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Presented at Alfaisal University Scholar Program in Research Excellence (ASPIRE) on October 8, 2021, by Dr. Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City.
DOCUMENTS
SUBMITTED FOR IRB REVIEW:
} Exempt proposals are submitted on a
special form with the proposal attached. The form must be signed by the PI and
HOD. Also attached is the questionnaire, and consent (if needed)
} Full and expedited: Protocols,
investigator brochures, and consent documents of proposals with potentially
significant patient risk are sent to all IRB members at least 2 weeks in
advance for review with those from the relevant disciplines being asked to make
a more detailed analysis and make a presentation to the IRB.
} The CVs of investigators and certification of GCP must be attached.
CRITERIA OF IRB
APPROVAL - 1:
} The two main considerations in IRB
decisions are: informed consent and patient safety.
} Informed and voluntary consent following full disclosure of
objectives, risks, and benefits of the research, the right to abstain or
withdraw from the study. Special scrutiny of proxy consent for the vulnerable
will be made to ensure no abuse. The investigator must submit reasons
in writing in cases where full disclosure is deemed inappropriate.
} Patient safety is based on a careful weighing of
benefits and risks.
} Confidentiality (use of certificates of
confidentiality7) and security of the data.
CRITERIA OF IRB
APPROVAL - 2:
} Scientific merit: objectives clearly stated and
attainable, research design and statistical methods are adequate to produce
clinically and scientifically valuable results. Outside experts may be
consulted. The committee will compare
the scientific merit and benefit of the research against risks and costs to
patients. Decision-making procedures may improve the risk-benefit discourse.
} Qualification of the researchers based on the study of their detailed
resumes.
} Adequacy of research facilities
} No conflicts of interest
DECISIONS
OF IRB:
} IRB decisions are best taken by
consensus but if this is not possible the decision will be based on a simple
majority of the members attending if the quorum is assured. Minority views
should be recorded.
} The decision of the committee may
be full approval, conditional approval, deferment, or rejection. Reasons should
be provided for projects approved conditionally or those that are rejected. If
the investigator fulfills the missing information the chairman may approve a
conditional approval without returning to the full committee.