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Application for Renewal of Protocol Applications

Rev. 2/2/11

A research project employing human subjects that will extend beyond its twelve month approval period must be renewed on or before the anniversary date of the approval letter from the IRB (Office of Research and Sponsored Programs). Please submit renewal applications 30 days prior to expiration of protocol. No activity may take place on a project after its expiration date.  All approvals are for twelve-month periods only.

If a Principal Researcher wishes to continue/renew/reinitiate a project after its expiration date, an Annual Report must be provided to and approved by the IRB before activity can resume.

To renew a Protocol, the researcher must provide an Annual Report (format given below) AND resubmit together with it the updated Protocol Application with such amendments and revisions as the research may suggest.  All appendices must also be attached to the Protocol Application.

This form/format is for Annual Reports on "Standard," "Expedited," and "Administrative" categories of research. (There is no template.)

Annual Report

  1. Principal Researcher: (Name)
    • Position: (Professor, M.A. thesis student, etc.):
    • Faculty Department:
    • Student Home Address:
    • Daytime Telephone Number:
    • Project Title:
  2. Student Thesis Advisor / Faculty Supervisor(if applicable):
  3. Faculty University Telephone Number:
  4. Number of subjects recruited and used in the research to date:
  5. Number of subjects recruited who withdrew of their own accord:
  6. Number of subjects recruited who were dropped from the research by the researcher for any reason:
  7. Summarize the recent year's research, including descriptions of unforeseen procedural problems, unanticipated responses by subjects, adverse physical reactions of subjects, and a description of the measures taken as a consequence. State whether the attached protocol application incorporates these measures as amendments or revisions.
  8. Summarize all changes, amendments, and revisions to the attached protocol not already mentioned in the answer to Question #7 above.
  9. Summarize the risks and benefits to human subjects in the perspective of the recent year's research.
  10. Describe the positive accomplishments of the research.
  11. Describe any changes to internal or external funding of this research as well as any projected change to the expenses for the forthcoming research period.
  12. Attach the protocol application (Standard, Expedited, or Administrative) for the forthcoming year AND all appendices.

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