Presentation Transcript

1. CATSApril 23, 2008

   Office of Research Administration
2. Why OVPRA? Growth in Activity Grant Awards $ 2X in last 10 years 4X in last 20 years On pace for over $0.5 Billion for FY 2008
3. Why OVPRA? Growth in Activity Grant Awards $ 2X in last 10 years 4X in last 20 years On pace for over $0.5 Billion for FY 2008 Sponsored Projects
4. Why OVPRA? Growth in Activity Human subject protocols Nearly 2X in last 10 years Both IUB and IUPUI
5. Why OVPRA? Growth in Activity Human subject protocols Nearly 2X in last 10 years Both IUB and IUPUI
6. Why OVPRA? Growth in Activity Increase in lab and animal space Results in increased demands for bio-safety chemical safety radiation safety animal care and use
7. Why OVPRA? Changing competitive environment Decline in funding of research 15% decline in purchasing power since end of NIH doubling
8. Why OVPRA? Changing competitive environment Decline in funding of research 15% decline in purchasing power since end of NIH doubling
9. Why OVPRA? Changing competitive environment Increase in applications + declining funding Falling funding rates Success rate for NIH and NSF has fallen from roughly 1 in 3 proposals awarded to 1 in 5
10. Why OVPRA? Changing competitive environment Increase in applications + declining funding Falling funding rates Success rate for NIH and NSF has fallen from roughly 1 in 3 proposals awarded to 1 in 5 NIH Competing Research Project Grant (RPG*) Applications: Trends in Number, Awards and Success Rates
11. Why OVPRA? Institutions with Major Compliance Incidents Stanford University SUNY U. of Minnesota Northwestern UC - Lawrence Livermore Johns Hopkins San Diego State Harvard U. Virginia Commonwealth U. of Texas Austin U of Ill. Chicago U. of Alabama UC Irvine George Washington U. Northeastern U. Florida International U. of Alabama Birmingham Mayo Clinic Cornell Florida A&M Yale U. of Pennsylvania Duke U. U. of Oklahoma
12. Why OVPRA? Changing compliance environment More rules to follow (export controls, conflict of interest, Privacy Act, etc.) Severe penalties for non-compliance Increased need for coordinated policies and education Inconsistent across components IU exposed to high risk
13. OVPRA Mission Provideexceptionalsupport for Indiana University’s research community in order to: Catalyze research productivity Protect from risk
14. Advisory Committees
15. Advisory Committees
16. Advisory Committees
17. New Organization: Benefits Single, university-wide organization Single point of contact Preservation of unique campus presence Enhanced environment for intercampus research collaborations
18. Status of Reorganization Personnel Update Consolidated 3 approved positions Matrix reporting line with OVPA/OVPRA established for Chemical Safety Filled all leadership appointments Moved over 100 employees and their functions to the new organization Space Very important part of improving coordination IUB – September target date for moving to single location IUPUI – still identifying options for office location
19. Highlights Reorganization of Grants Administration Clinical Trials Office OVPRA Survey REEP Systems and Decision Support Initiatives Research Compliance Initiatives
20. Grants Admin Reorg Initiative
21. Grants Admin Reorg Initiative
22. Grants Admin Reorg Initiative BENEFITS Single POC Greater familiarity with specific projects and its needs Greater sponsor expertise, Specialization in staff responsibilities will also improve efficiency, timeliness, and effectiveness. Local delivery of grant support services Improved career path will lead to better retention
23. Grants Admin Reorg Initiative Status of Reorganization Job descriptions under review by HR Training is on-going IUPUI Grants Services currently recruiting staff Bakers and Daniels has been contracted to assist with clinical trial agreements Discussions are underway with IURTC to contract out material transfer agreements Goal to move to new structure by July 1
24. Clinical Trials Office Centralized coordination of commercial clinical trials Benefits: Budget review (also for federal clinical trials) Proposal preparation services Separate specialized staff for faster response times Centralized invoice management July 1 implementation on new clinical trials Roll out over time across departments
25. OVPRA Satisfaction Survey Annual Survey of OVPRA customers - faculty and departmental administrative support To be sent out about May 15 and close on June 15 Survey conducted by IU Center for Survey Research Input provided by: OVPRA directors OVPRA Faculty Advisory Committee OVPRA Executive Oversight Committee
26. OVPRA REEP Initiative Need for greater research ethics and compliance education NIH heavily encourages Responsible Conduct in Research (RCR) education America Competes Act mandates RCR education for NSF research A comprehensive program of ethics and compliance education does NOT exist at IU A education program can be critical at the time of an audit or inspection Need for improved research policy structure Many currently outdated, poorly written, and in some cases conflicting Improved feedback and approval process for new policy Improved communication of policies and central repository
27. OVPRA REEP Initiative REEP Task Force Formed on September 14, 2007 Met from 4 times between October 1 the end of November Co-chaired by Eric Meslin and Jeff White Included faculty from IUB, IUPUI and a regional campus Key Recommendations from Written Report Strong support for the creation of REEP REEP should be led by individuals with sufficient expertise and skills to assure credibility REEP should draw on and build on the strengths of distributed expertise that exists (e.g. Poynter Center, Center for Bioethics, etc.)
28. OVPRA REEP Initiative REEP Functions Provide Infrastructure Maintain and classroom and web-based offerings Track educational participation Research Ethics Education Provide offerings for stewardship of data, collaborative research strategies, mentoring, authorship practices and intellectual property Provide offerings by leading experts from around the country
29. OVPRA REEP Initiative REEP Functions (continued) Research Compliance Education Organize a comprehensive program of compliance education in: Grant compliance Human subjects Conflicts of interest Export Controls Animal research Privacy Act Billing Compliance Coordinate compliance committee (IRB, IACUC, etc) education at all campuses
30. OVPRA REEP Initiative REEP Functions (continued) Research Policy Coordination & Dissemination Coordinate the creation and on-going maintenance of the complete body of university policies for research administration. REEP will ensure that all research policies at Indiana University are current, coherent, and readily available online.
31. Kuali Research Administration (KRA) Initiative Collaborative UITS / OVPRA effort Community Source effort to build a Research Admin / Research Compliance IT System Brad Wheeler is P.I. on$1.5M from Mellon Foundation Grant MIT system (COEUS) to be used as the starting point Recently added UC Davis and Colorado State Broad and increased participation to include both campuses, currently >20 OVPRA employees Indiana University Cornell University Michigan State U. Colorado State U. U. of Arizona U. of California, Davis Huron Consulting MIT, Boston Medical Center, Boston University Medical Campus, Brown University, Carnegie Mellon University, Columbia University, Dartmouth College, Johns Hopkins, Purdue University, SUNY, University of Maryland, University of North Carolina-Chapel Hill, University of Rochester, University of Tennessee, Wayne State University, Whitehead Institute, Yale University
32. Other IT System Initiatives COEUS IRB Implementation Summer 2008 for inter-office module – will replace unsupported access database Fall 2008 for electronic protocol submission COI Disclosure form Fall 2008 for e-doc form and routing Working with KRA partners on specifications
33. Other IT System Initiatives Grants Admin Tracking Working to merge 3 separate systems 2nd phase will be to provide web based tool to update on status of proposals and awards Proposal, Award, and Expenditure Statistics and Reports
34. OVPRA Web May 2008 rollout Consolidation of 4 websites Improved contact information Single repository for research policies Research Statistics and Reports Ethics and Compliance Education Announcements
35. External Compliance Reviews Human Research Protection Program (HRPP) Re-Accreditation Upon site visit, received pending re-accreditation, with only minor issues to address. Full re-accreditation should be granted in June 2008. NRC Inspections IUB General Inspection - no findings IUB Institutional Controls for sources New regulations 4 security findings All findings have been addressed
36. External Compliance Reviews NIH Office of Research Integrity Inquiry General survey of COI policy and procedures at IUPUI Requested specific management plans for selected individuals Annual A-133 Single Audit (Neil Theobald) University-wide audit of financial aid and sponsored projects that includes IU’s financial statements as well as its federal awards General audit of compliance controls No findings
37. Human Subjects Initiatives IUB and IUPUI collaborating to: Craft consistent IRB Policies and Procedures Implementation of the Coeus System IUB Reviewing ‘self-imposed’ policies and procedures IUB Piloting "The IRB Is In” OHRPP staff hold open hours to pre-review and answer questions Bi-weekly
38. Human Subjects Initiatives IUPUI Office Restructuring Goal of improving efficiency in processing research applications Roles have been changed to create greater specialization that will result in more knowledgeable support and greater efficiency Use of Western IRB Working on agreement with the Western IRB to provide review of certain Phase II, III, and IV industry-sponsored research.
39. Human Subjects Initiatives ClinicalTrials.gov Working on a process to identify and register trials that must be listed on the Clinical Trials registry. HOG IRB Initiative – implemented a central IRB process for statewide HOG projects. Sponsoring CIC IRB Conference April 2008
40. Animal Compliance Initiatives IUB Administrative Changes New attending veterinarian (Dr. Randy Peper) hired by Sarita with extensive experience New IACUC administrator position created and filled in January 2008 IUB Response Plan Task Force - formed to create response plan to animal rights groups
41. Animal Compliance Initiatives IUPUI Animal Compliance VA began using the IUSM IACUC and animal facilities. Assurance change so faculty from the School of Engineering may begin using the School’s IACUC and animal facilities. Electronic application by fall 2008.
42. Conflict of Interest Initiatives COI Electronic disclosure being developed IUPUI COI Manager hired and Committee appointed Prepared response to recent DHHS COI survey at IUPUI/SOM Drafted and adopted IUPUI Interim Procedures University-wide COI Task Group – to review and streamline policies and procedures
43. Questions?