Human Research Protection Program
Standard Operation Procedures (SOP)


Table of Contents and Definitions

SOP Introduction

1.0- Ethical and Regulatory Mandates for the Protection of Human Research Subjects

2.0- Roles in the Protection of Human Research Subjects at PVAMU

3.0- IRB Purpose, Responsibility and Authority

4.0- IRB Membership

5.0- IRB Administrative Support

6.0- IRB Record Requirements

7.0- Meeting Minutes

8.0- Determination if an Activity Constitutes Human Research Subject to PVAMU IRB Review

9.0- Applications for IRB Review

10.0- Miscategorized Protocols

11.0- Review by Convened IRB 

12.0- IRB Actions Following Review by the Convened IRB

13.0- Expedited Review of Research

14.0- IRB Actions Following Expedited Review

15.0- Exemption from Continuing IRB Review

16.0- Modifications to Previously Approved Research

17.0- Continuing Review for Renewal

18.0- Study Completion, Closure or Termination

19.0- Reporting of Unanticipated Problems to the IRB

22.0- Allegations of Noncompliance, Subject Complaints and Other Concerns

23.0- Protocol Violations, Deviations and Exceptions

24.0- Evaluation Criteria

25.0- Recruitment

26.0- Recruitment Incentives

27.0- Investigator Conflict of Interest

28.0- Informed Consent

29.0- HIPAA and IRB Review

30.0- Special Topics: Research Design and Context

31.0- Special Topics: International Research

32.0- Special Topics: Research Subject Groups

33.0- Research Involving Data Use Agreements

34.0- Research Involving Prisoners

35.0- Research Involving Children

36.0- Reporting to Institutional Officials and External Agencies: Unanticipated Problems, Terminations, Suspensions and Non-Compliance

37.0- Post Approval Monitoring


Appendix A: The Belmont Report

Appendix B: 45 CFR 46

Appendix C: 21 CFR 50

Appendix D: 21 CFR 56

Appendix E: IRB Guidance for Student Research and Class Projects

Appendix F: Confidentiality Statement

Appendix G: Individual Identifiability of Data

Appendix H: Department of Energy Template for IRBs on Reviewing Human Subjects Research Protocols that Utilize Personally Identifiable Information (PII)


Office of Research Compliance
Wilhelmina Delco Building, Room 120
Contact Telephone Numbers: (936) 261-1553
(936) 261-1588

Last Revised: December 10, 2015