Administrative closures
Exempt, Expedite, and Full Board NAU IRB projects that have been granted approval receive an expiration date. The period of approval corresponds to the IRB’s determination of risk. Reapproval is required before the expiration of the study, if the study is continuing. Federal regulations do not allow for a grace period after a project’s approval period expires.
Projects that are not reapproved by the expiration date of the study will be administratively closed by the Human Research Protection Program (HRPP). If the approval of human research expires, all human research procedures related to the protocol under review must cease, including:
- Recruitment
- Advertisement
- Screening
- Enrollment
- Consent
- Interventions and interactions
- Collection and data analysis of private identifiable information
The principal investigator may be restricted from submitting new human research to the HRPP until a completed Closure Form has been received.
If current subjects will be harmed by stopping research procedures (e.g. those procedures specifically for human research), immediately contact the HRPP office. See reporting local event information guidance. You will be asked to provide:
- A reportable local event form,
- A coded list of the currently enrolled subjects,
- what procedures must be continued, and
- in what way(s) subjects will be harmed by stopping human research procedures.
No research data can be collected outside of the IRB approval period. To continue research activities for an expired project, investigators must submit a new project for review and approval.