Continuing Review: Everything You Need to Know

Continuing review represents one of the most important ongoing responsibilities for research teams conducting clinical trials and human subjects research. While obtaining initial IRB approval is a significant milestone, maintaining that approval through continuing review is essential for ethical compliance and participant protection. This comprehensive guide will walk you through everything you need to know about continuing review requirements, processes, and best practices.

What Is Continuing Review?

Continuing review is the periodic assessment of an ongoing research study by an Institutional Review Board (IRB). This process ensures that research continues to meet ethical standards, protect participant rights and welfare, and comply with regulatory requirements throughout the study's duration.

The IRB examines several key elements during continuing review:

Current research progress and enrollment status
Any adverse events or unanticipated problems
Recent protocol modifications or amendments
Ongoing risk-benefit analysis for participants
Adequacy of informed consent processes
Data safety monitoring activities

Unlike the initial IRB submission, which focuses on study design and initial risk assessment, continuing review emphasizes the actual conduct of research and emerging safety information.

When Is Continuing Review Required?

Understanding when continuing review is necessary has become more nuanced following the 2018 revisions to the Common Rule (45 CFR 46). The regulations now distinguish between studies that require continuing review and those that don't.

Studies That Require Continuing Review

Continuing review is required for:

Research not eligible for expedited review - Studies involving greater than minimal risk typically require continuing review at intervals appropriate to the degree of risk, but not less than once per year.

Research reviewed by the full IRB board - If your study underwent full board IRB review initially, it generally requires continuing review.

FDA-regulated research - Studies involving investigational drugs, biologics, or devices under FDA jurisdiction typically require continuing review regardless of risk level.

Studies Exempt from Continuing Review

Under the revised Common Rule, continuing review is not required for:

Research eligible for expedited review under certain categories
Research that has progressed to the point where it only involves data analysis
Studies where participants are no longer being followed or interacted with
Research that has completed all interventions and only involves long-term follow-up of participants

It's important to note that even when continuing review is not required, investigators must still promptly report significant changes, adverse events, and unanticipated problems to the IRB.

The Continuing Review Timeline

Timing is critical for continuing review. Research approval expires on the anniversary date specified in your approval letter, and conducting research with an expired IRB approval constitutes a serious violation of federal regulations.

Standard Review Periods

Most IRBs set continuing review intervals at:

12 months for minimal risk studies requiring continuing review
6-12 months for greater than minimal risk research
More frequent intervals for studies with significant safety concerns or vulnerable populations

Planning Ahead

Successful research teams follow these timeline best practices:

Mark your calendar - Note the approval expiration date and set reminders 60-90 days in advance
Prepare early - Begin gathering required information at least 45-60 days before expiration
Submit timely - Most IRBs require submission 30-45 days before the expiration date
Account for revisions - Build in time for potential IRB questions or requested modifications

If your approval is about to expire and continuing review is pending, you may need to suspend research activities until approval is renewed. Some IRBs offer emergency procedures for preventing lapses, but these should be avoided through proper planning.

What to Include in Your Continuing Review Submission

A complete continuing review submission typically includes several key components. Providing comprehensive, accurate information facilitates efficient review and helps avoid delays.

Progress Report

Your progress report should include:

Enrollment data: Number of participants enrolled, withdrawn, and completed
Demographic information: Age, gender, and other relevant participant characteristics
Study status: Whether the study is actively enrolling, in follow-up, or closing
Multi-site information: For studies using a single IRB, provide enrollment data across all sites

Safety Information

Comprehensive safety reporting includes:

Summary of all adverse events (AEs) and serious adverse events (SAEs)
Any unanticipated problems involving risks to participants or others
Summary of relevant findings from Data Safety Monitoring Board (DSMB) reports
Analysis of whether the risk-benefit profile has changed

Protocol Modifications

Document all changes since initial approval or the last continuing review:

Previously approved amendments and modifications
Changes in study personnel
Updates to recruitment materials or informed consent documents
Modifications to data collection procedures

Current Study Documents

Include the most recent versions of:

Study protocol (with version date)
Informed consent forms
Recruitment materials
Investigator's brochure (for investigational products)
Any new supporting documents or literature

Common Continuing Review Mistakes to Avoid

Many of the issues that cause continuing review delays are preventable. Understanding common reasons IRB applications get rejected can help you avoid similar pitfalls during continuing review.

Missing or Incomplete Information

Ensure all required fields are completed and all requested documents are included. Incomplete submissions inevitably result in delays.

Inconsistent Data

Verify that enrollment numbers, adverse event totals, and other data are accurate and consistent across all sections of your submission.

Outdated Documents

Submit the most current versions of your protocol and consent forms. Using outdated documents creates confusion and delays approval.

Late Submission

Submitting too close to the expiration date leaves insufficient time for review and any necessary revisions, potentially forcing research suspension.

Inadequate Safety Reporting

Provide meaningful analysis of safety data, not just lists of events. The IRB needs to understand whether the study's risk profile has changed.

Special Considerations for Different Study Types

Clinical Trials

For FDA-regulated clinical trials, continuing review often requires additional documentation such as:

FDA Form 1572 updates (if changes in personnel occurred)
Current investigator's brochure
DSMB reports or meeting minutes
Protocol deviations and violations summary

Supplement Studies

Researchers conducting supplement studies should pay particular attention to:

Any new scientific literature on the supplement's safety
Updates to product labeling or composition
Participant-reported side effects or reactions

Decentralized Clinical Trials

For decentralized clinical trials, continuing review should address:

Technology-related issues or participant concerns
Home health provider incidents
Data security or privacy breaches
Effectiveness of remote monitoring procedures

Best Practices for Streamlined Continuing Review

Implementing systematic processes can make continuing review more efficient and reduce the administrative burden on your research team.

Maintain Organized Records

Create a comprehensive study file that includes:

All IRB correspondence and approvals
Adverse event logs and reports
Enrollment tracking spreadsheets
Protocol deviation logs
Signed consent forms (properly filed and tracked)

Implement Continuous Monitoring

Don't wait until continuing review is due to assess your study. Regular internal monitoring helps you:

Identify trends in adverse events early
Catch protocol deviations before they become systematic
Maintain accurate enrollment data
Ensure research integrity throughout the study

Use Templates and Checklists

Develop standardized templates for continuing review submissions that include all required elements. Create checklists to verify completeness before submission.

Designate Responsibility

Assign a specific team member to oversee continuing review preparation and submission. This person should track deadlines, gather required information, and serve as the IRB contact.

Communicate with Your IRB

Establish a good working relationship with your IRB staff. Don't hesitate to:

Ask questions about submission requirements
Clarify reporting expectations
Seek guidance on unusual situations
Request pre-review of complex submissions when possible

What Happens During the IRB's Continuing Review?

Understanding the IRB's review process can help you prepare better submissions and anticipate potential questions.

The IRB evaluates whether:

Risks to participants are still minimized and reasonable - Have new risks emerged? Does the study still offer benefits that outweigh the risks?

The consent process remains adequate - Are participants still being fully informed? Do consent documents need updating based on new information?

Participant selection remains equitable - Is enrollment occurring as planned? Are vulnerable populations being appropriately protected?

The research plan is being followed - Are deviations acceptable and properly documented? Do significant changes require protocol amendments?

Monitoring and reporting are adequate - Are adverse events being properly tracked and reported? Is oversight appropriate for the risk level?

The IRB may approve your continuing review as submitted, request modifications, or require additional information before making a determination.

After Continuing Review Approval

Once your continuing review is approved, you'll receive a new approval letter specifying:

The new approval period and expiration date
Any conditions or requirements for continued approval
Reporting requirements for the coming year

Important next steps:

Update your study team on the new expiration date
Implement any required modifications or conditions
File the approval letter in your regulatory binder
Calendar the next continuing review deadline
Notify sponsors, collaborators, or other relevant parties of renewed approval

Conclusion

Continuing review is more than a regulatory checkbox—it's an essential mechanism for ensuring ongoing participant protection and research quality. By understanding the requirements, planning ahead, maintaining comprehensive records, and submitting complete, accurate reports, you can navigate the continuing review process efficiently while maintaining the highest ethical standards.

Whether you're conducting a minimal-risk survey study or a complex multi-site clinical trial, staying current with continuing review obligations protects your participants, your research, and your institution.

Partner with Elemental IRB for Streamlined Continuing Review

Navigating continuing review requirements doesn't have to be complicated. Elemental IRB offers responsive, expert guidance throughout your study's lifecycle, from initial submission through continuing review and study closure. Our experienced team understands the nuances of modern research oversight and can help you maintain compliance while focusing on what matters most—your research.

Contact Elemental IRB today to learn how we can support your research with efficient, thorough IRB review services tailored to your study's needs.