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Protocol Content List

In reviewing your protocol the members of the IMR IRB and the MRAC will be looking for specific information about your proposed study. Following is a list of contents which if appropriate, should be contained within the study protocol prior to submission. Making sure that this information is not only included but also clearly marked will expediate the review process.

Suggested Protocol Content

Signature page confirming agreement and acceptance of protocol from all principal investigators

  1. List of all abbreviations and/or acronyms used in the protocol
  2. Layman Protocol summary
  3. List of key staff
    • Principal Investigators
    • Co Investigators
  4. Background information and rationale
  5. Objectives
  6. Study population
    • Inclusion and exclusion criteria
    • Subject confidentiality
    • Informed Consent
  7. Study design
    • Study procedures
    • Laboratory procedures
    • Study evaluations
    • Statistical considerations
  8. Risks and Benefits
    • Potential Risks
    • Known Potential Benefits
  9. Literature References

 

Appendices

  1. Curriculum vitas for all principal and co investigators

  2. Advertising in all languages

  3. Information Sheet in all languages

  4. Consent Form in pidgin and English. Pidgin version of the consent form must use standardized pidgin in the Gutnius Bible or pidgin dictionary.

IMR Institutional Review Board

Contact

Dr William Pomat
IRB Secretary

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