Medical Research Ethics

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Medical Research Ethics and Institutional
Review Board (IRB)
Dr. Azza Saleh ,MD Ass. Prof. of Clinical and
Chemical Pathology. General Secretary TBRI
IRB. April,2008
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There is no enhancement of the healthcare without
proper medical education and health research.
During carrying out the research, the patient's
safety may be threatened. The research subject
may be exposed to different types of risks. We
need to balance between the advancement of
science and protection of the human subject.
Protection of Subjects
Advancement of science
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Why?
Ethical
Historical
People who participate in clinical research are a
means to securing that generalizable knowledge.

• Withholding antibiotics from men with rheumatic
  fever,
• Injecting live cancer cells into nursing home
  patients .
• Tuskegee

As means, these people can be exploited, that is
be used as a means for the benefits of others.
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The Three Basic Ethical Principles

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What?

• 8 Ethical Requirements
• Community Partnership
• Social value
• Scientific validity
• Fair subject selection ?
• Favorable risk-benefit ratio
• Independent review
• Informed consent
• Respect for human subjects

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Who?

• Institutional Review Board (IRB)
• The purpose of an IRB is to review biomedical
• research and ensure that the research does not
• infringe on the rights and welfare of the
• human subjects.

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TBRI - IRB

• TBRI-IRB started in May 2006, the board
  constitutes of 9 persons
• Prof. Sanaa Botros as a Chair
• Prof. Mohamed El Wishahy
• Prof. Moataz Hassan
• Prof. Haider Ghaleb
• Prof. Mostafa El Hadary
• Prof. Sherif Kamel
• Mrs Bothaina Abdel Hamid
• Mr Mohamed Salah
• Myself as General Secretary

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TBRI - IRB.

• Role Initial as well as Continuing review of ALL
  researches conducted by TBRI members.

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Principal Investigator have the following
responsibilities

• Protocol design, approval, conduct, monitoring
  and analysis.

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Your annual report must do the following

• Summarize and explain all amendments.
• Present informed consents for the patients
  studied.
• Review observed risks and benefits.
• Report any patient withdrawal from the study .
• Provide an update on publications .

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The TBRI-IRB decisions

• Approval

Disapproval
Approval after amendments
Approval after clarifications
Deferment
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TBRI - IRB.
FWA00010609
What is a Federalwide Assurance (FWA)?

• It is the only type of new assurance of
  compliance accepted and approved by Office for
  Human Research Protections(OHRP ) ,USA, for
  institutions engaged in human subjects research
  conducted or supported by Health and Human
  Services ( HHS),USA. Under an FWA, an institution
  commits to HHS that it will comply with the
  requirements set forth in the Terms of Assurance.
• The FWA covers all human subjects research at the
  submitting institution that is HHS-conducted or
  -supported or funded by any other federal
  department or agency that has adopted the Common
  Rule and relies upon the FWA. It is not project
  specific.

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http//www.hhs.gov/ohrp/
Last Updated August 22, 2007
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Take Home Message
Following ethical guidelines WILL NOT hinder
Research on the opposite , it WILL enhance
Research.
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Questions / Comments
azzasaleh_at_hotmail.com