L10 Ethics in research.ppt

Learning Objectives
• At the end of this session the student will
be able to:
• Understand the historical development of
ethics in health research
• Understand the major ethical principles of
research
• Develop consent forms

References
1. Robert B. Wallace, Nearl Kohatsu, Brownson, Schetcer, Scutchfield, Zaza. Public health and
preventive Medicine
2. Tom L. Beauchamp, James F. Childress. Principles of biomedical Ethcs, 5th Edition, Oxford
University Press, 2001
3. Ann Aschengrau, George R. Seage III. Essentials of Epidemiology in Public Health (2nd edn).
Jones and Bartlet Publishers,2008

Ethical Considerations
• Professional obligation to safeguard the safety of
study subjects
• Refer to national and international guidelines
• Describe potential ethical concerns and
mechanisms to minimize harm and maximize
benefits
• Remember: every research can potentially cause ethical
concerns!!

Ethics
Ethics – is the branch of philosophy that
deals with distinctions between right and
wrong-with the moral consequences of
human actions.

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

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

• 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….

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”

The Nuremberg principles served to inform
the development of subsequent
professional and governmental codes that
would guide the ethical conduct of
research with human subjects

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

• They were not told about the study’s
objective
• Study procedures such as spinal taps
were represented as “free treatment”, and
burial stipends motivated family members
to allow autopsies on participants who
reached the study’s “endpoint”

• 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

• 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

• 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.

• The declaration of Helsinki (1964)
• was adopted by the World Medical
Association in 1964 to guide application of
the ethical principles for clinical research
specified in the Declaration of Helsinki

International Ethical and Research
Practice Guidelines
• In addition to the Declaration of Helsinki,
there are a number of ethical research and
practice guidelines that are internationally
oriented. Some of these are:
– WHO/CIOMS(Council for International Organizations of Medical
Sciences) guidelines
– International conference on Harmonization Guidelines for Good
Clinical Practice

WHO/CIOMS Guidelines
A) International Guidelines for Biomedical
Research Involving Human Subjects –
• Published in 1982 by the WHO & CIOMS
• 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

B) “International Guidelines for the Ethical
Review of Epidemiologic Studies”.
• Published in 1991
– Outlined unique ethical considerations for
epidemiological research,
– Emphasis given to groups of people as
opposed to individual patients

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

General Ethical Principles
• These 4 principles are applied to show
how we try to arrive logically at “correct”
decisions when we are faced with ethical
tension and ambiguous situations in public
health research and practice
• There is not always a “right answer”

Small group work
Is the Tuskegee Syphilis Study ethical?
Comment from the perspective of the 4
ethical principles

Respect for autonomy
• Autonomy has diverse meanings:
– self governance
– Privacy
– individual choice
– freedom of the will
– causing one’s own behavior
– being one’s own person

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

Respect for autonomy
Moral rules
1. tell the truth
2. respect the privacy of others
3. protect confidential information
4. obtain consent
5. when asked, help others make
important decisions

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/research

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

Disclosure
In research disclosures should generally
cover:
• the aims and methods of the research,
• anticipated benefits and risks,
• any anticipated inconvenience or
discomfort, and
• the subject’s right to withdraw, without
penalty, from the research

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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

Contents of the consent form
The consent form 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

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

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Confidentiality
• Confidentiality is necessary in diagnostic,
therapeutic and research context
• Confidential information is both private and
voluntarily imparted in confidence and
trust
• If research subject authorizes release of
the information to others, then there is no
violation of rights or confidentiality

Confidentiality cont..
• Research may involve collecting and storing data
relating to individuals and groups
• such data, if disclosed to third parties, may cause harm
or distress.
• investigators should make arrangements for protecting
the confidentiality of such 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.

Confidentiality 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.

Confidentiality 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

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Principle of Non-Maleficence/do no harm
Minimizing harm: considerations
•Careful use of local health resources and respect for local priorities
•Avoid stigmatization, prejudice, economic loss …
•Prepare research staff for special situations
•Propose measures against eminent risks observed during the study
•Avoid harmful publicity
•Respect local social and cultural norms
•Confidentiality
•Disclosure of conflict of interest

37
Principles of beneficence/duty to do good
Is the ethical obligation to maximize benefits and to
minimize harms
the risks of research be reasonable in the light of the
expected benefits
use sound research design, and involve competent
investigators to conduct the research and to safeguard the
welfare of the research subjects

Principles of beneficence
cont..
Maximizing benefits: considerations
• Communication of study results
• Provision of health care
• Training of local health staff

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Principle of Justice
• Is the ethical obligation to treat each person
in accordance with what is morally right and
proper
• Distributive justice - equitable distribution
of both the burdens and the benefits of
participation in research
•Special provision for the protection of the
rights and welfare of vulnerable persons.

Principle of Justice cont…
• Cases considered to be alike should be treated
alike
• Cases considered to be different should be
treated in ways that acknowledge the difference

Principle of Justice cont…
• Studies should be designed to obtain knowledge
that benefits the class of persons of which the
subjects are representative
• The class of persons bearing the burden should
receive an appropriate benefit, and
• the class primarily intended to benefit should
bear a fair proportion of the risks and burdens of
the study

Small group work
• Suppose you plan to conduct research on
different outcomes of HIV infected individuals
who are on treatment (ART). You preferred
collecting data from records in University of
Gondar Hospital.
• Is this research ethically acceptable? Discuss
from the perspective of the 4 ethical principles.
• If there are any ethical problems how do you
overcome these problems?

43
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

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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.

45
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.

46
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.

47
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.

48
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.

49
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.

50
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.

51
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.

52
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.

53
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.

54
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.

55
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.

56
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.

57
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.

58
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.

59
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.

60
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.

61
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.

62
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.

63
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.

64
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*)

65
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.

66
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.

67
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.

L10 Ethics in research.ppt

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