The document presents an introduction to medical bioethics, emphasizing the ethical treatment of patients through historical frameworks like the Hippocratic Oath and the four pillars of bioethical decision-making: autonomy, beneficence, nonmaleficence, and justice. It discusses the importance of ethics in clinical research, informed consent, and ethical guidelines such as the Nuremberg Code and the Declaration of Helsinki. Numerous examples and scenarios illustrate the application of these ethical principles in healthcare settings.

1. INTRODUCTION TO MEDICAL BIOETHICS
dr. Bagus Putu Putra Suryana, SpPD,K-R, FINASIM
KOMISI ETIK PENELITIAN KEDOKTERAN
FKUB Universitas Brawijaya, Malang
Kuliah MKKDU Prodi Spesialis FKUB
Tanggal 9-7-2024
Slide source : Mwenyekonde Elled (DCM, BHM, M.Phil. MCH)
Principle and Practice

4. Short History of Ethics in Healthcare
Since the era of Hippocrates (460 – 370 BC), the
proper, ethical treatment of patients by healthcare
providers has been emphasized. The hippocratic
oath and other more modern versions have all
stated how to appropriately treat patients.
More recently, four pillars of bioethical decision
making in healthcare have been developed:
autonomy, beneficence, nonmaleficence and
justice. Each of these must be taken into
consideration when treating patients.
https://medschool.ucla.edu/body.cfm?id=1158&action=detail&ref=1056
https://vtethicsnetwork.org/medical-ethics
https://www.ama-assn.org/delivering-care/ethics/ethics-committees-health-care-institu
tions

5. Philosophy and Ethics
Philosophy- use of reasoning in seeking truth and
knowledge of reality and principles governing
existence
Epistemology- what is knowledge?
Ontology- what is nature of existence?
Aesthetics- What is beauty?
Ethics- what should I do?

6. Ethics
Branch of philosophy dealing with morality
It attempts to distinguish between what is right and what is
wrong.
In health and research, we deal with new situations hence
ethical reasoning is important.
The application of ethics to medical, health practice and
research is called Bioethics.

7. 4 Ethical Rules
 Veracity – truth telling, informed consent, respect for autonomy
 Privacy – a persons right to remain private, to not disclose information
 Confidentiality – only sharing private information on a ‘need to know
basis’
 Fidelity – loyalty, maintaining the duty to care for all no matter who
they are or what they may have done

8. CLINICAL RESEARCH
is research involving humans
 To examine physical, mental and / or behavioral
attributes of an individual or group of people
 To collect information that contributes to our
collective memory and general knowledge about
individuals and groups of people

9. Justification of Research in Humans
• Human physiologic studies,
because animal responses often
are not the same
• Epidemiological studies, because
they depend on human
susceptibilities and human
interactions
• Drugs for treating humans because
animal experiments don’t always
predict human responses
Impossible to reach important conclusions without studying
humans

10. Why is ethics important in research (1)
Human participants in research may be harmed
Protections and safeguards needed to prevent harms
Not all risks can be predicted in advance
Harms may outweigh benefits
Human participants may be wronged

11. Why is ethics important in research (2)
To treat people as a “mere means” or “object” to
benefit others wrong them
Individual posses human rights
Access to research may provide benefits to
participants that are otherwise unavailable
Health benefits to society result from research

12. First Controlled Clinical Trial
Lind’s Experiment (Year 1747)
Twelve sailors with same
symptoms of Scurvy
Each pair received one of the
following interventions
 Quart of cider a day
 25 drops vitriol 3x a day
 2 spoons of vinegar 3x a day
 Half pint of sea water a day
 Paste of garlic, mustard seed,
dried radish and myrrh
 An orange and two lemons

13. History of the
Ethical Research
Movement

14. Chronology of Regulation of
Research Involving Human Subjects
Nuremburg Code, 1947 (CODE)
Declaration of Helsinki, 1964 (GUIDELINES)
U.S. National Research Act, 1974 (LAW)
Belmont Report, 1979 (REPORT)
ICH-GCP, 1996 (SOP)

15. The Nuremberg Code 1947
(World War II)
Informed consent is absolutely essential
Qualified researchers must use appropriate
research designs
There must be a favorable risk/ benefit ratio
Participants must be free to stop at any time

16. The Declaration of Helsinki
World Medical Association
(1964, 1975, 1983, 1989, 1996, 2002)
“The well-being of the subject should take precedence
over the interests of science and society”
Consent should be in writing
Use caution if participant is in dependent relationship
with researcher
Limited use of placebo, especially if treatment is
available
Greater access to benefit once research is concluded

17. Council for International Organizations of Medical Science
(CIOMS) Guidelines 1993, 2002
Nuremberg Helsinki CIOMS
 Informed consent
 Research in developing countries
 Protection of vulnerable populations
 Distribution of the burdens and benefits
 Role and responsibilities of ethics committees

18. Bioethical Fundamentals
There are four pillars of bioethical decision making in healthcare :
1. Autonomy – the ability to make your own decisions. The patient has the right
to determine what can or cannot happen during treatment by making an
informed, uncoerced decision (consent).
2. Beneficence – an act of charity or kindness. A healthcare professional must
act for the benefit of the patient with no other motives.
3. Nonmaleficence – “do no harm”. A healthcare professional must not harm
the patient.
4. Justice – providing fairness in healthcare decisions. A healthcare professional
must treat all individuals equally with an equitable distribution of resources.
https://www.themedicportal.com/blog/medical-ethics-explained-justice/
https://vtethicsnetwork.org/medical-ethics

19.  Relates to the notion that competent individual has a right
to self-determination.
 Health workers have to provide information that allows
individuals to make autonomous decisions.
 Respect a person’s right to make their own decisions
 Teach people to be able to make their own choices
 Support people in their individual choices
 Do not force or coerce people to do things
AUTONOMY (1)

20. AUTONOMY (2)
Maximize expected benefits minimize potential harms
‘Informed Consent’ is an important outcome of this principle
Ensure that research design is adequate to derive benefits from
results
Measures to be taken for individuals to autonomise and protect
incompetent persons. E.g. prisoners, children, refugees,
intellectual disability, drunk etc.

21. Scenario 1
HIV test for patient before having major
operation.
Should get approval from patient or family?
Consider the risk for operator?

22. 5 Conditions for autonomous decision
Person must be taken to make decisions
There must be disclosure of information
There has to be understanding of information
Any decision whether consent or refusal has to be
voluntary
A specific authorization needs to be given by the
participant

23. Scenario 2
Decision for chemotherapy in patient with
malignancy.
Should get approval from patient or family?
Consider the response and side effects?

24. NON-MALEFICIENCE
A duty to do no harm
‘Benefit’ should be defined by the person
themselves. It’s not what we think that is
important.
Act on behalf of ‘vulnerable’ people to protect
their rights
Create a safe and supportive environment
Help people in crises

25. Scenario 3
Cyclophosphamide infusion for young female.
Consider the risk for ovarian failure (irreversible
infertility).

26. BENEFICENCE
Acting in best interest.
Do not to inflict harm on people
Do not cause pain or suffering
Do not incapacitate
Do not cause offence
Do not deprive people
Do not kill

27. Scenario 4
Stem cell therapy in patients with osteoarthritis?
Consider benefits, efficacy, cost and risks?

28. JUSTICE (1)
Treating people fairly
Not favouring some individuals/groups over others
Acting in a non–discriminatory / non-prejudicial way
Respect for peoples rights
Respect for the law
Justice incorporates notions of equity and of the fair
distribution of resources.

29. JUSTICE (2)
Right of the person to demand certain things and duty
of the other person to provide these
In health care ethics subdivided obligations of justice
are in three categories: fair distribution of scarce
resources (distributive justice), respect for people's
rights (rights based justice) and respect for morally
acceptable laws (legal justice).

30. Scenario 5
During the Covid outbreaks, intensive unit and
ventilators out of capacity.
Who should get?

31. INFORMED CONSENT
Is a process (presenting information, explaining,
answering questions, discussing)
Informed decision making include dissent-right to
decline

32. The Consent Form
It documents consent process
It cannot substitute for the consent dialogue
Its purpose is not to provide legal protection for the
researcher
Its purpose is to familiarize participants with the
purpose and details of the research

33. What an informed consent document must cover
Withdrawal of participation by the investigator
Consequences of withdrawal
Participation and withdrawal
Privacy and confidentiality
Emergency care and compensation for injury
Financial obligation

34. What must be disclosed
Purpose of the research
Procedure to be undertaken
Foreseeable risks, discomforts, inconvenience
Possible benefits
Appropriate alternatives, if any
Extent to which confidentiality will be maintained

35. What must be cont…
A statement that participation is voluntary and that refusal to
participate or withdrawal at any stage will not prejudice
participant’s future care or loss of other benefits
An explanation of what would happen in case of injury arising
from participation
Use of simple non-technical language
Avoid coercive statement

36. Example of Ethical Decision Making in Healthcare
One example of ethical decision making in
healthcare is managing the inadequate supply of
donor organs that are needed for transplant.
Societies that develop the guidelines for the use
of donor organs must take into consideration all
four pillars of bioethical decision making.
https://archive.hshsl.umaryland.edu/bitstream/handle/10713/6488/Tarzian%20Talk%20110116.pdf
https://catholicmoraltheology.com/on-the-ethics-of-organ-transplantation-a-catholic-perspective-part-i/
Some societies decide on an “opt in” response
which requires all donors to specifically choose to
donate their organs while other societies decide
on an “opt out” response which states that the
organs of the deceased will be available for
transplant unless the donor specifically opts out.
Notice how these two responses provide more
weight to autonomy (“opt in”) versus beneficence
and justice (“opt out”). These are bioethical
decisions that must be discussed and agreed
upon by all those involved in the process.

37. CONCLUSION
Ethics is essential in health and needs to be applied in the
management of health services.
The decision should aim at ethical theories and ethical
principles and not merely by other traditions