Administrative closures

Projects that have been granted approval and receive an expiration date (expedited and full committee studies) can only be approved for up to one year from the date of approval. The IRB makes a determination of risk in determining the period of approval. Reapproval is required before the expiration of the study. 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 will be restricted from submitting new Human Research to the HRPP until a completed Continuing review 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. You will be asked to provide:

• 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.

While permission may be granted to continue providing research procedures, no research data can be collected outside of the IRB approval period. To re-open the expired project, investigators must submit a new application for review and approval.

Version 2017-1