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

 

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Pertinent Sections:

1. Human Research Protection Program

2. Institutional Review Board

3. IRB Review Process

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 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

4.11 Investigator Records

4.12 Records for FDA-Regulated Studies

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 to be Applied, 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 Waiver 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

7. Investigational Drugs

7.8 Investigational Devices in Research

8. Unanticipated Problems Involving Risks to Subjects or Others

9. Protocol Violations, Deviations, and Exceptions

10. Complaints and Non-Compliance

11. Reporting to Regulatory Agencies and Institutional Officials

12. Investigator Responsibilities

13. Sponsored Research

14. Conflicts of Interest in Research

15. Participant Outreach

16. Health Insurance Portability and Accountability Act (HIPAA)

17. Collaborative Resarch and Off-Site Research

18.1 Certificate of Confidentiality

18.2 Mandatory Reporting of Abuse and Neglect

18.4 Student Research

18.5 Oral History

18.6 Public Registration of Clinical Trials

18.7 Genetic Studies

18.8 Research Involving Coded private Information or Biological Specimens

18.9 Case Reports Requiring IRB Review

19. Glossary

20. Common Acronyms