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• ABOUT UCLA IRBS
• Federalwide Assurance
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Download the Entire Manual (550KB)
Search the Index
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View the Appendix

Prologue

1. Introduction

•  
  • Research Defined
  • Research: A Shared Responsibility
• The Foundation of 45 CFR 46: The Belmont Report
  • Respect
  • Beneficence
  • Justice

2. Application Submission

•  
  • The Basic Application
  • Pilot Studies:
  • If The Research is Conducted Off Campus or Recruitment is Performed Off-Campus:
  • When Research Requires the Review of Other Institutional Committees:
  • If the Research Involves Advertisements, Posters, Flyers, Press Releases, etc., to Recruit Subjects:
  • If the Research Includes Surveys, Questionnaires, etc.,
  • Drug and Device Brochures:
  • Claim of Exemption
  • Modifications to Currently Approved Research (Addendum):
    • Changing Investigators:
  • Continuation Review:
  • Renewal:
  • Completion/Termination:
  • Training Grants, Program Projects/Multiple Project Grants, Center Grants:

3. The HSPC Review Process

•  
  • The Human Subject Protection Committees
  • Issues Considered by the HSPC
• Levels of Review
  • Full Committee Review
  • HSPC Meetings
  • Expedited Review
• Exempt from HSPC Review
  •  
    • Anonymous data:
    • Residual Biological Material or Tissue/A Prospective Study:
    • Residual Biological Material or Tissue/A Retrospective Study:
    • Extra Biological Material or Tissue/A Prospective Study:
• Study of Existing Data or Human Biological Specimens for Non-genetic Research
  • Existing Material/Data
  • Extra Material

4. Informed Consent Requirements

• The Process of Informed Consent
  • Writing the Consent Form
• Description of Informed Consent Forms
  • General Requirements
  • Purpose of the Study
    • Pilot Studies or Phase I Drug Studies:
  • Procedures
  • Potential Risks and Discomforts
  • Anticipated Benefits to Subjects
  • Anticipated Benefits to Society
  • Alternatives to Participation
  • Payment for Participation
  • Possible Commercial Products
  • Financial Obligation
  • Emergency Care and Compensation for Injury
    • Privately Sponsored Drug and Device Trials
  • Privacy and Confidentiality
    • Limits to Confidentiality:
    • Confidentiality of Audio/Video-Tapes and Photographs:
    • Releasing Information:
  • Participation and Withdrawal
    • Consequences of Withdrawal
  • New Findings
  • Identification of Investigators
  • Rights of Research Subjects
  • Additional Elements
• Modifying the Consent Process
  • Waiver of Documentation of Informed Consent
  • Waiver or Alteration of Informed Consent
• Assent and Parental Permission for the Participation of Children in Research
  • Assent for Children
  • Parental Permission
    • Conditions of Confidentiality for Parental Permission:
  • Waiver of Parental or Guardian Permission
  • Children Under Seven Years of Age
  • Writing the Assent Form for Children From 7-12 Years of Age
    • Condition of Confidentiality for Child’s Assent:
  • Youth Assent Form
• Assessing Capacity to Consent
  • HSPC Approved Research in the Emergency Room or ICU
  • Individuals With Severe Cognitive or Psychiatric Disorders
    • Determining Decision-Making Capacity
  • Who May Consent on Behalf of Incapacitated Individuals
  • Research Involving Withdrawal of Psychotherapeutic Drugs
• Deception or Withholding Information
  • Debriefing

5. Risk/Benefit Assessment

• HSPC Considerations
• Identification and Assessment of Risks
  • Physical Risks
  • Psychological Risks
  • Social and Economic Risks
  • Minimal Risk
• Benefits

6. Selection & Recruitment of Subjects

•  
  • Selection of Subjects
  • Recruitment of Subjects
    • Recruitment tools:
  • Payment for Participation in Research
  • Recruitment of Children
    • Permission of the School:

7. Responsibilities of Principal Investigators

• Application and Definitions
• Student Research
  • Classroom Research
• Research Files
• Record Retention and Confidentiality of Data
  • Record Retention
  • Confidentiality
    • Guidelines for Protecting Confidentiality
  • Certificates of Confidentiality
• Reporting Adverse Events, Complications or Complaints
• Audits
• Research Performed at Non-UCLA Sites
  • Research Conducted at other Institutions with an OPRR Approved MPA
  • Research Conducted at a Site Without an OPRR Approved MPA
  • Research Conducted at a Foreign Site
• Closing Studies
• Conflicts of Interest

8. Special Classes of Research Subjects

• Fetuses
  
• Research Involving Pregnant Women or Fetuses and the Requirements for Informed Consent


• Science/Risk-Benefit: 45 CFR 46.204
  
• Informed Consent: 45 CFR 46.204
• Research with Pregnant Women or Fetuses that is Not Otherwise Approvable
  
• Research with Human Embryonic Stem Cells (hESC)
  
  Compliance with State and Local Laws
• Research Involving After Delivery, the Placenta, the Dead Fetus, or Fetal Material
• Women
  • Pregnant Women as Human Research Subjects
  • Women of Childbearing Potential as Human Research Subjects
    • Risk to Fertility
    • Risk to Fetus and/or Infant
    • Active Recruitment of Women
    • Sample Informed Consent Statement to be Included for a Potentially Toxic Drug Study
• Minorities
• Children
  •  
    • Parental Permission and Research of Minimal Risk:
    • Parental Permission and Research of More than Minimal Risk:
• Terminally Ill Patients
• Prisoners
  • Categories of Research in Which Prisoners May Participate
  • Additional Duties of the HSPC
• Students and Employees
  • Students
  • Employees

9. FDA Requirements

• Investigational Drugs, Biologics, and Devices
  • INDs and IDEs
    • Investigators as Sponsors
    • Protocol Design Requirements
      • Sufficiency of Animal and In Vitro Studies
      • 30-day Hold
    • The Approved Protocol Must Be Followed
    • Records Required by FDA
• Studies of Investigational Drugs or Biologics
  • Controlled Studies
  • Phase 1 Drug Trials
  • Phase 2 Drug Trials
  • Phase 3 Drug Trials
  • Phase 4 Drug Trials
• Informed Consent Requirements
  • Permissible Exceptions for Patient Care
    • "Off-Label" (Unapproved) Use in Medical Practice
    • Treatment Use of Investigational New Drugs (Treatment INDs)
  • HSPC Responsibility for Treatment INDs
  • Single Patient ("Non-Emergency") Use
  • Parallel Track
    • HSPC Responsibility for Parallel Track
    • Investigators’ Responsibility for Parallel Track Studies
• Investigations Involving Medical Devices (IDE)
  • Class 1 Medical Devices
  • Class 2 Medical Devices
  • Class 3 Medical Devices
  • 510(K) Devices
  • Significant and Non-Significant Risk Devices
  • Studies Involving Nonsignificant Risk Devices
  • Studies Involving Significant Risk Devices
• Emergency Use of a Test Article
  • UCLA Procedures for Emergency Use of a Test Article
• Radiology Devices and Radioactive Materials
  • Reviews Required by the HSPC, MRSC, RDRC
    • MRSC Authority
    • RDRC Authority
    • RDRC Review
  • Informed Consent
    • Radiation Exposure for Clinical Care (Diagnosis or Therapy)
    • Radiation Exposure for Research Purposes (Including Use of Radioactive Tracers)
  • Positron Emission Tomography (PET)
  • Federal and State Requirements

10. Special State of California Requirements

• Subject’s Bill of Rights
• Reporting Suspected Abuse of Children, Elderly Individuals, and Others
  • Child Abuse
  • Elder Abuse
    • Physical Abuse of an Elder:
    • Other Forms of Elder Abuse:
  • Definitions
• State of California Cancer Reporting System
  • HSPC Policy
  • Research Advisory Panel

11. Glossary

12. Application Forms

• Application to Involve Human Subjects in Research (Form HS-1)
• Sample Consent Form for Medical Research (Form HS-2)
• Sample Informed Consent Form for Research that Includes Identified Tissue or Genetic Material (Form HS-2a)
• Sample Informed Consent Form for Research that Includes Anonymous or Anonymized Tissue or Genetic Material (Form HS-2b)
• Sample Consent Form for Non-Medical Research (Form HS-3)
• Sample Assent Form (Form HS-3a)
• Reporting Adverse Events Occurring at UCLA (Form HS-5)
• Reporting Adverse Events Occurring at Non-UCLA Locations (Form HS-6)
• Claim of Exemption from Human Subject Protection Committee Review (Form HS-7)
• Final Report Form (Form HS-8)

13. Appendix For photocopies of the appendices please contact OPRS.

1. Title 45, Code of Federal Regulations, Part 46
2. Title 21, Code of Federal Regulations, Part 50, 56 (FDA, Informed Consent, IRBs)
3. Title 21, Code of Federal Regulations, Part 312, 600 (FDA, Investigational Drugs, Biologics)
4. Title 21, Code of Federal Regulations, Parts 361.1 (FDA Radioactive Drugs for Certain Research Uses)
5. Title 21, Code of Federal Regulations Part 812 (FDA, Investigational Devices)
6. FDA Examples of Nonsignificant Risk and Significant Risk Devices
7. The Belmont Report
8. NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research
9. UCLA FWA
10. California State Law on Child and Elder Abuse
11. (370KB) February 3, 1995, memorandum from the Office of the President, "Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects"
12. (170KB) November 8, 1995, correspondence from Barbara A. Levey, Assistant Vice Chancellor-Biomedical Affairs to Dr. Brian Kimes, National Cancer Institute, regarding "Human Subject Cancer Research at UCLA"
13. (115KB) January 12, 1996, memorandum to Department Chairs, Division Chiefs, Cancer Center Members from Judith C. Gasson, Director, Jonsson Comprehensive Cancer Center, regarding, "New NCI Guidelines for Clinical Cancer Protocol Scientific Review"
14. (260KB) December 20, 1996. memorandum from Joanna M. Beam, Office of the General Counsel to Deans of Medical Schools and Vice Chancellors for Research, "California Application of FDA and NIH Exceptions to Informed Consent Requirements"
15. (70KB) Information regarding the General Clinical Research Center
16. Form for Assessing a Subject’s Capacity to Consent to Participation in Research
17. November 16, 1998, memorandum from Wyatt R. Hume, Executive Vice Chancellor, Chairperson, Human Research Policy Board, "Research with Human Tissues and Genetic Material"

14. Index

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