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Instructions The form must be typed. Any hand-written (Virginia State University)

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VSU IRB Protocol Form
(Rev 09/2017) Page 1
Instructions
• The form must be typed. Any hand-written form will be returned to you.
• Answer all questions in their entirety. Some questions may contain sub-questions. Failure to answer
all questions will result in your application being returned to you.
• Research Design: Attach as a separate document a detailed description of the study to include the
purpose, methodology, planned data analysis section. Please DO NOT append your entire
thesis/dissertation/grant proposal as a substitute for this document. Your document should not
exceed 5 pages.
• Supporting Documentation: Attach the Consent Form, all surveys, questionnaires, certificates, or
third party support letters along with the IRB Submission application.
• Remember both the Principal Investigator, and Co-Investigator/Advisor must sign the Investigator’s
Assurance Page. Both the Principal Investigator and Co-Investigator/Advisor must also provide
evidence of CITI training.
• Email the documents as one pdf or Word file, do not email documents separately. Email the
application to irb@vsu.edu
• Visit our web page for IRB submission and meeting dates
http://www.vsu.edu/files/docs/research/irb-meeting-dates.pdf
.
Contact: Address:
Dr. Larry Keen, IRB Chair Virginia State University
lkeen@vsu.edu P.O. Box 9407
Tel: 804-524-5523 Petersburg, VA 23806
Ms. Sharon Evans, IRB Liaison
sevans@vsu.edu
Tel: 804-524-5560
VSU IRB Protocol Form
(Rev 09/2017) Page 2
Virginia State University
Institutional Review Board
Research with Human Subjects
Submission Form
Federal regulations and Virginia State University policy require that all research involving human
subjects are to be reviewed and approved by the University Institutional Review Board (IRB). Any
person (faculty, staff, student or non-VSU person) wanting to engage in human subject research at
Virginia State University must received written approval from the IRB before conducting research.
Please complete this entire form, sign and return with the required documentation to the address
located at the bottom of the form.
I. GENERAL INFORMATION (Type in the gray area)
A. Research, Dissertation or Thesis Title:
Is this research part of a thesis? Yes No
Is this research part of a dissertation proposal? Yes No
If yes, has the thesis or dissertation proposal been approved? Yes No
Date approved:
Name of Thesis/Dissertation Advisor:
Department: Phone No.:
Principal Investigator Information (If the PI is a graduate student please indicate advisor’s name in item 3).
1. Principal Investigator
Department and Campus PO Box No.
2. Telephone and Fax Numbers
Email Address
Please check if PI is:
Faculty ( ) Staff ( ) Graduate Student
( ) Non-VSU faculty/staff or student
Non-VSU members complete this section:
Name of University and mailing address
3. Co-Principal Investigator or Advisor
Department and Campus PO Box No.
4. Telephone Number
Email Address
Please check if Co-PI is:
( ) Faculty ( ) Staff ( ) Graduate Student
( ) Non-VSU faculty/staff or student
Non-VSU members complete this section:
Name of University and mailing address
VSU IRB Protocol Form
(Rev 09/2017) Page 3
COMPLETE THIS SECTION IF PI IS AN UNDERGRADUATE STUDENT
Check one:
Class Project
Research Paper
Other
Yes, Date approved: No
Department:
Phone No.
II. PROTOCOL DESCRIPTION
Reason(s) for review by Human Subjects Committee (please check all that apply):
Virginia State University employees/students
Persons otherwise dependent on the researcher (such as students of the researchers, etc.)
Minors
Students in a school system
Name of school system:
Other populations (explain):
III. RECRUITMENT (Begin typing in the gray area)
A. Give an estimate of how many participants will be included in the study?
B. What is the age range?
C. Where will participants be recruited? (i.e., specific department, public school system, etc)
D. Describe in detail how participants will be recruited, or approached to participate in the research study.
E. Explain procedures/steps for obtaining informed consent from participants. Be specific regarding who
will obtain informed consent, and in what setting/time frame.
F. Describe any alternative activities available to those who choose not to participate in the study, if
applicable.
VSU IRB Protocol Form
(Rev 09/2017) Page 4
IV. DATA
A. How will the data be stored and kept secure? (Briefly describe where the data will be stored and kept
secured from persons other than the researcher)
B. 1) Who will have access? 2) How will the data be used [during and after the research (i.e., research
publications, journals, conferences, scholarly presentations)]?
C. How will the data be disposed and after how many years?
V. CONFIDENTIALITY
A. How will participant’s identity be kept confidential? (Describe how the participant privacy and
confidentiality of the research data will be protected)
B. Will participants be recorded (e.g., audio, video)
( ) No
( ) Yes – describe the type of recording(s) and specify how they will be used, stored/secured, and
their final disposition.
VI. BENEFIT
A. Who might find these results useful?
VSU IRB Protocol Form
(Rev 09/2017) Page 5
VII. RESEARCH INSTRUMENTS
Attach copies of surveys, interview or focus group questions that will be used in the project and if applicable,
any signed agreements between agencies/collaborators/school districts, etc.
VIII. TRAINING
VSU policy requires all investigators and/or researchers conducting human subjects’ research to complete
The CITI Responsible Conduct of Research (CITI RCR) training on protecting the rights and welfare of
research participants.
The training requirements may be satisfied by completing an online course at CITI RCR
https://www.citiprogram.org
.
NOTE:
Students, who are submitting their thesis, dissertation, or class projects for IRB review, please do not
complete the Basic/Refresher course, the Conflict of Interest or the Class project curriculum.
VSU IRB Protocol Form
(Rev 09/2017) Page 6
Investigator’s Assurance
The signature(s) below certify that:
• The information provided in this application is complete and accurate
• Each individual listed as principal, co-investigator, or research team possesses the necessary
experience for conducting research activities in their assigned role, and is aware of and will
abide by VSU policies and procedures for the protection of research participants
• Each individual listed as principal, co-investigator, or research team member has received
the required human research protection education
• No research procedures with human subjects will be initiated until documented approval has
been obtained from the IRB Office.
• I also agree to report any significant and relevant changes in the procedures or research
instruments to the Human Subjects Committee for additional review
Investigator’s Signature Date
Co-investigator’s/Advisor’s Signature Date
NOTE: Carefully review the application to ensure it is complete, contains sufficiently detailed responses to
all questions, and all required attachments. Incomplete applications will be returned to the researcher
potentially delaying the research.
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VSU IRB Protocol Form
(Rev 09/2017) Page 7
DO NOT COMPLETE THIS SECTION [For Sponsored Research & Programs Use Only]
IRB Number:
Date Received: Review Status:
Exempted
Date Reviewed: Categories 1 2 3
4 5 6
Name of Reviewer: Expedited
Categories 1 2 3
4 5 6
If Expedited: Name of Referred Committee Member:
Date Committee Member Reviewed:
For Committee Use Only
Full Committee Review Action:
APPROVED: DATE:
Chairman or Designee of IRB
CONDITIONALLY APPROVED: DATE:
Chairman or Designee of IRB
Conditional Provisions: (Use reverse side if necessary)
NOT APPROVED: DATE:
Chairman or Designee of IRB
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Completed 1 September 2020

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