Standard Operating Procedures (SOP)
SOP (July 2023)-download pdf
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
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 Topic
