The IRB may conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. Principal Investigators will be informed of the review by receipt of a Continuing Review Questionnaire. This Continuing Review/Progress Report Form is to be completed and returned to the Chair of the IRB along with the Informed Consent Form or Parental Informed Consent Form currently in use with the project being reviewed. The PI will be notified of the action taken (e.g., Approved, Approved Subject to Restrictions, etc.).
When a Continuing Review/Progress Report Form is submitted, the IRB Chair shall consider the following
If the protocol and/or other documents used in the project have been amended within the past five years, the PI will be requested to submit a new protocol incorporating these amendments if such have not previously been submitted.
Pursuant to OHRP guidelines, the IRB approval period may be held constant from year to year throughout the life of each project. When a continuing review occurs annually and the IRB performs a continuing review within 30 days before the IRB approval period expires, the IRB may retain the anniversary date as the date by which the continuing review must occur.
However, if an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop, unless the IRB Chair or Vice Chair find that it is in the best interests of individual subjects to continue participating in the research interventions or interactions, and this finding is ratified at the next convened IRB meeting.
However, after the expiration of IRB approval, the protocol will be considered closed and enrollment of new subjects cannot occur nor can any data collected be used for research purposes.