This document provides an overview of the foundations of bioethics. It defines ethics and health ethics, discusses important principles like beneficence, non-maleficence, and autonomy. It also covers topics like informed consent, truth-telling, conflicts of interest, capacity assessments, futile care, and the role of ethics committees. The document establishes that bioethics aims to guide complex medical decisions using moral frameworks to balance patient welfare, rights, justice, and professional standards.

1. FOUNDATION OF BIOETHICS

2. Definition
the branch of
►Ethics is
philosophy which deals
with moral aspects of
human behavior.
►Health ethics is primarily
a fieId of appIied ethics,
the study of moral values
and judgments as they
apply to healthcare.

3. Medical ethics
• A group of guidelines, such as the Oath of
Hippocrates, generally written by physicians,
about the physician's ideal relationship to his
peers and to his patients

4. Medical ethics
►The basic concept of medical ethics is that
the physician has a moral (and at times legal)
obligation to act for the patient's good, using
the most up-to-date information.
►The question is how to establish that "good,"
who defines it, and what are the components
thereof.

5. A number of reasons are
responsible for the interest
in health ethics

6. • scientific technological and Significant advanced
changes in clinical medicine and research have produced
totally new ethical dilemmas and exacerbated old ones.
• The change in philosophy from paternalism to
autonomy in the physician-patient relationship.
• The involvement of additional caregivers (various
medical specialists, a variety of health professionals,
students, administrators and investigators).

7. ►The involvement of society at large (through
the mass communication media, courts,
legislators).

8. Ethics and the Law
►Ethical decisions are based on what is best for the
common and generally, exceed what is required by
law.
► Legal decisions are based on what is
mandated by statutes or case law

9. Important principles
• Scientific and humanistic components must be
combined.
• The subjective feelings of the patient, which are
based on personal, social, cultural and economic
value systems, must be considered.

10. Difference between research and practice
►The Belmont Report distinguished between research and
practice
► Practice includes interventions designed to enhance the well-being
of a patient through either diagnosis or treatment and that have
a reasonable expectation of success.
► Research was defined as ''an activity designed to test a
hypothesis, permit conclusions to be drawn, and thereby to
develop or contribute to generalizable knowledge (expressed,
for example,in theories, principles and statements of
relationships).

11. Institution Review Bodies (IRBs)
The IRB must
□Identify risks of the research
□Minimize risks as much as possible
□Identify probable benefits
□Evaluate the risks in relation to the
benefits
□ensure that research subjects are provided
with an accurate and fair description of
the risks, discomforts and anticipated
benefits,

12. Institution Review Bodies (IRBs)
►ensure that research subjects are offered the opportunity
to voluntarily accept or reject participation in the
research, or discontinue participation, without coercion
or fear of reprisal or deprivation of treatment to which
the patient is otherwise entitled,
►determine intervals of periodic review and when
necessary determine the adequacy of mechanisms for
monitoring data collection.

13. Ethical Principles
1.Beneficence - a practitioner should act in the best
interest of the patient.
2. Non-malfeasance - "first, do no harm".
3.Autonomy - the patient has the right to refuse or
choose their treatment.
4.Justice - concerns the distribution of scarce health
resources and the decision of who gets what
treatment (fairness and equality).
5. Non discrim inatory treatment.

14. Ethical Principies
6. Dignity - the patient (and the person
treating the patient) have the right to dignity.
7. Truthfulness and honesty - the concept of
informed consent has increased in importance
since the historical events of the Doctors' Trial of
the Nuremberg trials and Tuskegee Syphilis Study.

16. Conflicts between values
For example, the principles of autonomy and
beneficence clash when patients refuse life saving
blood transfusion and truth-telling was not
emphasized to a large extent before the HIV era.

17. Beneficence
• The moral obligation to do good for others and to
help them in an active way.
• there are limits to the requirement that one act to
help others at all times. These vary with the degree
of need, the ability with which the help can be
rendered and the nature of the relationship
between the individual needing help and the one
able to provide it.

18. Autonomy
an approach in
Paternalism is
physician chooses the treatment for
which the
the
patient because the physician's professional
knowledge, experience and objectivity best
qualify him to judge the ideal treatment for
the patient.

19. • Autonomy means that only the patient knows what
is best for him and only he has the right to decide.
In order to do so he / she needs to receive from the
physician all the appropriate information about his
condition to permit him to make an informed
decision.
• The physician's values and even less his professional
knowledge and experience, play no role in the final
decision.

20. Traditionally, the physician's role was viewed as
giving "orders" to nurses and to patients (e.g.
order-entry, physician orders, etc.). In the
atmosphere of autonomy, physicians must use a
different language such as advise,
recommendation, etc.

21. Drawbacks of autonomy
►The main criticism of pure autonomy is that the
physician has little influence on the patient's
decision, which is often based on a lack of full
understanding of his condition.
• Such a decision may cause unnecessary and
avoidable harm to the patient

22. Autonomy
►Respect for autonomy is the basis for
informed consent and advance directives.
• Individuals'
making may
capacity for informed decision
come into question during
resolution of conflicts between Autonomy and
Beneficence.

23. Non-malfeasance
► is defined as the obligation not to harm others
and to remove and prevent potential harm. DO
NO HARM!!
• Thus, one must not only prevent intentional
harm but must also be appropriately cautious not
to cause harm.

24. Double effect
• Some interventions undertaken by physicians can create
a positive outcome while also potentially doing harm.
The combination of these two circumstances is known
as the "double effect."
• The most applicable example of this phenomenon is the
use of morphine in the dying patient. Such use of
morphine can ease the pain of patient, while
simultaneously hastening the demise of the patient
through suppression of the respiratory drive.

25. Case study-1
Maria Morales, head of the “Infectious Disease Control” unit of
the Ministry of Health of the State X, is asked by her minister
to make a suggestion if measles immunization should be made
mandatory in their region as recently 2 children died after a
measles outbreak. State X has an insufficient immunization rate
(1st dose 70%, 2nd 55%). Maria finds out that obligatory
measles immunization is effectively implemented in regions in
Hungary. She knows her minister is taking her advice most
seriously. What should she do?

26. Principles checklist/aide memoire
Non-Maleficence
✓ Will no one be harmed by the proposed intervention?
✓ Are especially children prevented from harm?
Beneficence
✓ Is the intervention of any good to every single person taking
part in this intervention?
✓ Overall, for both non-maleficence and beneficence, is it
possible to assess whether more benefit than harm is produced
by intervening (or not intervening) and, if so, on what side
(benefit or harm) does the equation finally fall?

27. Health Maximization
✓ Is the proposed intervention effective and evidence based?
Does it improve population health?
✓ Does it have a sustainable, long-term effect on the public’s
health?
✓ Is there a community added value to the proposed
intervention?
Efficiency
✓ Is the proposed intervention cost-effective?

28. Respect for Autonomy
✓ Does the intervention refrain from employing coercion and
manipulation? Does it foster free choice?
✓ Is there really ‘informed consent’ to take part in the
intervention?
✓ Is self-responsibility not only demanded but also possible for
every person?
✓ Are privacy and personal data respected?
✓ If the intervention is paternalistic, is this justifiable?
✓ Does the intervention promote the exercise of autonomy

29. Justice
✓ Is no one (including third parties) stigmatized, discriminated
against or excluded as a consequence of the proposed
intervention?
✓ Is the institution proposing the intervention publicly justified
and acting transparently?
✓ Is the proposed intervention not putting sub-populations at
risks of being excluded from social benefits and/or universal
access to health care?
✓ Does the intervention exacerbate social and health inequalities
(inequities).

30. ✓ Does the intervention consider and support vulnerable sub-
populations (e.g. migrants)?
✓ Does the intervention refrain from eroding a sense of social
cohesion and solidarity?
Proportionality
✓ Is the intervention the least infringing of possible
alternatives?
✓ Are costs and utility proportional?

31. Steps of applied ethical reasoning;
own source,
What is the underlying moral conflict? Can a parents’ right to not have an intervention
done with their child be overridden by the state
(for someone else’s good)? Furthermore: Can
parents exercise their will on behalf of their
children
Which ethical principles are relevant, how
can they be specified and might they be in
conflict to each other?
Overall, the principles respect for autonomy and
health maximization seem to be affected and seem
to mutually exclude each other. But one also has to
ask whose autonomy is at stake. Parents’ autonomy
– but what about the future autonomy of children?
Furthermore, the immunizing doctor might be
indecisive whether to advocate for autonomy,
health maximization or non-maleficence.
Do I have all relevant information? Can I get
more background information to understand
all particularities?
What are the potential side effects of measles
immunization? How severe are measles for
children? About how many persons (to be
vaccinated against their parents’ will) can be
protected, which effect would such an immunization
programme have on the incidence of measles and
which side-effects could actually be prevented?

32. Are alternative solutions feasible with
less moral issues/costs?
Can there be alternative approaches to
mandatory measles immunization? Can one raise
immunization rates by informing, advertising,
setting incentives for parents?
Do the specifications change with more
information?
If there are alternative ways that are less infringing
on the respect for autonomy but rather support
the health maximization and the protection of
those who cannot be immunized (ensuring non-
maleficence), then these alternatives have a higher
moral value.
Are all conflicting principles and their
specifications still of equal value?
If other measures (incentive setting, education
campaigns for immunization) can be successfully
implemented elsewhere, mandatory immunization
seems less necessary. Yet, autonomy of the
parents (who are safeguarding the autonomy of
their children) attains even more weight.
What do I conclude from the specification
and weighing? What would be my
solution to the problem?
Mandatory measles immunization would – in this
very particular situation – not be necessary in
order to achieve best health and given that it
would infringe autonomy of parents (and allegedly
of children), it should not be applied.

33. Can I personally accept the conclusion drawn? It seems to be a suitable solution to – at least
first – try other measures, rather than being in
charge of forcing parents and children to have
children’s bodies ‘invaded’ against their
‘guards’ will.
: I act according to my judgment and convince
colleagues and others also based on ethical
reasoning
I try to find resources within my professional
budget and start action to promote
immunization with other means

34. Case study-2
A 20-year old college student living in the college hostel is
brought by a friend to the Emergency Department (ED)
because of unrelenting headache and fever. He appeared
drowsy but was responsive and had fever (40 °C), and neck
rigidity on examination. Lumbar puncture was done, and
spinal fluid appeared cloudy and showed increased white
cells; Gram stain showed Gram-positive diplococcic. Based
on the diagnosis of bacterial meningitis, appropriate
antibiotics were begun, and hospitalization was instituted.

35. Although initial consent for diagnosis was implicit, and
consent for lumbar puncture was explicit, at this point, the
patient refuses treatment without giving any reason, and
insists to return to his hostel. Even after explanation by the
physician as to the seriousness of his diagnosis, and the
absolute need for prompt treatment (i.e., danger to life
without treatment), the patient is adamant in his refusal.

36. Comment. Because of this refusal, the medical indications and patient
preferences are at odds. Is it ethically right to treat against his will a
patient who is making a choice that has dire consequences (disability,
death) who gives no reason for this decision, and in whom a clear
determination of mental incapacity cannot be made (although altered
mental status may be presumed)? Here the principle of beneficence and
principle of autonomy are in conflict. The weighing of factors: (1) patient
may not be making a reasoned decision in his best interest because of
temporary mental incapacity; and (2) the severity of life-threatening illness
and the urgency to treat to save his life supports the decision in favor of
beneficence (i.e., to treat)

37. implications of ethics
in practice

38. Informed Consent
►Uninformed agent is at risk of mistakenly
making a choice not reflective of his or her
values.
• The value of informed consent is closely
related to the values of autonomy and truth
telling.

39. Other principles
►Patient Rights and
Responsibilities.
►Advance Directives:
delegate decision-making
another party. If the
Patients can
authority to
patient is
incapacitated, the next-of-kin make
decisions for the incapacitated patient.

40. Do Not Resuscitate (DNR).
□Governed at the state level.
□Requires a physician order
□Documented in the medical record
□Requires clear policy and procedure
□Documented education of patient, family and
staff
□Does not require an advance directive as a
precondition

41. Confidentiality
►This concept is commonly
patient-physician
known as
privilege.
► Legal protections
physicians from
their discussions
prevent
revealing
with
patients, even under oath in
court .

42. Confidentiality
• Confidentiality is challenged in cases such as
the diagnosis of a sexually transmitted
disease in a patient who refuses to reveal the
diagnosis to a spouse, or in the termination
patient,
patient's
of a pregnancy in an underage
without the knowledge of the
parents.

43. Importance of Communication
•
• "ethical conflicts" in medical ethics are
traceable back to a lack of communication.
Communication breakdowns between
patients and their healthcare team, between
family members, or between members of the
medical community, can all lead to
disagreements and strong feelings.

44. Ethics committee
• Many times, simple communication is not
enough to resolve a conflict, and a hospital
ethics committee of ad hoc nature must
convene to decide a complex matter.
• Permanent bodies, ethical boards are
established
increase. These bodies are
issues tend
comprised
to a greater extent as ethical
to
of health care professionals,
religious leaders.

45. Truth- telling
Some cultures do not place a great emphasis on
informing the patient of the diagnosis, especially
when cancer is the diagnosis.

46. Conflict of interest
►Physicians should not allow a conflict of
interest to influence medical judgment.
some cases, conflicts are hard to avoid,
• In
and doctors have a responsibi Iity to avoid
entering such situations.
• Unfortunately, research has shown that
conflicts of interests are very common among
both academic physicians and physicians in
practice.

47. Referral
• For example, doctors who receive income from
referring patients for medical tests have been
shown to refer more patients for medical tests.

48. Vendor relationship
►Studies show that doctors can be influenced by drug
company inducements, including gifts and food.
• Industry-sponsored Continuing Medical Education(CME)
programs influence prescribing patterns.
•A growing movement among physicians is
attempting to diminish the influence of pharmaceutical
industry marketing upon medical practice, as evidenced by
Stanford University's ban on drug company- sponsored
lunches and gifts.

49. Withholding and Withdrawing
Treatment
□ Life-sustaining treatment is any treatment
that serves to prolong Iife without reversing the
medical condition
□Clear policy and procedure
□Examples of such treatment
- Mechanical ventilation
- Renal dialysis
- Artificial nutrition and hydration
- Antibiotics
- Blood products

50. Capacity
□Patient must be:
- Able to understand the nature of the
situation and the consequences of the decision.
- Able to communicate the wishes to the care
giver.
□Capacity normally is determined by the physician

51. Futile Care
□Do not abandon the patient; arrange transfer.
□Have appropriate policies.
□Be sure decisions are based on medical issues, not
age, social status, etc.
□Avoid court if at all possible.
□Use the Ethics Committee.

52. Ethics committee
□Chairperson should be well educated or trained in
ethical issues.
□Appropriate medical and clinical staff should be
included.
□There should be a clerical representative from the
religiouscommunity.
□A layperson from the community should be a
member.
□Decisions are nonbinding.

53. Ethics Committee
□The risk manager should:
- Be a neutral party during the discussions.
- Serve as a facilitator.
- Act as a consultant on legal issues.
- Develop an ethics consultation mechanism.

54. Topics for Ethics Committees
□Abortion and reproductive rights
□End-of-life or futile care
□Quality of Iife
□Advance directives
□Staff rights that conflict with patient wishes

55. Sample Question
The committee that generally is charged with
oversight of investigative patient research is the:
A. Bioethics Committee.
B. Institutional Review Board.
C. Utilization Review Committee.
D. Quality Improvement Committee.

56. If a patient's physician and agent disagree about what
course of action is best for the patient, the best course
of action is to:
A. Refer the case to the Ethics Committee.
B. Follow the wishes of the patient's agent.
C.Allow the physician to make the decision since he is
ultimately liable.
D. Seek guidance from the appropriate court.

57. Thank
you