VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
12 Continued Compliance
Compliance does not end with initial IRB approval. To continue compliance, researchers have the following responsibilities:
- To conduct the study according to the protocol / IRB application
- Report to the IRB any deviations from the protocol / IRB application
- Report to the IRB any proposed changes to the originally approved IRB submission
- Report to the IRB any adverse events
- Unless waived by the IRB, obtain informed consent from each individual participant before conducting any study procedures with that particular participant
- Unless waived by the IRB, document consent by obtaining signatures of involved participants on the consent form
- Maintain signed consent documents for three years
- Report progress of approved research to the IRB in the manner prescribed by the IRB at the time of approval
- Monitor the rights and welfare of participants throughout the study
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