IRB approval does not include enrollment of pregnant women, the fetus or prisoners unless specifically included in the approval letter. If a participant becomes pregnant or incarcerated while on study, the IRB must be notified immediately. See IRB SOP 408: Unanticipated Problems. For details see IRB SOP 502: Pregnant Women and SOP 503: Prisoners.
Changes to Research Activities During the Approval Period: Amendments
The investigator is responsible for ensuring that no changes are made to the research activity without the prior approval of the IRB. In multi-center studies, the sponsor or Study Chair must also prospectively agree to the change in writing. The sole exception to this requirement is when changes are needed to eliminate an immediate hazard to a subject. In this eventuality, a description of the event, the implemented deviation or change, the reasons for the change, and if appropriate, the proposed protocol amendment(s) should be submitted to the IRB promptly.
Webpages Related to Changes to the Research During the Approval Period
- One-time Amendments (also referred to as Prospective Protocol Deviations)
- IRB SOP 403: Amendments and Reports of New Findings
- Reportable Events.
Continuing Review, Study Closure and Record Retention
Institutional policy and federal regulations require timely continuing review of ongoing research and reports of progress. For federally funded or regulated research this must take place at least once per year unless the approval letter indicates a more frequent review. The expiration date for IRB approval is provided on the Approval Letter and in the eIRB study workspace. For details of the continuing review reporting requirements, consult IRB SOP 304.
Study Closure or Termination
When all human subjects research activity is complete, the study may be closed. A study closure request should be submitted in the eIRB system. Studies that are completed should not be allowed to simply have their approval lapse, they should be formally closed.
Clinically Significant Findings
All clinically significant findings including incidental findings must be recorded in the subject's medical record in accordance with the CHOP Patient Health Record Policy. Recording the data in the medical record meets the requirements for records retention for clinical and research data.