Research Ethics

Practice of Medicine II
MPOA020

Dr AO Adefolalu
 What is Research Ethics?
Research ethics involves the systematic
analysis of all ethical and legal questions
relevant to the research process to ensure
that study participants are protected.

 At the same time, ensuring that clinical

research is conducted in a way that serves
the needs of such participants and of the
society as a whole.
 Historical Perspectives
Tuskegee syphilis study 1932-1972
◦ 400 men with syphilis & 200 men as controls
◦ They were not told they had syphilis and didn’t
give consent
◦ When penicillin was discovered in 1945, it was
withheld from them in order to study natural
history of syphilis
◦ The study ended in 1972
◦ US president had to apologise in 1997
 Historical Perspectives
The syphilis study in Guatemala
◦ 696 men deliberately infected between 1946-1948
◦ Study aimed to determine if penicillin will prevent
syphilis infection
◦ Participants were female sex workers, soldiers,
prisoners, mental hospital patients
◦ Prostitutes sent to prison deliberately to infect
prisoners
◦ None of them consented to participate in the study
◦ The story only came out in 2010
◦ In 2010, President Obama had to apologise to the
people of Guatemala
The Nazi experiments

 Gruesome experiments conducted by Nazi

doctors in German concentration camps
during WW II
 22 doctors found guilty of research
misconduct during the Nuremburg Trial
 Nuremburg Code followed as a result of
the Nazi atrocities.
 Thalidomide disaster
Thalidomide studies in late 1950s to
determine safety and efficacy of the drug as
a sedative
Also used by pregnant women
10,000 - 20,000 infants globally with severe
teratogenic/neuropathy side effects
 The Nuremberg Code- 1947
1. Voluntary Informed consent is essential
2. Experiment to be for the good of society
3. Experiment is based upon prior animal studies
4. Avoid physical & mental suffering and injury
5. Subjects must be protected against injury, disability
and death
6. Weigh risks against benefits
7. No expectation of death or disability
8. Human experimentation to be conducted only by
scientifically qualified individuals
9. Participants can terminate involvement at anytime
10.Investigators can terminate the experiment if injury,
disability or death is likely to occur
 The Declaration of Helsinki- 1964
World Medical Association published the
Declaration of Helsinki (DoH) in 1964
 DoH superseded the Nuremburg Code
 DoH objective: Interests of science and society
do not take precedence over well-being of
research participants
 Revised 8 times (latest version is 2013)
 The current (2013) version is the only official
one;
 All previous versions have been replaced and
should not be used or cited except for historical
purposes
 The Declaration of Helsinki (2013)
 Research physician to protect the life, health, dignity,
integrity, right to self-determination, privacy and
confidentiality of personal information of research
participants
 Research must conform to generally accepted
scientific principles: based on animal experimentation
 Appropriate caution exercised in conduct of research
that may harm the environment
 Study protocol should be available
 Protocol submitted to a research Ethic Committee
before study commences
 Research only to be conducted by individuals with
appropriate scientific training and qualifications
 The Declaration of Helsinki (2013)
 Research in disadvantaged/vulnerable population is
only justified if research is responsive to health needs
and priorities of this population
 Assessment of predictable risks and burdens
benefits should be foreseeable
 Trials to be registered in a publicly accessible database
 Research physicians to be confident that risks involved
have been adequately assessed and managed
 Important that the objective outweigh the inherent
risks and burdens
 Voluntary participation
 Protect privacy of research participants and
confidentiality of their personal information
 Participants to be adequately informed of all aspects of
the trial
The Declaration of Helsinki (2013)
 Consent given for collection, analysis, storage
and/or reuse of identifiable human material or
data
 No participants in a dependent relationship with
the investigator or consent under duress
 For incompetent potential participants, consent
to be obtained from the legally authorized
representative
 In case the incompetent potential participant
can give assent, the physician should seek
assent in addition to consent of the legally
authorized representative. Dissent should be
respected
The Declaration of Helsinki (2013)
 In case physical or mental incapability is a
necessary characteristic of the research
population, Informed consent to be obtained
from a legally authorized representative.
 Authors, editors and publishers all have
ethical obligations with regards to the
publication of the research results
Philosophical Principles guiding Ethical Research

The Belmont report of 1979 is based on the 3

major principles:
1. Autonomy and respect for the dignity of
persons:
2. Non-maleficence
3. Beneficence
4. Justice
 Elements of Ethical Research
1. Collaborative partnership
2. Social value
3. Scientific validity
4. Fair selection of participants
5. Favorable risk/benefit ratio
6. Independent ethical review
7. Informed consent
8. Ongoing respect for participants and study
communities
Good Clinical Practice (GCP)
“A standard for the design, conduct,
performance, monitoring, auditing,
recording, analyses and reporting of
clinical trials that provides assurance that
the data and reported results are credible
and accurate and that the rights, integrity
and confidentiality of trial subjects are
protected”
 Good Clinical Practice

Originally from FDA in the USA

Published in 1990 in Japan and 1991 in Europe

Much less stringent than the FDA requirements and

often inconsistent

1st edition was published in South Africa in 2000

Provides guidance on minimum standard acceptable

in conducting clinical trials
Guidelines for Good Clinical Practice
The guidelines cover the following areas:
1. Protection of study participants
2. Responsibilities of both principal and
participating investigators
3. Responsibilities of sponsor
4. Quality assurance
5. Data management and statistics
6. Multi-centred studies
7. Ethics committees
8. Ethical considerations for HIV/AIDS clinical
and epidemiological research
 Principles of GCP
1. Clinical trials should be conducted according to
Helsinki declaration
2. Risks and benefit of a clinical trial should be
established before initiating the trial
3. Right, safety and wellbeing of trial subjects should
prevail over the interest of science and society
4. Information on investigational product should be
adequate
5. Clinical trials need a clear and scientifically sound
protocol
6. Clinical trial should only be conducted after being
approved by an ethics committee
 Principles of GCP
7. Medial care of research subjects to be done by
qualified physician
8. All persons involved in a trial should be qualified
in education, training and experience
9. Voluntary informed consent should be given
10. Information should be stored in a way that allows
for accurate reporting and verification
11. Abide by the privacy and confidentiality rules
12. Investigational products should be manufactured,
handled and stored in accordance with GMP
13. Systems with procedures that ensure the quality of
the trial should be implemented
 THE REVISED DECLARATION OF GENEVA:
A MODERN-DAY PHYSICIAN’S PLEDGE

 Declarationof Geneva is the contemporary successor to

the 2500-year-old Hippocratic Oath

 Adopted by WMA at its 2nd General Assembly in 1948

 Concisely outlines the professional duties of physicians

 Affirms the ethical principles of the global medical

profession.