California State University, Long Beach
Institutional Review Board for the Protection of Human Subjects
Application for
Renewal of
Protocol Applications
Rev. 10/12/00
A research project employing human subjects which extends beyond twelve months must be renewed on or before the anniversary date of the approval letter from the IRB (Office of University Research). All approvals are for twelve-month periods only.
To renew a protocol the researcher must provide an Annual Report (format given below) AND resubmit together with it the original protocol application with such amendments and revisions as the research may suggest.
This form/format is for Annual Reports on "Standard," "Expedited," and "Exempt" categories of research.
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):
and Faculty University Telephone Number:
3. Number of subjects recruited and used in the research to date:
4. Number of subjects recruited who withdrew of their own accord:
5. Number of subjects recruited who were dropped from the research by the researcher for any reason:
6. 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.
7. Summarize all changes, amendments, and revisions to the original protocol not already mentioned in the answer to Question #6, above.
8. Summarize the risks and benefits to human subjects in the perspective of the recent year's research.
9. Describe the positive accomplishments of the research.
10. 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.
11. Attach the protocol application (Standard, Expedited, or Exempt) for the forthcoming year AND any materials which might bear on the Annual Report of activities.
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