a Right to Authorship 2

Laboratory data

Routine diagnostic or treatment investigations in a laboratory for patients,

unless:

i, the tests are carried out for purpose of the study;

ii, a significant laboratory data is being analysed and reported;

iii, the laboratory data constitutes or forms the subject of the study;

iv, Multiple laboratory data from a single laboratory are taken and highlighted;

v, Even single data, highlighted in case report.

 Not Necessarily a Right to Authorship 3

Clinical data: Routine registration of a patient/s in an OPD/Clinic/Ward does

not constitute the right to authorship, unless:

i, the work is based on one or more of these patients or from the material from
these patients, including the stored samples.

ii, a study is being done with reference to a clinical issue (eg. on clinical
patterns, therapy, prognosis and natural history).
 Order of Authorship

• The lead author is generally the person who took the lead and contributed
maximally.
• The subsequent order does usually not speak of the respective contribution
of individual authors. This could be either alphabetical in order or as
agreed upon by all the co-authors.
• Authors should specify in their manuscript a description of the
contributions of each author. This should at least be identifiable and
justifiable.
 Multi-centre Group and collaborative studies
• The group should identify the individual/s who accept direct responsibility for the
manuscript. These individuals should fully meet the three principle criteria defined
earlier.
• The issue of authorship should be frankly discussed very early in the course of the
work and a mutual decision should be made in writing.
• The first or the senior author should generally communicate with the journal-editor
and others related to the publication. He/she will take all the responsibility as the
primary author.

In case the first author is a student in the department, the corresponding author could
be the leader of the group performing the study.
• The first or the corresponding author should be able to speak on and defend the
paper.
 A CODE OF MEDICAL ETHICS

• Should not meet in consultation with non-registered practitioners

• Observe punctuality in consultation
• Announcing result of consultation
• Differences of opinion should not be divulged unnecessarily, but..
• Attendance should cease when consultation is concluded
• Should scrupulously avoid interference with or remarks upon the
treatment or diagnosis
• Communicate to the requesting practitioner.
Justified in refusing to continue attendance on cases
a.Another practitioner in attendance
b.Other remedies (than his) being used
c.His remedies refused
d.Where illness is an imposture
e.Patient persists in abuse of opium, alcohol, chloral etc.
f.Subsequent change of mind…
He is not in any way bound to give up a case because he cannot
cure it so long as the patient desire his services.
 Disputes & Plagiarism
Disputes over authorship & other issues should be best settled at the local
level by the authors themselves or with the help of the department head.

If local efforts fail, the Director/Dean/IRB of the Institute should be informed.

It does no good by directly writing to the journal’s office/editor.

Complaint sent directly to an Editor of a journal lowers the reputation of the

institution. The person should consult the Dean/Director before writing
to the Editor.
Preserve patient’s secrets. Not bound to answer to policemen, solicitors,
vakils…; only at the express discretion of judge or Magistrates presiding
in a Court of Law.

Not volunteer to give evidence in a Court of Law against his patient. Should
not appear subpoena.
 Ethical Practices and National
Ethics-Guidelines / Legislation
USA: National Bioethics Commission

India: Indian Council of Med Research

Pakistan: Lahore Study (Humayun et al 2008) Inadequate in hospitals

Iran: Structured approach to identify, analyse and resolve ethical issues –

National guidelines (Zahedi 2008)
 Brazilian Experience
Three different committees in hospitals:

1. Medical Ethics Committee: To evaluate professional conflicts

2. Research Ethics Committee

3. Clinical Bioethics Committee / Rounds

i. Provide consultancy on ethical questions

ii. Suggest institutional guidelines

iii. Trans disciplinary perspective

Goldim et al
2008
 Professional Domains

Knowing (Education & Research)

Doing (Practice)

Helping (Management)

These are the three ‘social values’ in a recognized concept of any profession.

Meston, 1981
 National Bioethics Commission (US)

1. Handling differences – World view

• Political orientation and discipline
• Dignity of difference
• Understanding than agreement

2. Experimenting with ‘prophetic’ bioethics

• Critique of modern medicine
• Alternative to “regulatory bioethics” (compromise-seeking)
 Ethics of questionnaire-based research

“It doesn't cost anything just to ask, does it?”

• Balance of benefits vs harms / time

• Harm – Creating / reinforcing anxiety about life threatening illnesses; level

of care; legal issues. Harms to participating professionals.

Evans et al, J Med Ethics

2002
 Public Policy Formulation
Public Policy leaders
N.G.Os.

Decision makers

Public “scientific literacy” is poor – short of acceptable criteria (only 7% in

American adults – 1979)

• Attitudes towards biotechnology ?

• Knowledge – attitude nexus

(Miller 1985; Bastels 1996;

Althaus 1998; Sturgis 2005)
 Patent Protection
• Intellectual property rights - Trademark / copyrights

• Right of researcher vs Societal issues

• Use of the past “unpatented” knowledge and wisdom

• Hiding information

• Depriving “known treatments” - Unethical culprit

 Patent as Unethical Culprit

• Creation of Western research

• Keeping prices high

• Depriving the global poor

• Creating a social divide and imbalance

• Uniting future research and development

 Special Ethical Considerations
Medical Futility
• There is general agreement that physicians never should unilaterally make
decisions about futility without explaining to the patient and family.
• The trend in futility cases is that while court did not permit life support
limit prospectively on appeal from doctors, they tend to defend decisions to
limit life sustaining therapy when made within acceptable professional
standards
 Drawbacks in the current strategies

• The dominance of autonomy over that of beneficence often leads to

inappropriate treatment
• The doctor often find himself in moral dilemma without adequate legal safe
guard against misinformed decision by families
• In this part of the world problems are compounded by the need to ration
recourses and moral obligation to protect families from financial ruin
• Societal pressure also erode the self esteem
 The Indian Scenario

• In India legal opinion and legalization relating to critical care is scarce

• There is no clearly stated legal opinion regarding discontinuation of life

support system even in brain dead patients
• In India Article 21 provides the right to life. However the concept of
autonomy is still weak
 The Indian Scenario…

• There have been a paucity of cases dealt with by Indian courts in the matter
of end of life care
• In the P-Rathinam VS Union of India 1994. The supreme court conceded
that in the case of terminal illness attempts to hasten death may be viewed
as an acceleration of dying process already started
• The court acknowledged that “ a person can not be forced to enjoy the
right to life to his detriment, disadvantage or dislike”
 The Indian Scenario…

• In the case of Gian Kaur vs State of Punjab the judgment disallows the
concept of euthanasia
• In India the predominant factor impacts decision making is the unbearable
financial burden that it entails
 Science or Philosophy of Medical
Jurisprudence Law (related to Medicine)
Medical Negligence

Lack of proper care and attention

Culpable carelessness

(Culpable-deserving blame)

Medical Ethics
• Professional practice (clinical indications/Commerce)
• Research and Technology
• Publications
 Principles : Fundamental

• Autonomy (self rule)

• Justice (Love of others)

• Non-maleficence (Loving life, do no harm)

• Beneficence (Loving good)

Macer 1998
• Ethics –Greek term “ethikos”,

Meaning customary, or nature, is the study of standards of conduct and

moral judgment.

• System or code of morals of a particular person, religion, group, or

profession. (Webster, 1980)

“Medical ethics is specifically concerned with moral principles and

decisions in the context of medical practice, policy and research”
 EQUITY

• Fairness

• Principles of justice used to correct or supplement the law.

Equity constitutes the basis of all ethics in the modern society.

 Positive rights vs. Negative rights
• “negative right” to refuse: based on autonomy
and informed consent, constitutional rights of
privacy, liberty and common law against
battery.
• “positive right” to demand treatment limited
by the physician’s clinical judgment and has
no foundations in biomedical ethics or in law.
What does ethical violation by doctors do?

– Damage the reputation of the profession and the person

– Erodes trust on doctors

– Interfere with people seeking therapy

– Invite judicial oversight with legal and regulatory systems – Personal

and Institutional
 HIPPOCRATIC ETHICS
• Oath Ascetic (self-discipline) philosophy
• Obligations of

Beneficence (helpful)

Nonmaleficence (official)

Confidentiality
• Prohibition against euthanasia, abortion, surgery, sexual relations with pt.
• “Pure” life – of virtue

Later additions: rules regarding dress, gossip, Reputation, cleanliness, truth-telling,

education, Consultations etc. Emphasis on duty, comparison, love and friendship