Division of Research
IRB Guidelines
PROCEDURES
| IRB Investigator Manual Provides procedures and policies for investigators |
| IRB SOP Manual Standard Operating Procedures for the FIU IRB |
INFORMED CONSENT
| Consent Information Information on obtaining informed consent |
REVIEW CRITERIA
| Exempt and Expedited Criteria For determining the IRB review category |
| Human Subjects Decision Charts Charts for determining types of IRB review |
DATA SECURITY
| Data Security Tips to manage and protect confidential human subjects data |
| Certificates of Confidentiality Guidance on protecting sensitive information |
| Privacy Practices and HIPAA |
| Social Security Numbers Notification of Usage of Social Security Numbers |
SAFETY & MONITORING
| Data Safety & Monitoring For use with clinical trials and/or interventions |
| Adverse Event Reporting Information on reporting events and incidents to the IRB |
| Florida Abuse Hotline FAQs on reporting abuse or neglect to the DCF |
CLINICAL TRIALS
| WIRB Submissions Information on submitting protocols to Western IRB (WIRB) |
| Reviewing Clinical Trials A guide for the ethics committee |
RESEARCH VOLUNTEERS
| Becoming a Research Volunteer OHRP Pamphlet on Becoming a Research Volunteer |
OTHER USEFUL INFORMATION
| Approved Data Sets Data sets that do not require IRB approval |
| Miami-Dade County School Research Guidance on submissions to the FIU IRB and the MDCPS RCC |
| Oral History Guidance to clarify the issue of oral history projects and the IRB |
| Ethnography & IRB Review Guidance to clarify the issue of ethnographic projects |
