Ethics in Medicine

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Ethics in Medicine
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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)

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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

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Medical Negligence

• Disease-diagnosis / Tests
• Medical Expertise Disease information
• Standards of care
• Treatment Drugs / Interventions
• Emergency Management
• Costs/Referrals
• Complications
• Violation of Acts

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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)

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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

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BASIC ETHICAL PRINCIPLES

• Autonomy an individuals right to self
  -determination
• Beneficence to do good
• Nonmaleficence -do no harm
• Distributive Justice - the just and equitable
  provision of finite health care resources

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Evolution of Medical Ethics

• Hippocratic tradition
• Philosophical inquiries
• (Principle based moral theories)
• Antiprinciplism
• (Competing moral theories)
• Crisis
• (Conceptual conflicts Skepticism of morality)
• (Pellegrino, 1993)

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Beneficence

• Has roots in the Hippocratic doctrine of
  fostering the patients 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

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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

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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

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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.

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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

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Autonomy Issues Concepts

• Capacity
• Informed consent
• Surrogate decision making
• The best argument
• Paternalism
• Resuscitation status

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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

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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.

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Surrogate Decision Making

• Patient loses capacity
• Most commonly a family member surrogate or
  proxy for the patient
• It is the surrogates responsibility to represent
  the personal values of the patient
• Difficulties when value set is not well defined
  or disagreement among family members

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Best Interest Argument

• When a patients 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 surrogates personal
  values than the patient.

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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 Jehovahs 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.

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Medical Ethics Domains

• Clinical practice
• Medical Research- Human
• - Animal
• - Laboratory
• Epidemiological
• Economical issues
• Medical teaching
• Biotechnology
• Management

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CLINICAL PRACICE

• Physicians are like kings they brook no
  contradiction
• John
  Webster, 1580-1625

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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

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• END-OF-LIFE (TERMINAL) CARE

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TRAJECTORIES of Death
1. Sudden Death
2. Progressive Illness
Health Status
Health Status
Death
Death
Time
Time
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3. Slow decline and Crises
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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

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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
• Patients obligations Family, financial, social,
  spiritual, religious
• After death handling
• Bereavement

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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)

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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

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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
  patients 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

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Rule of double effect (RDE)

• In terminal care, there is an obligation to
  maximize the patients 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 patients death( i.e. double effect)
• The US Supreme Court has given RDE legitimacy

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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

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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

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Health-Research Ethical Issues

• Subversion of research
• Entrepreneurship
• Conflicts of interest
• Growing alliance
• Dangers Unknown risks vs promise of benefits
• Patent protection
• Citation Publication

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BIOETHICS in Health-Research

• Restrictive / prohibitive to growth ?
• WHY NEEDED?
• Preventing misguidance
• Warning future misuse
• Protecting the public interest
• Bioethics promote a disciplined approach

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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

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ICMR Guidelines - I

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

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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

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Publication Authorship

• For intellectual works Papers, Project
  reports, images, electronic (etc.)
• Citation and Copy-right issues
• Plagiarism (Pass off another persons thoughts,
  writings as ones own).
• III. Authorship issues It involves -
• i. Accountability Intellectual ,Professional,
  Moral, Social, Legal
• ii. Responsibility for Contents Errors
  Omissions

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Fundamental principals for authorship

• All three
• Substantial, intellectual contribution
• Participation in writing, reviewing of the drafts
  and approval of the final version
• Precise contribution should be identifiable and
  justifiable.
• Authorship is not a charity should be earned as
  above.

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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).

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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/Pr
  ofessional/
• Commercial/Political
• 
  
  

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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

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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

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Handling Ethical Concerns

• New discovery / vision
• Social / Political /
• Professional criticism / concerns
• Commissions
• Guidelines
• Laws / Legislation

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Part IA Code of Medical Ethics (Pb. Med. Council)

• Dignity of Profession of medicine maintained on
  all occasionsfollowing and similar practices
  avoided.
• Soliciting pvt. Practiceadvts.
• Deriving pecuniary profit from sale of any secret
  remedy
• Share in profits
• Publishing or sanctioning publication of reports
  of cases, operations, letters of thanks
• Covering persons not regd. Under Medical Acts
• Keeping an open shop
• Talking to or association with the profession
  unconnected
• Agreeing to treat patient on the terms no cure
  no payment basis
• Giving certificates under their own names to
  manufacturers of secret remedies.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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• Justified in refusing to continue attendance on
  cases
• Another practitioner in attendance
• Other remedies (than his) being used
• His remedies refused
• Where illness is an imposture
• Patient persists in abuse of opium, alcohol,
  chloral etc.
• 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.

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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 journals
  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.

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• Preserve patients 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.
  

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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)

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Brazilian Experience

• Three different committees in hospitals
• Medical Ethics Committee To evaluate
  professional conflicts
• Research Ethics Committee
• Clinical Bioethics Committee / Rounds
• i. Provide consultancy on ethical questions
• ii. Suggest institutional guidelines
• iii. Trans disciplinary perspective
• 
  Goldim et al 2008

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Professional Domains

• Knowing (Education Research)
• Doing (Practice)
• Helping (Management)
• These are the three social values in a
  recognized concept of any profession.
• 
  
  Meston, 1981

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National Bioethics Commission (US)

• Handling differences World view
• Political orientation and discipline
• Dignity of difference
• Understanding than agreement
• Experimenting with prophetic bioethics
• Critique of modern medicine
• Alternative to regulatory bioethics
  (compromise-seeking)

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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Principles Fundamental

• Autonomy (self rule)
• Justice (Love of others)
• Non-maleficence (Loving life, do no harm)
• Beneficence (Loving good)
• 
  Macer 1998

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• 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

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EQUITY

• Fairness
• Principles of justice used to correct or
  supplement the law.
• Equity constitutes the basis of all ethics in the
  modern society.

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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 physicians clinical judgment and has no
  foundations in biomedical ethics or in law.

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• 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

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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

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THANK YOU