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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 bemaintained for the record with your application. The IRB will notutilize the grant during the reviewprocess other than to confirm that the grant proposal is consistent with the IRB proposal. You mustsubmit all necessary documentation for the application in addition tothe copy of the grant.PART III – EDUCATION AND TRAININGAll research personnel (faculty, staff, graduate students working on a thesis or dissertation,anyoneusing data for purposes of independent research, students involved in data collection, facultysponsors, persons receiving grant monies for human subject research or those personnel withmanagement 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 ASSURANCEPage 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 AgreementI 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 humanparticipants. I agree to comply and to assure that all affiliated personnel comply with all South UniversityIRB policies and procedures, as well as with all applicable federal, state and local lawsregarding 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 UniversityIRB 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 madewithout first submitting for review and approval by the South University IRB an amendment tothe approved protocol.
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Informed consent, South University, investigator, South University IRB