OFFICE OF RESEARCH ADMINISTRATION
CATSApril 23, 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
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?
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10%
15%
20%
25%
30%
35%
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10 15 20 25 30 35 40 45 50
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Succ
ess Rat
e
Num
ber o
f App
licat
ions
(in
Tho
usan
ds)
Fiscal Year
Reviewed Awarded Success Rate
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
Why OVPRA?
Institutions with Major Compliance Incidents
Stanford UniversitySUNYU. of MinnesotaNorthwestern UC - Lawrence Livermore Johns HopkinsSan Diego StateHarvard U.Virginia CommonwealthU. of Texas Austin U of Ill. Chicago
U. of AlabamaUC IrvineGeorge Washington U.Northeastern U.Florida InternationalU. of Alabama BirminghamMayo ClinicCornellFlorida A&MYaleU. of PennsylvaniaDuke 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 ChairsIUB Compliance Committee ChairsDirector of REEP
5 research faculty from IUPUI5 research faculty from IUB1 research faculty from regional campusCTSI Director
Advisory Committees
Executive Oversight Committee (EOC)
Faculty Advisory Committee (FAC)
Provides input from administration
Membership:VP for Research Admin. (Chair)Chancellor of IUPUIProvost for IUBVP for Life Sciences (and Dean IUSM)VP for EngagementVP for ITVP and CFOVP and University CounselVP for AdministrationDean of the College of Arts and SciencesFAC Co-Chairs (ex officio)
Provides input from researchers
Membership:Vice Provost, Research, IUB (co-chair)Vice Chancellor, Research, IUPUI (co-chair)IUPUI Compliance Committee ChairsIUB Compliance Committee ChairsDirector of REEP
5 research faculty from IUPUI5 research faculty from IUB1 research faculty from regional campusCTSI 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 2 NIH, USDE, NEA/NEH, Nat. Parks
Serv.
Grant Team 3Commercial, Non-Profits, Foundations
Grant Team 1NSF, NASA, DOE, NIST
Grant Team 4Federal
Contracts, State, Other
Gov.
Letter of Credit
IUPUI Grant Services
Grant Team 2Commercial, Non-Profits, Foundations
Grant Team 3 Fed Contracts,
State, Other Gov
Grant Team 1NIH & other
Fed.
Reports, Billings, Receivables,
Account Closeout
Audit, Compliance and Effort Reporting
University-wide Operations
IUB & Regional Grant Services
Grant Team 2 NIH, USDE, NEA/NEH, Nat. Parks
Serv.
Grant Team 3Commercial, Non-Profits, Foundations
Grant Team 1NSF, NASA, DOE, NIST
Grant Team 4Federal
Contracts, State, Other
Gov.
Letter of Credit
IUPUI Grant Services
Grant Team 2Commercial, Non-Profits, Foundations
Grant Team 3 Fed Contracts,
State, Other Gov
Grant Team 1NIH & other
Fed.
Reports, Billings, Receivables,
Account Closeout
Audit, Compliance and Effort Reporting
University-wide Operations
Grants Admin Reorg Initiative
GRANT TEAM COMPOSITIONResearch Consultants
* Assigned specific projects*Proposal review & submission
* Award review & setup* Transaction approvals
* Point of Contact
Contract Officer* Negotiate and Approve Award
Agreements, MTA’s, NDA’s* Draft and Approve Subcontracts
Team Leader* Lead responsibility for all service activity
for team
Grants Admin Reorg Initiative
IUB & Regional Grant Services
Grant Team 2 NIH, USDE, NEA/NEH, Nat. Parks
Serv.
Grant Team 3Commercial, Non-Profits, Foundations
Grant Team 1NSF, NASA, DOE, NIST
Grant Team 4Federal
Contracts, State, Other
Gov.
Letter of Credit
IUPUI Grant Services
Grant Team 2Commercial, Non-Profits, Foundations
Grant Team 3 Fed Contracts,
State, Other Gov
Grant Team 1NIH & other
Fed.
Reports, Billings, Receivables,
Account Closeout
Audit, Compliance and Effort Reporting
University-wide Operations BENEFITS
Single POCGreater familiarity with specific projects and its
needsGreater 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
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
IUB & Regional Grant Services
Grant Team 2 NIH, USDE, NEA/NEH, Nat. Parks
Serv.
Grant Team 3Commercial, Non-Profits, Foundations
Grant Team 1NSF, NASA, DOE, NIST
Grant Team 4Federal
Contracts, State, Other
Gov.
Letter of Credit
IUPUI Grant Services
Grant Team 2Commercial, Non-Profits, Foundations
Grant Team 3 Fed Contracts,
State, Other Gov
Grant Team 1NIH & other
Fed.
Reports, Billings, Receivables,
Account Closeout
Audit, Compliance and Effort Reporting
University-wide Operations
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
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
Indiana UniversityCornell UniversityMichigan State U.Colorado State U.U. of ArizonaU. of California, DavisHuron Consulting
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?
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