IRB#:
For GSP use only
Application for Institutional Review Board (IRB) Approval of Human Subjects Research
Date:
Renewal
Type: New Revision
Title of Study:
RESEARCHERS’ INFORMATION : For student and non-university employee’s applications, list an
Edinboro University advisor or sponsor as Principal Investigator.
Last name:
First name:
Department:
Affiliation:
Principal Investigator: Co-Investigator: Co-Investigator:
Phone:
E-mail:
Fax:
Mailing Address:
Faculty/Staff/Student:
Completed CITI training:
Yes No Yes No Yes No
*Applications will not be forwarded to the IRB committee for review until CITI training is verified and the application is complete.
Students:
1.
2.
3.
4.
List any other individuals who will assist or view data:
1.
2.
3.
PROJECT TYPE
Type of Project:
Faculty/Staff project to be submitted for external funding
( Include copies of grant applications with this application)
-Funding institution or agency:
-Date of grant submission:
Faculty/Staff project NOT to be submitted for external funding
Graduate research project
Undergraduate research project
Class project (Provide course name and number):__________________________________
Other_____________________________________________________________________
Revised 4/04/2016

SPECIAL CONSIDERATION CATEGORIES
Minors- Ages:
EUP Students
Blind/Visually Impaired
Cognitively Impaired
Non-English Speaking Individuals
Pregnant or Lactating Women
Prisoners
None
TYPES OF REVIEW
Please indicate which category you are applying for review. Please note that the IRB committee will make the final determination for type of review.
Exempt Review Expedited Review Full Review
PERMISSION FROM AGENCY/INSTITUTION
Permission from Agency on Letterhead specifying name of researcher(s), name of research, and signature with title of the person authorized to grant permission. Attached Not applicable
IRB RESEARCH PROJECT DESCRIPTION
*Complete each section below addressing each section’s content items as described in the IRB Research
Project Description Instructions. Any content item not addressed will delay the protocol from being reviewed by the IRB .
A.
Purpose and Significance of the Research Study:
Click here to type text
B.
Participants in this Study:
Click here to type text
C.
Identification and Recruitment of Potential Participants:
Click here to type text
D.
Interventions, Assessment Procedures and Other Sources of Data:
Click here to type text
E.
Does the research involve deception? No
Click here to type text
Revised 4/04/2016
Yes (explain)

F.
Potential Risks to Participants and Procedures to Minimize these Risks:
Click here to type text
G.
Benefit/Risk Assessment:
Click here to type text
H.
Procedures Used to Protect the Anonymity and/or Confidentiality or Participants and Records
Management:
Click here to type text
I.
Explain what you intend to do with the project’s results:
Click here to type text
J.
Informed consent – Attach consent and assent forms and/or script for oral explanation:
Attached N/A
K.
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Attached N/A
Revised 4/04/2016

SIGNATURES
The principal investigator, co-investigators and the advisor/sponsor must sign the application. By signing and submitting the application to the IRB, all parties listed verify that they have read and agree to the following statements.

I understand that I have responsibility for the protection of the right and welfare of human subjects and the ethical conduct of this research project.
 I agree to comply with all Edinboro University of Pennsylvania’s policies and procedures, applicable federal, state and local laws, and the ethical principles of my profession.

I understand that IRB approval is for one year (except exempt applications). If my research will continue beyond one year, I will file the yearly review form with the IRB prior to the expiration date. I understand that failure to file may result in termination of the project and require resubmission as a new project.

I will provide a final report upon completion of the project.

I will immediately report any adverse events or unanticipated problems to the IRB.

I understand that no part of the proposed research described in the application may be carried out until I have received final approval from the IRB.

I understand that the Principal Investigator (PI) will securely maintain documentation of all research materials until such time as they are no longer needed for research purposes or required by Granting agencies, but not less than three (3) years. Research materials include, but are not limited to, signed informed consents and project data. Should the PI separate from the University prior to the third year, maintenance of the research materials documentation shall be transferred to the University. The does not preclude the PI’s maintenance and use of the research materials. Any research materials that are destroyed will be done in a secure fashion.
Additional statement for advisors/sponsors:

I understand that I am the primary responsible party for legal and ethical performance of this project. I certify that I have read and approved this protocol, and I agree to meet with the co-investigator(s) on a regular basis to review project progress and help resolve any problems that arise. I also certify that I will provide written approval of all revisions and additions to this protocol.
Principal Investigator (PI): ________________________________ Date: __________
Co-Investigator: __________________________________________ Date: __________
Co-Investigator: __________________________________________ Date: __________
Co-Investigator: __________________________________________ Date: __________
Revised 4/04/2016