All human participants research done under the aegis of Montclair State University is required to be reviewed by the IRB. As part of the application process, all members of the research team must complete the Basic Course in Human Subjects Protection, which can be found at the CITI Program website. After completion of the training program, record of each member of the research team’s course completion will automatically be made available to the IRB office. View more information about the CITI program.
When the Montclair State researcher is a consultant, he or she is deemed to be “conducting” research and University IRB approval is required, unless all four of the following are true:
- The Montclair State researcher consults or is hired on his or her own time.
- The researcher does not utilize University space, equipment and supplies, personnel or students. Equipment includes University issued PCs, laptops or mobile devices.
- Neither the Montclair State researcher nor Montclair State University retains any data on University property or University server.
- The researcher does not present him/herself as a representative of Montclair State University in conducting the research or in documents or publications associated with any reported outcomes.
As mandated by the federal regulations, all applications to the IRB will be reviewed using one of three categories of review: 1) exempt review, 2) expedited review or 3) full board review. If you are uncertain about the characteristics of these review categories, please review the definitions of commonly used terms.
Please note: The IRB makes the ultimate decision regarding the category of review.
Steps in the Review Process for New Submissions
- The principal investigator (PI) submits all application materials as required in their initial submission. If it is a student-led project, then the submission must be certified by the faculty sponsor (listed as the PI) before the submission can be accepted for review. All application materials are submitted electronically through Cayuse IRB. If you have questions regarding the application or IRB processes, contact the IRB at firstname.lastname@example.org. PIs must be Montclair State University faculty or staff. Student-led projects must list the faculty sponsor as the PI and the student as the Primary Contact. Investigators outside of Montclair State University who are not collaborating with any researchers on our campus should consult the External Investigator Policy & Procedures.
- Review of an application cannot be performed until the submission is certified.
- Your submission materials will be screened for completeness. If complete, the appropriate review category will be assigned. If elements are missing that will interfere with the review process (e.g. consent documents, assent documents if appropriate, recruitment materials), you will be contacted by an IRB Analyst and advised that the review cannot be completed until the missing materials are submitted.
- After your application has been accepted and assigned for review, you will be able to view the progress of your review in Cayuse IRB.
- If your application was:
- designated as an Exempt review category and all the materials are complete, our goal is to have your approval within one to two weeks.
- designated as an Expedited review category and all the materials are complete, our goal is to have your approval within three to four weeks. This time frame is dependent on timely responses from the PIs.
- assigned to be reviewed by the Full Board and your application was approved without any conditions, our goal is to have your approval within five working days after the date of the meeting. If the application was approved with conditions, then the timeline for final approval depends on timely responses from the PIs.
After approval has been obtained, PIs are responsible for ensuring that:
- all members of the research team abide by the approved protocol
- if there is an adverse event, they notify the IRB in accordance with Montclair State University’s adverse event policy
- if there are changes in personnel or in the study protocol, the IRB is notified with a modification submission
- an application for renewal is submitted at least 30 days before the expiration date
Steps in the Review Process for Renewals in Cayuse IRB
- The PI submits the Renewal submission through Cayuse IRB, completing the required areas and certifying the submission. If you have questions regarding the submission or IRB processes, contact the IRB at email@example.com.
- All submissions for renewal (expedited or full) must be submitted in enough time to be sure that your current approval does not lapse. The amount of lead time depends on the process that was used to evaluate the initial proposal.
- If your submission was initially referred to the Full Board and the project is still active, then you should allow at least 60 days for the review process. By federal mandate, all applications that were initially submitted for Full Review must return for full review if the research protocol is still enrolling participants or if there is continuing involvement with the enrolled participants.
- If your submission was initially reviewed under the expedited category, then you should allow at least 30 days for the review process.
- After your submission has been accepted and assigned for review, you will be able to follow the progress in Cayuse IRB.
- After your submission for renewal is approved, it is our goal to have your approved materials available within the time frames listed above.
Steps in the Review Process for Modification Submissions in Cayuse IRB
- The PI and/or PC submits the modification submission through Cayuse IRB, completing required areas and certifying the submission. If you have questions regarding the submission or IRB processes, contact the IRB at firstname.lastname@example.org.
- The timeline for approval of modifications depends on the complexity of the modification request.