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 Writing a Protocol Narrative 



Your narrative should not exceed five (5) pages and should use nothing less than eleven (11) point font. The following eight (8) sections are necessary for inclusion in your narrative.

  • Introduction and Brief Background of the Study

This section should contain sufficient background data concerning results of previous studies performed by the investigator or by others and a description of how the present study relates to these findings. Use the "References" section described below to document related studies.

  • Specific Aims

Clearly state the purpose of the study and achievability based on the methodology described in the Introduction.

  • Methods

Describe the sequence and methods of the study that will be performed primarily for the purpose of the research activity and include description of following:

            Study population
            Method to determine sample size
            Recruitment process
            Comparison (control) group, if used
            Advertisements (approved by the IRB in advance of use)
            Location of study
            If deception of participants, justification and debriefing.
            Confidentiality statement
            Proposed statistical treatment of data

  • Significance

Discuss how the study might yield data of sufficient value to warrant risk to the participants
Discuss what scientific results may be expected from new information to be gained by this research

  • Risk/Benefit Ratio

Discuss the risks, both physical and psychological, and justify the terms of benefits to either the individual and/to society.

If participation precludes, or is in lieu of standard care, this must be stated and justified.

Descriptions of safeguards to reduce exposure to unnecessary risk.

Description of how possible adverse effects will be detected and handled.

Payment is not considered a benefit and should not be stated as one.

  • Reference List

           Include a Brief Reference list

  • Qualifications of Investigators

            Include a brief summary that includes the PI's relevant prior experiences, qualifications, and/or credentials as related to the research proposal

  • Appendices

Informed Consent, Assent documents
Recruitment flyers, pamphlets, newspaper ads which identify the department/school that is sponsoring the research

Institutional Review Board
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