Submission Guidelines For All New Studies

The principal investigator is responsible for preparing a proposal for Institutional Review Board review prior to initiation of research, and is advised to allow adequate lead time for the Institutional Review Board process, since it is not uncommon to be required to amend some aspects of the proposal to bring it in line with federal regulations prior to approval.

1. The principal investigator (PI) and all co-investigators must review the educational material on the Web and satisfactorily complete the research with human subjects test. The IRB does not need a copy of the certification, each investigator and sponsor will be verified by searching the IU IRB Certification database.
2. The principal investigator should carefully assess the proposed research with regard to whether it best fits as exempt, expedited, or full committee review.  The Institutional Review Board will make the final determination about the appropriate level of review.  In cases where the level of review is in question, the higher level of review will be required by the IU South Bend Institutional Review Board.
3. The PI should prepare the following materials which are available on the Web at the following address: http://www.iusb.edu/~sbirb/forms.shtml for consideration of the Institutional Review Board:
   1. Documentation of Review and Approval (DRA)
   2. Checklist for Appropriate Level of Review (exempt, expedited, or full)
   3. Summary Safeguard Statement (or Exempt Research Statement)
   4. Informed Consent(s) or Study Information Sheet
   5. Copies of instruments, questionnaires, letters
   6. Other as appropriate: package insert, letters of cooperation, HIPAA checklist, assent document