Continuing Review Of An Approved And Ongoing Study

Continuing review is a cornerstone of ethical research, ensuring the safety and well-being of participants in studies that extend over time. It's a systematic process, not just a formality, that allows Institutional Review Boards (IRBs) to monitor ongoing research and make informed decisions about whether a study should continue as is, be modified, or even terminated. Let's dig into the intricacies of continuing review, exploring its purpose, process, and significance in the research landscape.

The Purpose of Continuing Review

At its core, continuing review serves to protect human subjects involved in research. But the purpose extends beyond basic protection. It's about fostering a culture of ethical awareness and continuous improvement in research practices.

Protecting Participants' Rights and Welfare: This is the critical objective. The IRB re-evaluates the study to make sure the risks to participants remain reasonable in relation to the potential benefits, both to the individual and society.
Monitoring Study Progress and Safety: Continuing review allows the IRB to stay informed about the study's progress, including any unexpected problems, adverse events, or interim findings that may impact the risk-benefit ratio.
Ensuring Compliance with Regulations and Guidelines: Research is governed by a complex web of regulations, including those from the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). Continuing review ensures that the study remains compliant with all applicable rules.
Re-evaluating the Risk-Benefit Ratio: As a study progresses, new information may emerge that alters the perceived risks or benefits. The IRB reassesses this balance to ensure it remains ethically acceptable.
Identifying Potential Conflicts of Interest: The IRB reviews any changes in personnel or funding sources to identify potential conflicts of interest that could compromise the integrity of the research.
Promoting Informed Consent: Continuing review ensures that the informed consent process remains adequate and that participants are provided with updated information about the study as needed.
Encouraging Ethical Awareness: The process of preparing for and undergoing continuing review encourages researchers to reflect on the ethical implications of their work and to identify areas for improvement.

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

The continuing review process typically involves several key steps, each designed to ensure thorough evaluation and ongoing protection of human subjects.

Notification: The IRB office will typically send a notification to the principal investigator (PI) several weeks or months before the continuing review is due. This notification serves as a reminder to begin preparing the necessary documents. The exact timeframe can vary depending on the IRB's policies and workload.
Preparation of the Continuing Review Report: The PI is responsible for preparing a comprehensive report summarizing the study's progress, any changes to the protocol, and any adverse events or unanticipated problems. This report usually includes the following information:
- Study Status: Current enrollment numbers, number of participants who have completed the study, and reasons for any participant withdrawals.
- Summary of Findings: A brief summary of any interim findings or data analysis that has been conducted.
- Adverse Events and Unanticipated Problems: A detailed report of any adverse events, unanticipated problems involving risks to participants or others, and any steps taken to mitigate those risks.
- Protocol Deviations: A description of any deviations from the approved protocol and the reasons for those deviations.
- Changes to the Research Team: Any changes in the research team, including the addition or removal of investigators or key personnel.
- Changes to the Consent Form: Any changes made to the informed consent form and the rationale for those changes.
- Relevant New Information: Any new information relevant to the study, such as changes in regulations, new scientific findings, or relevant safety information.
Submission of the Continuing Review Report: The PI submits the completed continuing review report and any supporting documents to the IRB office by the specified deadline. This submission is often done electronically through an online IRB system.
IRB Review: The IRB reviews the submitted materials to assess the study's progress, safety, and compliance with ethical and regulatory requirements. The IRB may conduct the review through expedited procedures (for minimal risk research) or through a full board review (for higher risk research).
IRB Determination: Based on its review, the IRB makes one of the following determinations:
- Approval: The IRB approves the continuation of the study as is.
- Approval with Modifications: The IRB approves the continuation of the study, but requires specific modifications to the protocol, consent form, or other study documents.
- Deferral: The IRB defers a decision pending further information or clarification from the PI.
- Disapproval: The IRB disapproves the continuation of the study. This decision is typically made when the risks to participants are deemed unacceptable or when the study is not being conducted in accordance with the approved protocol.
Notification of the PI: The IRB office notifies the PI of the IRB's determination. If modifications are required, the PI must implement those changes before continuing the study.
Documentation: The IRB documents its review and determination in the IRB minutes. This documentation includes the rationale for the decision and any required modifications.
Renewal of Approval: If the study is approved, the IRB issues a renewed approval for a specified period, typically one year. The PI must submit another continuing review report before the expiration of the renewed approval.

Key Considerations for Researchers

Preparing for and undergoing continuing review requires careful attention to detail and a commitment to ethical research practices. Here are some key considerations for researchers:

Start Early: Don't wait until the last minute to prepare the continuing review report. Gather the necessary information and begin writing the report well in advance of the deadline.
Be Thorough: Provide a comprehensive and accurate account of the study's progress, any problems encountered, and any steps taken to address those problems.
Be Proactive: If you anticipate any potential issues or delays, contact the IRB office as soon as possible to discuss them.
Maintain Accurate Records: Keep detailed records of all aspects of the study, including enrollment data, adverse events, protocol deviations, and consent form changes.
Communicate Effectively: Respond promptly and thoroughly to any questions or requests from the IRB office.
Understand the Regulations: Familiarize yourself with the relevant regulations and guidelines governing human subjects research.
Prioritize Participant Safety: Always prioritize the safety and well-being of research participants.

Exemptions and Expedited Review: A Streamlined Approach

While continuing review is a standard requirement for many research studies, certain types of research may be eligible for exemption or expedited review, which can streamline the process. Worth keeping that in mind.

Exempt Research

Certain categories of research are exempt from the continuing review requirements, typically because they pose minimal risk to participants. Common examples of exempt research include:

Research in established or commonly accepted educational settings, involving normal educational practices.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food additive at or below the levels found to be safe and is used in a safe manner.

Expedited Review

Research that presents no more than minimal risk to participants and falls into specific categories may be eligible for expedited review. Basically, the review can be conducted by one or more experienced IRB members, rather than the full board. Examples of research that may qualify for expedited review include:

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Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
Collection of excreta and external secretions (including sweat).
Recording of data from subjects 18 years of age or older using noninvasive procedures (not involving general anesthesia or sedation). Examples include the use of clinical sensors.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior.

Even if a study is initially approved through an exemption or expedited review process, the IRB may still require some form of continuing review, particularly if there are changes to the study protocol or if any problems or adverse events occur.

The Impact of Regulatory Changes

The regulatory landscape governing human subjects research is constantly evolving. It's crucial for researchers and IRBs to stay informed about these changes and to adapt their practices accordingly. As an example, the 2018 revisions to the Common Rule (the federal policy for the protection of human subjects) included significant changes to the continuing review requirements. These changes aimed to reduce the administrative burden on IRBs and researchers while maintaining adequate protection for research participants.

Some of the key changes introduced by the 2018 revisions include:

Elimination of Continuing Review for Certain Minimal Risk Studies: The revised Common Rule eliminated the requirement for continuing review of certain categories of minimal risk research that have completed interventions. This change was intended to free up IRB resources to focus on higher-risk studies.
Emphasis on Prospective Review: The revised Common Rule emphasizes the importance of a thorough prospective review of research protocols, with the goal of identifying and mitigating potential risks upfront.
Increased Flexibility for Data Analysis: The revised Common Rule provides greater flexibility for researchers to analyze data that has already been collected, without requiring ongoing IRB review, as long as the data is de-identified.

Challenges and Best Practices

Despite the established framework for continuing review, challenges can arise. Here are some common challenges and best practices for addressing them:

Challenges:

Administrative Burden: Preparing and submitting continuing review reports can be time-consuming and burdensome for researchers, particularly for complex studies.
IRB Workload: IRBs often face heavy workloads, which can lead to delays in the review process.
Communication Barriers: Communication breakdowns between researchers and the IRB can lead to misunderstandings and delays.
Difficulty Assessing Risk: Accurately assessing the risks to participants can be challenging, particularly for studies involving vulnerable populations or novel interventions.
Keeping Up with Regulatory Changes: Staying informed about the ever-changing regulatory landscape can be difficult for both researchers and IRBs.

Best Practices:

Streamline the Reporting Process: Use electronic IRB systems and standardized reporting templates to simplify the preparation and submission of continuing review reports.
Prioritize High-Risk Studies: Focus IRB resources on reviewing higher-risk studies that require more intensive oversight.
build Open Communication: Establish clear lines of communication between researchers and the IRB. Encourage researchers to contact the IRB office with any questions or concerns.
Provide Training and Education: Offer regular training and education to researchers and IRB members on ethical research practices and regulatory requirements.
Use a Risk-Based Approach: Tailor the level of IRB review to the level of risk involved in the study.
Stay Informed: Subscribe to relevant newsletters and publications to stay up-to-date on regulatory changes and best practices in human subjects research.

The Future of Continuing Review

As research continues to evolve, so too will the process of continuing review. Emerging technologies, such as artificial intelligence and machine learning, are creating new opportunities and challenges for human subjects research. In real terms, it's likely that continuing review processes will need to adapt to address these new developments. Here's one way to look at it: IRBs may need to develop expertise in evaluating the ethical implications of AI-powered research tools and algorithms.

To build on this, there is a growing emphasis on promoting participant engagement in the research process. In the future, continuing review may involve seeking input from research participants themselves to assess the acceptability and impact of the study. This could involve incorporating participant feedback into the continuing review report or inviting participants to attend IRB meetings.

The Importance of Education and Training

Effective continuing review requires a well-informed research community. Ongoing education and training are essential for both researchers and IRB members. Training should cover a wide range of topics, including:

Ethical principles of human subjects research
Relevant regulations and guidelines
The continuing review process
Risk assessment
Informed consent
Conflict of interest
Data security and privacy

Education and training should be designed for the specific needs of the research community and should be updated regularly to reflect changes in regulations and best practices.

Conclusion

Continuing review is an indispensable component of ethical research, serving as a vital safeguard for protecting the rights and welfare of human subjects. Also, by systematically monitoring ongoing research, IRBs can confirm that studies remain compliant with ethical and regulatory standards, while also promoting a culture of continuous improvement in research practices. While challenges exist, by embracing best practices, staying informed about regulatory changes, and prioritizing education and training, researchers and IRBs can work together to strengthen the continuing review process and uphold the highest standards of ethical research. The future of continuing review will likely involve adapting to emerging technologies, promoting participant engagement, and fostering a more collaborative and transparent research environment.