Policies & Procedures

Below is a listing if the standard operating procedures followed by the UCF IRB and IRB Office, as well as a listing of the checklists and worksheets that the IRB and IRB Office use to guide and document their decision-making. Investigators may be particularly interested in referencing checklist “HRP-414: Criteria for Approval and Additional Considerations.” IRB members must verify that these criteria are met, in compliance with federal regulations, in order to approve a protocol. Investigators may wish to review these checklists to ensure that, where applicable, they have addressed these issues in advance of IRB submission.

General References:

• HRP-101 – HUMAN RESEARCH PROTECTION PROGRAM PLAN
• HRP-102 – FLOWCHART
• HRP-103 – INVESTIGATOR MANUAL

Standard Operating Procedures:

• HRP-001 – SOP: Definitions
• HRP-010 – SOP: Annual Evaluations of the Human Research Protection Program
• HRP-011 – SOP: Observation of the Consent Process
• HRP-012 – SOP: Legally Authorized Representatives Children and Guardians
• HRP-020 – SOP: IRB Formation
• HRP-021 – SOP: IRB Removal
• HRP-022 – SOP: IRB Membership Addition
• HRP-023 – SOP: IRB Membership Removal
• HRP-024 – SOP: IRB Meeting Scheduling and Notification
• HRP-030 – SOP: IRB Meeting Preparation
• HRP-031 – SOP: IRB Meeting Conduct
• HRP-032 – SOP: IRB Meeting Attendance Monitoring
• HRP-033 – SOP: IRB Meeting Minutes
• HRP-034 – SOP: Review of Not Otherwise Approvable Research
• HRP-040 – SOP: Daily Tasks
• HRP-041 – SOP: Expiration of IRB Approval
• HRP-050 – SOP: Incoming Items Directed to the IRB
• HRP-051 – SOP: Pre-Review
• HRP-052 – SOP: Modifications Required to Secure Approval
• HRP-053 – SOP: Emergency Use of a Test Article in a Life Threatening Situation Review
• HRP-054 – SOP: New Information
• HRP-055 – SOP: Investigations
• HRP-056 – SOP: Suspension or Termination of IRB Approval
• HRP-060 – SOP: Designated Reviewers
• HRP-061 – SOP: Administrative Review Conduct
• HRP-062 – SOP: Administrative Review Preparation
• HRP-070 – SOP: IRB Records
• HRP-071 – SOP: Standard Operating Procedures
• HRP-072 – SOP: IRB Records Retention
• HRP-080 – SOP: Conflicting Interests of IRB Members and Consultants
• HRP-081 – SOP: Consultation to the IRB
• HRP-082 – SOP: Post-Review
• HRP-085 - SOP - Financial Conflicts of Interests of Investigators and Research Staff-sh

Checklists:

• HRP-411 – CHECKLIST: Human Research Determination
• HRP-412 – CHECKLIST: Exemption Determination
• HRP-413 – CHECKLIST: Review Using the Expedited Procedure
• HRP-414 – CHECKLIST: Criteria for Approval and Additional Considerations
• HRP-416 – CHECKLIST: Waiver or Alteration of the Consent Process
• HRP-417 – CHECKLIST: Waiver of Written Documentation of the Consent Process
• HRP-420 – CHECKLIST: Criteria for Approval and Additional Considerations for Humanitarian Use Device (HDE)
• HRP-431 – CHECKLIST: Research Involving Prisoners
• HRP-432 – CHECKLIST: Research Involving Pregnant Women
• HRP-433 – CHECKLIST: Research Involving Non-Viable Neonates
• HRP-434 – CHECKLIST: Research Involving Neonates of Uncertain Viability
• HRP-435 – CHECKLIST: Research Involving Children
• HRP-436 – CHECKLIST: Research Involving Adults Unable to Consent
• HRP-440 – CHECKLIST: Waiver of the Consent Process for Planned Emergency Research
• HRP-451 – CHECKLIST: Administrative Review
• HRP-452 – CHECKLIST: Contract Items Related to Human Participant Protections
• HRP-458 – CHECKLIST: Scientific or Scholarly Review
• HRP-461 – CHECKLIST: Drugs
• HRP-462 – CHECKLIST: Devices

Worksheets:

• HRP-501 – WORKSHEET: Expectations for Reviewers
• HRP-502 – WORKSHEET: Calculation of Approval Intervals and Expiration Dates
• HRP-503 – WORKSHEET: Communication of Review Results
• HRP-504 – WORKSHEET: Submission Materials
• HRP-515 – WORKSHEET: Short Form of Consent Documentation
• HRP-518 – WORKSHEET: Advertisements
• HRP-519 – WORKSHEET: Payments
• HRP-530 – WORKSHEET: Non-Significant Risk Device
• HRP-553 – WORKSHEET: Emergency Use of a Test Article in a Life Threatening Situation
• HRP-554 – WORKSHEET: Evaluation of Quorum and Expertise
• HRP-555 – WORKSHEET: IRB Composition
• HRP-556 – WORKSHEET: IRB Member Information
• HRP-557 – WORKSHEET: Review of Information Items
• HRP-561 - WORKSHEET - Drugs
• HRP-562 - WORKSHEET - Devices