1. 1
Public Health Ethics
Prof. Yigzaw Kebede

2. 2
Objectives of the course
At the end of the course students will be able to:
• Understand the definition of ethics
• Understand the principles of ethics
• Appreciate ethical controversies in health care,
public health, and research
• design consent forms

3. 3
Definition
Ethics – is the branch of philosophy that
deals with distinctions between right and
wrong-with the moral consequences of
human actions.
Morality: refers to norms about right and
wrong human conduct that are so widely
shared that they form a stable social
consensus

4. Definition cont..
• There is a clear relationship between ethics and
law.
• Ethics is a branch of philosophy that deals with
moral principles
• law is the whole system of rules that every
citizen of the country must obey.
• Ethics requires legal backing, and law plays an
important role in enforcing the implementation of
ethics.
• A breach of ethics is considered a legal offence.
4

5. 5
Historical Perspectives
Nazi War Crimes and the Nuremberg Code
• Prior to and during the World War II (1940s), Nazi
physicians and scientists conducted experiments on
concentration camp prisoners without their consent
• Many of these experiments involved exposing subjects to
extreme suffering for observational purposes such as:
– To determine the time to death for individuals
submerged in freezing water
– To determine the ability of subjects to withstand high
altitude conditions by forcing them into low-pressure
chambers

6. 6
Historical Perspectives cont…
• Other experiments
– Deliberately inflicting wounds or burns;
– Infecting subjects;
– Poisoning them;
in order to test various treatments or to
perform autopsies afterwards….

7. 7
Historical Perspectives cont…
• During the Nuremberg Military
Tribunals at the end of World War II,
– the scientists who conducted these
experiments were held accountable for
their actions, and
– many issues in research ethics
received public scrutiny….

8. 8
Historical Perspectives cont…
The Nuremberg Code (1947)
• The 10 principles outlined in Nuremberg Code
were among the 1st
rules for experimentation
involving human subjects
• The first and most famous principle from this
historic code states “the voluntary consent of the
human subject is absolutely essential”

9. 9
Historical Perspectives cont…
The Tuskegee Syphilis Study
• In 1932 the U.S Public Health Service (PHS)
began a study of the natural course of
untreated syphilis among rural black males in
Macon Country, Alabama
• About 400 men with syphilis and 200
uninfected controls were enrolled in the study
• Informed consent was not obtained from study
participants

10. 10
Historical Perspectives cont…
• They were not told about the study’s
objective
• Study procedures such as spinal taps
were represented as “free treatment”
• Burial stipends motivated family members
to allow autopsies on participants who
reached the study’s “endpoint”

11. 11
Historical Perspectives cont…
• When penicillin became widely available
by 1947 as a standard cure for syphilis,
treatment was denied to these subjects
• The PHS actively sought to prevent study
subjects from obtaining treatment and
information from other sources

12. 12
Historical Perspectives cont…
• This study was halted in 1972 when national press
reports prompted public outrage
• This was the longest non-therapeutic experiment on
human beings in medical history
• By the time the study was stopped dozens of the
participants had died of syphilis
• Many of their wives had been infected
• Many of their children had been born with congenital
syphilis

13. 13
Historical Perspectives cont…
• The study has come to symbolize racism in
medicine and science, ethical misconduct in
research, and governmental exploitation of the
vulnerable
• The history of this study in the U.S has
contributed to persistent mistrust of public health
authorities today, particularly among racial and
ethnic minority groups
• President Clinton formally apologized for the
study’s injustices on behalf of the U.S
government in 1997.

14. Historical Perspectives cont…
The Belmont Report
• In 1972, the public became aware of the
Tuskegee study
• As a result, in 1974 the National Commission for
the Protection of Human Subjects of Biomedical
and Behavioral Research was established.
• In 1978, the commission submitted its report
titled, The Belmont Report: Ethical Principles
and Guidelines for the Protection of Human
Subjects of Research.
14

15. Historical Perspectives cont…
• The report sets forth the fundamental
ethical principles underlying the
acceptable conduct of research involving
human participants.
• These principles are:
– respect for persons
– beneficence and
– justice
15

16. 16
Historical Perspectives cont…
• The declaration of Helsinki (1964)
• was adopted by the World Medical
Association in 1964 to guide application
of the ethical principles for clinical
research

17. 17
Historical Perspectives cont…
Other international guidelines
A) International Guidelines for Biomedical
Research Involving Human Subjects –
• Published in 1982 by WHO/CIOMS (Council for International
Organizations of Medical Sciences)
• Addressed issues of:
– informed consent;
– standards for ethical review; and
– protections for vulnerable persons such as pregnant women,
children, people with mental illness, and communities in
resource limited countries
• Guideline revised in 1993 and 2002

18. 18
Historical Perspectives cont…
B) International Conference on Harmonization
(ICH)
• In 1990, representatives of the regulatory
agencies and industry associations of the
United States, Japan and Europe met and
formed the International Conference on
Harmonization (ICH)
•The goal of ICH was to standardize the
process by which new drugs are developed,
tested and brought to market.

19. Historical Perspectives cont…
• In 1996 the ICH finalized the Guideline for Good Clinical
Practice (GCP).
• GCP is an international ethical and scientific quality
standard for designing, conducting, recording and
reporting trials that involve human subjects.
• Many pharmaceutical companies have adopted the GCP
as the standard for conducting clinical trials.
• The ICH guidelines require review by an ethics
committee and informed consent of participants.
• The guideline also details the responsibilities of both the
sponsor of the research and the researcher who
conducts it.
19

20. Historical Perspectives cont…
C) “International Guidelines for the Ethical
Review of Epidemiologic Studies”.
• Published in 1991 by WHO/CIOMS
– Outlined unique ethical considerations for
epidemiological research,
– Emphasis given to groups of people as
opposed to individual patients
20

21. 21
General Ethical Principles
1. Respect for autonomy
- a norm of respecting the decision-making
capacities of autonomous persons
2. Beneficence
-a group of norms for providing benefits and
balancing benefits against risks and costs
3. Nonmaleficence
-a norm of avoiding the causation of harm
4) Justice
- a group of norms for distributing benefits,
risks, and costs fairly

22. 22
General Ethical Principles cont…
• It is unlikely that all 4 principles can
operate with equal weight in relation to
every action to be considered
• The principle-based approach to ethical
analysis allows to be transparent in the
rational for actions

23. 23
• Respect for persons recognizes the capacity
and rights of all individuals to make their
own choices and decisions.
• There is a need to provide special protection
to vulnerable persons.
• Examples of vulnerable groups
• Children, prisoners, mentally ill
• people with limited education, living in poverty,
limited access to health care services
• Women (in some cultures)
1. Respect for autonomy/ Respect for
person

24. 24
Respect for autonomy
cont…
• Respect for persons is embodied in the
informed consent process.
• Informed consent is designed to empower the
individual to make a voluntary informed decision.
• Potential research participants must fully
comprehend all elements of the informed
consent process.

25. Respect for autonomy
cont…
• A person of diminished autonomy is in
some respect controlled by others or
incapable of deliberating or acting on the
basis of his/her desires and plans
• E.g prisoners and mentally retarded
individuals
• Mental incapacitation limits the autonomy
of the retarded person
• Coercive institutionalization constrains the
autonomy of prisoners
25

26. 26
Group work
• Compare ethical acceptability of isolating
HIV and SARS patients
• Your comment should address the 4
ethical principles
• What is your final decision?

27. 27
Rights and needs in communicable
disease control
• Notifying cases of infectious disease may
lead to stigma
• Isolation & quarantine → restrict freedom
• Notification, isolation, and quarantine can
be applied to individuals, to families, even
to the entire communities

28. 28
Rights and needs in communicable
disease control cont…
• Notification, isolation, and quarantine are
widely accepted features for
communicable disease control
• Stigmatizing by notifying & restricting
freedom infringes individual autonomy
• These practices are generally held to be
necessary restrictions whose purpose is to
benefit society as a whole

29. 29
Rights and needs in communicable
disease control cont…
• For surveillance purpose, public health
authorities need data on the prevalence of HIV
infection
• WHO agree that unlinked HIV testing is the best
way to generate prevalence data
• Blood taken for other purposes from large
representative populations, are tested for HIV
after all personal identifiers have been removed
• Suitable populations include pregnant women
and newborn infants

30. 30
Rights and needs in communicable
disease control cont…
• In United Kingdom & Netherlands, it was
held for a time that unlinked testing is
unethical
• Identifying & counseling cases and their
sexual partners was regarded as a higher
moral responsibility than determining
community-wide prevalence trends

31. 31
Informed consent
• Process of informed consent consists of:
– transfer of information
– understanding of its significance, followed by
– explicit consent of the person (or responsible proxies)
to take part in the intervention
• Consent is usually active i.e agreement takes
place
• Some times it is passive or tacit i.e people are
regarded as taking part unless they explicitly
refuse

32. 32
Informed consent cont…
• Consent need not be written
• In some cultures, patients regard their personal
physician as responsible for decisions about
participation
• In other cultures, a village headman, tribal elder,
or religious leader is considered to have
responsibility for the group, in which individuals
do not perceive themselves as autonomous
• Nevertheless, each individual in such a group
should be asked to provide consent to whatever
procedure is being conducted

33. 33
Elements (components) of informed
consent
1. competence
2. disclosure
3. understanding
4. voluntariness
5. Consent
In other words,
One gives an informed consent to an intervention if (and
perhaps only if) one:
– is competent to act,
– receives a thorough disclosure,
– comprehends the disclosure,
– acts voluntarily, and
– consents to the intervention

34. 34
Competence
• means the ability to make choices based on an
understanding of the relevant consequences of
that choice on oneself and others
• The ability to understand the relevant
consequences is to be judged by common
sense, rather than a technical or professional
standard
• The competent patient must understand the
consequences of her/his decision to accept or
reject a particular treatment

35. 35
Classifying the incompetent
• In general, the assumption is that adults
are competent unless there is clear
evidence to the contrary
• Unconscious people are temporarily
incompetent
• People under the influence of alcohol or
drugs may be temporarily incompetent
• A few patients have so permanently lost
contact with reality

36. 36
Disclosure
• Disclosure is a necessary, and some
times the sole, condition of informed
consent
• Without adequate way for professionals to
deliver information, many patients and
subjects will have an inadequate basis for
decision making

37. 37
Disclosure cont…
The core set of information during disclosure
include:
1. those facts or descriptions that patients or
subjects usually consider material in deciding
whether to refuse or consent to the proposed
intervention or research
2. information the professional believes to be
material
3. the professional’s recommendation
4. the purpose of seeking consent
5. the nature and limits of consent as an act of
authorization

38. 38
Consent by surrogates
• Surrogates or substitutes are people who
are authorized by law or custom to make
decisions when the patient is incompetent
or doubtfully competent
• There is no handy list of surrogates that
can be relied on with certitude

39. 39
Consent by surrogates cont…
• Parents are considered surrogates for
their minor children
• Spouses for one another
• Adult children for parents when parents
are lacking
• Adult grand children for grand parents

40. 40
Contents of the consent
form
The consent form for research need to
include the following (Sarantakos, 2005)
• Identification of the researcher
• Identification of the sponsoring institution
• Indication of how the participants were
selected
• Identification of the purpose of the research

41. 41
Contents cont…
• Identification of the benefits for participating
• Identification of the level and type of
participant involvement
• Notation of risks to the participant
• Guarantee of confidentiality to the participant
• Assurance that the participant can withdraw at
any time
• Provision of names of persons to contact if
questions arise

42. 42
Minor Assent & Parental
Permission
• Minor / Children- are persons who have not
attained the legal age for consent (18 years
of age in most countries), and thus cannot
legally provide "consent" to treatments or
procedures involved in research
• When children/minors are involved in
research, the regulations require the assent
of the child/minor and the permission of the
parent
• Assent means a child's affirmative
agreement to participate in research.

43. 43
Parental Permission & Assent
Forms
• The Parental Permission Form must
contain the same elements as a typical
Consent Form.
• The child should be given an
explanation of the proposed research
procedures in a language that is
appropriate to the child's age,
experience, maturity, and condition.

44. 44
Parental Permission &
Assent Forms cont..
Children less than 5 years of age
• A simple oral explanation of the study
should be offered to the child before
study related procedures are
conducted.
• A signed Parental Permission form is
required as well.

45. 45
Parental Permission &
Assent Forms cont..
Children between the ages of 5 and 12
years
Informed voluntary assent should be
obtained without pressure from
parents or investigators.

46. 46
Parental Permission &
Assent Forms cont..
Children between the ages of 12 and 16
years
An assent form should cover:
• What the study is about
• Why he/she qualifies for the study
• The voluntary nature of the study
• The procedures that will be done
• Potential benefits & potential risks
• An assurance that he/she will be treated the same whether or not
he/she agrees to join the study
• An invitation to ask questions
• Assurance that he/she may withdraw from the study after
discussing it with his/her parents

47. 47
Consenting minors
Minors may consent to participate in
research without parental or guardian
permission (i.e as if adults) if legally
emancipated and in certain treatment
circumstances

48. 48
Paternalism
Paternalism involves acting without
consent or even overriding a person’s
wishes, wants, or actions in order to
benefit the patient or at least to prevent
harm to the patient

49. 49
Paternalism cont..
There are 2 elements in this definition:
1. the absence of consent or even the
overriding of consent
2. the beneficient motive (the welfare of the
patient)

50. 50
Paternalism cont…
• Paternalism exists when the health care
worker intervenes to prevent patients from
harming themselves in some serious way
• E.g they can intervene in the case of those
who are attempting suicide

51. 51
Paternalism cont…
Strong Vs weak paternalism
1) strong (extended) paternalism
• Attempts to overrule the wishes of a competent
person
2) weak (or limited and restricted) paternalism
• Consent is missing or the health care provider
overrules the wishes of an incompetent or a
doubtfully competent patient
• Weak paternalism is sometimes called
cooperative paternalism when one of its purpose
is to restore the person’s competence so that the
patient may give informed consent

52. 52
Paternalism cont…
• From an ethical point of view, writers generally
reject the right of health care providers to use
strong paternalism
• The courts have sometimes allowed treatment
without informed consent to relieve serious pain
or suffering
• This treatment may remove doubts about
competency of the person and allow informed
consent
• Here the treatment is directly in the service of
autonomy

53. 53
Confidentiality
• Confidentiality is necessary in diagnostic,
therapeutic and research context
• Confidential information is both private
and voluntarily communicated in
confidence and trust

54. 54
Confidentiality in research
• During research, investigators should make
arrangements for protecting the confidentiality of
data by:
– omitting information that might lead to
identification of individual subjects
– limiting access to the data, or by other means.
• When personal identifiers remain on records
used for a study, investigators should explain
why this is necessary and how confidentiality will
be protected.

55. 55
Confidentiality in research cont…
Unlinked information
• Refers to information that can not be
linked, associated or connected with the
person to whom it refers.
• As this person is not known to the
investigator, confidentiality is not at stake
and the question of consent does not
arise.

56. 56
Confidentiality in research cont…
Linked information may be:
• anonymous – when the information can not be linked to
the person to whom it refers except by a code or other
means known only to that person, and the investigator
can not know the identity of that person
• non-nominal –when the information can be linked to the
person by a code which is not a personal identifier and
which is known to the person and the investigator
• nominal or nominative – when the information is linked
to the person by means of personal identification, usually
the name

57. 57
2. Principles of beneficence/duty
to do good
• No personal motive
• Benefiting the public
• Minimizing the risk and managing if any
• Outweighing the benefit over the risk
• Bringing new knowledge to the society

58. 58
3. Principle of Non-Maleficence/do no harm
• The protection of the well-being of the
participant is the primary responsibility
of the researcher.
• Protecting the participant is more
important than:
– the pursuit of new knowledge
– the benefit to science that will result from the
research
– personal or professional research interest

59. Principle of Non-Maleficence
cont..
• There should be no or minimal harm to the
respondent;
• Harms: can include economical & social
damages;
• There should be precautions to handle
cases seen during the study
59

60. 4. Principle of Justice (equitable
distribution)
• Researcher’s obligation - distribute equally the risks
and benefits of participation in the research.
• Recruitment and selection of research participants
should be done in an equitable manner.
• The principle of justice forbids placing one group of
people at risk solely for the benefit of another.
• E.g justice would not permit using vulnerable groups as
research participants for the exclusive benefit of more
privileged groups. 60

61. Scientific Misconduct
• Scientific misconduct includes
fabrication, falsification, plagiarism, or
other practices that deviate from those
that are commonly accepted within the
scientific community for proposing,
conducting or reporting research.
• Scientific misconduct does not include
honest error or honest differences in
interpretations or judgments of data.
61

62. 62
Scientific Misconduct cont..
Plagiarism
- is the use or close imitation of the language and
thoughts of another author and the
representation of them as one's own original
work
• Within academia, plagiarism by students,
professors, or researchers is considered
academic dishonesty or academic fraud

63. Scientific Misconduct cont…
• Self-plagiarism -is the reuse of
significant, identical, or nearly identical
portions of one’s own work without
acknowledging that one is doing so or
without citing the original work.
• Articles of this nature are often referred to
as multiple publications.
63

64. 64
The World Medical Association
Declaration of Helenski
• Adopted in 1964, amended in 1975, 1983, 1989,
1996, 2000, 2002
Has 32 articles under three Chapters
A. INTRODUCTION
B. BASIC PRINCIPLES FOR ALL MEDICAL
RESEARCH
C. ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH COMBINED WITH MEDICAL
CARE

65. 65
A. INTRODUCTION
1. The World Medical Association has developed
the Declaration of Helsinki as statement of
ethical principle to provide guidance to
physicians and other participants in medical
research involving human subjects. Medical
research involving human subjects includes
research on identifiable human material or
identifiable data.
2. 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.

66. 66
INTRODUCTION cont…
3. The Declaration of Geneva of the World Medical
Association binds the physician with the worlds,
“The health of my patient will be my first
consideration,” and the International Code of
Medical Ethics declares that, “A physician shall
act only in the patient’s interest when providing
medical care which might have the effect of
weakening the physical and mental condition of
the patient.”
4. Medical progress is based on research which
ultimately must rest in part on experimentation
involving human subjects.

67. 67
INTRODUCTION cont…
5. In medical research on human subjects, considerations
related to the well-being of the human subject should
take precedence over the interests of science and
society.
6. The primary purpose of medical research involving
human subjects is to improve prophylactic, diagnostic
and therapeutic procedures and the understanding of the
aetiology and pathogenesis of disease. Even the best
proven prophylactic, diagnostic, and therapeutic
methods must continuously be challenged through
research for their effectiveness, efficiency, accessibility
and quality.

68. 68
INTRODUCTION cont…
7. In current medical practice and in medical research, most
prophylactic, diagnostic and therapeutic procedures involve risks
and burdens.
8. Medical research is subject to ethical standards that promote respect
for all human beings and protect their health and rights. Some
research populations are vulnerable and need special protection.
The particular needs of the economically and medically
disadvantaged must be recognized. Special attention is also
required for those who cannot give or refuse consent for
themselves, for those who may be subject to giving consent under
duress, for those who will not benefit personally from the research
and for those for whom the research is combined with care.

69. 69
INTRODUCTION cont…
9. Research Investigators should be aware
of the ethical, legal and regulatory
requirements for research on human
subjects in their own countries as well as
applicable international requirements. No
national ethical, legal or regulatory
requirement should be allowed to reduce
or eliminate any of the protections for
human subjects set forth in this
declaration.

70. 70
B. BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH
10. It is the duty of the physician in medical
research to protect the life, health, privacy, and
dignity of the human subject.
11. Medical research involving human subjects
must conform to generally accepted scientific
principles, be based on a thorough knowledge of
the scientific literature, other relevant sources of
information, and on adequate laboratory and,
where appropriate, animal experimentation.

71. 71
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
12. Appropriate caution must be exercised
in the conduct of research which may
affect the environment, and the welfare of
animals used for research must be
respected.

72. 72
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
13. The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol. This protocol should be submitted for
consideration, comment, guidance, and where appropriate, approval
to a specially appointed ethical review committee, which must be
independent of the investigator, the sponsor or any other kind of
undue influence. This independent committee should be in
conformity with the laws and regulations of the country in which the
research experiment is performed. The committee has the right to
monitor ongoing trials. The researcher has the obligation to provide
monitoring information to the committee, especially any serious
adverse events. The researcher should also submit to the
committee, for review, information regarding funding, sponsors,
institutional affiliations, other potential conflicts of interest and
incentives for subjects.

73. 73
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
14. The research protocol should always contain a
statement of the ethical considerations involved and
should indicate that there is compliance with the
principles enunciated in this Declaration.
15. Medical research involving human subjects should be
conducted only by scientifically qualified persons and
under the supervision of a clinically competent medical
person. The responsibility for the human subject must
always rest with a medically qualified person and never
rest on the subject of the research, even though the
subject has given consent.

74. 74
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
16. Every medical research project involving
human subjects should be preceded by
careful assessment of predictable risks
and burdens in comparison with
foreseeable benefits to the subject or to
others. This does not preclude the
participation of healthy volunteers in
medical research. The design of all
studies should be publicly available.

75. 75
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
17. Physicians should abstain from
engaging in research projects involving
human subjects unless they are confident
that the risks involved have been
adequately assessed and can be
satisfactorily managed. Physicians should
cease any investigation if the risks are
found to outweigh the potential benefits or
if there is conclusive proof of positive and
beneficial results.

76. 76
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
18. Medical research involving human subjects
should only be conducted if the importance of
the objective outweighs the inherent risks and
burdens to the subject. This is especially
important when the human subjects are healthy
volunteers.
19. Medical research is only justified if there is a
reasonable likelihood that the populations in
which the research is carried out stand to benefit
from the results of the research.

77. 77
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
20. The subjects must be volunteers and informed
participants in the research project.
21. The right of research subjects to safeguard
their integrity must always be respected. Every
precaution should be taken to respect the
privacy of the subject, the confidentiality of the
patient’s information and to minimize the impact
of the study on the subject’s physical and mental
integrity and on the personality of the subject.

78. 78
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
22. In any research on human beings, each potential
subject must be adequately informed of the aims,
methods, sources of funding, any possible conflicts of
interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and
the discomfort it may entail. The subject should be
informed of the right to abstain from participation in the
study or to withdraw consent to participate at any time
without reprisal. After ensuring that the subject has
understood the information, the physician should then
obtain the subject’s freely-given informed consent,
preferably in writing. If the consent can not be obtained
in writing, the non-written consent must be formally
documented and witnessed.

79. 79
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
23. When obtaining informed consent for the
research project the physician should be
particularly cautious if the subject is in a
dependent relationship with the physician
or may consent under duress. In that case
the informed consent should be obtained
by a well-informed physician who is not
engaged in the investigation and who is
completely independent of this
relationship.

80. 80
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
24. For a research subject who is legally
incompetent, physically or mentally incapable of
giving consent or is a legally incompetent minor,
the investigator must obtain informed consent
from the legally authorized representative in
accordance with applicable law. These groups
should not be included in research unless the
research is necessary to promote the health of
the population represented and this research
cannot instead be performed on legally
competent persons.

81. 81
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
25. When a subject deemed legally
incompetent, such as a minor child, is
able to give assent to decisions about
participation in research, the investigator
must obtain that assent in addition to the
consent of the legally authorized
representative.

82. 82
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
26. Research on individuals from who it is not possible to
obtain consent, including proxy or advance consent,
should be done only if the physical/mental condition that
prevents obtaining informed consent is a necessary
characteristic of the research population. The specific
reasons for involving research subjects with a condition
that renders them unable to give informed consent
should be stated in the experimental protocol for
consideration and approval of the review committee. The
protocol should state that consent to remain in the
research should be obtained as soon as possible from
the individual or a legally authorized surrogate.

83. 83
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
27. Both authors and publishers have ethical
obligations. In publication of the results of
research, the investigators are obliged to
preserve the accuracy of the results. Negative
as well as positive results should be published or
otherwise publicly available. Sources of funding,
institutional affiliations and any possible conflicts
of interest should be declared in the publication.
Reports of experimentation not in accordance
with the principles laid down in this Declaration
should not be accepted for publication.

84. 84
C. ADDITIONAL PRINCIPLES FOR
MEDICAL RESEARCH
COMBINED WITH MEDICAL CARE
28. The physician may combine medical
research with medical care, only to the
extent that the research is justified by its
potential prophylactic, diagnostic or
therapeutic value. When medical research
is combined with medical care, additional
standards apply to protect the patients
who are research subjects.

85. 85
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE
cont…
29. The benefits, risks, burdens and
effectiveness of a new method should be
tested against those of the best current
prophylactic, diagnostic, and therapeutic
methods. This does not exclude the use of
placebo, or no treatment, in studies where
no proven prophylactic, diagnostic or
therapeutic method exists. (See footnote*)

86. 86
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE
cont…
30. At the conclusion of the study, every patient
entered into the study should be assured of
access to the best proven prophylactic,
diagnostic and therapeutic methods identified by
the study.
31. The physician should fully inform the patient
which aspects of the care are related to the
research. The refusal of a patient to participate
in a study must never interfere with the patient-
physician relationship.

87. 87
C. ADDITIONAL PRINCIPLES FOR
MEDICAL RESEARCH
COMBINED WITH MEDICAL CARE
cont…32. In the treatment of a patient, where proven
prophylactic, diagnostic and therapeutic methods do not
exist or have been ineffective, the physician, with
informed consent from the patient, must be free to use
unproven or new prophylactic, diagnostic and
therapeutic measures, if in the physician’s judgement it
offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures
should be made the object of research, designed to
evaluate their safety and efficacy. In all cases, new
information should be recorded and, where appropriate,
published. The other relevant guidelines of this
Declaration should be followed.

88. 88
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE
cont…*FOOTNOTE:
Note of Clarification on Paragraph 29 of the WMA Declaration of Helsinki
• The WMA hereby reaffirms its position that extreme care must be taken in
making use of a placebo-controlled trial and that in general this methodology
should only be used in the absence of existing proven therapy. However, a
placebo-controlled trial may be ethically acceptable, even if proven therapy
is available, under the following circumstances:
• Where for compelling and scientifically sound methodological reasons its
use is necessary to determine the efficacy or safety of a prophylactic,
diagnostic or therapeutic method; or
• Where a prophylactic, diagnostic or therapeutic method is being
investigated for a minor conditions and the patients who receive placebo will
not be subject to any additional risk of serious or irreversible harm
• All other provisions of the Declaration of Helsinki must be adhered to,
especially the need for appropriate ethical and scientific review.

89. 89
References
1. http:://www.apha.org. Ethical guideline
2. Robert B. Wallace, Nearl Kohatsu, Brownson, Schetcer, Scutchfield, Zaza. Public
health and preventive Medicine
3. Tom L. Beauchamp, James F. Childress. Principles of biomedical Ethcs, 5th
Edition,
Oxford University Press, 2001
4. Thomas M. Garrett, Harold W. Baillie, Rosellen M. Garrett. Health Care Ethics.
Principles and Problems (4th
edition). Upper Saddle River, New Jersey, 2001