All revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). Examples of revisions include changes to advertisements, study team members, methods and procedures, an increase in subject enrollment. Some revisions may necessitate changes to the consent forms. All revisions described on the project revision form must be incorporated into the appropriate study documents and submitted for review in track changes.
The IRB has a new process for the review of minor changes. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:
- the level of risks to subjects
- the research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
- the number of subjects enrolled in the research (no greater than 10% of the total requested)
- the qualifications of the research team
- the facilities available to support safe conduct of the research, or
- any other factor which would warrant review of the proposed changes by the convened IRB or was used to initially to evaluate the risk:benefit ratio or any other criteria for approval
Submit the Minor Change Form to request this type of change to an existing, acknowledged or approved study.
All non-exempt studies must be reviewed and re-approved at least annually. It is the responsibility of each investigator to be aware of when their study expires and submit a continuing review application (or final report) to the IRB at least 30 days prior to that date. In the event that a study expires prior to the submission of the annual application, the study will be closed and a new application must submitted. No research activities, including data analysis, may be conducted in the absence of a current IRB approval.
Exemptions are granted for five years and there is no requirement for annual renewal applications. If the research extends beyond the expiration date, the Investigator must request a new exemption. Investigators should submit a final report to the IRB if the project is completed prior to the 5 year term.
Protocol deviations, exceptions, adverse events and unanticipated problems must be reported to the IRB. The timeline for these reports depends on the nature of the event.
Final reports should be submitted at least 30 days prior to the annual expiration date or sooner if all study activities, including data analysis, are complete.