Policies and Procedures

The following policies and procedures implement federal Revised Common Rule regulations, which regulations generally were effective for FSU studies that were approved by the FSU IRB on or after January 21^st, 2019. Studies previously approved may still be subject to a prior iteration of the regulations. Please click this link for more information.

HUMAN RESEARCH PROTECTIONS PROGRAM

Florida State University has adopted Policy 7-IRB-0 as its University Human Subjects Policy.  This policy establishes the offices and jurisdiction of the Institutional Review Board (IRB) and the Office for Human Subjects Protection (OHSP) (also referred to as the University's Human Research Protections Program (or HRPP)), and the adoption of all subordinate Standard Operational Procedures which serve as the governing procedures for review and conduct of all human research conducted under the auspices of the University in accordance with applicable federal and state laws. 

To review the full Policy, please click the following link:  7-IRB-0

Note:  All of the documents on this page live in RAMP IRB under the IRB "Library" tab. Please check the IRB Library often, as the following documents are dynamic and will be updated according to applicable regulations, FSU, and/or other policies.

INVESTIGATOR PROCEDURES

• Soliciting, Recruiting and Paying Human Subjects—Investigator SOP
• Informed Consent Process for Research—Investigator SOP
• Written Documentation of Consent—Investigator SOP
• Investigator Manual—Investigator SOPs (in revision)
• Investigator Manual Appendix A-12—COVID-19 Considerations for Investigators Conducting Human Research

STANDARD OPERATIONAL PROCEDURES

• Definitions
• Observation of Consent Process
• Legally Authorized Representatives, Children, and Guardians
• Incoming Items
• Pre-Review
• Emergency and Device Compassionate Use Review
• New Information
• Investigations
• Suspension or Termination
• Emergency and Device Compassionate Use Post-Review
• Designated Reviewers
• Non-Committee Review Preparation
• Non-Committee Review Conduct
• Non-Committee Review Conduct (Pre-2018¹)
• IRB Meeting Preparation
• IRB Meeting Conduct
• IRB Meeting Attendance Monitoring
• IRB Meeting Minutes
• Not Otherwise Approvable Research
• Conflicting Interests of IRB Members
• Consultation
• Post-Review
• Daily Tasks
• Expiration of IRB Approval
• NIH GDS Institutional Certification
• IRB Records
• Standard Operating Procedures
• IRB Records Retention
• IRB Formation
• IRB Removal
• IRB Membership Addition
• IRB Membership Removal
• IRB Meeting Scheduling and Notification
• RAMP IRB Support Case Program
• COVID-19 Risk Mitigation Planning
• Group Email Management

OTHER

• Funding Allocated to IRB Members
• Membership of IRB Committee
• IRB Member Manual

¹Pre-2018: For studies originally approved before January 21^st, 2019.