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Participation of Human Subjects Approval

2. If you are a student, provide the following:
Has this project been previously considered by the Loyola Institutional Review Board?
Is a proposal for external support being submitted?
c) Is notification of human subjects approval required?
7. Description of Human Participants
In your judgement, does your research fall under one of the six exempt categories?
8b. If you are claiming exemption, skips questions 8b and 15-16
Does your project fall under one of the categories eligible for expedited review? A listing of expedited categories is included as an attachment to Loyola's Policies and Procedures for Research Human Participants, found on ORSP's website.
9. Student Projects Only
Is this project an independent research project, thesis, or dissertation?
If no, is your project a supervised student project that was assigned as a part of the requirements for a course?
Is any of the information being gathered Protected Health Information covered by the Health Insurance Portability and Accountability Act (HIPAA)?
If yes, are you using an informed consent document that is consistent with HIPAA regulations?

12. Procedures
13. Description
14. Consent

15. Benefits
16. Risks

Principal Investigators must submit a Request for Amendment form when seeking to make a change to a study that has already been approved. Committee approvals for expedited and full review applications are for one-year periods. If the research activity extends past one year, applicants must submit a Request for Renewal form at least three weeks prior to the expiration of the initial approval period. Any problems connected with the use of human participants once the project has begun must be reported to the office of research and sponsored programs and/or the Institutional Review Board immediately.*
19. Upload any other supporting documents