introduction to research ethics ghiath alahmad
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Introduction to research ethics Ghiath AlahmadTRANSCRIPT
Introduction to Research EthicsDr. Ghiath Alahmad
KAIMRC; KSU-HS
Overview
1. Medical research scandals2. Definition3. Importance 4. Principles5. Guidelines of research ethics6. 4. Explain how should we approach research
ethics in practice
• Rise of experimental medicine1716-1794 (1753): James Lind: first clinical trial (Lemon and scurvy)
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• Rise of experimental medicine1798 Edward Jenner: smallpox vaccination
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• First scandals1755–1843 (1811) Samuel Hahnemann try-outs on his children
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1855-1916 (1879) Neisser: gonococcus infection of prostitutes
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Watershed : involvement of medical science in Second World War: Nuremberg Tribunal
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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.
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1964: Declaration of HelsinkiInformed consentRisk-benefit assessment
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1966: H. Beecher (N Engl J Med)22 examples of clearly unethical research
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1967: Maurice Henry Pappworth: Human Guinea Pigs
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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!
Physician Researcher
Complaint Problem Starting point
Therapy Knowledge Aim
End Means Patient/Person
Patient Researcher Interested party
Research ethics – basic problem!
Physician Researcher
Complaint Problem Starting point
Therapy Knowledge Aim
End Means Patient/Person
Patient Researcher Interested party
Research ethics – basic problem!
Physician Researcher
Complaint Problem Starting point
Therapy Knowledge Aim
End Means Patient/Person
Patient Researcher Interested party
Research ethics – basic problem!
Physician Researcher
Complaint Problem Starting point
Therapy Knowledge Aim
End Means Patient/Person
Patient Researcher Interested party
Research ethics – basic problem!
Principles Research Ethics
Principles Research Ethics
R e s p e c t f o r P e r s o n
B e n e fi c e n c e
J u s ti c e
Principles Research Ethics
R e s p e c t f o r P e r s o n
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
R e s p e c t f o r P e r s o n
B e n e fi c e n c e
J u s ti c e
Physical, mental and social well-being
Risks reduced to a minimum, non-maleficence
Protection of the participant is the primaryResponsibility of the researcher
Benefits for the communities where theresearch will be conducted
Principles Research Ethics
R e s p e c t f o r P e r s o n
B e n e fi c e n c e
J u s ti c 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 somecircumstances
Summary-Principles of Research Ethics
R e s p e c t f o r P e r s o n
B e n e fi c e n c e
J u s ti c e
19791947 1964
2011
20101982 1996 2004
The Development of Contemporary Research Ethics
19791947 1964
2011
20101982 1996 2004
The Development of Contemporary Research Ethics
19961979200520042005 1964
2011
2004 201019821947
The Development of Contemporary Research Ethics
1996200520042005 1964
2011
2004 2010198219791947
The Development of Contemporary Research Ethics
19961964
2011
2004 20101979
International Ethical Guidelines for Biomedical Research Involving
Human
1947 1982
The Development of Contemporary Research Ethics
19791964
2011
20101982 20041947 1996
The Development of Contemporary Research Ethics
19791964
2011
20101982 1996 20041947
The Development of Contemporary Research Ethics
19791964
2011
20101982 2001 20031947
The Development of Contemporary Research Ethics
19791947 1964
2011
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
Sponsor or monitorRegulatory agencies
Institutional regulatory and compliance offices
Public interest groups
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
communityResearcher
Community Representative
Why Have Community Participation?
After the studyShare the research findings
During the study
Follow study progress
Before the study
Informed the community
Primary Responsibilities of Research EthicsCommittees and Community Representative Groups
Review and Approval of research protocols
RegulationsREC
Community Representative
Resp
onsi
ble advise
