IRB Policies & Procedures

IRB TOPAZ Online Protocol Submissions: Instructions on submitting an online IRB application
IRB Investigator Manual: Procedures and policies for investigators
IRB SOP Manual: Standard Operating Procedures for the FIU IRB
IRB Non-Compliance SOP: Process for Allegations of IRB Non-Compliance
IRB SOP on MRI Research: IRB requirements for using the FIU MRI machine

Determining if IRB Review is Needed: Types of studies that do not need IRB review
Types of IRB Review: Brief Overview of Exempt, Expedited, and Full Board Review
IRB Exempt Review: Explanation of Exempt Review and Categories
IRB Expedited Review: Explanation of Expedited Review and Categories
IRB Full Board Review: Explanation of Full Board Review Process

Privacy Practices and HIPAA: Information on using medical records
Educational Records and FERPA: Information on using student records
Data Safety & Monitoring: Information on monitoring and protecting human subjects data
Data Management Security: Tips to help manage and secure human subjects data
Certificates of Confidentiality: Guidance on protecting sensitive information
Use of Social Security Numbers: Notification of Usage of Social Security Numbers

Adverse Event Reporting: Information on reporting events and incidents to the IRB
Protocol Deviation Reporting: Information on reporting protocol deviations to the IRB
Data Safety & Monitoring: Information on monitoring your research project
Florida Abuse Hotline Information: FAQs on reporting abuse or neglect to the DCF
QA/QI Program: Information on quality assurance and improvement

Clinical Trials: Information on registration, training requirements, and other resources
WCG IRB Submissions: Information on submitting protocols to WCG IRB (formerly WIRB)

IRB Reliances: Information on making requests to rely on an external IRB for oversight
Single IRB: Information on the NIH and OHRP Single IRB requirements

Florida Laws: Information on Florida laws that impact human subject research
Lotteries, Raffles, or Drawings: Guidance on why these cannot be used for compensation
Useful Acronyms: Acronyms on IRB-related subjects
Regulatory Resources: Helpful links to regulatory information
Miami-Dade County School Research: Guidance on submissions to the MDCPS RCC
Ethnography Projects: Guidance to clarify the issue of ethnographic projects
Non-FIU Researchers: Procedures for external researchers to recruit on the FIU campus
International Research: International Compilation of Human Research Standards
Community-Engaged Research – Helpful resources on Community-Engaged Research (CEnR)
Student Agreement: An “optional” agreement template for advisors to use with their students