Responsibilities of the Research Investigator

Responsibilities of the Research Investigator as prescribed in the State University of New York at Buffalo Multiple Project Assurance of Compliance with Department of Health and Human Services regulations for the protections of human research subjects.

1. Responsibilities of investigators
2. Determination of human subject involvement
3. Determination of exemption eligibility
4. Preparation of protocol
5. Submission and approval of the Proposal/Protocol
6. Submission of a supplement to an original protocol to the IRB
7. Complying with IRB decisions
8. Obtaining informed consent
9. Providing basic elements of informed consent
10. Providing additional elements of information
11. Documentation of informed consent
12. Retention of signed consent documents
13. Submission of progress reports on the research
14. Submission of injury reports and reports of unanticipated problems involving risks
15. Requesting re-approval
16. Reporting changes in the research
17. Prohibition of use of emergency medical care for purposes of research
18. Notification of IRB of intent to admit
19. Reporting non-compliance
20. Attending IRB meetings
21. Notifying the OSPA concerning investigational new drugs