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JHSPH Human Subject Research Quality Protections Program

JHSPH Human Subject Research Quality Protections Program. Leah Mendelsohn, J.D. Research Regulations Specialist Office of Graduate Education and Research. Goals of the JHSPH Human Subject Research Quality Protections Program. Foster a culture of ethical research.

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JHSPH Human Subject Research Quality Protections Program

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  1. JHSPH Human Subject Research Quality Protections Program Leah Mendelsohn, J.D. Research Regulations Specialist Office of Graduate Education and Research

  2. Goals of the JHSPH Human Subject Research Quality Protections Program • Foster a culture of ethical research. • Promote responsible research practices through the cultivation of collaborative relationships between researchers and the HRPP.  • Ensure compliance with federal and state laws and JHSPH Policies and Procedures.

  3. “If you always do what you always did, then you will always get what you always got.” • Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, D.C.: National Academies Press, 2003, p.163.

  4. Three related principles: • Quality Assessment – Are we doing what we should be doing? • Quality Assurance – What should we do that we are not doing? • Quality Improvement – How can we improve our outcomes?

  5. Internal Assessment and On-Site Reviews • Purpose: • Education • Identify non-compliance and areas that need improvement • Promote communication between investigators and the rest of the HRPP • Improve the quality of the HRPP

  6. Internal Assessment and On-Site Reviews • Approximately 20 CHR-approved studies were randomly selected to be the subject of an internal assessment and review (IA&R).

  7. What happens during an IA&R? • Preliminary conference with the PI

  8. What happens during an IA&R? • Investigative Fieldwork • Subject selection • Subject enrollment • Informed consent process • Intervention/interaction • Oversight and management • CHR functions

  9. What happens during an IA&R? • Draft IA&R

  10. What happens during an IA&R? • Opportunity to Respond

  11. What happens during an IA&R? • Final IA&R

  12. Handling of IA&R Findings • The entire final report is sent to: • Principal Investigator, • Institutional Official, and • Associate Dean for Graduate Education and Research • The part of the report that reviews CHR functions is also sent to the Director of the Office for Research Subjects.

  13. Handling of IA&R Findings • Examples of how IA&R findings will be used: • Develop pertinent educational programs • Identify and rectify deficiencies • Create or modify Policies & Procedures

  14. Suggestion • DOCUMENT! • If you do not have it documented, you never did it!

  15. Suggestion • ORGANIZE! • It should be easy for an outsider to recreate the “story.”

  16. Investigator Self-Assessment Program • Foster the conduct of ethical research. • Aid Investigators in complying with federal and state laws and JHSPH policies and procedures. • Provide an independent regulatory and compliance resource for Principal Investigators. • Help Principal Investigators to identify weaknesses in research management • Provide recommendations and best practices to promote improvement.

  17. ISAP addresses: • Continuing reviews • Consent process • Amendments • CHR required Approvals, Documentations and Notifications • Conflict of Interest • Protocol Adherence • Safety Monitoring • Clinical Trials- Essential Documents • Subject Records • Drug/Device Accountability/Handling

  18. Access the ISAP: • The ISAP is available on the Office of Graduate Education and Research Website: • http://www.jhsph.edu/GER/InvestigatorSelf%20Assessment

  19. Questions? Leah Mendelsohn, JD Research Regulations Specialist Office of Graduate Education and Research 410-502-0433 lmendels@jhsph.edu

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