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For Administrative Use Only Protocol # University of Illinois at Springfield Institutional Committee for the Care and Use of Animals (ICCA) Continuing Review of an Existing Animal Care and Use Protocol

How to fill out continuing review of an

How to Fill Out Continuing Review of an:

1. Start by reviewing the instructions provided by your institution or the regulatory body overseeing the review process. It is important to familiarize yourself with the specific requirements and guidelines to ensure that your review is completed accurately and efficiently.
2. Gather all relevant documents and information related to the study or project. This may include previous approval letters, protocol amendments, participant information sheets, consent forms, and any adverse event reports or changes made since the initial approval.
3. Begin by completing the cover page of the continuing review form. This typically includes basic information such as the title of the study, principal investigator's name, contact information, and the date of the review.
4. Provide a summary of the progress of the study or project since the last review. Highlight any significant milestones, recruitment updates, changes in personnel, or modifications made to the study protocol. Be thorough and concise in your descriptions.
5. Evaluate the overall risk level associated with the study. Assess whether there have been any adverse events, unanticipated problems, or deviations from the approved protocol during the review period. It is crucial to document any risks or issues and provide a plan for mitigation or corrective actions if necessary.
6. Consider whether any changes to the study design, procedures, or informed consent process are required. If so, provide a detailed description of the proposed changes and the rationale behind them. This may include updates to recruitment strategies, data collection methods, or participant eligibility criteria.
7. Review the status of informed consent for all participants and ensure that necessary documentation is on file. Confirm that participants have given their informed consent, understand the nature of the study, and are aware of any potential risks or benefits. This is a critical aspect of ensuring ethical conduct throughout the research or project.
8. Complete any additional sections or questions included in the continuing review form, such as those related to financial conflicts of interest or updates on research funding.

Who Needs Continuing Review of an:

1. Researchers or investigators conducting studies involving human subjects typically need to undergo a continuing review process. This ensures that ethical standards are maintained, participant safety is prioritized, and any necessary modifications or updates are evaluated.
2. Institutional review boards (IRBs) or ethics committees are responsible for overseeing the continuing review of studies. They ensure that the research complies with applicable laws, regulations, and institutional policies. IRBs play a vital role in protecting the rights and welfare of human subjects involved in research.
3. Sponsors or funding agencies may also require researchers to undergo continuing review as part of the ongoing monitoring and assessment process. This helps to ensure that the research remains within the scope of the original approved protocol and that any adverse events or risks are promptly addressed.

Overall, the continuing review process serves as a mechanism for ongoing evaluation and oversight, promoting the responsible conduct of research and the protection of human subjects' rights and welfare.

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