Continuing Review Of An Approved And Ongoing Study

Continuing Review of an Approved and Ongoing Study: Ensuring Ethical Research Practices

The ethical conduct of research involving human subjects is paramount. Once a study receives initial approval from an Institutional Review Board (IRB) or equivalent ethics committee, the journey doesn't end. Ongoing research requires continuous monitoring and evaluation through a process known as continuing review. This article delves into the crucial aspects of continuing review, explaining its purpose, process, and importance in maintaining research integrity and protecting participant welfare. Understanding continuing review is essential for researchers, IRB members, and anyone involved in human subject research.

Why is Continuing Review Necessary?

The initial IRB review assesses the study's design, methodology, and risks to participants. However, research is a dynamic process. Several factors necessitate regular review to ensure the ongoing protection of participants and the ethical conduct of the study. These include:

• Changes in the study protocol: Researchers might need to modify the study design, procedures, or data collection methods during the study's lifespan. These changes, however minor, require IRB review to ensure they align with ethical guidelines and don't increase participant risk. This could include adjustments to recruitment strategies, inclusion/exclusion criteria, or data analysis techniques.

• Unforeseen risks or adverse events: During the study, unexpected problems or adverse events may emerge. These might involve participant discomfort, unexpected side effects of an intervention, or breaches of confidentiality. Continuing review allows the IRB to assess the situation, recommend mitigation strategies, and determine whether the study should continue.

• Monitoring participant safety and well-being: Regular review provides an opportunity to assess the overall safety and well-being of participants. The IRB can evaluate the effectiveness of safeguards implemented to protect participant rights and welfare. This includes examining data on adverse events, participant feedback, and overall study progress.

• Maintaining data integrity and security: Continuing review ensures that data collected is handled appropriately, stored securely, and analyzed according to ethical guidelines. The IRB can assess the researchers' adherence to data management plans and investigate potential data breaches or irregularities.

• Ensuring compliance with regulations: Ethical guidelines and regulations concerning human subject research are constantly evolving. Continuing review provides a mechanism to confirm that the study remains compliant with current regulations and best practices. This includes adhering to updated guidelines on informed consent, data privacy, and vulnerable populations.

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

The continuing review process varies slightly depending on the IRB and the nature of the study, but it typically involves the following steps:

1. Researcher's Submission: The principal investigator (PI) is responsible for submitting a continuing review application to the IRB. This typically includes a progress report summarizing the study's progress, any changes to the protocol, any adverse events reported, and a summary of participant recruitment and retention rates. The application will also include updated consent forms if any changes are made to the study procedures.

2. IRB Review: The IRB reviews the application to assess the study's continued ethical conduct and adherence to regulations. They scrutinize the progress report, looking for any deviations from the approved protocol, unexpected risks, or problems with participant safety or well-being. The IRB may request additional information from the PI if clarification is needed.

3. IRB Decision: Based on the review, the IRB makes a decision regarding the study's continuation. This decision might be:

   • Full Approval: The study can continue as planned.
   • Approval with Modifications: The study can continue, but with specific changes or modifications to the protocol.
   • Suspension: The study is temporarily halted until certain issues are addressed.
   • Termination: The study is permanently ended due to ethical concerns or other serious issues.

4. Notification to the Researcher: The IRB notifies the PI of their decision in writing. This notification outlines the terms of approval, any modifications required, or the reasons for suspension or termination.

5. Implementation of Changes: If modifications are required, the PI must implement those changes and document their implementation.

6. Ongoing Monitoring: Even with approval, the IRB may conduct ongoing monitoring of the study through regular reports, site visits, or other mechanisms. This ensures that the study continues to meet ethical standards.

Frequency of Continuing Review

The frequency of continuing review depends on several factors, including the study's risk level, duration, and the nature of the intervention. Generally, continuing review is required at least annually for ongoing studies. However, more frequent reviews might be necessary if:

• The study involves significant risks to participants.
• There are significant changes to the study protocol.
• Adverse events occur.
• The IRB identifies areas of concern during monitoring.

Documenting Adverse Events and Protocol Deviations

Accurate and timely documentation is crucial throughout the continuing review process. Any adverse events or protocol deviations must be documented thoroughly and reported promptly to the IRB. This includes:

• Detailed description of the event: A clear and concise account of what occurred, including the date, time, and circumstances.
• Participant identification: Identifying information (while maintaining confidentiality) to allow for tracking and follow-up.
• Assessment of the event's severity: Evaluation of the event's impact on the participant's safety and well-being.
• Actions taken in response: Steps taken to address the event, provide support to the participant, and mitigate future risks.
• Analysis of the cause: Investigation into the underlying cause of the event to prevent recurrence.

The Role of the IRB in Continuing Review

The IRB plays a critical role in protecting the rights and welfare of participants in ongoing studies. Their responsibilities during continuing review include:

• Independent review of the study's progress: Objectively assessing the study's ethical conduct and adherence to regulations.
• Ensuring participant safety and well-being: Monitoring for any risks or adverse events and recommending appropriate actions.
• Assessing the integrity of the research: Evaluating the quality of data collection, storage, and analysis.
• Providing guidance and support to researchers: Offering advice and assistance to researchers on maintaining ethical research practices.
• Ensuring compliance with regulations: Confirming that the study adheres to all applicable ethical guidelines and regulations.

Common Questions and Answers (FAQ)

Q: What happens if I fail to submit a continuing review application on time?

A: Failure to submit a continuing review application on time can lead to the suspension or termination of your study. The IRB may also impose other sanctions. It's crucial to submit applications well in advance of the deadline.

Q: How much detail is required in the progress report?

A: The level of detail required in the progress report depends on the study's complexity and risk level. However, it should always provide a comprehensive summary of the study's progress, any changes to the protocol, adverse events, and participant outcomes. Be as transparent as possible in your reporting.

Q: Can I make minor changes to the protocol without submitting a continuing review application?

A: Generally, no. Even seemingly minor changes to the protocol, such as adjusting recruitment strategies or data collection methods, require IRB review. Consult with your IRB to determine whether a modification requires a full continuing review application or a less formal notification.

Q: What constitutes an adverse event?

A: An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and/or biologic that doesn't necessarily have a causal relationship with this treatment. This includes physical injuries, psychological distress, or any other negative impact on the participant.

Q: What happens if a serious adverse event occurs?

A: Serious adverse events require immediate reporting to the IRB. The IRB will assess the situation and determine the appropriate course of action, which may involve modifications to the protocol, suspension of the study, or other measures to protect participants.

Conclusion

Continuing review is not merely a bureaucratic process; it's a cornerstone of ethical research. It provides a crucial mechanism for ensuring the ongoing protection of human participants, safeguarding the integrity of research findings, and maintaining public trust in the scientific community. By proactively addressing potential ethical challenges and promptly reporting any issues, researchers can ensure their studies remain ethically sound and contribute meaningfully to advancing knowledge while respecting the rights and welfare of those who participate. Active engagement with the IRB throughout the research process fosters a collaborative relationship that prioritizes ethical conduct and participant well-being.