UCI Irvine Web App

HRP Policies and Procedures

I.IRB Authority & Institutional Committment
01
Institutional Oversight of Assurance
Policy
02
Activities Subject to IRB Jurisdiction
Policy
II.Conducting Research
03
Research Involving Performance Sites
Policy
04
Offsite Research, Cooperative Research and Research at UCI-affiliated Institutions
Policy
15
Research with Human Specimens and Data; Establishment of Specimen-Data Repositories
Policy
16
Human Subject Research- Non Human Subject Research Determination
Policy
24
Subject Privacy, Protection of Confidentiality and Data Security
Policy
26
Compensation for Injury that Occurs During Participation in Research
Policy
27
Research Conducted at International Performance Sites
Policy
28
Research Involving Use of the Internet
Policy
29
Applicable State Laws-Regulations
Policy
44
Data and Safety Monitoring
Policy
47
Billing of Research Participants
Policy
56
Department of Defense Supported Research
Policy
III.Records, Documentation & Fees
05
IRB Records and Documentation
Policy
06
IRB Fees for Industry-Supported Applications
Policy
IV.Committee Roles & Responsibilities
07
Composition of IRB Committees
Policy
08
Committee Member Compensation and Responsibilities
Policy
09
IRB Committee Member and Consultant Conflicting Interest
Policy
10
IRB Committees' Relationship to Other University Committees Departments and Units
Policy
V.IRB Review Process
11
IRB Committee Determinations-Motion
Policy
12
IRB Review of Human Subjects Research - Exempt
Policy
13
IRB Review of Human Subjects Research – Expedited
Policy
14
IRB Review of Human Subjects Research Full Committee
Policy
23
Risk-Benefit Analysis
Policy
VI.Researcher Responsibilities
17
Modifications to Previously Approved or Registered Research
Policy
18
IRB Continuing Review
Policy
19
Reporting of Adverse Events and Unanticipated Problems
Policy
20
Completion of Study-Study Closure
Policy
25
Investigator and Research Personnel Conflicts of Interest
Policy
VII.Informed Consent Process
21
Participant Compensation
Policy
22
Advertisement and Recruitment
Policy
30
Prospectively Obtained and Legally Effective Informed Consent
Policy
31
Documentation of Informed Consent for Human Subjects
Policy
32
Waiver of Informed Consent for Human Subjects Research or for Planned Emergency
Policy
33
Assent-Dissent by Children or Cog Impaired Adults
Policy
34
Approval and Expiration Dates on Informed Consent Documents
Policy
35
Policy for the Role of a Witness and-or Participant Advocate
Policy
VIII. Vulnerable Populations
36
Children
Policy
37
Prisoners
Policy
38
Pregnant Women, Human Fetuses, Neonates, and Fetal Tissue
Policy
39
Individuals Who Are Cognitively Impaired or Mentally Disabled
Policy
40
UCI Students and Employees
Policy
IX.Investigational Drugs & Devices
41
Investigational Drugs, Agents, and Biologics
Policy
42
Investigational Devices
Policy
43
Use of a Placebo
Policy
45
Emergency Use of a Test Article in a Life Threatening Situation
Policy
46
Humanitarian Use Devices
Policy
X.Education & Training
48
Education and Training of Lead Researchers and Research Personnel
Policy
49
Education and Training of IRB Members
Policy
57
UCI HRPP Policy and Procedure Glossary
Policy
XI.IRB Compliance & Quality Improvement
50
HRP EQUIP Activities
Policy
51
Administrative Hold, Suspension, and Termination of IRB Approval
Policy
52
Research Non-compliance
Policy
53
Reporting to the Appropriate Institutional Officials
Policy
54
Concerns and Complaints Regarding Human Subjects Research
Policy
55
Protocol Deviation and Violation Reporting
Policy