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Ensuring Ethical Research: JHSPH Quality Protections Program & Investigator Self-Assessment

Promoting ethical research practices, compliance with laws, and quality improvement through internal assessment. Investigator self-assessment program aiding in regulatory compliance and best practices for improvements.

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Ensuring Ethical Research: JHSPH Quality Protections Program & Investigator Self-Assessment

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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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