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?