IRB approval must be obtained prior to initiating any research activity that meets either the DHHS definition of research involving human participants or the FDA definition of clinical investigation involving human participants and prior to implementing amendments to previously approved research (except when necessary to eliminate apparent immediate hazards to participants). The IRB will publish submission deadlines for studies requiring review by the convened board at the start of each semester. New submissions requesting expedited review or exempt status can be submitted at any time and are reviewed on an on-going basis.
All forms required for an IRB submission are available on the IRB website. The PI is responsible for submitting complete forms and required supporting documentation. The PI must sign all submissions. Students are required to sign the submission when the research is student initiated (research is related to the doctoral dissertation or master’s degree). The signature of the Department Head or Dean is required for all submissions unless the research is funded by an external grant or contract. The signature of the medical monitor is required for interventional studies that are monitored by a physician. The IRB staff and reviewer reserve the right to return any submission that is incomplete or on out-dated forms.
Determination of Level of Review
Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit the required number of copies of the protocol and supporting documentation. Upon receipt, the IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the PI’s initial determination. The protocol is then placed into the appropriate queue for review. The Chair, or his/her designee, makes the final determination of the type of review required and the appropriate expedited or exempt category.
When Submission to the IRB is Required
A protocol application must be submitted to the IRB for any study for which research is the intent and the researcher proposes to use or involve any of the following:
- identifiable data collected for non-research purposes (e.g., academic or medical records);
- interaction (communication or interpersonal contact between investigator and participant) through interviews, surveys, and other forms of communication;
- intervention (physical procedures by which data are gathered and manipulations of the participant or the participant’s environment that are performed for research purposes);
- student research projects conducted as part of Research Methods Courses;
- access to medical records and data through the medical information systems;
- pathological specimens (directly identifiable or identifiable via codes);
- diagnostic specimens (directly identifiable or identifiable via codes).
The IRB reviews projects when the research:
- is sponsored by the institution;
- is conducted by or under the direction of an employee or agent of the institution in relation to his/her institutional responsibilities;
- is conducted by or under the direction of an employee or agent of the institution using resources of the institution; or
- involves the use of the institution’s non-public information (i.e. alumni, students, staff, etc.) to identify or contact human research participants or prospective participants.
