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  1. INSIDE EDITION: The Scoop on the NIH Compliance Site Visits

  2. NIHPROACTIVE GRANTSCOMPLIANCE PROGRAM SITE VISITS

  3. Cheryl-Lee Howard, Assistant Provost, Research Projects Administration Johns Hopkins University 410-516-8668/FAX 410-516-7775 clh@jhu.edu

  4. Gary Thompson, Director, Division of Grants Compliance Oversight OPERA, NIH 301-435-0934/FAX 301-435-3059 gt7g@nih.gov

  5. Elizabeth Mora, Director, Sponsored Research Harvard University 617-405-0716/FAX 617-495-2900 Elizabeth_Mora@harvard.edu

  6. Steven H. Smartt, Director, Division of Sponsored Research Vanderbilt University 615-322-3825/FAX 615-322-3827 steven.smartt@vanderbilt.edu

  7. Why Did NIH Undertake this Project? (Gary) What Happened at Three Sites: Hopkins was first (Cheryl) Harvard was the first of the “second wave” (Beth) Vanderbilt was last (Steve) Thoughts from the Site Visit Team: Did it work? What Happens Next? What is the Long Range Impact on Academic Research Community? Today’s Presentation:

  8. NIH COMPLIANCE SITE VISITS NCURA November 8, 2000 Gary Thompson, Director Division of Grants Compliance and Oversight, OPERA, NIH gt7g@nih.gov

  9. Why NIH undertook this project Organizational responsibility Propelling impetus... Institution selection S-V subject matter determination Selection of S-V Team S-V preparation At the S-V: Day 1 Opening plenary Subject matter experts PI’s/DC’s/DA’s Closing plenary SME feedback At the S-V: Day 2 Education/Outreach Evaluation Did it work? What happens next? Long range impact... Outline

  10. Organizational Responsibility Office of the Director, NIH • Office of Extramural Research (OER) • Office of Policy for Extramural Research Administration (OPERA) • Division of Grants Compliance and Oversight • Parallel with OHRP, OLAW, ORI and Grantees

  11. Propelling impetus... • Dramatic budget increases • Commitment to double budget by 2003 • Issues of noncompliance • University of Minnesota • Thomas Jefferson University • Loss of human life • University of Pennsylvania • Increase in noncompliance issues, including a disproportional increase in OMA case workload related to grant issues

  12. Why NIH undertook this project Moving from Reactive Noncompliance* to Proactive Compliance *recognize that we’ll never eliminate reactive noncompliance

  13. Why NIH undertookthis project • It is not always apparent that a culture of compliance and oversight is universally present in the biomedical research enterprise.

  14. Expanding Resources = Increased Scrutiny • FY1999 = +$2M over 1998 • 2,430 $12.856B 100% • Top 25 $4.879B 38.0% • FY2000 = +$2M over 1999 • Projected for FY2001*: • ??? +2.7M over FY2000 • Double between 1998 - 2003 *still on continuing resolution

  15. Dramatic increase in grant related cases in (OMA) • 37% increase in grant related allegations from FY99 to FY2000 • Grant cases increased from 40% of total cases in FY99 to 53% in FY2000 • FY1999 = 30/75 total cases • FY2000 = 41/78 total cases • Most allegations are institutional and involve Universities

  16. Institution selection CRITERIA • Level of support • Nature of support • Medical School (seven in Phase II) • Geographic Diversity • OPERA not engaged in active compliance case

  17. Three N-F-C-S-V's March 2000 OHSU HARVARD U. INDIANA U. JHU UCSF VANDERBILT U. U. ARIZONA MUSC UTSWMC/D Seven PCSV's Summer 2000 U. MIAMI

  18. N-F-C-S-V’s and PCSV’s • JHU[1/1] 1010 $351M $255M • UCSF [4/4] 778 $256M $218M • HARVARD U.[8/19] 625 $217M $109M • VANDERBILT[29/25] 393 $111M $94M • OHSU*[34/29] 365 $103M $81M • UTSWMC/D[35/21] 325 $102M $102M • INDIANA U. [40/38] 345 $92M $71M • U. ARIZONA[49/50] 252 $72M $43M • U. MIAMI[50/42] 207 $72M $59M • MUSC[84/60] 162 $37M $36M THESE 10 INSTITUTIONS ONLY4462 $1.413M [11%] $1.068M [16%] ALL INSTITUTIONS/MED SCHOOLS $12.856M $6.562M

  19. N-F-C Phase I and PCSV Phase IITheme: Institutional Oversight • Roles and Responsibilities (Dean) • Training and Education (Dean) • Financial Management of Sponsored Projects* (Payne) • Financial Conflict of Interest (McCormack; Mizzell; and Pryor) • Inventions and Patents (Stone) • Data and Safety Monitoring (Dixon) • Clinical Gene Therapy Research (Groesch; Rosenthal; and Jambou) • Hazardous Waste Disposal* (Demsey) • Interactive Education/Outreach Seminar* *not in Phase I NFC’s

  20. S-V: Preparation forand Conduct of… GOALS: • Increase Educational Outreach • Enhance Administrative Oversight of Sponsored Research • Renew Institutional Commitment to Compliance • Receive feedback on obstacles to implementing Federal rules/NIH policies

  21. S-V: Preparation for and Conduct of… PURPOSE OF SITE VISIT: • Assess level of understanding of certain NIH rules by discussing policies, procedures, and practices at recipient institutions to ensure compliance with NIH requirements

  22. S-V: Hoped for outcome • To increase NIH’s level of confidence in grantee institutions’ ability to effectively manage NIH grant funds

  23. At the SV: Day One • Opening plenary • Overview • S-V Team • Institutional Officials • Breakout Sessions • Subject Matter Experts • Principal Investigator’s; Department Chairs; Departmental Administrators; Sponsored Projects Staff • Closing Plenary • SME Feedback • S-V Team • Institutional Officials

  24. At the S-V: Day Two**No Day Two for Phase I • Education/Outreach • Phase I • Compliance Seminar at UCSF • Phase II • All Seven Institutions • Promoted by Institution • Faculty and Staff • Averaged around 150/Institution • OHSU: More than 300 state wide

  25. NIH Site Visits END PART I OF NIH DISCUSSION

  26. Johns Hopkins University

  27. THE GOOD NEWS:

  28. # 1

  29. THE BAD NEWS:

  30. # 1

  31. Difficulties • NIH Team using Hopkins visit as a model for developping the process • At the time of our visit, had only scheduled UCSF and UTDallas(subsequently changed to UT Southwestern Med Ctr Dallas) • Very general guidelines • Visit scheduled during Spring Break when many faculty unavailable

  32. THE PLANNING PROCESS

  33. JHU TEAM • Vice Provost for Research • Deans for Research from 3 Divisions with NIH Funding • Controller • Director of Internal Audit • Compliance Officer

  34. JHU Team (continued) • University Counsel • IRB Chair • Directors of Offices of Technology Transfer • With consultation (and lots of effort) from many others

  35. Guidelines from the NIH Team Key areas: • Roles and Responsibilities • Training and Education • Financial Conflict of Interest • Inventions and Patents • Institutional Review Boards • Institutional Biosafety Committees • Reporting Adverse Events

  36. Guidelines from the Team (continued) • Provide in advance: • Roles and Responsibilities matrix • Relevant materials on: • internal audit • institutional oversight • internal controls • training programs (mandatory and optional)

  37. “but please don’t inundate us with paper!”

  38. List of URL’s for policy and other related materials 3 pages single spaced Research Admin-Roles and Responsibilities 1-page matrix of who does what Research Compliance Committee membership list Research Compliance Organizational Chart Detail on the course outlines for training in existence or in design What we provided:

  39. The Visit • One day (March 20)--9AM to 4:30 PM • Opening plenary session to present both NIH overview and JHU overview • Breakout Sessions in four areas: • Roles & Responsibilities/Education & Training • Financial Conflict of Interest • Inventions and Patents • IRB/Adverse Events

  40. The Visit (continued) • Group and individual interviews with a dozen faculty and our Biosafety Officer • Three opportunities for Executive Session conferences for the team • Exit Conference

  41. Conflict of Interest NIH has no central file NIH requires reporting of all COI unlike NSF Adverse Events interpretation as to when common rule requires reporting Inventions and Patents Well educated faculty Gene Therapy NIH needs to clarify guidelines for reporting (when and to whom) NIH knows they need to streamline and simplify the reporting process (checklists/clearing house) The Exit Conference

  42. The Exit Conference (continued) • General Comments • Climate, Commitment,Culture to/of excellence • JHU should have a 101 course in Research Admininstration for Faculty • Decentralization (team approach) works! • Need for consistency in rules and regulations to reduce confusion • Plans for Web Based Training a plus • Shadow systems:do they indicate poor systems?

  43. Advice on Outcomes • There will be no written report--no “findings” to be acted upon unless evidence of criminal activity were found • Best practices will be written and communicated after all 10 visits done

  44. HARVARD

  45. NIH Proactive Site Review:A Perspective from Harvard University Elizabeth Mora Director of Sponsored Research Harvard University Harvard

  46. Agenda • Background and preparation • The experience of being the first institution in “Phase Two” of the site visits • The sentencing • Afterthoughts

  47. Background • Here is a picture of the sequence of events timeline (view next three slides):

  48. Johns Hopkins Univ receives letter about visit Feb `00 Harvard’s Office of General Counsel mobilizes task force to prepare (in case!) March `00 Background, cont’d

  49. NIH visits JHU, University of Texas SW, UCSF March `00 Every Friday afternoon for two hours (3-5 pm) OGC convenes task force to prepare, inventory plus research current practices, etc. Late March May-June-July `00 Background, cont’d