A detailed discussion on Ethical consideration concerning physician, patient, co-workers and research. It also discusses publication ethics and Ethics in India

1. Ethical Issues in Medicine and
Research
Dr. Jishnu Sathees Lalu
Community Medicine
AIMS-Kochi

2. Table of Contents
Introduction
History
Principles of Ethics
Physician patient relation
Physician society relation
Physician colleague relation
Medical research
Medical education
Medical ethics in India
Conclusion
Contents 1 Contents 2

3. Introduction
• Scientific knowledge arises from experiments
• In medical science, experiments provide the basis for
induction.
• Claude Bernard- experiments should be conducted in a
way that shows respect for the ethical principles that
have always prescribed over the practice of medicine.
• Doctors make constant ethical decisions everyday in
clinical work. Unlike medical paternalism- patients are
better informed

4. Ethics
• Study of morality and moral principles that governs a
person’s behaviour or the conducting of an activity.
• Medical ethics- moral values and judgment as they
applied to medicine.
• Bioethics- ethical issues arising from new situation and
possibilities brought about by advances in biology and
medicine.
• Ethics helps medical professionals to recognize difficult
situations and to deal with them in a rational and
principled manner.

5. What is an Ethical issue?
• When you have to judge what is right or
wrong.
• A dilemma- making a different choice.
• Prolonging life,ending life..etc
• Day to day issues can involve:
• Respecting people,treating people with dignity,
supporting patient choice etc.

6. Historical background
• Ethics in clinical practice
evolved from priest -
supplicant relationship in
4000BC .
• Greeks separated medicine
from religion
• Physician paternalism
prevailed till the early 20th
century.
• Unethical behaviour was
common among scientists.
• Insufficiently informed of
what was done or who could
not refuse to participate.
• In 1714, Charles Maitland
inoculated smallpox in 6
prisoners, promising them
release.

7. • Antidotes of Hemlock were tested on prisoners.
• William Wallace demonstrated the infectivity of
Syphilis by inoculating healthy subjects.
• Medical ethics gained importance – to respect
individual decision and protect morality.

8. Thomas Percival- 1803 1900 Berlin code of ethics

9. Nuremberg code

10. International Code of reference for
biomedical research – Declaration of
Helsinki

11. • In 1978,the Belmont report of US commissioners
stated ethical principles and guidelines: Respect,
beneficence and Justice.
• 1982, CIOMS proposed International guidelines
based on the Nuremberg code, DoH and the
Belmont report, to apply in developing countries.

12. 1985, Beachamp and Childress-

13. Principles of ethics
ethics
Autonomy
Beneficence
Non maleficence
Justice

14. Who decides what is Ethical?
• It can differ from society to society
• Some fundamental ethical principles are
agreed by most human beings – Universal
declaration of human rights.
• At the global level- WMA has set forth ethical
statements for physicians no matter where
they live and practice.

15. WMA
• Only international Org represent all physicians
• They have undertaken the role of establishing
general standards in medical ethics that are
applicable world wide.
• They updated the Hippocratic Oath for 20th
century use. Declaration of Geneva.
• 3rd general assembly – developed an
International code of Ethics

16. Hippocratic Oath

17. • Declaration of Helsinki- Ethical guidelines for
research on human subjects.
• Adopted policy statements on socio medical
topics including medical education and health
systems.

18. Non rational Rational
• Obedience
• Imitation
• Feeling or desire
• Intuition
• Habit
• Deontology
• Consequentalism
• Principlism
• Virtue ethics
History
How do individual decide what is ethical?

19. Description of the contents
1.Respect & equal
treatment
2.Communication
and consent
3.Decision making
4.Confidentiality
5.Beginning of life
issues
6.End of life issues
1.Dual loyalty
2.Resource
allocation
3.Global health
1.Challenges to
medical authority
2.Relationship with
colleague ,
teachers and
students
3.Relationship with
other health
professionals
1.Research in
medical practice
2.Declaration of
Helsinki
3.Honest reporting
of ressults
4.Whistle blowing
Physicians and
patients
Physicians and
society
Physician and
colleague
Medical research
Ethical application

20. Physicians and Patients

21.  PP relationship is the cornerstone of medical practice
and therefore of medical ethics.
 Declaration of Geneva- “the health of my patient will
be my first consideration”
 Physician autonomy Patient Autonomy

22. Respect and equal treatment
• “All humans are born free and equal in dignity
and rights.”-universal declaration of human rights
• No factors to intervene between his/her duty
and his/her patient.
• Physician compassion enables patients trust-
contributes to the healing process

23.  Challenges in care of infectious cases like
HIV/AIDS.
 WMA states that such pts need competent and
compassionate treatment.
 Intimate nature of the PP relationship can give
rise to sexual attraction- should be resisted
 Emotional attachment with a patient can
adversely affect the clinical judgment

24. Communication and Consent
• Informed consent is one of the central concept
of the present day medical ethics.
• No more medical paternalism - now
communication requires much more
information provided by the physician to make
their decision.

25. 2 exceptions for informed consent
by competent patients
1)Gives over the decision making authority to the
physician or to a third party
2)Instances where the disclosure of information
would cause harm to the patient.

26. Decision making for incompetent
patients
• Many patients are not competent to make
decisions for themselves. eg; young children,
comatose, mental or neurological condition
• Ethical issue arises in the determination of the
appropriate substitute decision maker and in the
choice of criteria for discussion on behalf of
incompetent patients.

27. • Physicians make decision for patient only if
the designated substitute cannot be found.
• Physician should challenge the decision of the
substitute through relevant legal authorities if
required.

28. Confidentiality
• The physician duty to keep patient information confidential
has been a corner stone of medical ethics.
• The International code of Medical Ethics states “It is ethical
to disclose confidential information when the patient
consents to it or when there is a real and immenent threat of
harm can be only removed by a breach of confidentiality”
• The high value placed on Confidentiality has 3 sources:1.
Autonomy 2.respect for others and 3. Trust

29. Breach of confidentiality
• Healthcare institutions
• Medical students
• When communication is impossible
• Legal requirement
• Psychiatric patient intends to harm
• HIV/AIDS patient continues unprotected sex

30. Beginning of life issues
• Laws , regulation and policies related to this are:
• Contraception
• Assisted reproduction
• Prenatal genetic screening
• Abortion
• Severely compromised neonates
• Research issues : incl production of new embryos
or the use of spare embryos to obtain stem cells

31. End of life issue
• Ranges from attempts to prolong lives of dying
patients through highly experimental
technologies to effort to terminate life
prematurely through Euthanasia and medically
assisted suicide.
• Euthanasia
• Assistance in suicide

32. Euthanasia
• Means knowingly and intentionally performing
an act that is clearly intended to end another
person’s life.
• Commits the act with the primary intention of
ending the life of that person , undertaken with
compassion and without personal gain.

33. Types of Euthanasia
• Euthanasia can be classified in different ways,
including:
1. Active euthanasia – where a person deliberately
intervenes to end someone’s life – for example,
by injecting them with a large dose of sedatives
2. Passive euthanasia – where a person causes death
by withholding or withdrawing treatment that is
necessary to maintain life.
3. Voluntary euthanasia – where a person makes a
conscious decision to die and asks for help to do this
4. Non-voluntary euthanasia –
5. Involuntary euthanasia – where a person is killed
against their expressed wishes

34. Euthanasia status
• Legalized
1)Netherlands
2)Belgium
3)Colombia
4)Luxemburg
• Criminalized
1)Mexico
2)Thailand
3)Northern territory of
Australia

35. Recent cases of Euthanasia
• Passive euthanasia is legal in India.
• In 2011 for a bedridden rape victim late Aruna
Shanbaug.
• The Marlize munoz case of 2013- brain dead-
remove life support- unethical and illegal to do
so in a pregnant mother

36. Assistance in suicide
• Knowingly and intentionally providing a person with
the knowledge to commit suicide.
• Arise as a result of pain or suffering that is considered
by the patient intolerable.
• Physicians are regarded as the appropriate instrument
of death.
• Hampering the natural course of death is unethical in
any code of ethics

37. AIS in the world
• Legalized
1)Switzerland
2)Germany
3)Japan
4)Some of the US states

38. CASE STUDY
Dr. Sam, an experienced and skilled surgeon, is about to finish
night duty at a community hospital. A young woman is
brought to the hospital by her mother, who leaves immediately
after telling the intake nurse that she has to look after her other
children. The patient is bleeding vaginally and is in a great
deal of pain.
Dr. Sam examines her and decides that she has had
either a miscarriage or a self-induced abortion. He does a
quick dilatation and curettage and tells the nurse to ask the
patient whether she can afford to stay in the hospital until it is
safe for her to be discharged. Dr.Amritesh comes in to replace
Dr. Sam, who goes home without having spoken to the patient.

39. Case analysis
Dr. Sam’s conduct was deficient in several respects:
(1) communication – he made no attempt to
communicate with the patient regarding the cause of
her condition , treatment options or her ability to afford
to stay in the hospital while she recovered;
(2) consent – he did not obtain her informed consent to
treatment:
(3) compassion – his dealings with her displayed little
compassion for her plight. His surgical treatment may
have been highly competent and he may have been
tired at the end of a long shift, but that does not excuse
the breaches of ethics.

40. Physician and society

41. • Medicine is more social rather than a strictly
individual activity. It relies on government,
medical researches, health institutions etc and
treat disease and illness that are much social as
biological in origin.
• Medical profession have significant roles in
public health, health education, environment
protection, laws affecting the health and well
being of the community. Etc

42. Dual Loyalty
• When physicians are accountable both to their
patients and to a third
party(governments,employers, insurances ,
police , family members etc)
• Physicians should resolve any conflicts
between their own interests and those of their
patients, in their patients favour.

43. Resource allocation
• In circumstances where a choice must be made
between potential patients for a particular
treatment that in limited supply, the selection
should be based on medical criteria and made
without discrimination.
• Avoid wasteful and inefficient practices ,even
when patient requests

44. Global health
• Globalization encompasses information
exchange, commerce , politics, tourism and
many other human activities.
• The failure to recognize and treat highly
contagious disease by a physicians in one
country can have devastating effect on patients
in other countries.

45. Case study 2
• Dr. Reshma is becoming increasingly frustrated with
patients who come to her either before or after
consulting another health practitioner for the same
ailment. She considers this to be a waste of health
resources as well as counterproductive for the health of
the patients.
• She decides to tell these patients that she will no longer
treat them if they continue to see other practitioners for
the same ailment. She intends to approach her national
medical association to lobby the government to prevent
this form of misallocation of healthcare resources.

46. Case analysis
• the patient is taking up Dr. Reshma’s time that could be
devoted to other patients in need of her services.
• However, physicians such as Dr. Reshma must be
cautious in dealing with situations such as this. Patients
are often unable to make fully rational decisions for a
variety of reasons
• Dr. Reshma is also right to approach her medical
association to seek a societal solution to this problem ,
since it affects not just herself and this one patient but
other physicians and patients as well.

47. Physician and colleagues

48. Challenges to medical authority
• Physician belongs to a hierarchical system,
internally and externally
• Internally :
I. Among specialties
II. Within specialties
III. Primary caregiver of the specific patient
• Externally: physicians are traditionally at the
top of the hierarchy of caregivers, above the
nurses and other health professionals.

49. Relationship with colleagues, teachers
and students
• Physicians are expected to treat all members of the medical
profession as family members.
• Treat colleagues respectfully and work cooperatively to
maximize patient care.
• Physicians are restricted from paying or receiving any fees
etc for referral of a patient and stealing patients from
colleagues.
• Respect entails an appreciation of skills and experience of
healthcare providers physicians ,nurses etc contribute to the
care of patient.

50. Report unsafe or unethical medical
practices.
• Report unsafe or unethical medical practices to
appropriate authorities.
• Other alternatives can be considered before
informing the authorities

51. Case study 3
• Dr. Arjun, a newly appointed Anesthetist in a city
hospital, is alarmed by the behaviour of the senior
surgeon in the operating room. The surgeon uses out-
of-date techniques that prolong operations and result
in greater post-operative pain and longer recovery
times. Moreover, he makes frequent crude jokes about
the patients that obviously bother the assisting nurses.
• As a more junior staff member, Dr. Arjun is reluctant to
criticize the surgeon personally or to report him to
higher authorities. However, he feels that he must do
something to improve the situation.

52. Case analysis
• Not only is he endangering the health of the
patient but he is being disrespectful to both the
patient and his colleagues.
• Dr. Arjun has an ethical duty not to ignore this
behaviour but to do something about it. As a first
step, he should not indicate any support for the
offensive behaviour, for example, by laughing at
the jokes.
• If he thinks that discussing the matter with the
surgeon might be effective, he should go ahead
and do this. Otherwise, he may have to go
directly to higher authorities in the hospital

53. Medical Research

54. Medical research
• Ethics in clinical research focuses on
identifying and implementing the acceptable
conditions for exposure of some individuals to
risks and burdens for the benefit of society at
large.

55. Research in medical practice
• Has to maintain competence through
CME,Journals etc
• The ethical values of the physician – compassion,
competence, autonomy – apply to the medical
researcher as well.
• Rewards offered by medical research companies
can conflict with the right of the patient to receive
all the necessary information for making a
decision on taking part in the trial.

56. Declaration of Helsinki
• Ethical review committee approval-The ethics
committee may approve the project as presented,
require changes before it can start, or refuse
approval altogether.
• Scientific merit-
• Social value-
• Risks and benefits-
• Informed consent-
• Confidentiality
• Conflicts of interest

57. Publication ethics
• Defined as a self regulatory mechanism insisting on
integrity on the part of authors, peer reviewers and
publishers to establish higher standards of editorial
processing for the scholarly journals.
• Violation : duplicate submission, multiple submissions,
plagiarism, gift authorship, ghost authorship, salami
publications etc
• Treatment based on such results can harm the patients
• Harms other researchers who waste time following up such
studies

58. Whistle blowing
• To prevent unethical research
• Those who are aware of such practices can inform
the appropriate authorities.
• Whistle blowers are usually punished or
prevented from disclosing the wrong doing.
• Juniors who are helpless can at least stay away
from participating in such studies.

59. Unresolved issues
• All aspect of medical research doesn’t enjoy
general agreement.
• Ethical acceptability of techniques in genetics,
neurosciences and organ and tissue transplant
is still questionable.
• Questions on what continuing care should be
provided for the participants of research.

60. Unethical research cases
• The monster study on orphans in Davenport,1939
• Doctor's trial-1946-criminal trial for Nazi human
exp
• Tuskegee syphilis experiments in 1972
• In jan 2012 GSK was fined $240000 for falsifying
parental consent for a vaccine trial on 15000
children

61. Nazi human experiments
• Exp on prisoners(Jews from across Europe)
• Exp conducted on twins, bone , muscle and nerve
transplant, freezing exp , high altitude exp..etc
• To help German military in combat situations, develop
new weapons..etc
• Most died and others were executed for post mortem
studies

62. Case study 4
• Dr. Diya, a general practitioner in a small rural town, is
approached by a contract research organization
(C.R.O.) to participate in a clinical trial of a new non-
steroidal anti inflammatory drug (NSAID) for
osteoarthritis. She is offered a sum of money for each
patient that she enrolls in the trial.
• The C.R.O. representative assures her that the trial has
received all the necessary approvals, including one
from an ethics review committee. Dr. Diya has never
participated in a trial before and is pleased to have this
opportunity, especially with the extra money. She
accepts without inquiring further about the scientific or
ethical aspects of the trial.

63. Case analysis
• Dr. Diya should not have accepted so quickly. She should first
find out more about the project and ensure that it meets all the
requirements for ethical research.
• She should only participate in projects in her area of practice,
and she should satisfy herself about the scientific merit and
social value of the project. If she is not confident in her ability
to evaluate the project, she should seek the advice of
colleagues in larger centers.
• She should ensure that she acts in the best interests of her
patients and only enrolls those who will not be harmed by
changing their current treatment to the experimental one or to
a placebo. She should not agree to enroll a fixed number of
patients as subjects since this could lead her to pressure
patients to agree, perhaps against their best interests. they
become available.

64.  Medical students and doctors in training need
to hone their clinical skills on patients to make
themselves better doctors, but patients may not
benefit directly from such attention.
 Patients may be misinformed about the
qualifications and experience of their care
givers.
 Ethical principles are applicable
Ethics in Medical Education

65. Medical Ethics in India

66. Ethics and ethical principles was
followed during the Ayurvedic period
of Charaka (600BC- 800AD).

67. Flash back
• Policy statement on Ethical Considerations
involved in research on human subjects. –
1980 by ICMR.
• Ethical guidelines for biomedical research on
Human Subjects- 2000
• Put in to force through Schedule Y.
• 12 principles by inducting the 3 basic ethical
principles

68. MCI guidelines
• Duties and responsibilities of
the physician in general
• Duties of physicians to their
patients
• Duties of physician in
consultation
• Responsibilities of physician
to each other
• Duties of physician to the
public and to the paramedical
profession
• Unethical acts
• Misconduct
• Punishment and disciplinary
action

69. The way ahead
• Though we formulated these guidelines, are
we adequately following them?
• The PG/PhD thesis- trains investigators the
element of ethical research.

70. Conclusion
• Despite all these potential problems, medical
research is a valuable and rewarding activity
for physicians and medical students as well as
for the research subjects themselves. Indeed,
physicians and medical students should
consider serving as research subjects so that
they can appreciate the other side of the
researcher-research subject relationship.

71. “Doing well and doing good might not
always go hand in hand.”

72. References
• Ethical issues in the development and use of guidelines for clinical
practice.Redman BK
• Ethics and clinical practice guidelines- Margaret A Somerville
• Ethical issues in implementation research: a discussion of the problems in
achieving informed consentJane L Hutton1*, Martin P Eccles2 and Jeremy M
Grimshaw3
• Systematic and transparent inclusion of ethical issues and recommendations in
clinical practice guidelines: a six-step approach Marcel Mertz12 and Daniel
Strech1
• Ethics in Medical Research in Humans: A Historical PerspectiveX. Sierra
• Medical Ethics Mannual-2nd edition by WMA
• Violation of publication ethics in manuscripts: analysis and perspectives:
subramani parasuraman et al
• Ethics in clinical research : The Indian Perspective : J Sanmukhani
• Ethical issues in the practice of Medicine: Dr. M S Valiathan