Standard Operating Procedures (SOP)
SOP Addendum (Oct 2020) - download pdf
Table of Contents
1: Human Research Protection Program
2: Quality Assurance
3: Education & Training
4: Institutional Review Board
5: Human Subject Research Determination
6: Exempt Studies
7: IRB Review Process
- 7.01: Definitions
- 7.02: Expedited Review
- 7.03: Convened IRB Meetings
- 7.04: Criteria for IRB Approval of Research
- 7.05: Additional Considerations
- 7.06: Possible IRB Actions
- 7.07: Continuing Review
- 7.08: Modification of an Approved Protocol
- 7.09: Closing a Research Study
- 7.10-7.12: Failure to Respond, Appeal of IRB Decisions, Research Previously Approved By Another IRB
8: Study Suspension, Termination and Investigator Hold
9: Research overseen by a non-UVA IRB of Record
10: Documentation and Records
11: Obtaining Informed Consent from Research Subjects
12: Vulnerable Subjects in Research
13: FDA-Regulated Research
14: Reportable Events
15: Unanticipated Problems Involving Risks to Subjects or Others
16: Non-compliance
17: Complaints
18: Reporting to Regulatory Agencies and Organizational Officials
19: Investigator Responsibilities
20: Sponsored Research
21: Conflict of Interest in Research
22: Participant Outreach
23: Health Insurance Portability and Accountability Act (HIPAA)
24: Information Security
25: Special Topics
- 25.01: Community Based Research
- 25.02: International (Transnational) Research
- 25.03: Research Involving Data and or Biological Specimens
- 25.04: Certificate of Confidentiality (CoC)
- 25.05: Mandatory Reporting
- 25.06: UVA Students and Employees as Subjects
- 25.07: Student Research
- 25.08: Oral History
- 25.09: Genetic Studies
- 25.10: Case Reports Requiring IRB Review
- 25.11: Research Supported by Department of Defense (DoD)
- 25.12: Research Supported by Department of Justice (DOJ)
- 25.13: Research Supported by Department of Education (DOE)