Once a determination has been decided, a formal letter will be sent outlining if the exclusion determination has been approved or disapproved.
If the proposal/prospectus does not meet the exclusion determination criteria, then it must be sent to ORRC for review.
The project is not a “systematic investigation”;
The project's conclusions will not contribute to “generalizable knowledge”;
The project does not involve data collection through “intervention or interaction” with individuals; and/or
The project does not involve the collection of private information that is directly or indirectly individually identifiable.
Please note that an approved letter of exclusion determination for the reviewed project applies only to the activities described in the documentation submitted for review. It does not apply should any changes be made to the project.
If changes are being considered and there are questions about whether IRB review is needed, please submit a modification of the project to the ORRC/IRB for another determination. In iMedRis select the non-medical option.