Health Research Ethics

Prof. Diaa Marzouk Abd El Hamid

Community Medicine Department
Ain Shams University
2006-2007
 Definition of medical
ethics
 Is the set of moral principles that
should govern the practice of
medicine
 Questions
 The norms of research ethics are driven
by the principles articulated in the
Hippocratic Oath.
 True or False?

 The most pressing issue for research performed

in developing countries is how to avoid
exploitation.
 True or False?

 Respect for persons, as manifested by the

requirement for informed consent, is the essence
of research ethics.
 True or False?
 What is Research?
 Is any social, biomedical, behavioral, or
epidemiological activity that requires
systematic collection or analysis of data with
the intent to generate new knowledge; in
which human beings are exposed to

 Intervention,
 Observation
 Definition of research ethics

 Research involving human subjects

can raise difficult and important
ethical and legal questions.
 Research should ensure

Research

Participants Serves Participants

are protected & society Needs
How To Balance Two Goals?

Protection of
Subject Welfare/Rights

Advancement
of Science
Some Historical Events
 High Altitude Experiments

• High altitude experiments were performed to test how long pilots

would survive after being ejected from their planes. Prisoners
were put into low-pressure tanks with little oxygen. Many of
those who did not die immediately were put under water until
they died. Autopsies followed.
.
Nazi Doctors’ Trial (1947)
 Nazi Doctors’ Trial
 Nazi doctors and
scientists put on trial for
the murder of
concentration camp
inmates who were used
as research subjects
 How could this happen?
 Hippocratic Oath

Could not protect human rights

Expand on Hippocratic Ethics to

Protect Research Subjects
 Nuremberg Code
Hippocratic Oath Do No Harm

+
Galen

Concept of Human Rights

Protection of Subject Welfare and Human Rights
 Nuremberg Judges
Distinction between Medicine and
Research
 Medical Practice Research
 Ethics: guided by Lies outside
Hippocratic Oath physician-patient
 patient is silent; relationship
obedient to the Primary goal is to
beneficent physician test a hypothesis
 Doctor’s primary Secondary
obligation is the patient obligation is to
 Doctor acts in the subject
patients’ best Conflict of roles?
Tuskegee Syphilis Study (1932 -
1972)
Ethical Issues
• Inadequate disclosure of
information
• Subjects believed they were
getting free treatment
• Told that spinal taps was
therapy
• US Gov’t actively prevented
men from receiving penicillin
• 1972 press reports caused the
U.S. Gov’t to stop the study
 Belmont Report (1979)

The three ethical principles:

 (1) Respect for persons

 (2) Beneficence
 (3) Justice.
 1. Respect for Persons
Achieved through:
 Individuals should be treated as autonomous
agents and are entitled to protection.
 Subjects should be given the opportunity to
choose what shall or shall not happen to them.
 Obtaining of informed consent from potential
study participants. That contains three main
elements:
1. Information,
2. Comprehension and
3. Voluntariness.
 Autonomy - respect for persons
‫ ﺣﻖ ﺍﻻﺨﺘﻴﺎ ﺭ‬- the right to make a decision
 Respect for Informed consent
personal self-
determination Confidentiality
Protections
 Respect for privacy
 Respect for persons
with limited
autonomy Family Consent
 i) Information includes

 The research procedures, their purposes,

 Risks and anticipated benefits,
 Alternative procedures (where therapy is
involved),
 A statement offering the subject the
opportunity to ask questions
 To withdraw at any time from the
research.
 ii) Comprehension
 The manner in which information is
conveyed to the participant is
extremely important. e.g, :
 Presenting information in a
disorganized and rapid fashion,
 Allowing too little time for consideration
or for questioning,
All may adversely affect a subject's
ability to make an informed choice.
 iii) Voluntariness
 An agreement to participate in research
constitutes a valid Informed consent only if
voluntarily given.
 This consent requires conditions free of
coercion and undue inducement.
 Coercion occurs when an overt threat of harm
is intentionally presented by one person to
another in order to obtain compliance.
 Undue inducement, occurs through an offer of
an excessive, inappropriate reward in order to
obtain compliance.
 2. Beneficence
 Research Participants are treated in an
ethical manner by:
 Respecting their decisions and

 Protecting them from harm.

 Two general rules have been extracted

from this concept
(1) Do not harm and
(2) Maximize possible benefits and
minimize possible harms.
 For research to be ethical
 Assessment of risks and benefits is required or
Risk /Benefit Analysis

 For the Investigator; it is a mean to examine

whether the proposed research is properly designed.

 For a Review committee, it is a method for

determining whether the risks that will be presented
to subjects are justified.

 For Prospective subjects, the assessment will assist

the determination whether or not to participate.
Analysis of Risks and Benefits

Risk Level

Minimal Above Minimal Too RISKY

 Types of Risks
 Pathological
 Psychological
 Social
 Economic
Balance Risks and Benefits
Procedures with potential benefits
Risks are reasonable to potential benefits

Procedures with no potential benefits

Risks are reasonable with knowledge
Risk/knowledge ratio
 3. Justice
 Who ought to receive the
benefits of research and bear
its burdens (Risks)?
 This is a question of justice, in
the sense of "fairness in
distribution"
 Or Fair selection of subjects
 Justice
 justice requires that there is an order
of preference in the selection of
classes of subjects (e.g., adults before
children)
 Or some classes of potential subjects
may be involved as research subjects,
(e.g., the poor, mentally infirm or
prisoners) only on certain conditions.
 Vulnerable Groups
 One special instance of injustice
results from the involvement of
vulnerable subjects.
 As economically disadvantaged
(poor, most developing countries)
 The very sick, and
 the institutionalized (prisoners,
mentally ill, orphans)
 Vulnerable Groups
May continually be targeted as research
subjects, owing to:

 Their ready availability in settings where

research is conducted.
 Given their dependent status and their
frequently compromised capacity for free
consent,

They should be protected against the danger of

being involved in research.
 Questions
 The norms of research ethics are driven by the
principles articulated in the Hippocratic Oath.
False
 The most pressing issue for research performed
in the International arena is how to avoid
exploitation. True: prevent exploitation
 Respect for persons, as manifested by the
requirement for informed consent, is the
essence of research ethics. Somewhat True:
Other items important