Application to The University of Tennessee at Martin Institutional Review Board for the
Protection of Human Subjects in Research
Please provide responses for all items in the form, attaching additional sheets as needed.
ALL SIGNATURES MUST BE ORIGINAL. The application, with all necessary signatures and copies as appropriate, should be submitted by the PI to the Office of Research, Grants, and Contracts, 100 Hall-Moody Administration Building. Please refer to the Handbook for descriptions of the categories of review and additional instructions, if needed. Please note that applications requiring Full Review must be submitted a minimum of ten (10) working days before the regularly scheduled Institutional Review Board (IRB) meeting. Applications requiring exempt or expedited review may be submitted at any time. Also note that student-led research is subject to, at minimum, expedited review, even if it would otherwise fall into an exempt category.
ExemptOriginal only (faculty and staff only)
Expedited Original and 2 copies
FullOriginal and 6 copies
If the project is externally funded, final approval must be obtained from the IRBCommittee before grant award can be used:
If this research project is externally funded, an IRB docket number must be issued before grant funds may be used.
1. Office use only. Date received in ORGC:______
2. Principal Investigator (PI) name:
PI mailing address:
PI email:PI phone:
Status: Faculty ; Staff ; Graduate Student ; Undergraduate Student
3. Other investigators, if applicable:
4. Faculty advisor(s), if applicable:
5. Date PI completed standardized Human Subjects Training, required for all student PIs (per Academic Policy, effective 8/31/2012): Attach documentation.
- Proposed project period: upon IRB approval until
7.Title of Project
8. Project classification: ExemptExpedited Full
Please refer to the Handbook for descriptions of research categories.
9.Site(s) of research
10. If this research is externally funded, please provide the following.
- Name of funding agency:
- Title of Funded Project:
- Duration of Project: From to
- Sponsoring Agency contract Number:
(If this project is not externally funded, check "N/A” and proceed to next question). N/A
11.Provide a brief description of the general purpose of the research:
12.Fully describe how you will recruit participants/subjects for the research:
13.Describe any inducements to be offered to participants/subjects:
14.Describe the number and salient characteristics of the participants/subjects:
- List the legal name(s) of any cooperating institutions (school, hospital, clinic, prison, etc.) and attach copies of written permissions.
16.Fully describe how and when observations will be made and/or data will be collected.
17. Fully describe what participants/subjects will be expected to do in this study.
18.Fully describe what will be done to the participants/subjects in this study.
19.How will you make it clear to the participants/subjects that their participation is fully voluntary?
20.How will you make it clear to the participants/subjects that they may withdraw at any time without penalty?
21. How will you make it clear to participants/subjects that they may refuse to answer any specific question(s) that may be asked of them without penalty?
- Cite your experience with this type of research. Append a current two-page vita. (For student researchers with little or no experience, refer to the experience and append the two-page vita of your faculty advisor).
23. Fully describe how you will obtain the informed consent of your participants/subjects? (Please see the ORGC website for additional information about informed consent.)
24. Describe how, in your opinion, your participants/subjects may benefit from participation in this research.
25. Describe any risks to your participants/subjects that may be associated with their participation in this research.
26. What steps will you, as PI, take to ensure the confidentiality of all data that you collect in association with this research?
- How will the data be stored? (Please refer to the Handbook for a discussion related to data storage and security.)
- What UT Martin facilities and equipment will be used in this research study?
ORIGINAL SIGNATURES:
Principal
Investigator:
______
Typed orPrinted Name Signature Date
Co-Principal
Investigator:
______
Typed or Printed Name Signature Date
Co-Principal
Investigator:
______
Typed or Printed Name Signature Date
Co-Principal
Investigator:
______
Typed or Printed NameSignature Date
Co-Principal
Investigator:
______
Typed or Printed NameSignature Date
Faculty
Advisor:
______
Typed or Printed Name Signature Date
Departmental Review and Approval
Refer to the Handbook for descriptions of review categories. The Academic Department Chair and the IRB Departmental Review Committee (DRC) have reviewed and approved this application and recommend that it be submitted to the UT Martin Institutional Review Board under the following category:
Exempt from Full Review (Faculty and staff)
Under review category (Circle one)
AB CDEF
Expedited Review
Under review category (Circle one)
GHIJKLMNO
Full Review
Under review category (Circle one)
ABCDEF
Chair, DRC
______
Printed nameSignatureDate
Dept. Chair
______
Printed nameSignatureDate
Attachments:
- Documentation of completion of standardized human subjects research training (required for student investigators, recommended for faculty and staff)
- Two-page vita for principal investigator or faulty advisor
- Letter(s) from cooperating institution(s) (if applicable)
- Informed consent documentation
- Informed assent documentation (if applicable)
- Copy of instrument(s) to be used (surveys, questionnaires, interview questions, forms, etc.)
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Updated 9/11/13