Application Process and Researcher Information

 

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 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. For more information about the CITI program click here.

When the MSU researcher is a consultant, he or she is deemed to be "conducting" research and MSU IRB approval is required, unless all four of the following are true:

  • The MSU 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 MSU researcher nor MSU retains any data on University property or University server.
  • The researcher does not present him/herself as a representative of MSU 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; therefore, all applications must be submitted for review.

See below for the processes used for review of:

Steps in the Review Process for New Applications

  1. The principal investigator (PI) submits the application, consent documents, assent documents if needed, and all recruitment materials including flyers, e-mail scripts, telephone scripts, newspaper advertisements, letter(s) of agreement from an individual authorized to provide such support at off-site locations. If the PI is a student, then the application must include a signature from the faculty sponsor, before the application can be accepted for review. Applications, consent forms, surveys, tutorial certificates, etc. should be submitted electronically as separate attachments in an email to the IRB at reviewboard@mail.montclair.edu. Another option is to put applications, consent forms, surveys, letters, tutorial certificates, etc. as separate files into a zipped file and email the zipped file as an email attachment to the IRB at reviewboard@mail.montclair.edu. If you have questions about compiling your application, please contact your school/college technical liaison. If you have questions regarding the application or IRB processes, contact the IRB at reviewboard@mail.montclair.edu. PIs must be MSU faculty, staff or students.  Investigators outside of MSU, who are not collaborating with any researchers on our campus, should consult the External Investigator Policy & Procedures.

  2. All pieces of the application that require an original signature must be delivered either in person, by fax, or by mail to the IRB office. Final approval of an application will not be provided until the original signature pages are received by the IRB Administrator.

  3. Your application materials will be screened for completeness. If it is complete, it will be assigned to the appropriate review category.

      • If it is missing elements that will interfere with the review process (e.g. consent documents, assent documents if appropriate, recruitment materials), you will be contacted by the IRB Administrator and advised that the review cannot be completed until the missing materials are submitted.
      • If there are materials missing that won't interfere with the review process, then it will be assigned to the appropriate review category. You will be contacted by the IRB Administrator and advised that final approval will not be provided until the missing materials are submitted.
  4. After your application has been accepted and assigned for review, you will be contacted by the IRB Administrator and advised of its status.
  5. If your application was:
    1. approved at the Exempt category and all the materials are complete, our goal is to have your approved materials available as soon as possible.
    2. approved at the Expedited category and all the materials are complete, our goal is to have your approved materials available in twenty-one working days. This time frame of course depends on timely responses from the PIs.
    3. assigned to be reviewed by the Full Board and all the materials are complete, our goal is to have your approved materials available within seven working days from the date of the meeting at which the application was approved without conditions. If the application was approved with conditions, then the timeline for final approval depends on timely responses from the PIs.
  6. 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 MSU's adverse event policy
      • if there are changes in personnel or in the study protocol, the IRB is notified with an amendment application
      • an application for Continuing Review is submitted at least 30 days before the approval that is in place expires

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Steps in the Review Process for Continuing Review Applications

  1. The PI submits the application, consent documents, assent documents if needed, and all recruitment materials (including flyers, e-mail scripts, telephone scripts, newspaper advertisements, letter(s) of agreement from an individual authorized to provide such support at off-site locations). Applications, consent forms, surveys, tutorial certificates, etc. should be submitted electronically as separate attachments in an email to the IRB at reviewboard@mail.montclair.edu. Another option is to put applications, consent forms, surveys, letters, tutorial certificates, etc. as separate files into a zipped file and email the zipped file as an email attachment to the IRB at reviewboard@mail.montclair.edu. If the application for continuing review is for data analysis only, then only the application is needed. If you have questions about compiling your application, please contact your school/college technical liaison. If you have questions regarding the application or IRB processes, contact the IRB at reviewboard@mail.montclair.edu.

  2. All pieces of the application that require an original signature must be delivered either in person, by fax, or by mail to the IRB office. Final approval of an application will not be provided until the original signature pages are received by the IRB administrator.

  3. All applications for continuing review (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 application was initially referred to the Full Board and the project is still active, then you should allow at least 60 working 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 application was initially reviewed under the expedited category, then you should allow at least 21 working days for the review process.
  4. After your application has been accepted and assigned for review, you will be contacted by the IRB Administrator and advised of its status.
  5. After your application for continuing review is approved, it is our goal to have your approved materials available within the time frames listed above.
  6. 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 MSU's adverse event policy
      • if there are changes in personnel or in the study protocol, the IRB is notified with an amendment application
      • an application for Continuing Review is submitted at least 30 days before the approval that is in place expires

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Steps in the Review Process for Amendment Applications

    1. The PI submits the amendment application and all support materials, including any changes in recruitment materials, consent and assent forms (if appropriate), letters of agreement, e-mail scripts, telephone solicitation scripts, and newspaper advertisements. All materials should be submitted electronically as separate attachments in an email to the IRB at reviewboard@mail.montclair.edu. Another option is to put applications, consent forms, surveys, letters, tutorial certificates, etc. as separate files into a zipped file and email the zipped file as an email attachment to the IRB at reviewboard@mail.montclair.edu.

        • If the PI requests a change in the personnel of the research team, then they must confirm that the new members of the team have completed human subjects training. 
        • If the PI requests a change in protocol, then any new surveys, test materials, etc. must be submitted before the review can be completed.
        • If the PI requests a change in or addition of a site in which the project will be done, then letter(s) of agreement from an individual authorized to provide such support must be included.
    2. All pieces of the application that require an original signature must be delivered either in person, by fax, or by mail to the IRB office. Final approval of an application will not be provided until the original signature pages are received by the IRB Administrator.

 

  1. The time-line for approval of amendments depends on the complexity of the amendment request.
  2. 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 MSU's adverse event policy
      • if there are additional changes in personnel or in the study protocol, the IRB is notified with another amendment application
      • an application for Continuing Review is submitted at least 30 days before the approval that is in place expires

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