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# 3rd lect research ethics
1. Dr. Eman M. Mortada
Professor
In public health and preventive medicine
Avoiding Scientific Misconduct -
by Ethical regulations
2. Define basic concepts related to research
ethics
The Consequences of Scientific Misconduct
Need and objectives for Research Ethics
Historical Perspective of Unethical Practices
Development of code of ethics
Ethical principals
Lecture Outline
3. ▪ Research with human subjects is of paramount importance for:
▪ the individual,
▪ Society & public health,
▪ Science and
▪ The economy.
Introduction
4. Dr. Eman Mortada
❑ The progressive development &Major expansion in the
biomedical research raised the concern about the research ethics
5. Research ethics
✓Defined as a set of guidelines to be followed
during carrying out research for protection of the
participants right
Dr / Eman Mortada
6. Recently, A lot of debates have been raised regarding:
Researcher
Dr. Eman Mortada
❑ researchers awareness of ethical, moral and legal
responsibilities
❑ If they are well trained to avoid ethical pitfalls
7. Every research, we face situations that require
ethical judgment and challenged by:
Ethical questions and dilemmas.
Some are relatively easy to answer
Others are much more difficult
Dr. Eman Mortada
16. ❑ Will our research do more harm than
good?
❑ How will we ensure the safety of people
we interview???
The answer is not easy
It is a clear example of ethical
dilemma
Dr. Eman Mortada
18. Ethical Dilemma:
Situations necessitating a choice
between two equal (usually
undesirable) alternatives.
Significant technological and
scientific advances
changes in clinical practice and
research
have produced totally new ethical
dilemmas and exacerbated old ones
22. The answer is: YES
Ethics is about making
choices…
Dr. Eman Mortada
23. ❑ All researchers should be familiar with the basic
ethical principles and have up-to-date knowledge
about policies and procedures designed to:
❖ ensure the safety of research subjects and
❖ to prevent sloppy or irresponsible research,
❑ because ignorance of policies designed to protect
research subjects is not considered a viable excuse for
ethically questionable projects. Dr. Eman Mortada
24. The Consequences of Scientific
Misconduct
❑ Blacklisted in the scientific
community
❑ Banned from future research or
publication
❑ Banned from requesting or receiving
grant funds
❑ Possible monetary fines
❑ Termination of Employment
25. ❑ Increasing need for experimentation on human subjects.
Dr. Eman Mortada
Need for Research Ethics
27. Dr. Eman Mortada
Paternalism Autonomy
❑ The change in philosophy from (passive to active
participant)
Need for Research Ethics
28. ❑ To protect right and welfare of the
participants
❑ To examine research activities for their ethical
soundness
❑ To ensure that research is conducted in a way
that serves interests of individuals, groups
and/or society as a whole
Dr. Eman Mortada
Objectives of Research Ethics
29. ▪ Research is however not only associated with
social benefits, it also involves risks.
▪ Scientific advances are ethically justifiable only
if respect for the human dignity of all persons is
guaranteed.
Protection of
Subject
Welfare/Rights
Advancement
of Science
Without an Adequate Framework of Research Ethics
Balancing Twin Goals
35. 1932
2011
❑ US Public Health Services began to study the
natural progression of untreated syphilis,
❑ 399 rural African-American men who had
contracted syphilis
❑ Joined Tuskegee Institute for free medical care,
meals
Historical
Timeline
1- Tuskegee syphilis study (1932-72)
36. What do you know about
syphilis ?
Syphilis is a sexually transmitted
infectious disease.
39. ❑ Deception and withholding information and ttt:
➢ Study participants were never told they had syphilis, nor
were they ever treated for it
➢ Although, penicillin proven to be effective treatment for
syphilis
➢ Researchers prevented men from being treated elsewhere
❑ Putting men and their families at risk
They were
betrayed
Ethical problems
Tuskegee syphilis study cont..1
40. The tragedy
By the time the study was exposed in 1972:
❑ 28 men had died of syphilis,
❑ 100 others were dead of related complications,
❑ at least 40 wives had been infected and
❑ About 20 child had contracted the disease at birth."
Dr. Eman Mortada
Tuskegee syphilis study cont..2
41. knowledge worth sacrificing few
Ethical justification
Images taken from: https://www.msu.edu/course/hm/546/tuskegee.htm and
http://alondranelson.wordpress.com/2012/07/25/tuskegee-and-the-black-panther-party/
Dr. Eman Mortada
It was clearly racist.
45. 2011
❑ The experiment, referred to by some as the
“Monster Experiment” turned some of the children into
lifelong stutters despite later efforts to reverse the damage.
The Monster Study
47. 2011
1940
❑ Conducted by Nazi physicians during WW II.
❑ Experiments involving a wide variety of
deadly, painful, and disfiguring procedures
❑ were conducted on thousands of concentration
camp prisoners.
❑ Covering around 26 research areas
Historical
Timeline
3- The Nazi Experimentation
48. 2011
The goal of this type
of experiments was
to determine:
how long German
pilots would
survive after
parachuting into
the cold north sea.
A- Hypothermia Experiments
A prisoner is submerged in a
tank filled with cold water.
The Nazi experimentation cont..1
49. 2011
B- High Altitude Experiments
❑High altitude experiments were performed to test how long pilots
would survive after being ejected from their planes.
❑Many of those who did not die immediately were put under water
until they died.
❑Prisoners were put into low-pressure tanks with little oxygen.
The Nazi experimentation cont..2
50. C- other horrible actions
❑ Sterilization tests
❑ Scaring then infect with bacteria
❑ Inject sea water and gasoline
❑ Female Jewish victim
❑ Children in concentration camps who
had been used for medical
experiments
The image is from been the website:
http://fcit.usf.edu/holocaust/resource/gallery/n1945.htm
The Nazi experimentation cont..3
51. Experiments on twins (1943-1944)
Bone, muscle, and nerve transplantation experiments (1942-1943)
55. 1- War allows everything
2- Sacrifice few to benefit
many
Ethical justification
The Nazi experimentation cont..4
Dr. Eman Mortada
Consequences of Nazi Experiments
Experiments led to foundation of Nuremberg Code to
control future trials involving human subjects
56. 2011
1945
❑ During and after WWII, American
soldiers were forced to observe nuclear
blasts within 50 miles of ground zero.
❑ Thousands of these soldiers later died of
leukemia and other rare forms of cancer.
Historical
Timeline
4- Human Radiation Experimentation
57. 2011
1950
❑ More than 100 boys living in an orphanage
were fed Quaker Oats with radioactive iron
and calcium in the 1950's.
❑ The diet was part of an experiment to prove
that the nutrients in Quaker oatmeal travel
throughout the body.
Historical
Timeline
5- Oatmeal study
58. 2011
❑ Thalidomide was used in the 1960s to
combat unpleasant symptoms associated with
pregnancy
❑ After women in Europe, Canada, and the U.S.
were treated with the drug it was discovered
that the drug had teratogenic effects, causing
severe deformities in the fetus.
1960
Historical
Timeline
6- Thalidomide use
60. 2011
2010
❑ A Korean researcher, Woo Suk Hwang,
fabricated evidence that he had
successfully cloned human embryos.
❑ The journal Science, retracted two studies
he had published.
Recently
7- Cloning Fraud
62. Year Benchmark
Pre-1900 Edward Jenner smallpox vaccines
1900 Walter Reed’s ‘consent’ for yellow fever experiments
1947 The Nuremberg Code
1964 World Medical Association (WMA) published the Declaration of Helsinki (DOH)
1966 Dr. Beecher’s Article “Ethics and Clinical Research”
1975 WMA updates DOH (Tokyo)
1979 The Belmont Report
1981 US Common rule updated
1983 WMA updates DOH (Venice)
1989 WMA updates DOH (Hong Kong)
1991 US CFR title 45, Part 46 issued CIOMS Guidelines for Epidemiological studies
1993 CIOMS guidelines for biomedical research involving human subjects
1996 WMA updates DOH (South Africa)
1998 Tri-Council Policy Statement (TCPS)published in Canada
2000 WMA updates DOH (Edinburgh)
The Nuremberg
Code
Declarations
of Helsinki
Belmont
report
Dr. Eman Mortada
63. 1948
❑ Issued in 1948, in Nuremberg, Germany
❑ 1st international code in research ethics
❑ In response to the experiments of Nazi
doctors, by American judges sitting in
judgment of Nazi doctors accused of
conducting murderous and torturous cruel
experiments conducted on humans during
WWII 15 of 23 guilty, 7 hanged
1900 10 20 30 40 50 60 70 80 90 2000
1- Nuremberg Code
71. Dr. Eman Mortada
1) Voluntary Informed consent.
2) Anticipate scientific benefits, Useful. For good of society
3) Animal experimentation first.
4) Avoid any unnecessary (physical and mental) suffering.
5) Benefits outweigh risks.
6) No intentional death or disability.
7) Protection from harm.
8) Subject free to withdraw.
9) Qualified investigators.
10) Investigator will stop if harm occurs.
Main features of Nuremberg code
72. 2011
1964
1947
❑ 1st issued in 1964 in Helsinki, Finland
❑ The Helsinki Declaration was developed
by the World Medical Association
(WMA).
❑ Responding to thalidomide use
❑ has been revised and updated
periodically since 1964, several times
2- The Declaration of Helsinki(DoH)
73. Dr. Eman Mortada
Year Benchmark
Pre-1900 Edward Jenner smallpox vaccines
1900 Walter Reed’s ‘consent’ for yellow fever experiments
1947 The Nuremberg Code
1964 World Medical Association (WMA) published the Declaration of Helsinki (DOH)
1966 Dr. Beecher’s Article “Ethics and Clinical Research”
1975 WMA updates DOH (Tokyo)
1979 The Belmont Report
1981 US Common rule updated
1983 WMA updates DOH (Venice)
1989 WMA updates DOH (Hong Kong)
1991 US CFR title 45, Part 46 issued CIOMS Guidelines for Epidemiological studies
1993 CIOMS guidelines for biomedical research involving human subjects
1996 WMA updates DOH (South Africa)
1998 Tri-Council Policy Statement (TCPS)published in Canada
2000 WMA updates DOH (Edinburgh)
2002 WMA updates DOH (Washington) CIOMS Guidelines updated
2004 WMA updates DOH (Tokyo)
2008 WMA updates DOH (Seoul)
2010 TCPS updated
2013 WMA updates DOH (Brazil)
74. Main features:
Subject
wellbeing
• 1- Emphasized on:
Wellbeing of subject
takes higher priority
over interests of
science and society
Ethics
committee
• 2 - introduced the
concept of oversight
by an 'independent
committee” Or ethics
committees
Helsinki declaration cont..1
75. 2011
1979
❑ Issued in 1979
❑ In response to Tuskegee Syphilis Study
❑ Summarizes 3 fundamental ethical
principles:
Respect for Person
Beneficence
Justice
❑ They are considered universal regardless of geographic,
economic, legal and political boundaries.
3- Belmont report
76. 2011
Saudi council for health specialists set guidelines, 2003 has
three different documents referring to the regulation of
research ethics
❑ Which ensure the conformity with sharia
❑ Benefits must outweigh the potential harm
❑ Research must be by a qualified researcher
4- Ethical guidelines in Saudi Arabia
77. Saudi Arabia is the only country that has three different
documents referring to the regulation of research ethics
79. a) Respect autonomy*
➢ Autonomy means Capacity to decide, make choices
➢ Voluntary participation
b) Protection of persons with diminished or
impaired autonomy.
• Addresses 3 main ethical considerations.
c) Protect privacy and confidentiality
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Principle 1- Respect for Person
80. **
Individuals should be treated as an autonomous
agents; avoid paternalism; let subject make
decision about what will or will not happen
However, not every human being is capable of self-
determination. Therefore, those with diminished
autonomy should be protected
81. Consent is Defined as permission,
approval
Informed Consent means: permission
given by the participant based on
knowledge of the procedure to be
performed*
Dr. Eman Mortada
Application → Informed Consent
82. It is no longer an option.
It is now a must under the current guidelines
& regulations
Understand nature of research
Respect Subject’s Will and freedom in
self determination.
Dr. Eman Mortada
84. “...consent must be
freely given or
truly voluntary.”
Coercion
Potential for coercion in relationships
❑ Teacher-Student
❑ Employer-Employee
❑ Service Provider-Service Recipient
Voluntariness
85. Individuals ppting in the study shouldn’t be
influenced by anyone conducting the study
However, voluntariness may be compromised when
use coercion to ppt, pressure by authorized body
88. Informed consent Basic Elements
1.Statement that the study involves research
2.Description of Risks
3.Description of Benefits
4.Confidentiality
5.If more than minimal risk, compensation
and/or medical treatment
6.Whom to Contact
7.Participation is voluntary
Dr. Eman Mortada
89. termination costs
be provided Number
Unexpected
Risks
Consequences of
Withdrawal
Informed consent additional Elements
When Appropriate
90. Informed consent additional Elements
1.Unforeseeable risks
2.Early termination
3.Additional costs to subjects
4.Consequences of a subject's decision to
withdraw from study participation
5.Disclosing new findings which may impact a
subject's willingness to continue participation
6.Number of subjects involved
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93. Informed Consent process
Informed consent is not only a document.
It is a process:
a dialogue between the researcher and the subject.
Information exchange needs to take place before,
during, and sometimes after the study.
Dr. Eman Mortada
Informed Consent = Shared Decision-Making
94. Vulnerable Groups
Pregnant women
Children
Prisoners
Mentally ill
Limited education
Poor
Terminally ill
Women in some
circumstances
Additional protection
Those persons who are
relatively or absolutely
incapable of protecting
their own interests.
Protection of persons with diminished or
impaired autonomy.
An individual’s autonomy can be affected by several factors
including age, cognitive impairment, illness, and treatments.
Proxy
Dr. Eman Mortada
95. $$
• Not every individual is, however, capable of
decision-making.
• Lack of maturity (as in the case of children),
• mental disability, or
• circumstances that severely restrict liberty (as in the
case of prisoners),
• may all decrease the capacity for decision-
making.
96. Pregnant Women
Father is not reasonably
available
The pregnancy is the result
of rape
The father’s signature is required unless:
Dr. Eman Mortada
97. 18
17
16
15
14
13
12
11
10
9
8
7
6
5
For children under 7 years of age, Parent/Guardian,
consent sign the IC
Child Age 7–11 years, Verbal Assent is obtained
Minors 12 – 17– Written Assent Required
A
s
s
e
n
t
Consent
Children and minors
Age >/=18
Yes
No
Dr. Eman Mortada
98. Cognitively Impaired
The signature
of Representative
mental retardation
dementia
coma
Diminish the
individual’s
Capacity to give
informed consent
Cognitive
Impairment
Regains
ability
Re-consent
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99. Deception
At times, researchers may choose to hide from participants the
true nature of the study
❑ Deception by Omission
Withholding important facts from the participants
❑ Deception by Commission
Lie to or purposely mislead research participants
❑Subjects should be debriefed after the study
❑given the option to withdraw from the study, have their data removed.
Dr. Eman Mortada
100. There are two types of consent that may be
required:
❑ Adult capable of giving
permission to participate in a
study can provide consent.
❑ Parents/legal guardians of
minors (under the age of 18)
can also provide consent to
allow their children to
participate in a study.
Consent Assent
❑ Assent must be obtained with
minors under the age of 18.
❑ Assent is a child's affirmative
agreement to participate in
research, written at the
appropriate reading level of
the youngest subject.
101. Types of Consent
Expressed consent =either oral or
written consent by the patient to undergo
a specific procedure or treatment.
Implied consent =inferred from the
circumstances. It is rarely documented
and is relied upon for care or treatment
that is routine and does not involve
significant risk.
102. Whistle-blowing
Researchers are in a privileged position
They may come across information about
wrong-doing or danger to the public
The reporting of this information may go
against any confidentiality agreement
The reporting of such information is likely to
damage their career
The Public Disclosure Act 1998 protects
certain classes of workers from the
consequences of whistle-blowing
103. Types of justice
Individual justice requires that investigators“ should not offer
potentially beneficial research only to some patients who are in
their favor or select only ‘undesirable’ persons for risky
research .
”
Social justice“ requires that distinction be drawn between classes
of subjects that ought, and ought not, to participate in any
particular kind of research, based on the ability of members of
that class to bear burdens and on the appropriateness of placing
further burdens on already burdened persons .
”
104. Privacy is
about people.
Confidentiality is
about data.
Investigators are responsible for protecting
Privacy of individuals &Confidentiality of data
Dr. Eman Mortada
Confidentiality vs. Privacy
What is the difference between
Privacy and Confidentiality?
105. Confidentiality vs. Privacy
Privacy means Subject controls the
extent, timing, and circumstances of sharing
Personal information/data with others.
Confidentiality means identifiable information
from or about a participant that is maintained
by the researcher and is protected from
unauthorized or accidental disclosure
Anonymity means no one, including the
researcher, can identify the participant
Smith, John
X
Dr. Eman Mortada
106. Are there any exceptions to maintaining
confidentiality?
Protect subject himself from harm:
1. Child abuse
2. Domestic violence
Protect others:
1. Infectious diseases(e.g., AIDS)
Dr. Eman Mortada
108. Physical, mental and social well-being
Application:
Assessment of risks and benefits
Minimising the risks
Maximising the potential benefits
Dr. Eman Mortada
* this assessment includes evaluation
of the study design and the ability of the researcher
Principal 2- Beneficence
109. A. Medical Risks:
1. Therapeutics: (Tuskegee experiment)
2. Preventive: (Trials of polio vaccine)
3. Diagnostic:
◼ Irradiation:
- Teratogenic effect to the fetus.
- Carcinogenic effect.
◼ Samplings:
- Biopsies: tissues that contain genetic information about the
participant.
- Surgical hazards.
- Too risky procedures (under anesthesia)
Forms of Harm to Human Subjects in Research
110. The Forgotten Risks
B. Social Risks:
Stigma (e.g. research on HIV-AIDS, STDs).
Social stigma –Social risks can range from loss of reputation and
social standing, to placing the individual at-risk of political or social
reprisals.
C.Emotional Risks:
On families when their children were chosen for trial of new
vaccine; research in war.
D. Psychological Risks:
Questionnaires with sensitive questions to participants
in sensitive positions, as to ask poor people about there
nutrition and houses.
Psychological harm include: anxiety, sadness, regret and emotional
distress, among others. Specially in behavioral studies.
111. Risk to the Society
❖ Manipulating environmental factors (Pathogenic organisms and
toxic chemicals).
❖ Economic risk
Economic risks may exist if knowledge of one’s participation in
research, for example, could make it difficult for a research
participant to retain a job or to find a job, or if insurance
premiums increase or loss of insurance is a result of the
disclosure of research data.
❖ Legal risks:
Vulnerable groups, e.g., prisoners, children, pregnant women.
Legal risks include the exposure of activities of a research subject
“that could reasonably place the subjects at risk of criminal or
civil liability
112. Responsibilities of Researchers
Qualification and competent
Integrity and legality
Honesty and transparency
The Investigator bears
primary
responsibility for the
protection of human
subjects in the study
Dr. Eman Mortada
113. Risks Benefit
To Whom Individual, investigators and the community
Duration Short term, i.e., only for the study period
Long term. i.e., extends beyond the study period
Forms Major potential risks to
participants
Major potential benefits to
participants
Risk/ Benefit Ratio
Dr. Eman Mortada
114. Benefits and risks…
Research on vulnerable groups may be justified in special
circumstances:
the health advantages clearly outweigh the minimal risks
the problem to be studied is clearly relevant to the unique health
problem of the vulnerable group
every effort is made to maximize the right of the group to self
direction and protection
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115. Ethical Obligation:
fair sharing of burdens and benefits
of research
Application:
Equitable selection of research subjects;
Fairness in inclusion and exclusion criteria
Dr. Eman Mortada
Principal 3- Justice
116. Third Ethical Principle: Justice**
Distribute benefits and burdens of the research
fairly and without bias
Do not select or restrict participants based on
gender, class, ethnicity, socioeconomic status, or
language ability (unless justified by study objectives)
Avoid selection of participants based on
➢ Convenience of researcher
➢ Participant availability
➢ Compromised position of participants
➢ Ability to manipulate participants
117. Equity vs. Equality in Human Subjects
Research
The meanings of “equity” and “equality” not the same.
“equitably ”means to deal fairly;
“ equally ”means to deal in exactly the same way.
118. How to Apply the 3 Principles?
Ethical principle Ethical rule
Respect for persons Obtain the informed consent of prospective
research subjects
Protect the confidentiality of private
information
Beneficence Qualifications of PI
Good research design
Risk -benefit analysis
Justice Subject selection procedures must be fair
Ethical principles and rules
Dr. Eman Mortada
122. 1. Recruit the students in her upper level classes and the
technicians from her lab to participate in the study
From which population would you
advise the researcher to recruit?
Dr. Eman Mortada
2. Post fliers around campus to recruit participants from the
campus population (students, faculty and staff)
126. Treatment and Prevention
Research in Adolescents
A study proposes to examine the effectiveness of a medical
treatment and prevention program for adolescents in a
location where the legal age for consent to such treatment
is 12. The adolescents involved range from ages 12 to 17.
Does this study require additional protections
be provided for the subject population?
Dr. Eman Mortada
