- Authority and Overview of the Human Research Protection Program
- OHRPP Educational Outreach and Requirements
- Activities that Require IRB Review
- Applying to the IRB
- Pre-IRB Submission
- Levels and Types of IRB Review
- Post-IRB Submission
- Recruitment, Screening and Informed Consent
- Protection of Privacy, Confidentiality and Data
- Research Involving Use and Storage of Data and/or Human Biological Specimens
- Types of Research and Procedures
- Biomedical
- Social, Behavioral and Educational Research
- Populations
- Financial Considerations
- Post IRB Approval Activity and PI Reporting Requirements
- PI Reporting Requirements
- Decision Trees for Reporting
- Other Post Approval Activities
- IRB Activities, Procedures and Documentation
- Quality Improvement Activities
2. OHRPP Educational Outreach and Requirements
3. Activities that Require IRB Review
- Determining which Activities Require UCLA OHRPP/IRB Review
- Collection, Use, Sharing and Secondary Analyses of Human Specimens and/or Data for Research Purposes
- Research Conducted by UCLA Students
- Research Conducted in International Settings
- Reliance (Guidance and Procedures)
- Administrative Review for Human Research Studies Not Being Conducted by a UCLA Principal Investigator But Accessing UCLA Facilities, Patients or Personnel (Faculty, Staff or Students)
4. Applying to the IRB
Pre-IRB Submission:
- Getting Started with an IRB Application-A Guide for Investigators and Research Staff
- Brief Overview of webIRB Submission Procedures
- Conducting Risk-Benefit Assessments and Determining Level of IRB Review
- Describing Research Design and Methods
- Scientific or Scholarly Review of Human Subjects Research Protocols
- Tip Sheet: Minimal Risk
- Funding Considerations for Federally-Funded and Industry Sponsored Human Research
- Funding Applications and UCLA IRB Review
- Tip Sheet: Delayed Onset Determinations
- Research Supported by the Department of Defense
- Additional Requirements for Federally Supported Research
Levels and Types of IRB Review
- Certification of Exemption from IRB Review
- Expedited Review
- Extended Approval for Minimal Risk Research Not Subject to Federal Oversight
- Full Committee Review
- Amendments to Previously Approved Research
- Continuing Review
- Tip Sheet: Annual Assurances *NEW
- Materials Required for IRB Review and Approval
Post-IRB Submission
5. Recruitment, Screening and Informed Consent
6. Protection of Privacy, Confidentiality and Data
- Quick Guide: Protecting Privacy and Maintaining Confidentiality
- Tip Sheet: Certificates of Confidentiality
- Health Insurance Portability and Accountability Act (HIPAA)
- HIPAA Authorization Form: University of California Permission to Use PHI for Research
- Tip Sheet: Protected Health Information and Personal Identifying Information
- Data Security in Research
- Family Educational Rights and Privacy Act (FERPA)
- Reporting of Diseases and Conditions Identified in the Course of Research
- Reporting Suspected Abuse of Children, Elderly Individuals, and Others
- Media Interviews
7. Research Involving Use and Storage of Data and/or Human Biological Specimens
8. Types of Research and Procedures
Biomedical:
- ClinicalTrials.gov Registry
- Experimental Drugs and Devices
- Use of Drugs and Biologics in Clinical Research and Treatment
- Tip Sheet: Exemptions from IND Requirements for Clinical Research
- Emergency Use of a Test Article
- Right to Try
- Humanitarian Use Device (HUD)
- Sample Investigational Agent Accountability Log
- Use of Devices in Clinical Research and Treatment
- Significant and Non-Significant Risk Devices
- Tip Sheet: Exemptions from IDE Requirements for Clinical Research
- Sample Investigational Device Accountability Log
- Planned Research in an Emergency Setting with Waiver of Consent
9. Populations
- Research Involving Children and Minors
- Child Assent and Permission by Parents or Guardians
- Chart for Regulatory Requirements for Children
- Research Involving Persons with Cognitive Impairments
- Research Involving Non-English Speaking Research Subjects
- Checklist for Using the "Short Form" Method of Consent for Non-English Speaking Research Participants
- Research Involving Pregnant Women, Fetuses and Neonates or InVitro Fertilization
- Chart for Regulatory Requirements for Pregnant Women, Fetuses and Neonates
- Research Involving Prisoners
- Research Involving Visually and/or Hearing Impaired Participants or Participants Who Are Illiterate
- Students and Employees
- Student Subject Pools
- Secondary Subjects
10. Financial Considerations
- Payment for Participation in Research
- Payment Options for Human Research Participants *NEW
- Treatment and Compensation for Research Related Injury
- Researcher Financial Interests and Conflict of Interest
- UCLA-OHRPP Review Fees for IRB Protocol Review
- Commensurate Protections for Non-Federally Funded Human Subjects Research
11. Post IRB Approval Activity and PI Reporting Requirements
PI Reporting Requirements
- Post-Approval Reporting (PAR)
- Complaints, Concerns and Suggestions, and Reports of Undue Influence Regarding the Conduct of Human Participants Research
- Closure of Human Subjects Research Studies
- Protocol Deviation or Incident Summary log
Decision Trees for Reporting
Other Post Approval Activities
12. IRB Activities, Procedures and Documentation
- Requirements for IRB Review and Approval
- IRB Documentation of Activities
- IRB Membership
- IRB Member Conflict of Interest
- Communication of Results of IRB Review
- Use of Human Subjects Research Data and/or Biospecimens Collected Without Prior IRB Approval
- Referral to the IRB Executive Committee
- IRB Reporting Procedures for Unanticipated Problems, Noncompliance, Suspension or Termination
- Commensurate Protections for Non-Federally Funded Human Subjects Research
13. Quality Improvement Activities
Page Last Updated: December 5, 2023