Informed Consent Form and IRB Application
Informed Consent Form and IRB Application
Submit the Informed Consent Letter and the South University IRB Application (please note that this is only an example and no data may be collected).
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Informed Consent Letter
- Procedure section is clear, described in detail, specific, and all inclusive. Written in lay language (as documented by reading level score). Includes risks and benefits relevant to study. Address assent (if applicable).
This form is to be used for requesting IRB review for exempt, expedited and full board studies
Please note that handwritten and/or incomplete forms will be returned to you.
CHECKLIST FOR IRB APPLICATION SUBMISSION
(to be completed by PI before submission to IRB)
Application Form with Signatures/ Confidentiality Agreements
NIH Training Certificate(s)
Protocol or Attached Research Proposal and/ or Contract/ Grant
Solicitation Announcements/Recruitment Flyers
Data Collection Instruments/Research Questions/Questionnaires/Surveys
Informed Consent Documents
Parental/Legal Guardian Permission Form (if applicable)
Child Assent Form (if applicable)
Approval from Study Sites (if applicable)
Medical Screening Instrument (if applicable)
Debriefing Plan (if applicable)
Student as Principal Investigator Worksheet (if applicable)
Project Title
PART I INVESTIGATOR and RESEARCH PERSONNEL
1) PRINCIPAL INVESTIGATOR
(Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)
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Dr. Mr. Ms. Professor |
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| Investigator Status: | Faculty Graduate Student Staff | |
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2) CO-INVESTIGATOR 1
(if applicable)
| Name: |
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Dr. Mr. Ms. Professor |
| Highest Degree Completed: |
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| Investigator Status: |
Faculty Graduate Student Other |
Undergraduate Staff |
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3) CO-INVESTIGATOR 2
(if applicable)
| Name: |
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Dr. Mr. Ms. Professor |
| Highest Degree Completed: |
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| Investigator Status: |
Faculty Graduate Student Other |
Undergraduate Staff |
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4) FACULTY SPONSOR
(if applicable)
| Name: |
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Dr. Mr. Ms. Professor |
| Highest Degree Completed: |
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| E-mail Address: |
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| College/Department: |
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5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS
(if applicable)
| Name: |
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E-mail: |
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Phone: |
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| Name: |
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E-mail: |
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Phone: |
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| Name: |
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E-mail: |
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Phone: |
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| Name: |
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E-mail: |
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Phone: |
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E-mail: |
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PART II FUNDING INFORMATION
1) Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
| Extramural | College | Department | |
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| P.I. of Grant or Contract: |
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Contract/Grant No.
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***Please provide one complete copy of the proposal submitted to the sponsor with this application. Please note that submission of your grant application is a regulatory requirement and will be maintained for the record with your application. The IRB
will not
utilize the grant during the review process other than to confirm that the grant proposal is consistent with the IRB proposal. You must submit all necessary documentation for the application
in addition to
the copy of the grant.
PART III EDUCATION AND TRAINING
All research personnel
(faculty, staff, graduate students working on a thesis or dissertation
,
anyone using data for purposes of independent research, students involved in data collection, faculty sponsors, persons receiving grant monies for human subject research or those personnel with management responsibilities)
must complete this section.
1) Have all key research personnel completed the required NIH training? No Yes Informed Consent Form and IRB Application
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