The HRPP Toolkit library is a set of documents primarily for use and reference by the Human Research Protection Program (HRPP), IRB staff, and IRB members. The research community is encouraged to review the documents that may pertain to their studies, including the standard operating procedures for consent processes and documentation (HRP-090, HRP-091).
Investigator Manual
The Investigator Manual is designed to guide investigators through the policies and procedures relating to the conduct of human research that are specific to The University of Alabama.
Templates & Forms for Investigators
Investigators preparing IRB submissions use these templates for protocols and consent documents. Additional IRB templates are provided to promote transparency of IRB operations. Forms are used by IRB staff, members, and investigators as a reference or tool for IRB submissions.
Templates
- Protocol Writing
- Informed Consent
- Multisite Research
- Other
Forms
- Multisite
- Incident Reporting
- Continuing Review
- IRB and HRPP Review Documents
General Documents, Resources & Guidance
These general documents are for general information and use by the IRB and investigators. The UA HRPP also provides other resources and guidance related to IRB submissions.
General Documents
- HRP-100 – Huron HRPP Toolkit Table of Contents
- HRP-101 – Human Research Protection Program Plan
- HRP-103 – Investigator Manual
- HRP-103p – Investigator Manual – pSite
- HRP-104 – Brochure – Should I Take Part in Research?
- HRP-105 – OHRP FDA Written Procedure Crosswalk
- HRP-108 – FLOWCHART – Study-Specific Emergency-Disaster Risk Mitigation Planning
Resources & Guidance
Informed Consent
- Guidance: Writing Understandable Consent Forms
- Exempt Consent Information Sheet
- Guidance: Deception Concealment
- Guidance: Decision Making Capacity Assessment
- University Medical Center Authorization for Use or Disclosure of Health Information
- Guidance: Examples of Assent Forms
Privacy and Confidentiality
- Family Educational Rights and Privacy Act (FERPA)
- Guidance: Anonymous Confidential De-identified
- Guidance: Mandatory Reporting Laws Alabama
Research with Special Populations
- Guidance: Human Subjects in HIV AIDS Research
- Guidance: Student Research Participants
- Guidance: International Research
Secondary use Research
Other
IRB and HRPP Review Documents
Standard Operating Procedures (SOPs)
These standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, and function.
Standard Operating Procedures
- HRP-001 – SOP – Definitions
- HRP-012 – SOP – Observation of Consent Process
- HRP-013 – SOP – LARs, Children, and Guardians
- HRP-020 – SOP – Incoming Items
- HRP-021 – SOP – Pre-Review
- HRP-023 – SOP – Emerg and Device Comp Use Review
- HRP-024 – SOP – New Information
- HRP-025 – SOP – Investigations
- HRP-026 – SOP- Susp or Term Issued Outside of Conv IRB
- HRP-027 – SOP – Emerg Use Comp Use Indiv Pt Access Post Rev
- HRP-030 – SOP – Designated Reviewers
- HRP-031 – SOP – Non-Committee Review Preparation
- HRP-032 – SOP – Non-Committee Review Conduct
- HRP-040 – SOP – IRB Meeting Preparation
- HRP-041 – SOP – IRB Meeting Conduct
- HRP-042 – SOP – IRB Meeting Attendance Monitoring
- HRP-043 – SOP – IRB Meeting Minutes
- HRP-044 – SOP – Not Otherwise Approvable Research
- HRP-050 – SOP – Conflicting Interests of IRB Members
- HRP-051 – SOP – Consultation
- HRP-052 – SOP – Post-Review
- HRP-060 – SOP – Annual Evaluations of the HRPP
- HRP-061 – SOP – Quarterly Evaluations of the HRPP
- HRP-062 – SOP – Daily Tasks
- HRP-063 – SOP – Expiration of IRB Approval
- HRP-064 – SOP – NIH GDS Institutional Certification
- HRP-065 – SOP – Response Plan for Emergencies-Disasters Impacting the HRPP
- HRP-070 – SOP – IRB Records
- HRP-071 – SOP – Toolkit Management
- HRP-072 – SOP – IRB Records Retention
- HRP-080 – SOP – IRB Formation and Registration
- HRP-081 – SOP – IRB Removal
- HRP-082 – SOP – IRB Membership Addition
- HRP-083 – SOP – IRB Membership Removal
- HRP-084 – SOP – IRB Meeting Scheduling and Notification
- HRP-090 – SOP – Informed Consent Process for Research
- HRP-091 – SOP – Written Documentation of Consent
- HRP-801 – SOP – Establishing Authorization Agreements
- HRP-802 – SOP – Institutional Profile Management
- HRP-804 – SOP – External IRB Post-Review
- HRP-805 – SOP – External IRB Updates
- HRP-806 – SOP – Review Request to Rely on External IRB
Worksheets
IRB staff and members use these worksheets as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.
Worksheets
- HRP-301 – WORKSHEET – Review Materials
- HRP-302 – WORKSHEET – Approval Intervals
- HRP-303 – WORKSHEET – Communication of Review Results
- HRP-304 – WORKSHEET – IRB Composition
- HRP-305 – WORKSHEET – Quorum and Expertise
- HRP-306 – WORKSHEET – Drugs and Biologics
- HRP-307 – WORKSHEET – Devices
- HRP-308 – WORKSHEET – Pre-Review
- HRP-309 – WORKSHEET – Ancillary Review Matrix
- HRP-310 – WORKSHEET – Human Research Determination
- HRP-311 – WORKSHEET – Engagement Determination
- HRP-312 – WORKSHEET – Exemption Determination
- HRP-313 – WORKSHEET – Expedited Review
- HRP-314 – WORKSHEET – Criteria for Approval
- HRP-315 – WORKSHEET – Advertisements
- HRP-316 – WORKSHEET – Payments
- HRP-317 – WORKSHEET – Short Form of Consent Documentation
- HRP-318 – WORKSHEET – Additional Federal Agency Criteria
- HRP-319 – WORKSHEET – Limited IRB Review and Broad Consent
- HRP-320 – WORKSHEET – Scientific or Scholarly Review
- HRP-321 – WORKSHEET – Review of Information Items
- HRP-322 – WORKSHEET – Emergency Use
- HRP-323 – WORKSHEET – Criteria for Approval HUD
- HRP-324 – WORKSHEET – Contracts
- HRP-325 – WORKSHEET – Device Compassionate Use
- HRP-326 – WORKSHEET – Performance Evaluation for IRB Chairs
- HRP-327 – WORKSHEET – Performance Evaluation for IRB Members
- HRP-328 – WORKSHEET – Performance Evaluation for IRB Staff
- HRP-330 – WORKSHEET – HIPAA Authorization
- HRP-331 – WORKSHEET – FERPA Compliance
- HRP-332 – WORKSHEET – NIH GDS Institutional Certification
- HRP-333 – WORKSHEET – Certificate of Confidentiality
- HRP-351 – WORKSHEET – Protocol-Specific Emergency-Disaster Risk Mitigation Planning
- HRP-352 – WORKSHEET – Additional Emergency-Disaster Review Considerations
- HRP-830 – WORKSHEET – Communication and Responsibilities
- HRP-832 – WORKSHEET – Considerations for Relying on External IRB
- HRP-833 – WORKSHEET – Considerations for Serving as sIRB
Checklists
IRB members and staff use these checklists to consider and document regulatory items and enhance compliance with federal, state, and local requirements.
Checklists
- HRP-401 – CHECKLIST – Pre-Review
- HRP-402 – CHECKLIST – Non-Committee Review
- HRP-410 – CHECKLIST – Waiver or Alteration of Consent Process
- HRP-411 – CHECKLIST – Waiver of Written Documentation of Consent
- HRP-412 – CHECKLIST – Pregnant Women
- HRP-413 – CHECKLIST – Non-Viable Neonates
- HRP-414 – CHECKLIST – Neonates of Uncertain Viability
- HRP-415 – CHECKLIST – Prisoners
- HRP-416 – CHECKLIST – Children
- HRP-417 – CHECKLIST – Cognitively Impaired Adults
- HRP-418 – CHECKLIST – Non-Significant Risk Device
- HRP-419 – CHECKLIST – Waiver of Consent Process for Emergency Research
- HRP-430 – CHECKLIST – Investigator Quality Improvement
- HRP-431 – CHECKLIST – Minutes Quality Improvement
- HRP-441 – CHECKLIST – HIPAA Waiver of Authorization