Appendix 1

Application for the Use of Human and Animal Subjects in Research

I. General Information:

Principal Investigator if any ________________________________________________________

School: _________________________________________________________________________

Department: _____________________________________________________________________

Phone ____________________     Fax ____________________     e mail ____________________

 

Student or Co-Investigator if any ____________________________________________________

School: _________________________________________________________________________

Department: _____________________________________________________________________

Phone ____________________     Fax ____________________     e mail ____________________

Project Title ____________________________________________________________________

Proposed Study Dates ____________________________________________________________________
(Note: Data collection may not begin until project is approved by the IRB)

Physical Location of Activity ______________________________________________________________
(Note: Include a letter of collaboration and consent if activity location is off-campus)

Source of Funding ________________________________________________________________________
(Include funding that has been budgeted, awarded and/or is a part of a pending proposal)


II. General Purpose of Research Project:

Describe the general purpose of the project and identify anticipated results __________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

III. Project Description:

Describe the project objectives: ___________________________________________________________________

____________________________________________________________________________________________

How will subjects be selected or recruited?___________________________________________________________

____________________________________________________________________________________________

How will the data on the subjects be obtained?________________________________________________________

____________________________________________________________________________________________

What will happen to the subjects and the data they provide?______________________________________________

____________________________________________________________________________________________

What are the potential risks and/or benefits to the subjects?______________________________________________

____________________________________________________________________________________________

How will these risks be managed and minimized? _______________________________________________________

____________________________________________________________________________________________


IV. Description of Subjects:

Ages of Subjects: ______________________________________________________________________________

Number of Subjects: ____________________________________________________________________________

Identifying Characteristics of Subjects: ______________________________________________________________

____________________________________________________________________________________________


V. Protections of Human Subjects Rights:

How will the subjects be informed of the intent of study, potential risks to them, and their rights regarding

participation? _________________________________________________________________________________

____________________________________________________________________________________________

How and where will consent documents be maintained? _______________________________________________

___________________________________________________________________________________________

How will subject's privacy, confidentiality and/or anonymity be protected? ________________________________

___________________________________________________________________________________________


VI. Signatures:

**Signing below indicates acceptance of the following statement**
In making this application, I certify that I have read and understand the SPSU P&P #604.0, and that I intend to
comply with the letter and spirit of that document. Significant changes in the protocol will be submitted to the
IRB for written approval prior to the implementation of these changes. Informed consent/assent records of the
participants will be kept for at least three (3) years after the completion of the research.

 

__________________________________________________________________

 _______________
Project Investigator/Project Director Date

 

__________________________________________________________________

 _______________
Student Investigator Date

 

__________________________________________________________________

 _______________
Department Chair Date

 

__________________________________________________________________

 _______________
School Dean Date

Please submit one signed original and four copies of this application and any supporting
documents. Incomplete applications will be returned without review.

The IRB has reviewed this project and made the following determination:
_____ The project is exempt from approval.
_____ The project is approved.
_____ The project is conditionally approved (see notes below).
_____ The project is disapproved. (see notes below)
_____

IRB Chair Signature Date

__________________________________________________________________

 _______________
IRB Chair Signature Date

IRB Comments:
________________________________________________________________________________
________________________________________________________________________________