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The signed/approved pre-IRB form (as a cover sheet for each packet) (Pre-IRB Requirements)
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The signed IRB Request for Approval form
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The IRB Review Sheets with typed responses
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The Solicitation/Recruitment Letter/Recruitment Flyers, Oral Script, etc.
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The Informed Consent Form/Assent Form/Oral Assent Procedure or Script covering all 16 points in separate paragraphs and with paragraph headings on department letterhead
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Approval to Conduct Research Letters/Performance Site's IRB Approval(s)
http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm -
Special Populations Concerns
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Equipment utilized in research (testing instruments, questionnaires, etc.)
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Certificate indicating completion of Human Subjects Tutorial (Certificate Requirements)
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"Approval of Doctoral Dissertation Proposal" form signed by all members of the dissertation committee, if appropriate
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completed IRB Review Checklist
In materials, such as the Informed Consent form, given to prospective subjects, the names of the tests to be administered should be specified and a brief description given unless the purpose and/or subject matter are obvious from the title of the instrument. The IRB reserves the right to request additional copies of all materials provided for the review of the project activities.
NO RESEARCH INVOLVING HUMAN SUBJECTS
SHOULD BE CONDUCTED PRIOR TO RECEIPT OF FINAL APPROVAL.
If the research has been conducted without formal approval, the IRB cannot consider the proposal, and the materials will be returned. Appropriate University and government offices will be informed of this unauthorized activity.
Materials will be returned un-reviewed: (1) if the materials are not typed, collated and stapled; (2) if a substantial amount of information is missing; (3) or if there are multiple grammatical and spelling errors.