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17. Adverse Events

HSRP Manual Sub Navigation

  • 1. Goals of the Institutional Review Board (IRB)
  • 2. Required Training for Research Involving Human Subjects
  • 3. Responsibilities of the Investigator
  • 4. HIPAA and Health Information Privacy Laws
  • 5. Exceptions to HIPAA’s Authorization Requirement
  • 6. What Research Requires Review?
  • 7. Procedures for Submitting Proposals for Review
  • 8. Review Process
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  • 10. Classroom Research Involving Faculty and Students
  • 11. Using Students as Subjects
  • 12. Research Involving Children
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  • 14. Diversity in Research
  • 15. Continuing Review Procedures
  • 16. Modifying/Changing an Approved Protocol
  • 17. Adverse Events
  • 18. On Site Monitoring
  • 19. Suspension or Termination of IRB Approval
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  • 17. Adverse Events

Adverse Events

Any adverse events involving human subjects must be promptly reported in writing to the Office of Human Subject Research Protection [46.103(b5)].  Reporting must be made to Northeastern in addition to other sites that may be involved.

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