Application to UTM IRB

Application to UTM IRB

Form Date: April 2017

Application to The University of Tennessee at Martin Institutional Review Board for the
Protection of Human Subjects in Research

Notes:

1. / The application, with all necessary signatures and attachments as appropriate, should be submitted by the PI to the Office of Research, Grants, and Contracts (ORGC), 100 Hall-Moody Administration Building.
Refer to the Handbook for descriptions of the categories of review and additional instructions, as needed.
2. / Applications requiring Full Review must be submitted a minimum of ten (10) working days before the regularly scheduled Institutional Review Board (IRB) meeting.
3. / Applications requiring exempt or expedited review may be submitted at any time.
4. / Student-led research is subject to, at minimum, an expedited review, even if it would otherwise fall into an exempt category.
5. / If this research project is externally funded, an IRB approval and docket number must be issued before the grant funds may be used.
6. / Submission of an application to the IRB DOES NOT equal IRB approval. You MAY NOT BEGIN this research until you have received notification of approval and have been issued an IRB docket number.
7. / Please provide responses for all items in the form, attaching additional sheets as needed.
8. / All signatures must be original.
9. / Enter your information in the boxes provided,using non-bolded Calibri 10-point font. The boxes will expand to accommodate your typing.
10. / The IRB Committee strongly encourages the facultyto carefully review their student’s IRB Application before submission to the IRB. Better submissions from the beginning will smooth the approval process.
The IRB Committee also strongly encourages students to make full use of the Hortense Parrish Writing Center, Room 209 Humanities Building.
Responsibilities of the Principal and Co-Investigator(s)
In compliance with the policies established by the Institutional Review Board of the University of Tennessee at Martin, the principal and co-investigators subscribe to the principles stated in “The Belmont Report” and the standards of professional ethics in all research, development, and related activities involving human subjects under the auspices of the University of Tennessee. The principal and co-investigator(s) further agree that:
1. / Approval will be obtained from the Institutional Review Board prior to instituting any change(s) in this research project.
2. / Development of any unexpected risks will be immediately reported to the Director of the Office of Research, Grants, and Contracts (Compliance Office).
3. / An annual review and progress report will be completed and submitted when requested by the Institutional Review Board.
4. / Signed informed consent documents and research data will be kept in a secure location approved by the Institutional Review Board for the duration of the project and for at least three (3) years thereafter.
1. / Office Use Only: / Date received in ORGC:
2. / Principal Investigator Information:
Name:
Mailing Address:
Email Address
Phone:
Status: / Faculty / Staff
Graduate Student / Undergraduate Student
3. / Other Investigator(s), If Applicable:
Name:
4. / Faculty Advisor(s), If Applicable:
Name:
Department:
5. / Date PI completed standardized Human Subjects Training:
Required for all student PIs (per Academic Policy, effective 8/31/2012).
Attach documentation.
6. / Proposed project period upon IRB approval: from / to
7. / Title of Project:
8. / Project Classification: Please refer to the Handbook for descriptions of research categories.
Exempt / Expedited / Full
9. / Site(s) of research:
10. / If this research is externally funded, please provide the following:
Name of the Funding Agency:
Title of the Funded Project:
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.
15. / 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?
22. / 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. / Participants/subjects must be able to legally provide consent or consent must be provided by a parent or legal guardian. Fully describe how you will obtain the informed consent of your participants/subjects. Include a statement in the consent document that removes participants/subjects if they are under 18 years of age (if applicable).
(Please see the Handbook and/or the ORGC website for additional information regarding 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?
27. / Regulations governing the use of human subjects in research require that data be stored in a secure location for three (3) years after the completion of the research. Please describe how and where the data will be stored.
(Please refer to the Handbook for a discussion related to data storage and security.)
28. / What UT Martin facilities and equipment will be used in this research study?

ORIGINAL SIGNATURES:

Title of Project
Principal Investigator:
Typed or Printed 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 Name / Signature / Date
Co-Principal Investigator:
Typed or Printed Name / Signature / 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) / A / B / C / D / E / F
Expedited Review
Under Review Category (Circle One) / G / H / I / J / K / L / M / N / O
Full Review
Under Review Category (Circle One) / A / B / C / D / E / F
Chair, DRC:
Typed or Printed Name / Signature / Date
Department Chair:
Typed or Printed Name / Signature / Date
Attachments:
1. / Documentation of completion of standardized human subjects research training (required for student investigators, recommended for faculty and staff).
2. / Two-page vita of the principal investigator or faulty advisor.
3. / Letter(s) from cooperating institution(s), if applicable.
4. / Informed consent documentation which includes a statement that participants must be at least 18 years of age to participate, if applicable.
5. / Informed assent documentation, if applicable, written in age appropriate language.
6. / Copy of instrument(s) to be used (surveys, questionnaires, interview questions, forms, etc.)