IRB Checklist
IRB Checklist
General Items
- Understand the ethical principles of research involving human subjects
- Ensure participant confidentiality and data security measures are in place
- Plan for adverse event reporting and monitoring
Pre-Submission Preparation
- Identify the research project type
- Determine if IRB review is needed
- Consult institution's IRB guidelines
- Prepare all study materials (protocol, consent forms, etc.)
- Ensure all team members have completed required training
- Gather any additional documents (e.g., data collection tools, recruitment materials)
Submission Process
- Complete the IRB application form
- Attach all required documents
- Review application for completeness
- Submit application through the designated platform
- Confirm receipt of submission with the IRB
Post-Submission Steps
- Respond promptly to IRB requests for additional information
- Review IRB feedback and make necessary revisions
- Obtain IRB approval before starting the study
- Disseminate IRB approval to all team members
Ongoing Compliance
- Monitor for any changes in the study that require IRB notification
- Submit annual reports if required
- Ensure informed consent is obtained from participants
- Keep records of all communications with IRB
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