CATS April 23, 2008 OFFICE OF RESEARCH ADMINISTRATION 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 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 Why OVPRA? Growth in Activity • Human subject protocols • Nearly 2X in last 10 years • Both IUB and IUPUI Why OVPRA? Growth in Activity • Human subject protocols • Nearly 2X in last 10 years • Both IUB and IUPUI 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 Why OVPRA? Changing competitive environment • Decline in funding of research • 15% decline in purchasing power since end of NIH doubling Why OVPRA? Changing competitive environment • Decline in funding of research • 15% decline in purchasing power since end of NIH doubling 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 Why OVPRA? 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 35% 45 30% 40 35 25% 30 20% 25 20 15% 15 10% 10 5% 5 0 0% 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Fiscal Year Reviewed Awarded Success Rate NIH Competing Research Project Grant (RPG*) Applications: Trends in Number, Awards and Success Rates Success Rate • 50 Number of Applications (in Thousands) Changing competitive environment 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 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 OVPRA Mission Provide exceptional support for Indiana University’s research community in order to: Catalyze research productivity Protect from risk Advisory Committees Executive Oversight Committee (EOC) Faculty Advisory Committee (FAC) Advisory Committees Executive Oversight Committee (EOC) Faculty Advisory Committee (FAC) Provides input from researchers Membership: Vice Provost, Research, IUB (co-chair) Vice Chancellor, Research IUPUI (co-chair) IUPUI Compliance Committee Chairs IUB Compliance Committee Chairs Director of REEP 5 research faculty from IUPUI 5 research faculty from IUB 1 research faculty from regional campus CTSI Director Advisory Committees Executive Oversight Committee (EOC) Faculty Advisory Committee (FAC) Provides input from administration Provides input from researchers Membership: VP for Research Admin. (Chair) Chancellor of IUPUI Provost for IUB VP for Life Sciences (and Dean IUSM) VP for Engagement VP for IT VP and CFO VP and University Counsel VP for Administration Dean of the College of Arts and Sciences FAC Co-Chairs (ex officio) Membership: Vice Provost, Research, IUB (co-chair) Vice Chancellor, Research, IUPUI (co-chair) IUPUI Compliance Committee Chairs IUB Compliance Committee Chairs Director of REEP 5 research faculty from IUPUI 5 research faculty from IUB 1 research faculty from regional campus CTSI Director New Organization: Benefits Single, university-wide organization Single point of contact Preservation of unique campus presence Enhanced environment for intercampus research collaborations 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 Highlights Reorganization of Grants Administration Clinical Trials Office OVPRA Survey REEP Systems and Decision Support Initiatives Research Compliance Initiatives Grants Admin Reorg Initiative IUB & Regional Grant Services Grant Team 1 Grant Team 2 NSF, NASA, NIH, USDE, DOE, NIST NEA/NEH, Nat. Parks Serv. Grant Team 3 Grant Team 4 Commercial, Federal Non-Profits, Contracts, Foundations State, Other Gov. University-wide Operations Reports, Billings, Receivables, Account Closeout Audit, Compliance and Effort Reporting Letter of Credit IUPUI Grant Services Grant Team 1 Grant Team 2 NIH & other Commercial, Fed. Non-Profits, Foundations Grant Team 3 Fed Contracts, State, Other Gov Grants Admin Reorg Initiative IUB & Regional Grant Services University-wide Operations GRANT TEAM COMPOSITION Research Consultants * Assigned specific projects *Proposal review & submission Award &3setup Grant Team 1 *Grant Team 2 review Grant Team Grant Team 4 NSF, NASA, * NIH, USDE, Commercial, Federal Transaction approvals DOE, NIST NEA/NEH, * Point Non-Profits, of ContactContracts, Nat. Parks Serv. Foundations State, Other Gov. Contract Officer * Negotiate and Approve Award Agreements, MTA’s, NDA’s * Draft and Approve Subcontracts Reports, Billings, Receivables, Account Closeout Audit, Compliance and Effort Reporting Letter of Credit Team Leader * Lead responsibility for all service activity for team IUPUI Grant Services Grant Team 1 Grant Team 2 NIH & other Commercial, Fed. Non-Profits, Foundations Grant Team 3 Fed Contracts, State, Other Gov Grants Admin Reorg Initiative IUB & Regional Grant Services Grant Team 1 NSF, NASA, DOE, NIST University-wide Operations IUPUI Grant Services BENEFITS Single POC Greater familiarity with projects and its Reports,specific Billings, Receivables, needs Grant Team 2 Grant Team 3 Grant Team 4 Account Closeout Grant Team 1 Grant Team 2 Grant Team 3 NIH, USDE, Commercial, Federal NIH & other Commercial, Fed Contracts, Greater sponsor expertise, NEA/NEH, Non-Profits, Contracts, Fed. Non-Profits, State, Other Nat. Parks Foundations State, Other Audit, Compliance Specialization in staff responsibilities willFoundations also Gov Serv. Gov. and Effort improve efficiency, timeliness, and Reporting effectiveness. Letter of Credit Local delivery of grant support services Improved career path will lead to better retention Grants Admin Reorg Initiative Status of Reorganization IUB & Regional Grant Services University-wide Operations Reports, Billings, Receivables, Account Closeout IUPUI Grant Services 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 Grant Team 1 Grant Team 2 NSF, NASA, NIH, USDE, DOE, NIST NEA/NEH, Nat. Parks Serv. Grant Team 3 Grant Team 4 Commercial, Federal Non-Profits, Contracts, Foundations State, Other Gov. Audit, Compliance and Effort Reporting Letter of Credit Grant Team 1 Grant Team 2 NIH & other Commercial, Fed. Non-Profits, Foundations Grant Team 3 Fed Contracts, State, Other Gov 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 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 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 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.) 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 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 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. 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 CarolinaChapel Hill, University of Rochester, University of Tennessee, Wayne State University, Whitehead Institute, Yale University 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 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 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 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 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 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 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. 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 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 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. 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 Questions?