Continuing Review Of An Approved And Ongoing Study Posing

Continuing review is a cornerstone of ethical research, a process designed to protect participants in studies that extend over time. It ensures that research, even after initial approval, continues to meet ethical standards and adequately safeguards the rights and welfare of participants. This article dives deep into the continuing review process for an approved and ongoing study, elucidating its purpose, procedures, challenges, and best practices.

The Essence of Continuing Review

Continuing review is the periodic assessment conducted by an Institutional Review Board (IRB) of research that has already been approved. It’s not merely a formality but a critical evaluation to ensure that the study's risks and benefits remain acceptable, new information is incorporated, and participant protections are maintained throughout the study's duration.

Why is Continuing Review Necessary?

• Evolving Risks: Research studies may uncover unforeseen risks or side effects as they progress. Continuing review allows the IRB to reassess the risk-benefit ratio in light of new data.
• Changes in Regulations: Ethical standards and regulations governing research can evolve over time. Continuing review ensures that the study remains compliant with current guidelines.
• Study Modifications: Amendments to the research protocol, such as changes in recruitment strategies, study procedures, or data analysis methods, may impact participant safety and require IRB oversight.
• Longitudinal Studies: Studies that follow participants over extended periods require ongoing monitoring to address potential changes in their health status, circumstances, or vulnerability.
• Ethical Oversight: Continuing review provides ongoing ethical oversight, affirming that the study's conduct aligns with ethical principles and respects participants' rights.

The Continuing Review Process: A Step-by-Step Guide

The continuing review process typically involves several key steps, designed to provide the IRB with the information needed to make an informed assessment.

1. Scheduling and Notification

• IRB Responsibilities: The IRB is responsible for tracking the approval period for each study and scheduling the continuing review in advance. They typically send a notification to the principal investigator (PI) well before the approval expires.
• PI Responsibilities: The PI must be aware of the study's approval expiration date and promptly respond to the IRB's notification.

2. Preparing the Continuing Review Submission

• Reporting Period: The continuing review submission typically covers the period since the last IRB review (usually one year).
• Key Documents: The PI must prepare and submit several key documents, including:
  • Continuing Review Form: This form usually includes questions about study progress, recruitment numbers, adverse events, protocol deviations, and relevant new information.
  • Progress Report: A detailed summary of the study's progress, including the number of participants enrolled, data collected, preliminary findings, and any challenges encountered.
  • Adverse Event Report: A comprehensive report of all adverse events experienced by participants, including their severity, relationship to the study intervention, and actions taken.
  • Protocol Deviations: A description of any deviations from the approved protocol, including the reasons for the deviations and their impact on participant safety.
  • Updated Consent Form (if applicable): If there have been any changes to the study procedures or risks, the consent form must be updated and resubmitted.
  • Relevant Publications or Reports: Any publications, presentations, or reports related to the study that have been published or presented during the reporting period.
  • Summary of Relevant New Information: This includes literature updates, new safety information from other studies, or changes in regulatory guidelines that may impact the study.

3. IRB Review and Evaluation

• Review Process: The IRB reviews the submitted materials to assess the study's ongoing risks and benefits, adherence to the approved protocol, and compliance with ethical guidelines.
• Key Considerations: The IRB considers the following factors during the review:
  • Progress of the Study: Is the study progressing as planned? Are there any significant delays or challenges?
  • Enrollment Rate: Is the study enrolling participants at the expected rate? Are there any barriers to recruitment?
  • Adverse Events: Have there been any unexpected or serious adverse events? Are the adverse events adequately reported and managed?
  • Protocol Deviations: Have there been any deviations from the approved protocol? Are the deviations justified and appropriately addressed?
  • New Information: Is there any new information that may impact the study's risks or benefits? This could include new publications, safety alerts, or regulatory changes.
  • Risk-Benefit Ratio: Does the study's potential benefits continue to outweigh the risks to participants?
  • Informed Consent: Is the informed consent process still adequate? Are participants being provided with all the information they need to make an informed decision about participation?
  • Data Security and Privacy: Are data being stored and handled securely? Are participants' privacy and confidentiality being protected?

4. IRB Decision and Communication

• Possible Outcomes: Based on the review, the IRB may take one of several actions:
  • Approval: The IRB approves the study for another specified period (typically one year).
  • Approval with Modifications: The IRB approves the study with required modifications, such as changes to the protocol, consent form, or data collection procedures.
  • Deferred: The IRB defers the decision, requesting additional information or clarification from the PI.
  • Suspension or Termination: In rare cases, the IRB may suspend or terminate the study if it determines that the risks to participants are unacceptable or the study is not being conducted in accordance with ethical standards.
• Communication: The IRB communicates its decision to the PI in writing, along with any required modifications or recommendations.

5. Post-Approval Monitoring

• Ongoing Responsibilities: Even after approval, the PI has ongoing responsibilities to monitor the study and report any significant events to the IRB, such as:
  • Unanticipated Problems: Any unanticipated problems involving risks to participants or others must be reported to the IRB promptly.
  • Protocol Deviations: Any deviations from the approved protocol must be reported to the IRB.
  • Adverse Events: Serious or unexpected adverse events must be reported to the IRB.
  • Changes to the Research: Any proposed changes to the research protocol must be submitted to the IRB for review and approval before implementation.

Challenges in Continuing Review

Despite its importance, the continuing review process can present several challenges for both IRBs and researchers.

1. Administrative Burden

• For Researchers: Preparing the continuing review submission can be time-consuming, requiring the PI to compile data, write reports, and update documents.
• For IRBs: Reviewing the submissions, tracking deadlines, and communicating with researchers can place a significant administrative burden on IRB staff.

2. Determining the Level of Review

• Exempt vs. Expedited vs. Full Board: Determining the appropriate level of review for a continuing review submission can be challenging. Some studies may qualify for expedited review or even exemption, while others require full board review.
• Consistency: Ensuring consistency in the level of review across different IRBs and studies can be difficult.

3. Assessing Risk and Benefit

• Subjectivity: Assessing the risk-benefit ratio can be subjective, as different IRB members may have different perspectives on the acceptability of risks.
• Context: The risk-benefit ratio may change over time, requiring the IRB to carefully consider the context of the study and any new information that has emerged.

4. Managing Amendments

• Multiple Amendments: Studies may undergo multiple amendments during their lifespan, each requiring IRB review and approval.
• Coordination: Coordinating the review of amendments with the continuing review process can be complex.

5. Communication and Collaboration

• Clarity: Ensuring clear communication between the IRB and researchers is essential to avoid misunderstandings and delays.
• Collaboration: Fostering a collaborative relationship between the IRB and researchers can promote a culture of ethical research.

Best Practices for Continuing Review

To address these challenges and ensure the effectiveness of continuing review, several best practices can be implemented.

1. Streamline the Process

• Standardized Forms: Use standardized forms for continuing review submissions to ensure that all necessary information is collected.
• Electronic Submission Systems: Implement electronic submission systems to streamline the submission and review process.
• Risk-Based Approach: Adopt a risk-based approach to continuing review, focusing resources on studies that pose the greatest risk to participants.

2. Provide Training and Education

• For Researchers: Provide training to researchers on the continuing review process, including the requirements for submission, the criteria for IRB review, and the importance of ethical conduct.
• For IRB Members: Provide ongoing training to IRB members on ethical principles, regulatory requirements, and best practices for reviewing research.

3. Enhance Communication and Collaboration

• Open Dialogue: Foster open dialogue between the IRB and researchers to address concerns and clarify expectations.
• Consultation: Encourage researchers to consult with the IRB early in the study planning process to identify potential ethical issues.
• Feedback: Provide constructive feedback to researchers on their continuing review submissions.

4. Utilize Technology

• Data Management Systems: Utilize data management systems to track study progress, adverse events, and protocol deviations.
• Reporting Tools: Implement reporting tools to generate summaries of key data for the continuing review submission.
• Communication Platforms: Use communication platforms to facilitate communication between the IRB and researchers.

5. Focus on Participant Protection

• Prioritize Safety: Prioritize participant safety in all aspects of the continuing review process.
• Independent Monitoring: Consider using independent data monitoring committees to oversee studies that pose a significant risk to participants.
• Participant Feedback: Solicit feedback from participants on their experiences in the study to identify potential problems or areas for improvement.

The Future of Continuing Review

The continuing review process is constantly evolving to meet the changing landscape of research. Several trends are shaping the future of continuing review.

1. Reliance on Data

• Data-Driven Decisions: IRBs are increasingly relying on data to inform their decisions, using data on enrollment rates, adverse events, and protocol deviations to identify potential problems.
• Real-Time Monitoring: Some IRBs are exploring the use of real-time monitoring systems to track study progress and identify potential risks as they emerge.

2. Focus on Quality Improvement

• Continuous Improvement: IRBs are adopting a continuous quality improvement approach, using data and feedback to improve their processes and procedures.
• Accreditation: Accreditation programs are helping to standardize IRB practices and ensure that IRBs are meeting ethical and regulatory requirements.

3. Flexibility and Adaptability

• Tailored Reviews: IRBs are tailoring their review processes to the specific risks and complexities of each study.
• Adaptive Designs: IRBs are developing new approaches for reviewing studies with adaptive designs, which allow for changes to the protocol based on accumulating data.

4. Technology Integration

• Artificial Intelligence: Some IRBs are exploring the use of artificial intelligence to automate certain aspects of the review process, such as screening for conflicts of interest or identifying potential protocol deviations.
• Blockchain Technology: Blockchain technology could be used to enhance data security and transparency in research.

Conclusion

Continuing review is an essential component of ethical research, ensuring that studies are conducted in accordance with ethical principles and regulatory requirements. By implementing best practices, utilizing technology, and focusing on participant protection, IRBs can enhance the effectiveness of the continuing review process and promote a culture of ethical research. As research continues to evolve, the continuing review process must adapt to meet new challenges and ensure that the rights and welfare of research participants are protected. Ultimately, the goal of continuing review is to foster trust in research and advance scientific knowledge while upholding the highest ethical standards. The collaborative effort between researchers and IRBs, guided by a shared commitment to ethical principles, is crucial for the success and integrity of ongoing research endeavors.