Closures, Amendments, and Continuations

Study Closures

Once all data collection and de-identification of the data set is completed, the study can be closed. All researchers must complete and submit a Closure Form to officially finish the IRB process. 

View instructions for submitting a Closure Form. 

Amendments

Intended modifications to active human subjects research at any review level must be approved by the IRB before changes may be implemented by the investigator or research team. An Application to Amend Previously Approved Research for protocols that originally went through full review must also be reviewed by the full board if the amendment will change participant information, research methods, interview or survey questions, recruitment processes, or informed consent documents or procedures. Changes to the originally approved research protocol are allowed without approval of an amendment to address any immediate hazards to participants or others. In the case of changes due to immediate hazards, the investigator must submit an Application to Amend Previously Approved Research as soon as is feasible and an Unanticipated Problems Involving Risks to Participants or Others reporting form within one (1) business day of the change.  

View instructions for submitting an Application to Amend Previously Approved Research.

Continuing Review

If a project was approved at the expedited or full review level, researchers must submit an Application for Continuing Review to continue research with human participants or analysis of their private, identifiable information past an expiration date. Expiration dates for studies under expedited or full review occur within one (1) year of project approval. The IRB requests that all Applications for Continuing Review be submitted at least one month prior to the expiration date. Projects approved under exempt or limited review do not expire and therefore do not require continuing review.

View instructions for submitting an Application for Continuing Review.