introduction to research ethics ghiath alahmad

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)

17531753

17531753

• Rise of experimental medicine1798 Edward Jenner: smallpox vaccination

17531753 17981798

1753175317981798

• First scandals1755–1843 (1811) Samuel Hahnemann try-outs on his children

17531753 17981798 18111811

1753175317981798

18111811

1855-1916 (1879) Neisser: gonococcus infection of prostitutes

17531753 17981798 18111811 18791879

17531753

17981798

18111811

18791879

Watershed : involvement of medical science in Second World War: Nuremberg Tribunal

17531753 17981798 18111811 1941194118791879

17531753

17981798

18111811

18791879

19411941

1947194717531753 17981798 18111811 1941194118791879

17531753

17981798

18111811

18791879

19411941

19471947

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.

1947194717531753 17981798 18111811 1941194118791879 1960s1960s

17531753

17981798

18111811

18791879

19411941

19471947

1964: Declaration of HelsinkiInformed consentRisk-benefit assessment

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966: H. Beecher (N Engl J Med)22 examples of clearly unethical research

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966

17531753

17981798

18111811

18791879

19411941

19471947

19641964

19661966

1967: Maurice Henry Pappworth: Human Guinea Pigs

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

1970s Tuskegee syphilis study

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

1947194717981798 18111811 1941194118791879 1960s1960s 19641964

1970s1970s

1970s1970s

1997

1996 Trovan trial in Nigeria

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

1947194718111811 1941194118791879 1960s1960s 19641964

1970s1970s

1970s1970s 19961996

19961996

1997 AZT trials

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

194719471941194118791879 1960s1960s 19641964

1970s1970s

1970s1970s 19961996

19961996

19971997

19971997 19971997

20052005

2005 Malaria study in Amapa, Brazil

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

1947194719411941 1960s1960s 19641964

1970s1970s

1970s1970s 19961996

19961996

19971997

19971997 19971997

20052005

20052005

20102010

20102010

2010201020102010

2005 Malaria study in Amapa, Brazil

1947194717531753 17981798 18111811 1941194118791879 1960s1960s 19641964 19661966 19671967

17531753

17981798

18111811

18791879

19411941

19471947

19641964

1966196619671967

1960s1960s 19661966 ????????

1970s1970s

1970s1970s 19961996

19961996

19971997

19971997 19971997

20052005

20052005

20102010

20102010

20102010

2010201020102010

????????

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

THANK youDr. Ghiath Alahmad

ghiathalahmad@hotmail.com00966567629770