12. Continuing Review and Approval

12. Continuing Review and Approval

Institutional Review Board (IRB) Guidebook 12. Continuing Review and Approval

12. Continuing Review and Approval

For multi-year projects, continuing IRB review and approval is required. The Investigator's Progress Report is the application form for continuing review. Applications approved as Exempt or given a designation of Not Human Subjects Research do not require continuing IRB review.

See the IRB Meeting Schedule​ for submission deadlines
of materials for continuing review. 

Protocols are subject to continuing review if subjects are still being enrolled, being followed, in long-term follow-up, or if the protocol is in data analysis. For example, if a protocol involves long-term follow-up for survival after data analysis is complete, that protocol must still receive continuing approval until no participants remain alive. In some cases, protocols that were initially approved through convened review become eligible for expedited review. The IRB will notify the investigator in such cases.
The IRB expects findings to be included for all studies that have been ongoing for 5 or more years. In addition, if the protocol remains open for enrollment, an updated ("new") HSP must be submitted every 5 years. The determination letter will advise the investigator when the updated HSP must be submitted.

Plans for Future Participant Enrollment

Open for Enrollment
If the protocol is still open for enrollment, plans for future enrollment must be described. If informed consent is documented, the application must include
  • one copy of the most recently approved informed consent document(s) and
  • one "clean" copy of the consent document(s) for the IRB approval stamp
​Closed to Enrollment

If the protocol is closed to enrollment, do not include a copy of the informed consent document unless participants are being "re-consented" or provided with additional information. The Investigator's Progress Report provides three possible categories for the status of participants in such protocols:​​
  • ​Still on therapy or receiving intervention related to the protocol
  • Off study therapy/interventions, in long-term follow-up only for survival data
  • Off study therapy/interventions, in data analysis only
​Continuing review and approval is necessary as long as participants fit any one of these categories. Questions about the selection of a category should be directed to the OIRB (934-3789, irb@uab.edu).

Final Report

If the project is completed (i.e., participants no longer fit any of the categories under "Closed to Enrollment"), the principal investigator is required to submit a Final Report before approval expires. Use the Investigator's Progress Report and check "FINAL report” on the top of the form. Findings from the study must be reported to the IRB at this time if they have not previously been reported.

Application Process

Investigators must submit applications for continuing review in a timeframe that allows the IRB to approve the protocol before the current approval period ends. The IRB recommends submitting the application materials at least 4 weeks, preferably 6 weeks, before the end of the approval period. (See "Approval Period" in General Information.) The following application materials are required:
  1. ​The Investigator’s Progress Report with the investigator's original signature.
  2. A copy of the most recently approved informed consent document unless (a) the protocol is closed to enrollment of new participants or (b) participants are being "re-consented" with an addendum form. If you are requesting review of changes to the consent document, include
    1. A copy of the revised consent document with all changes highlighted and
    2. A "clean" copy for the IRB approval stamp.
  3. One copy of each of the following items:
    1. For convened or expedited review
      • All amendments/revisions to the study that have been reviewed and approved by the IRB but are not incorporated into the most recently approved Human Subjects Protocol (HSP)
      • The Problem Summary Sheet, if applicable.
    2. For convened review, also include
      • The most recently approved HSP
      • All Investigator’s Progress Reports submitted since the inception of the project.
  4. A copy of any other materials applicable to the protocol, as indicated on the Investigator's Progress Report (e.g., age-sex-race of individuals screened and/or enrolled, confirmation of CRL, copy of applicable items such as monitoring reports).

Ethnic and Racial Categories

The table on the Investigator's Progress Report follows the reporting requirements of the NIH. The following is their description of how the ethnic and racial categories are defined:​​
​Ethnic Categories
  • ​​Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.  The term “Spanish origin” can also be used in addition to “Hispanic or Latino.
  • Not Hispanic or Latino​.
​​​​​​Racial Categories
  • ​American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.​
  • Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.) 
  • Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
  • Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”
  • White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.