HRPP Standard Operating Procedures

Standard Operating Procedures (SOP)

SOP (July 2019) - download pdf

SOP Addendum (Jan 2019) - 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 Topics