Important Note:
UCLA is in the process of seeking accreditation of its Human Research Protection Program from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The policies and procedures listed below have been submitted to AAHRPP for review.
These policies and procedures are in effect, but may undergo revision as UCLA progresses through the accreditation process. Some items are currently unavailable as they undergo review by counsel.
The text of any Federal regulation cited in these policies may be found using the Electronic Code of Federal Regulations (e-CFR).
The text of any California law cited in these policies may be found using the Official California Legislative Information website.
The IRB/OPRS Policy Compilation (a 3 Mb searchable PDF file) includes all the individual policies listed below.
| 1 |
Human Subject Research Overview |
July 5, 2007 |
| 2 |
Activities Subject to UCLA IRB/OPRS Jurisdiction |
July 5, 2007 |
| 3 |
Human Subject Research Determinations |
July 5, 2007 |
| 4 |
Research Conducted by UCLA Students |
July 5, 2007 |
| 5 |
OPRS Review Process - Certification of Exemption from IRB Review |
July 5, 2007 |
| 6 |
IRB Review Process - Initial Review |
July 5, 2007 |
| 7 |
Materials Required for IRB Review |
July 5, 2007 |
| 8 |
IRB Review Process - Expedited Review |
February 11, 2008 |
| 9 |
IRB Review Process - Full Committee Review |
July 5, 2007 |
| 10 |
IRB Review Process - Continuing Review |
July 5, 2007 |
| 11 |
IRB Review of Modifications to Previously Approved Research |
July 5, 2007 |
| 12 |
IRB Review Process - Communication of IRB Actions |
February 12, 2008 |
| 13 |
IRB Review Process - Executive Committee |
July 5, 2007 |
| 14 |
IRB Process: Administrative Acceptance Review and Administrative Approval |
July 5, 2007 |
| 15 |
Biomedical Adverse Event Reporting |
July 6, 2006 |
| 16 |
IRB Process - Consultant Review |
July 5, 2007 |
| 17 |
Study Closure |
July 5, 2007 |
| 18 |
Approvals From Other Committees |
July 5, 2007 |
| 19 |
IRB Review Requirements |
July 5, 2007 |
| 20 |
Special Considerations for Projects Involving Vulnerable Populations |
July 5, 2007 |
| 21 |
Special Subject Populations: Children |
July 5, 2007 |
| 22 |
Special Subject Populations: Pregnant Women, Human Fetuses, and Neonates |
July 5, 2007 |
| 23 |
Special Subject Populations: Prisoners |
July 5, 2007 |
| 24 |
Special Subject Populations: Cognitively Impaired |
July 5, 2007 |
| 25 |
Special Subject Populations: Students and Employees |
July 5, 2007 |
| 26 |
Special Subject Populations: Non-English Speaking Subjects |
July 5, 2007 |
| 27 |
Third Party Subjects (a.k.a., Secondary Subjects) |
July 5, 2007 |
| 28 |
Subject Pools |
July 5, 2007 |
| 29 |
Informed Consent Process and Documentation |
February 11, 2008 |
| 30 |
Recruitment Methods & Tools |
July 5, 2007 |
| 31 |
Payment for Participation in Research |
July 5, 2007 |
| 32 |
Financial Obligations |
July 5, 2007 |
| 33 |
Emergency Care and Compensation for Injury |
July 5, 2007 |
| 34 |
FDA Requirements |
February 11, 2008 |
| 35 |
IRB Approved Research in an Emergency Setting |
February 11, 2008 |
| 36 |
Emergency Use of a Test Article |
February 11, 2008 |
| 37 |
Genetics Research |
July 27, 2007 |
| 38 |
Human Embryonic Stem Cell Research |
July 5, 2007 |
| 39 |
Research Involving Use of Human Specimens, and Specimen Banking |
July 5, 2007 |
| 40 |
Data Repositories (a.k.a., "Banks") |
July 5, 2007 |
| 41 |
Research Involving Secondary Use of Existing Data |
July 5, 2007 |
| 42 |
Research Involving Public Use Data Files |
June 17, 2008 |
| 43 |
Data Security Guidelines |
July 5, 2007 |
| 44 |
Research Involving the Internet |
July 5, 2007 |
| 45 |
Research Involving Multiple Performance Sites or Collaborating Agencies or Institutions |
February 11, 2008 |
| 46 |
Research Conducted in International Settings |
July 5, 2007 |
| 47 |
Family Educational Rights and Privacy Act (FERPA) |
July 5, 2007 |
| 48 |
Protection of Pupil Rights Amendment (PPRA) |
July 5, 2007 |
| 49 |
Health Insurance Portability and Accountability Act (HIPAA) |
|
| 50 |
Special State Laws: Minor Subjects |
|
| 51 |
Reporting Suspected Abuse of Children, Elderly Individuals, and Others |
July 5, 2007 |
| 52 |
Reporting of Diseases and Conditions Identified in the Course of Research |
July 5, 2007 |
| 53 |
Noncompliance |
July 27, 2007 |
| 54 |
Consent Monitoring |
July 5, 2007 |
| 55 |
Protocol Violations |
July 27, 2007 |
| 56 |
Incident Reporting |
July 27, 2007 |
| 57 |
Unanticipated Problems Involving Risks to Subjects or Others |
July 6, 2006 |
| 58 |
Subject Complaints |
July 27, 2007 |
| 59 |
Suspension and Termination of Research |
July 27, 2007 |
| 60 |
Reporting Procedures For Unanticipated Problems, Suspension, or Termination |
July 27, 2007 |
| 61 |
Investigator Responsibilities |
July 27, 2007 |
| 62 |
Investigator and Key Personnel Training |
July 5, 2007 |
| 63 |
Investigator Financial Interests and Conflicts of Interest |
July 5, 2007 |
| 64 |
IRB Staff Training |
July 5, 2007 |
| 65 |
IRB Membership |
July 5, 2007 |
| 66 |
IRB Member Training |
July 5, 2007 |
| 67 |
IRB Member Conflict of Interest |
July 5, 2007 |
| 68 |
IRB Meeting Administration |
July 5, 2007 |
| 69 |
IRB Meeting Minutes |
July 5, 2007 |
| 70 |
IRB Office Records |
February 11, 2008 |
| 71 |
Media Interviews |
July 5, 2007 |
|
Adverse Events (Biomedical) |
April 1, 2005 |
|
Certificate of Confidentiality |
November 14, 2007 |
|
Data Banking |
|
|
Disclosure of Financial Interests |
February 20, 2007 |
|
Emergency Care and Compensation for Injury |
March 16, 2006 |
|
Fees for Reviews of Industry-Sponsored Clinical Trials |
2002 |
|
Gift Policy and Human Subjects Research |
April 6, 2004 |
|
HIPAA |
May 2005 |
|
HIV Reporting |
July 6, 2006 |
|
Incident Reports (General) |
|
|
International Research Checklist - For Researchers |
June 2, 2008 |
|
Multisite Research |
May 26, 2006 |
|
Navy-Supported Research |
June 6, 2007 |
|
Oral History |
December 10, 2003 |
|
Proxy Informed Consent |
November 25, 2002 |
|
Screening Research Subjects |
October 7, 2001 |
|
Suicide Risk and Research Protocols |
May 26, 2006 |
|
Tissue Banking |
2005 |
|
UCLA/RAND Memorandum of Understanding |
August 29, 2006 |
|
