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Standard Operating Procedures

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Tulane University Human Research Protections Office Standard Operating Procedures - Full Version 



 

 






Pertinent Sections:

1. Human Research Protection Program

2. Institutional Review Board

3. IRB Review Process

3.4 Human Subjects Research Determination

3.5 Exempt Studies

3.6 Expedited Review

3.7 Convened IRB Review

3.8 Criteria for IRB Approval of Research

3.9 Additional Considerations during Review

3.10 Compliance with all Applicable Laws and Regulations

3.11 Possible IRB Actions

3.12 Study Suspension, Termination and Investigator Hold

3.13 Continuing Review

3.14 Amendment of an Approved Protocol

3.15 Closure of Protocols

3.16 Notice to PI of IRB Actions

3.17 Appeal of IRB Decision to Disapprove

3.18 National Cancer Institute's Central IRB

4. Documentation and Records

5. Obtaining Informed Consent from Research Subjects

5.4 Informed Consent Process

5.5 Basic Elements of Informed Consent Process

5.6 Additional Elements of Informed Consent, as Appropriate

5.7 Documentation of Informed Consent

5.8 Special Consent Circumstances

5.9 Braille Consent

5.10 Consenting in American Sign Language

5.11 Oral Consent

5.12 Consent Monitoring

5.13 Subject Withdrawal or Termination

5.14 Waive of Informed Consent

5.15 Waiver of Documentation of Informed Consent

6. Vulnerable Subjects in Research

6.6 Research Involving Pregnant Women or Fetuses

6.7 Research Involving Neonates

6.8 Research Involving Prisoners

6.9 Research Involving Children

6.10 Surrogate Consent/Consent for Persons with Impaired Decision Making Capacity

7. FDA-Regulated Research (Drugs and Devices)

7.5 Dietary Supplements

7.6 Investigational Drugs and Devices in Research

7.7 IND Requirements

7.8 Investigational Devices in Research

8. Unanticipated Problems Involving Risks to Subjects or Others

9. Protocol Deviations and Exceptions

10. Complaints and Non-compliance

11. Reporting to Regulatory Agencies and Institutional Officials

12. Investigator Responsibilities

13. Sponsored Research

14. Conflict of Interest in Research

15. Participant Outreach

16. Health Insurance Portability and Accountability Act (HIPAA)

17. Collaborative Research and Off-Site Research

18.1 Certificate of Confidentiality

18.2 Mandatory Reporting of Abuse and Neglect

18.3 Tulane Students and Employees as Subjects

18.4 Student Research

18.5 Oral History

18.6 Community Based Research (CBR)

18.7 Public Registration of Clinical Trials

19. Glossary

20. Common Acronyms

Institutional Review Board, New Orleans, LA 70112 504-988-2665 irbmain@tulane.edu