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Continuing Review

Continuing review past the initial approval period

IRB approval for an expedited study lasts for two years. For studies reviewed by the convened board study approval is good for one year. For many studies, the research will take longer than this initial approval period. In these cases a continuing review application must be submitted. The CAP system will send you a reminder when your study expiration date is getting close.

Continuing review applications must be submitted on or before the expiration date.

Do I need to submit a continuing review application?

If your project meets all of the following criteria, you may not need to submit a continuing review application and should instead submit a closure application:

  • The only on-going research activities are data analysis and/or writing. All interactions, interventions, and data collection with participants have been completed.
  • All identifying information has been removed from the data and destroyed, unless participants gave explicit consent for identifiers to be maintained after the research has been completed (such as participants signing an agreement to donate the research records to a public archive). All code keys that link participants’ ID numbers with identifying information have been destroyed.
  • The final data disposition procedures have been completed as they were detailed in the consent form and protocol application.

If your study does not meet all of these requirements a continuing review application must be submitted.

Submitting your Continuing Review Application

When you submit your continuing review application, you should read through the original application to make sure that no outdated information is included. If you plan to make changes to research procedures you can make them at this time instead of submitting a separate amendment application.

At the bottom of the page is the continuing review application where you will update your reviewers on the status of research and any planned changes. All changes should be summarized here, no matter how small. However, this will not be part of the final approved protocol, so any changes discussed here must also be made in the body of the application. Changes to the body of the application and the summary must be saved separately, otherwise they will be lost.

Once the continuing review application is completed, you will submit to ORS just as you did with the initial application.

Continuing Review Process

As long as there has been no increase in risk, continuing reviews go through the same review process as the initial application. That means if the project was initially expedited, it will be reviewed at the expedited level. If the project was initially reviewed by the convened board, it will be reviewed at the next convened meeting. See the IRB meeting schedule to plan your submission.

If you are requesting amendments during the continuing review process, note that none of the new procedures or documents can be used prior to approval. All previously approved procedures can continue to take place while the continuing review takes place.

What happens if I miss the continuing review deadline?

The federal regulations do not allow for grace periods. Once an approval period is over that means the study is no longer approved. Following the federal regulations, the IRB cannot conduct a continuing review on a project that has expired. This applies even if the expiration date was a single day prior.

Once approval has ended, all research must pause. This includes recruitment, data collection, and analysis of study data. If research activities continue (even unintentionally) this is considered unapproved research activity, or non-compliance. The IRB may ask that an unanticipated problem report is filled for review.

Once the research is paused, you should submit a closure for the original project. Then you can create a new IRB project in CAP and submit a new application for initial review. You should carry over the information from the prior project as well explaining the circumstances surrounding the expiration.

Research activities can only continue once the new application is approved.

Continuing review past the initial approval period

IRB approval for an expedited study lasts for two years. For studies reviewed by the convened board study approval is good for one year. For many studies, the research will take longer than this initial approval period. In these cases a continuing review application must be submitted. The CAP system will send you a reminder when your study expiration date is getting close.

Continuing review applications must be submitted on or before the expiration date.

Do I need to submit a continuing review application?

If your project meets all of the following criteria, you may not need to submit a continuing review application and should instead submit a closure application:

  • The only on-going research activities are data analysis and/or writing. All interactions, interventions, and data collection with participants have been completed.
  • All identifying information has been removed from the data and destroyed, unless participants gave explicit consent for identifiers to be maintained after the research has been completed (such as participants signing an agreement to donate the research records to a public archive). All code keys that link participants’ ID numbers with identifying information have been destroyed.
  • The final data disposition procedures have been completed as they were detailed in the consent form and protocol application.

If your study does not meet all of these requirements a continuing review application must be submitted.

Submitting your Continuing Review Application

When you submit your continuing review application, you should read through the original application to make sure that no outdated information is included. If you plan to make changes to research procedures you can make them at this time instead of submitting a separate amendment application.

At the bottom of the page is the continuing review application where you will update your reviewers on the status of research and any planned changes. All changes should be summarized here, no matter how small. However, this will not be part of the final approved protocol, so any changes discussed here must also be made in the body of the application. Changes to the body of the application and the summary must be saved separately, otherwise they will be lost.

Once the continuing review application is completed, you will submit to ORS just as you did with the initial application.

Continuing Review Process

As long as there has been no increase in risk, continuing reviews go through the same review process as the initial application. That means if the project was initially expedited, it will be reviewed at the expedited level. If the project was initially reviewed by the convened board, it will be reviewed at the next convened meeting. See the IRB meeting schedule to plan your submission.

If you are requesting amendments during the continuing review process, note that none of the new procedures or documents can be used prior to approval. All previously approved procedures can continue to take place while the continuing review takes place.

What happens if I miss the continuing review deadline?

The federal regulations do not allow for grace periods. Once an approval period is over that means the study is no longer approved. Following the federal regulations, the IRB cannot conduct a continuing review on a project that has expired. This applies even if the expiration date was a single day prior.

Once approval has ended, all research must pause. This includes recruitment, data collection, and analysis of study data. If research activities continue (even unintentionally) this is considered unapproved research activity, or non-compliance. The IRB may ask that an unanticipated problem report is filled for review.

Once the research is paused, you should submit a closure for the original project. Then you can create a new IRB project in CAP and submit a new application for initial review. You should carry over the information from the prior project as well explaining the circumstances surrounding the expiration.

Research activities can only continue once the new application is approved.