Procedures for Submission of Forms
The principal investigator accesses the IRB web site for information regarding adherence to IRB information and protocols. Forms for submission are found on the web site. After completion, forms are submitted electronically to the appropriate IRB member, and IRB office as indicated.
Form A: Decision Making Tool: Does the project fall under the category of human subjects research?
The investigator provides an abstract or summary of the proposed research project and completes the check list and form, in consultation with the designated IRB member. The designated IRB member is found on the IRB website. The IRB member determines if the project is research or not, and responds to the investigator. This form is sent by the IRB member to the IRB Office. If the project is determined to be research, the Application for Research must be submitted.
Form B: Application for IRB Approval
The investigator fills out the form, attaching all appropriate documents, which may include, but are not limited to: consent form, letters of agreement from appropriate facility, or permissions to perform research at a facility, research proposal. The investigator may consult with the IRB member who assisted them with Form A, if questions arise, or the IRB chair. Incomplete applications or applications missing components will be returned to the investigator.
After submission of a completed Application for IRB approval, the IRB member will review and approve exempt research, and communicate to the investigator the outcome. If the IRB member determines that the research is expedited, a consultation with the IRB chair is required. Upon agreement that the research is exempt or expedited, the completed form is sent electronically to the IRB office for filing. The time frame for review and decision making will be 7 business days. In the event of vacation or absence from the University, the IRB chair may appoint another IRB member to review the application.
In the event that the application needs a full board review, the IRB chair convenes an electronic meeting to review the proposal. The time frame for convening the meeting date is within 14 business days from time of notification to IRB chair. The chair will notify the investigator of the outcome of IRB’s decision. A copy of the application and approval letter is sent electronically to the IRB office for filing.
If the research application is denied, the denied application goes to the full board for review. A rationale is provided by the IRB member for denial of the research.
The appeal process will be handled by the Office of the Provost.