Continuing Review Process
- Overview
- Level of Review: Expedited or Full Board
- Investigator Responsibilities for Continuing Review of Projects
- What and When to Submit for Continuing Review
- How to submit documents to the HSIRB: electronically or by mail
Overview
The purpose of continuing review is to review the progress of the entire study including any changes since the last HSIRB review. All expedited and full board approved projects are required to undergo continuing review at intervals appropriate to the degree of risk but not less than once per year. The HSIRB may require more frequent review based on known or potential study risks to the subject population, previously reported issues with the drug, biologic or device, previous issues with the PI, nature and location of the study, or the vulnerability of the study subject population.
Continuing review must occur for all non-exempt human research that remains "active." IMPORTANT: The term "closed to enrollment" indicates only that the study is no longer "enrolling" subjects. Therefore, a study may be "closed to enrollment" but is considered to be "active" study requiring continuing review if data analysis or follow-up is taking place.
Continuing review must also occur for research that includes the collection and analysis of identifiable private information, such as chart reviews.
Level of Review: Expedited or Full Board
The level of review process at the time of continuing review (renewal) is determined by the previous type of review for the project and any changes in the project since the last review. Generally, if research did not qualify for expedited review at the time of initial review, it will not qualify for expedited review at the time of continuing review except in limited circumstances as follows:
- When no subjects have been enrolled and no additional risks have been identified, OR
- When the board previously approved the expedited process for subsequent reviews:
- For research that is permanently closed to the enrollment of new subjects, and all subjects have completed all research related interventions, and the research remains active only for long-term follow-up of subjects OR
- When the remaining research activities are limited to data analysis, OR
- For research NOT conducted under an investigational new drug application or investigational device exemption where the IRB has determined and documented at a full board meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Usually, renewals of protocols that were previously reviewed through expedited procedures will be reviewed using the same process if:
- There are no proposed changes, or
- Any proposed changes are minor
Investigator Responsibilities for Continuing Review of Projects:
The Investigator’s responsibilities include providing the HSIRB with all appropriate documentation in a timely manner and ensuring that the necessary forms are accurately completed so that approval of the project is not delayed.
What and When to Submit for Continuing Review
An Application for Continuing Review is sent to the PI two months before the anniversary date of full review protocols and one month before expedited review protocols. If the HSIRB office has not received a completed application for Continuing Review by the renewal submission due date, the PI will receive a lapsed notice. If there is no response by the expiration date, the study will be administratively closed. Federal regulations make no provisions for any grace period for extending IRB approval beyond the expiration date; research, including subject enrollment, cannot continue beyond the expiration date. If the HSIRB administratively closes the study, appropriate University administration and the study sponsor (if sponsored) will be notified.
“How” to submit to the HSIRB: Electronically or by Mail
See: Submission Deadline Dates and How to Submit Materials for HSIRB Review