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Dr. Ghiath Alahmad
KAIMRC; KSU-HS
Overview
1. Medical research scandals
2. Definition
3. Importance
4. Principles
5. Guidelines of research ethics
6. 4. Explain how should we approach research
ethics in practice
• Rise of experimental medicine
1716-1794 (1753): James Lind: first clinical trial (Lemon and
scurvy)
1753
1753
• Rise of experimental medicine
1798 Edward Jenner: smallpox vaccination
1753 1798
1798
• First scandals
1755–1843 (1811) Samuel Hahnemann try-outs on his
children
1753 1798 1811
1798
1855-1916 (1879) Neisser: gonococcus infection of prostitutes
1753 1798 1811 1879
1798
Watershed : involvement of medical science in Second
World War: Nuremberg Tribunal
1753 1798 1811 19411879
1798
19471753 1798 1811 19411879
1798
1947
1947 Nuremberg Code
In the late 1950s and early 1960s, more than 10,000 children in 46
countries were born with deformities such as phocomelia, as a
consequence of thalidomide use.
19471753 1798 1811 19411879 1960s
1798
1947
1964: Declaration of Helsinki
Informed consent
Risk-benefit assessment
19471753 1798 1811 19411879 1960s 1964
1798
1947
1966: H. Beecher (N Engl J Med)
22 examples of clearly unethical research
19471753 1798 1811 19411879 1960s 1964 1966
1798
1966
1967: Maurice Henry Pappworth: Human Guinea Pigs
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
1970s Tuskegee syphilis study
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
19471798 1811 19411879 1960s 1964
1970s
1970s
1997
1996 Trovan trial in Nigeria
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
19471811 19411879 1960s 1964
1970s
1970s 1996
1996
1997 AZT trials
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
194719411879 1960s 1964
1970s
1970s 1996
1996
1997
1997
2005
2005 Malaria study in Amapa, Brazil
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
19471941 1960s 1964
1970s
1970s 1996
1996
1997
1997
2005
2005
2010
2010
2010
2010
2005 Malaria study in Amapa, Brazil
19471753 1798 1811 19411879 1960s 1964 1966 1967
1798
1966
1967
1960s 1966 ????
1970s
1970s 1996
1996
1997
1997
2005
2005
2010
2010
2010
2010
2010
????
Bioethics
Health Ethics
Medical Ethics
Clinical Ethics Research Ethics
What is research ethics?
Why research ethics is important?
Research ethics is important!
Why it is important?
Human
Rights
Financial
interest
Excessive of
review
committees
Why research ethics is important?
Good
knowledge
• How to be a good
researcher?
Good ethics
Science &
Knowledge Care
Research ethics – basic problem!
Science &
Knowledge CareResearch
Research ethics – basic problem!
Science &
Knowledge CareResearch Health
Research ethics – basic problem!
Science &
Knowledge CareResearch Health
Researcher
Research ethics – basic problem!
Science &
Knowledge CareResearch Health
Researcher Physician
Research ethics – basic problem!
PhysicianResearcher
ComplaintProblemStarting
point
TherapyKnowledgeAim
EndMeansPatient/Person
PatientResearcherInterested party
Research ethics – basic problem!
PhysicianResearcher
ComplaintProblemStarting point
TherapyKnowledgeAim
EndMeansPatient/Person
PatientResearcherInterested party
Research ethics – basic problem!
PhysicianResearcher
ComplaintProblemStarting point
TherapyKnowledgeAim
EndMeansPatient/
Person
PatientResearcherInterested party
Research ethics – basic problem!
PhysicianResearcher
ComplaintProblemStarting point
TherapyKnowledgeAim
EndMeansPatient/Person
PatientResearcherInterested
party
Research ethics – basic problem!
Principles Research Ethics
Principles Research Ethics
Respect for Person
Ben efic en c e
Ju stic e
Principles Research Ethics
Respect for Person
Beneficence
Justice
Autonomy, self-determination
Capacity to decide, make choices
The dignity of people and individual
Respect for community and local culture
Principles Research Ethics
Respect for Person
Ben efic en c e
Ju stic e
Physical, mental and social well-being
Risks reduced to a minimum, non-maleficence
Protection of the participant is the primary
Responsibility of the researcher
Benefits for the communities where the
research will be conducted
Principles Research Ethics
Respect for Person
Ben efic en c e
Ju stic e
Distribution of risk and benefit
Equitable recruitment of research participants
Special protection for vulnerable groups
Principles Research Ethics
Special protection for vulnerable groups
Pregnant womenChildrenPrisonersMentally illLimited educationPoorTerminally illWomen in some
circumstances
Summary-Principles of Research Ethics
Respect for Person
Ben efic en c e
Ju stic e
19791947 1964 20101982 1996 2004
The Development of Contemporary Research Ethics
19791947 1964 20101982 1996 2004
The Development of Contemporary Research Ethics
199619791964 2004 201019821947
The Development of Contemporary Research Ethics
19961964 2004 2010198219791947
The Development of Contemporary Research Ethics
19961964 2004 20101979
International Ethical Guidelines for
Biomedical Research Involving
Human
1947 1982
The Development of Contemporary Research Ethics
19791964 20101982 20041947 1996
The Development of Contemporary Research Ethics
19791964 20101982 1996 20041947
The Development of Contemporary Research Ethics
19791964 20101982 2001 20031947
The Development of Contemporary Research Ethics
19791947 1964 20101982 1996 2004
The Development of Contemporary Research Ethics
Parties of Research Ethics
•REC or IRB
•Researcher
•Sponsor
•Community representative
Establishment of the REC
Protecting Research Participants:
Other Stakeholders
Provide
necessary
support
Select
qualified
researchers
Promote
research
integrity
Require
appropriate
ethical
review
Sponsor's Responsibilities
Honesty
Respect Sensitivity
Politeness
Compassion Professionalism
Researcher's Human Qualities
community
Researcher
Community
Representative
Why Have Community Participation?
After the study
Share the research findings
During the
study
Follow study
progress
Before the
study
Informed the
community
Primary Responsibilities of Research Ethics
Committees and Community Representative Groups
Review and Approval
of research protocols
Regulations
REC
Community
Representative
Responsible
advise
THANK you
Dr. Ghiath Alahmad
ghiathalahmad@hotmail.com
00966567629770

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Introduction to research ethics Ghiath Alahmad

Editor's Notes

  1. Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations