HRP Policies and Procedures

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I. IRB Authority & Institutional Commitment

01 Institutional Oversight of Assurance
02 Activities Subject to IRB Jurisdiction

II. Conducting Research

03 Research Involving Performance Sites
04 Offsite Research, Cooperative Research and Research at UCI-affiliated Institutions
15 Research with Human Specimens and Data; Establishment of Specimen-Data Repositories
16 Human Subject Research- Non Human Subject Research Determination
24 Subject Privacy, Protection of Confidentiality and Data Security
26 Compensation for Injury that Occurs During Participation in Research
27 Research Conducted at International Performance Sites
28 Research Involving Use of the Internet
29 Applicable State Laws-Regulations
44 Data and Safety Monitoring
47 Billing of Research Participants
56 Department of Defense Supported Research
57 Veterans Affairs Supported Research

III. Records, Documentation & Fees

05 IRB Records and Documentation
06 IRB Fees for Industry-Supported Applications

IV. Committee Roles & Responsibilities

7 Composition of IRB Committees
08 Committee Member Compensation and Responsibilities
09 IRB Committee Member and Consultant Conflicting Interest
10 IRB Committees' Relationship to Other University Committees Departments and Units

V. IRB Review Process

11 IRB Committee Determinations-Motion
12 IRB Review of Human Subjects Research - Exempt
13 IRB Review of Human Subjects Research – Expedited
14 IRB Review of Human Subjects Research Full Committee
23 Risk-Benefit Analysis

VI. Researcher Responsibilities

17 Modifications to Previously Approved or Registered Research
18 IRB Continuing Review
19 Reporting of Adverse Events and Unanticipated Problems
20 Completion of Study-Study Closure
25 Investigator and Research Personnel Conflicts of Interest

VII. Informed Consent Process

21 Participant Compensation
22 Advertisement and Recruitment
30 Prospectively Obtained and Legally Effective Informed Consent
31 Documentation of Informed Consent for Human Subjects
32 Waiver of Informed Consent for Human Subjects Research or for Planned Emergency
33 Assent-Dissent by Children or Cog Impaired Adults
34 Approval and Expiration Dates on Informed Consent Documents
35 Policy for the Role of a Witness and-or Participant Advocate

VIII. Vulnerable Populations

36 Children
37 Prisoners
38 Pregnant Women, Human Fetuses, Neonates, and Fetal Tissue
39 Individuals Who Are Cognitively Impaired or Mentally Disabled
40 UCI Students and Employees

IX. Investigational Drugs & Devices

41 Investigational Drugs, Agents, and Biologics
42 Investigational Devices
43 Use of a Placebo
45 Emergency Use of a Test Article in a Life Threatening Situation
46 Humanitarian Use Devices

X. Education & Training

48 Education and Training of Lead Researchers and Research Personnel
49 Education and Training of IRB Members
58 UCI HRPP Policy and Procedure Glossary

XI. IRB Compliance & Quality Improvement

50 HRP EQUIP Activities
51 Administrative Hold, Suspension, and Termination of IRB Approval
52 Research Non-compliance
53 Reporting to the Appropriate Institutional Officials
54 Concerns and Complaints Regarding Human Subjects Research
55 Protocol Deviation and Violation Reporting