Process for the Committee Review of New Applications

  1. Develop a research plan/grant application/study protocol.
  2. Determine if approval is required by one or more research review committees (e.g. IRB for studies with human subjects, IACUC for studies using animals, IBC for studies using recombinant or synthetic nucleic materials, or chemical hazards, or biological hazards). Please refer to the specific committee homepage for additional policies and guidance or contact research review committee staff for assistance
  3. Application forms for all review committees are located within the electronic protocol management system at www.IRBNet.org. Create a new user account in IRBNet to access these forms. Select Lifespan as your affiliate during this registration process.
  4. Determine when the application is due for each committee that will review the project. Please note: human subject applications that do not present greater than minimal risk may qualify for expedited or exempt review. Expedited/exempt projects are processed on a rolling basis and do not have a deadline. Please refer to the policies and procedure manual and the federal regulations or contact research protection office staff if you think that your project may qualify for expedited/exempt review. (See DHHS decision tree charts 2- 9).
  5. All applications must be signed electronically in IRBNet by the principal investigator and their departmental chief/chair. 
  6. Projects supported by department funds must include the cost center that will be used.
  7. If external funds are to be used (from a grant or contract), then the investigator must also prepare and submit the appropriate business forms. Please refer to the grants and contracts webpage
  8. To submit a new application, a new project must be created and all documents must be uploaded to a new package in IRBNet by the due date as appropriate (see the meeting dates and deadlines calendar for each committee in IRBNet under forms and templates). 
  9. Investigators should verify the date of committee review and reserve time in their schedule for the committee meeting.
  10. Research protection office (RPO) staff review applications for completeness and process committee review.
  11. RPO staff prepare the agenda for committee meetings. Investigators are notified of their scheduled time approximately one week before the meeting. Principal investigators, or their representatives, are required to appear before the committee to address any questions or concerns raised by the reviewers.
  12. After the meeting, RPO staff will prepare the minutes from the meeting and upload the minutes into a modifications required letter posted within the project on IRBNet. This letter can be found by clicking on the reviews tab off to the left hand side of the screen. It will be included under “board documents”.
  13. Investigators will then make the committee required changes and submit the revised form(s) and any requested information/clarifications by creating a new package within the study on IRBNet. RPO staff will review the submission for completeness, and send on to the chairperson or designate for final approval. Once approval has been received committee staff will process approval documents, which will be uploaded into IRBNet. The Investigator can then obtain approval documents, including the approval letter and any stamped or signed documents, by clicking on the reviews button and looking under “board documents”.
  14. All projects require two components before they can be initiated. Committee approval is required from all applicable review committees, and financial activation is required to ensure that adequate funds are in place to support the project.
  15. If the initial application indicated that the study was funded by internal/departmental funds, then the approval letter will indicate that the study is approved and also activated. Animal welfare protocols require a valid cost center to provide for the housing costs of the animals before any animal related work can begin.
  16. If the initial application indicated that the study was funded by an external source (grant/contract), then the approval letter will specify that the project is approved but not activated and that no activity is allowed until the activation is in place. When the grant/contract has been finalized, an activation notice with the new cost center will be sent to the investigator from the grants and contracts office. Investigators cannot begin the work until the approval latter and activation notice have been received.

03/18