Continuing Review

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What is Continuing Review?

How Often Is It Required?

When is Continuing Review Not Required?

If Approval Expires

Submitting in iRIS

IRB Review Process

 

What is Continuing Review?

If you want to continue working on a study beyond its expiration date, you must submit the study to the IRB for continuing review approval. The IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.

Continuing review is required even if: 

  • No changes have been made since the last approval
  • The only study activity is subject follow-up
  • The only study activity is data analysis*

* Note: You may be able to close your study if data analysis is being done by someone else, such as the sponsor or the lead site. You may also be able to close the study if data analysis or manuscript preparation no longer involves use or access to individually identifiable information, and they key has been destroyed.

How Often Is Continuing Review is Required?

Most studies must undergo continuing review annually. However, there is some variation to this requirement. The IRB may require more frequent review for some studies, while the requirement for continuing review may be waived for other studies (see below). Your approval letter will clearly list the study's expiration date, or it will state that there is no expiration date.

Continuing review reminders from iRIS

The iRIS system sends out several courtesy continuing review reminders to the Principal Investigator (PI) and study contacts starting eight weeks before a study expires. However, it is ultimately the PI's responsibility to keep track of when the continuing review is due and to submit a continuing review application at least 6 weeks before the expiration date to allow for review and re-approval. Per federal regulations, extensions cannot be granted for Continuing Review.

 

When is Continuing Review Not Required? 

Exempt studies do not expire and do not require continuing review.

There is also a subsection of expedited and full committee studies that, per 45 CFR 46.109(f) of the 2018 Common Rule requirements, are eligible to have no expiration date and thereby do not require annual continuing review. Please see the below tables for a description of the scenarios in which a study may be eligible.

Note: Even if your study meets the below criteria, please do not assume that it doesn’t require continuing review. Your approval letter will either include an expiration date if you need to renew each year, or it will indicate that the study has no expiration date. This determination is made by the IRB.

Studies initially approved ON or AFTER 1/21/2019 may be eligible for “No expiration” status if they meet the following criteria:

Study Status / Review Level

  1. Expedited
  2. Expedited- No Subject Contact

Consent Form Requirements

If there are study consent forms, the following elements are included:

  1. Study summary (not required if consent is 6 pages or fewer)
  2. Statement about whether study data may/will/will not be deidentified and shared for future research (always required)
  3. Statements about whole genome sequencing, and/or return of results, and/or sharing in commercial profits (only required if applicable to the study)

Note: These requirements are included in our Consent & Assent Form Templates.

Exclusions

Studies are not eligible for “No expire” if any of the following conditions exist:

  1. The study involves FDA funding and/or FDA oversight (the study involves drugs, devices, assays, or biologics)
  2. The IRB Reviewer requests annual review for a specific reason
  3. It is a COVID-19 study (these need at least 1 annual renewal)

Who makes this decision, and when?

A voting IRB member makes this decision at the time of initial IRB review.

Studies approved BEFORE 1/21/2019 may be eligible to transition to “No expiration” status if they meet the following criteria:

 

Study Status / Review Level

  1. Expedited and closed to accrual
  2. Expedited - No Subject Contact
  3. Full Committee, closed to accrual, and ALL subjects have completed ALL study interventions
  4. Full Committee, closed to accrual, and in Data Analysis Only

Consent Form Requirements

The study is either “no subject contact” or closed to accrual, therefore there should not be any active consent forms.

Exclusions

Studies are not eligible for transition to a “No expire” status if either of the following conditions exist:

  1. The study involves FDA funding and/or FDA oversight (the study involves drugs, devices, assays, or biologics)
  2. The IRB Reviewer requests annual review for a specific reason

Who decides if the study can be transitioned, and when?

A voting IRB member makes this decision at the time of continuing review.

 

If the IRB determines that your study is eligible for “No expiration,” your approval letter will clearly indicate that there is no expiration date.

Expedited and Full Committee studies without expiration dates are still under the oversight of the IRB, which means that:

  • The IRB may still request periodic updates on the status of the study.
  • You are still required to submit modifications, adverse events, protocol violations, and closeout reports as usual.
Please do not submit requests to the IRB for your study to not have an expiration date. This determination is made by the IRB at the time of initial or continuing review, based on specific regulatory criteria.

If Approval Expires

If approval expires, ALL RESEARCH ACTIVITIES INVOLVING HUMAN SUBJECTS MUST STOP, even if the continuing review application has been submitted to the IRB. Research activities include, but are not limited to, study visits, medical records review and data analysis. The only exception is that activities needed for participant safety should continue; contact the IRB if this occurs. No new subjects may be enrolled.

If any project activity occurs or continues after the expiration date, the investigator is out of compliance with both federal regulations and University policy. Retrospective approval for work done after the expiration date cannot be granted.

Submitting in iRIS

Allow at least 4 weeks for the continuing review to be processed. Incomplete submissions will not be assigned for review.

Follow these steps to submit the continuing review. For additional assistance, read the quick guide called "Submitting Post-approval Forms" in the Help section of iRIS.

1. Open the study via the IRB Study Assistant

Go to My Studies under the IRB Study Assistant. Open the active study you want to renew. 

2. Start and complete the new form

Click on the Continuing Review Submission Form link. Click Add New Form to start a blank form. 

3. Describe any new modifications

You can modify your study at the time of continuing review. Indicate in the first section of the Continuing Review Form that you are modifying the study, and then provide a description of the proposed changes in the "New Modifications" section. Attach any new or revised documents or applications later in the form.

Caution: If a study’s expiration date is close, consider not submitting a possibly controversial modification until after the continuing review has been approved. Delayed approval and study expiration may occur if the IRB has questions or problems with the modification.

4. Attach consent forms

In the "Attach Consent Forms" section, you must attach all consent documents that you plan to use during the next approval period – even if the documents are currently approved and are not being modified. The IRB will review them and give them an updated approval stamp. Follow the instructions on the form to attach the consent documents. If the study is closed to accrual and you don't need to re-consent, do not attach the consent forms. Note: You do not need to attach any other study documents that are currently approved and are not being modified.

5. PI must submit

The PI must sign off and submit the Continuing Review Form. 

IRB Review Process for Continuing Reviews

Studies initially reviewed as full committee

These submissions will be reviewed by the full committee at a convened meeting unless certain conditions apply (see below).

Studies initially reviewed as full committee, now eligible for expedited review

If one of the following apply, the continuing review can be reviewed under the expedited review procedures:

  1. The research is permanently closed to the enrollment of new subjects and the research remains active only for long-term follow-up, such as medical records review and telephone follow-up. (If one of the research follow-up procedures is an intervention such as a blood draw or an x-ray, the continuing review is not eligible for expedited review.)
  2. No subjects have ever been enrolled and no additional risks have been identified since the last full committee review.
  3. The remaining research activities are limited to data analysis.

Studies initially reviewed as expedited review

These submissions can be reviewed under the expedited review procedures if the study procedures continue to qualify for expedited review.