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Enduring Research Compliance

Enduring Research Compliance. NCURA National Workshop April 27, 2002 Mary Ellen Sheridan University of Chicago. “enduring”… (courtesy of Random House). Lasting; permanent Patient; longsuffering Sustaining without impairment Bearing without resistance. Institutional Overview.

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Enduring Research Compliance

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  1. Enduring Research Compliance NCURA National Workshop April 27, 2002 Mary Ellen Sheridan University of Chicago

  2. “enduring”…(courtesy of Random House) • Lasting; permanent • Patient; longsuffering • Sustaining without impairment • Bearing without resistance

  3. Institutional Overview • What you see depends on where you stand • The trustees expectation • The president’s delegation and so on • The research administration role

  4. What does Research Compliance mean? • Different things to different people • Depends on your role and responsibility • How to assess your special role

  5. Assume the wheel has been created • Looking for Evaluation Tools • Using the Tools • Communicating assessments • Developing consensus on priorities • Implementing the plan

  6. Focus on Research Compliance • Define what that means at the institution • Who (how many) own the responsibility? • Expect a mosaic • Form a committee

  7. Evaluation Tools • Resource Materials in handout • Assessment team is critical • Seek consensus about strengths and deficiencies

  8. Starting with the Broad Brush • COGR’s “Good Practices Guide” • Emphasis on Administrative Responsibilities • Principles-Practices-Indicators • Weak Indicators good litmus test for potential problem areas

  9. Where Others have cleared the path • NIH Proactive Site Visits – what’s in the wind at NIH? • OHRP Compliance Summary

  10. NIH’s Topical Interests • Roles & Responsibilities • Training & Education • Financial Conflict of Interest

  11. NIH’s Topical Interests, con’t • Financial Management of Sponsored Projects • Clinical Trial Data Safety & Monitoring • Bayh-Dole Act /Invention and Patent Reporting

  12. Roles & Responsibilities • Written succinct descriptions for each role • Established lines of reporting • Clear designation of who can sign(speaks) for institution(authorized institutional official)

  13. Training & Education • http://adminet.uchicago.edu/admintrain/train-index.html • Pre-post award core curriculum • Hard to be compliant if you are not educating responsible staff

  14. Financial Conflict of Interest: Risking the Objectivity of Research • Emerging as a leading compliance issue • AAU and AAMC Task Forces Issue Reports • Raising the bar for Disclosure and “unmanageable” conflicts

  15. Using the AAU Research Accountability/COI Study • Addresses both Individual & Institutional Conflicts of Interest • Outlines Operating Guidelines • Importance of Faculty Education about COI

  16. AAU Checklist of Questions for Campus Leaders • 14 questions to assess policy, practices, systems • Excellent institutional assessment tool for COI

  17. NIH’s Examples of COI Compliance in Action • Policy & Forms on line • Proposal Routing Form checks on COI compliance • MOU signed by Investigator and institutional official as management plan • Regular open forum for faculty/researchers and COI committee/official

  18. Financial Management of Sponsored Programs • COGR Good Practices is outstanding in this area • Close Working relationship between pre-and post-award • PI Handbook is recommended tool • Contact & Fiscal Information on a “Quick Look-Up” guide

  19. Clinical Trial Data Safety and Monitoring • Come back to this under Regulatory Committees

  20. Bayh-Dole Act/Invention and Patent Reporting • Increasing Congressional interest in federal investment • Are Institutions complying with Bayh-Dole • Is the government getting its B-D rights?

  21. Bayh-Dole Compliance Resources • COGR’s Technology Transfer Tutorial • COGR Guide to Bayh-Dole Act explains the requirements • Edison reporting • Is the TT Office keeping up here – compliance may not be on the reward profile

  22. NIH’s Compliance Cites for TT • Cross reference of TT Disclosure with Research Administration award systems • TT database systems that track disclosure, elect, license & utilization • Strong communication among TT staff, research admin, and faculty involved in TT

  23. Research compliance through institutional regulatory committees • IRB • IACUC • Institutional Biosafety • Radiation Safety/Human Use of Radioisotopes • Environmental Health & Safety • Academic Fraud (scientific misconduct)

  24. Human Research Protection Programs • Multiple shut-downs over last 3-4 years • Critical loss of public trust in clinical research • Emergence of Accreditation as a Compliance Marker • OHRP’s carrot and stick

  25. OHRP Compliance: Common Findings & Guidance (updated April 4, 2002) • Measure IRB against these common inadequacies and failure statements • Read the posted letters to other institutions • Initiate a program of internal audits of random protocols • Assure that senior institutional officials/trustees are briefed about human research protections

  26. OHRP new Quality Improvement Program • Help institutions improve quality of programs • Institutional assessment/self-study • Might be valuable pre-accreditation tool

  27. FDA & OHRP: Dueling regulations • Complicates institutional compliance • Data safety and monitoring also concern on NIH • Compliance would be improved with federal harmonization of regulations

  28. What IRBs can teach Other Regulatory Committees • Recommend internal assessment for all oversight committees • AAALAC benchmark for animal care & use programs • Post 2001 anthrax terrorism raises Biosafety profile • Don’t shortchange one committee to save another

  29. Compliance Officers/Committees • Not the same thing as medical compliance officer • Likely to focus on institutional financial and regulatory oversight • Institutions tend to adopt compliance oversight that mirrors institutional culture

  30. So what about Responsible Conduct of Research • Education requirements faculty, research associates and other investigators still unclear • Expectations for integrity in research haven’t changed at all • Clear roles & responsibilities including education requirements already likely in research areas with oversight committees • Training requirement for NIH Training Grants still in effect

  31. Summary for Enduring Research Compliance Know your institutional Culture Appreciate the consequences of Noncompliance Translate Knowledge of Weaknesses into Commitment for Continuous Improvement

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