Seminar on Medical Ethics, presented on 11/02/2018

1. MEDICAL ETHICS
Moderator : Prof. S. Ghoshal

2. We should not get confused – Ethics are not :
Feelings
Religion
Law
Science

3. Ethics ??????
• Ethical norms are not universal, they depend on the sub culture
of the society
Moral
Principles
Good and
bad
Right and
wrong
Based on
value
system
Ethics

4. Medical Ethics
•System of moral principles that apply values to the
practice of clinical medicine and in scientific research
• Rules of etiquette adapted by the medical profession
Considerations of the motives behind that conduct

5. Autonomy Beneficence
Non maleficience Justice
4 Basic
Principles

6. Principle of respect for Autonomy
• Patient has capacity to act intentionally with understanding
• Controlling influences that would imitigate against a free and voluntary
act – not allowed

7. Desiring to benefit the patient,
physician strongly want to
provide BloodTransfusion :
believing it to be clear “medical
benefit”
Patient must be so informed :
The consequences of refusing BT : made
clear to the patient at risk of dying from
blood loss
Properly and compassionately informed,
patient is free
To accept BT or
To refuse BT

8. The Principle of Non-maleficience
• “Above all, do no harm,“ – Make sure that the procedure does not harm
the patient or others in society
• Not to intentionally create a harm or injury to the patient, either through
acts of commission or omission
• This Principle affirms the need for medical competence

9. • Medical mistakes may occur, however, this principle articulate a
fundamental commitment as the part of health care professionals to protect
their patients from harm
• Eg. Most would be willing to experience some pain if the procedure in
question would prolong life

10. PRINCIPLE OF DOUBLE EFFECT
• When interventions undertaken by physicians create a
positive outcome while also potentially doing harm it is
known as the "double effect."
• Single action – two effects : good effect and bad effect

11. Uterine
Carcinoma
How to BestTreat her ?????
TAH + BSO : A Life Saving Procedure
Mother Fetus
What action is morally allowable or
what is our duty ?
Woman has the right to self defence
and action of hysterectomy is aimed at
defending and preserving her life

12. The Principle of Beneficence
• Ordinary meaning of this principle :
• Health care providers have a duty to be of benefit to the patient, as well
as to take positive steps to prevent or to remove harm from the patient
• Non maleficience : constant duty (one ought never to harm another
individual) whereas beneficence is a limited duty

13. • This duty becomes complex if two patients appeal for treatment at same
time
• ???? Criteria of urgency or
• ???? First come first served

14. • Eg. 1 case where principle of beneficience is given
priority over the principle of respect for patient
autonomy
• ?? Emergency medicine
• One person suffered grave accident and aggressive
treatment is required. Like stoping the bleeding and
mending the broken bone or suturing the wounded
Vs
• Patient who tried to hang himself and was brought to
hospital by attendants, where patients are clear and they
are danger to themselves

15. • Placing the patient in a protective
environment in the belief that
patient is compromised and cannot
exist in his own hest interest at the
moment.

16. The Principle of Justice
• The distribution of scarce health resources, and the decision of who gets
what treatment
• The burdens and benefits of new or experimental treatments must be
distributed equally among all groups in society

17. The Principle of Justice
• Aristotle once said “giving to each that which is his due” : fair distribution
of goods in society
• When some goods and services are in short supply, fair means of allocating
scarce resources must be determined

18. • Persons who are equals should qualify for equal treatment
• For eg. All people > 65 years, category of persons is equal with respect to
one factor, their age but the criteria chosen says nothing about need or
other noteworthy factors about the person in the authority.

19. •In fact, our society uses a variety of factors as criteria for
distributive justice, including the following :
• To each person as equal share
• To each person according to need
• To each person according to effort
• To each person according to contribution
• To each person according to merit

20. Most controversial issue in modern health care
• Question : who has the right to health care ?
• As a society we want to be beneficient and provide some decent
minimum level of health care for all citizen regardeless of ability to pay.

21. • The demand of the principle of justice must apply at the bed side of the
individual patients but also systemically in the laws and policies of society
that govern the access of a population to health care.
• MuchWorks remain to be done in this arena

22. History of Medical Ethics
Hipporcrates to the modern day
400 BC to 2018

23. Hippocrates (400 BC)
• Greek physician
• Code of ethical principles for doctors and their
students
• Hippocrtatic oath

25. • Some clinicians see the oath as a rite of passage, others can’t
remember taking it, and some think it is irrelevant.
Whether doctors view it as meaningful or not, the oath still has
the power to encourage debate, prompting them to consider
what kind of vow would uphold the standards of their
profession, or even if they should take a vow at all.
“I swear by Apollo the Healer, by Asclepius, by Hygieia, by
Panacea, and by all the gods and goddesses, making them my
witnesses, that I will carry out, according to my ability and
judgment, this oath and this indenture.”

26. Nuremberg code
• 20th august 1947, 16 german nazi
physicians conducted pseudoscientific
medical experiments upon concentration
camp prisoners
• Filled with description of torture,
deliberate mutilation and murder

27. Defence argued : no
international law governing
what was and what couldnot be
considered ethical human
experiment
Nuremberg code was drafted
A set of principles centred upon the
consent and autonomy of the patient, not
the physician
The DoctorsTrial

28. 1951 : Hanrietta Lacks : HeLa Cells
• Hanrietta’s cervical tumor : HeLa cells
• Young black woman : piece of her cancerous
tumor extracted without her knowledge
• 1st human cell line to survive in vitro, since
then immortalized for testing new medical
treatments
• Serious concerns surrounding the lack of
informed consent and taking samples from
living patients.

29. 2017 : Charlie Gard
• Born in UK, with exceedingly rare condition – Infantile onset
encephalopathy mithochondrial DNA depletion syndrome (MDDS)
• Legal battle between : parents and his doctors over withdrawing life support
• Social media : playing a dominant role to facilitate discussions autonomy,
end of life care and parental rights
The case became
controversial because
the medical team and
parents disagreed
about whether
experimental
treatment was in the
best interests of the
child
after Charlie had
seizures that caused
brain damage,
GOSH formed the
view that further
treatment
was futile and might
prolong suffering
Legal Battle
between Child’s
parents and medical
team over ending
life support and
continuing
experimental
medicines and life
support

30. Informed consent
•Definition
• A patient willing acceptance of a medical intervention after
adequate disclosure from understanding of the nature of the
intervention, risks, benefits and alternative treatment
options.

31. What constitutes Informed Consent
• Disclosure : information to allow reasonable person to make a
decision
• Understanding : Comprehension of the information given
• Voluntary : no coercion or incentive to accept or deny a treatment
• Aggrement : verbal or written (Preferred)

32. MEDICAL ETHICS AND LAW
• Medical ethics is closely related
to law.
• Quite often, ethics prescribes
higher standards of behavior
than does the law and
occasionally ethics requires
that physicians disobeys laws
that demand unethical
behavior.

33. Good Clinical Practice
• Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for the design, conduct, performance, monitoring, auditing,
recording, analyses and reporting of clinical trials.
• serves to protect the rights, integrity and confidentiality of trial subjects
• Today, the GCP guidelines are
• used in clinical trials throughout the globe with the main aim of protecting
and preserving human rights.

34. Historical Background of GCP

35. 1964, the Declaration of Helsinki
• “The World Medical Association has developed ethical principles to provide
guidance to physicians and other participants in medical research involving
human subjects. It is the duty of the physician to promote and safeguard the
health of the people.The physician’s knowledge and conscience are
dedicated to the fulfilment of this duty”

36. Reasons for GCP

37. • The is a harmonised standard that protects the rights, safety and welfare
of human subjects, minimises human exposure to investigational
products, improves quality of data, speeds up marketing of new drugs
and decreases the cost to sponsors and to the public.
• Compliance with this standard provides public assurance that the rights,
safety and well-being of trial subjects are protected and consistent with
the principles of theDeclaration of Helsinki, and that the clinical trial data
is credible

38. There are 13 core principles of GCP and they
are as follows
• When summarised, simply mean: All clinical trials should be conducted in
accordance with ethical principles, sound scientific evidence
and clear detailed protocols.The benefits of conducting trials should
outweighthe risks.The rights, safety and wellbeing of trial participants
are of paramount importance and these should be preserved by obtaining
informed consent and maintaining confidentiality.The care
must be given by appropriately qualified personnel with adequate
experience. Records should be easily accessible and retrievable for
accurate reporting, verification and interpretation. Investigational products
should be manufactured according to Good Manufacturing Practice

39. Ethics Commitee
• A heterogenous group of members who are qualified, experienced in their
professional field and proficient enough to review and evaluate both
scientific and ethical aspects

40. Basic role of Ethic Committee can be summed as:
•To protect the rights, safety and well being of patients; by
– Prevent studies that pose an unacceptable risk of harm to participants
– Ensure that all participants in research are aware about the pros and cons for
their participation and have given appropriate Informed Consent.
•To promote fair ethical policies and procedures which will maximize the
likelihood of achieving good and patient-oriented outcomes

41. •To enhance the ethical tenor between health care professionals and
organisations conducting clinical trials.
• Overview and monitor thoroughly, compliance of sites with Standard Operating
Procedures (SOPs), regulations, guidelines and ETHICS.
• Offering due consideration to community views

42. Ethics committee Composition
• There should be a heterogeneous group of at least 7 members (5 as per ICH-GCP).
The EC members should be – Qualified, experienced in their professional field and
proficient enough to review and evaluate both scientific & ethical aspects (familiar
with GCP).
• Adequate representation of age, gender etc is maintained.
• Maximum of 15 members are recommended
– Chairperson : Outsider (Not from the institution if its Institution Review Board)
– Member – Secretary
– Member list must include at least each one of the following– a basic medical
scientist, clinician, legal expert, social worker, philosopher/priest, & a lay person.
– Experts from different arenas may be also invited for scientific review.
– A representative of Patient groups like for HIV, may also be included.

43. Postgraduate Institute of Medical Education and
Research (PGIMER) Ethics Committee
• 13 members
• 1. Chair Person : Kare Narain Pathak
Professor Emeritus &
FormerVice-Chancellor
PanjabUniversity
Chandigarh 160014
India
• List can be seen @
http://pgimer.edu.in/PGIMER_PORTAL/AbstractFilePath?FileType=E&FileName=Institute%20Ethics%20Committee.pdf&PathKey=EDITORREPOSITOR
Y_PATH

44. Medical Ethics and Oncology
• In everyday oncology practice, we make a wide range of ethical decisions.
Many of these decisions seem straightforward, with those involved agreeing
on the right course of action
• Other decisions are difficult, with conflicting perspectives regarding the
wishes, needs and best interests of patients.

45. An article suggests an ethical framework to facilitate the decision-making
of practitioners in relation to challenging practice situations.

46. Medical Ethics and Oncology

47. Problems and their solutions ???

48. The situation is not that simple EveryTime
• Patient dying of painful intestinal carcinoma,
patient might chose to forego CPR in event of
cardiac arrest, ,or the patient might chose to
forego life-sustaining technology such as
dialysis or ventilator.
• The reason for such a choice is based on the
belief of the patient that prolonged living
with a painful and debilitating condition is
worse than death, a greater harm
Good
Palliative Care
VS
Euthanasia

49. Problem 2
• 80 years old female, Mrs Amarjeet from chandigarh, lives alone
• Recently diagnosed with carcinoma breast
• Prior to diagnosis she was independent woman, enjoyed the company of
friends and neighbor
• She has no family in india and her son lives in canada

50. • Now her mood seems low and she states she doesnot wish to live any longer
• She has refused all medical interventions and has given living will
• She doesnot want any hospitalization
• One morning her neighbor finds her on sofa, still fully dressed as previous
enening, incoherent
• Brought to hospital,
What would be Best treatment for her
Active treatment
No treatment
Hospice admission
Just ignore her
??????