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190407 - HOW TO OBTAIN ETHICAL APPROVAL FOR YOUR RESEARCH

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Presentation at the Writing Successful Research Proposal & Manuscript for Health Care Providers held at KFMC, Riyadh on 7-8 April 2019. By Prof. Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard) DrPH (Harvard) Chairman, Institutional Review Board - KFMC 

 

PRIOR PREPARATION:

}  Do you have a research question?

}  Do you have a clear hypothesis?

}  Have you determined the outcome variable(s)?

}  Have you determined the determinant variable(s)?

 

MAIN TYPES OF IRB SUBMISSION:

}  Exempt: has no risk to humans mostly interviews, data from records, or laboratory work.

}  Expedited: has minimal risk, the risk is what is associated with normal outpatient procedures.

}  Full review: this has major risk in the form of intervention by drugs or devices.

 

REQUIREMENTS FOR EXEMPT SUBMISSION:

 

REQUIREMENTS FOR EXPEDITED SUBMISSION:

 

REQUIREMENTS FOR FULL REVIEW SUBMISSION:

 

HOW TO SUBMIT:

}  All documents submitted electronically.

} The research forms must be signed by the PI and head of department.

} The proposal must be a separate word document to enable plagiarism check.

 

DETAILS OF THE MAIN FORMS:

}  The exempt form (see attached).

}  The expedited form (see attached).

}  The full review form (see attached).

 

THE EXEMPT FORM:


 

THE EXPEDITED FORM:




 

THE FULL REVIEW FORM:





 

DETAILS OF THE PROPOSAL:

}  Title.

}  Introduction/background/literature review.

}  Aims and objectives.

}  Methods.

 

MALPRACTICES:

}  Plagiarism.

}  Authorship.