Extramural college department other pi of grant or

Extramural College Department
Other:
P.I. of Grant or Contract:
Sponsor:
Contract/Grant No.
(if available):
Contract/Grant Title:
***Please provide one complete copy of the proposal submitted to the sponsor with this application.
Please note that submission of your grant application is a regulatory requirement and will be
maintained for the record with your application. The IRB will not utilize the grant during the review
process other than to confirm that the grant proposal is consistent with the IRB proposal. You must
submit all necessary documentation for the application in addition to the copy of the grant.
PART III – EDUCATION AND TRAINING
All research personnel (faculty, staff, graduate students working on a thesis or dissertation , anyone
using data for purposes of independent research, students involved in data collection, faculty
sponsors, persons receiving grant monies for human subject research or those personnel with
management responsibilities) must complete this section.
1) Have all key research personnel completed the required NIH training? No Yes
***If No, DO NOT submit this application . Your application will not be considered until you have
completed the IRB training and can provide a copy of your NIH course completion certificate.
(Please include a copy/copies of all certificate(s) with each application.)
***Please note that this NIH training is a mandatory requirement to be completed every three years.
***If you have not completed the NIH training, but have completed a comparable course (e.g. CITI
training), please include documentation of those courses.
2) If other necessary training/education is required for completion of this study, please attach copies
of certificates or other documentation (e.g., HIPAA training, phlebotomy training).
PART IV – INVESTIGATOR ASSURANCE
Page 3 of 16

THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101 .
1) Institutional Review Board Policy Compliance Agreement
 I certify that the information provided in this application is complete and correct.
 I understand that as Principal Investigator, I have the responsibility for the conduct of the study,
the ethical performance of the project and the protection of the rights and welfare of human
participants.
 I agree to comply and to assure that all affiliated personnel comply with all South University
IRB policies and procedures, as well as with all applicable federal, state and local laws
regarding the protection of human participants in research.
 I agree that I have the appropriate expertise to conduct this study.
 I assure that this study is performed by qualified personnel adhering to the South University
IRB approved protocol. Student PI’s must attach student PI worksheet (see appendix A).
 I assure that no modification to the approved protocol and consent materials will be made
without first submitting for review and approval by the South University IRB an amendment to
the approved protocol.