Federal regulations do not allow research to continue past the approval expiration date. The researcher must stop the research, "unless the IRB concludes that it is in the best interest of individual subjects to continue participation in research interventions or interactions." Enrollment of new subjects cannot occur after the expiration of IRB approval. This also applies to the release of data for use in the study.
If the DSHS IRB has not received a continuing review application by the IRB approval expiration date, the protocol will be administratively closed by the IRB. An administrative closure notice requesting a final report form and proof of data destruction will be sent to principal investigators and program contacts on the first business day of the month following the protocol's expiration.
If notification from the DSHS program requesting extended program approval time is received before the IRB approval expiration date, the program will have an additional 30 days to submit the protocol to the DSHS IRB.
To re-open the study, an initial application must be submitted for Full Board Review. The Principal Investigator must submit a signed letter of explanation with the re-submission detailing:
- the circumstances that led to the protocol closure;
- reasons why the investigator feels the research should be re-opened;
- corrective action the investigator has taken to avoid study expiration and closure in the future.
Principal Investigators who allow their protocols to lapse will be placed on probation for non-compliance.