Office of Institutional Compliance

Office of Institutional Compliance
Presentation to the Provost’s Department Chairs Leadership Program
October 8, 2009
Lynn Zentner, Director
Office of Institutional Compliance

Office of Institutional Compliance Office – Four Components
The Core Compliance Program
University Administrative Policies
Delegations Management
Conflict of Interest Program
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The University’s Core Compliance Program
Modeled in large part after the Federal Sentencing Guidelines
Approximately 30 different risk areas
Partnership with OGC and the University’s Office of Internal Audit
Ensures a coordinated approach:
Identification and management of risk
Setting compliance-related priorities
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The University’s Core Compliance Program – Subject Matter Areas
Athletics
Boynton Health Service
Community University Health Care Center
Copyright
Data Security/Privacy/HIPAA
Dining Services
Disability Services
Environmental Health & Safety
Equal Opportunity and Affirmative Action
Facilities Management
Fiscal Operations
Grants Management
HIPAA Compliance
Housing and Residential Life
Human Resources
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The University’s Core Compliance Program – Subject Matter Areas
Information Technology
Internal Audit
International Programs
Occupational Health & Safety
Privacy
Public Safety
Research – Animal Subjects
Research – Human Subjects
Research – BioSafety
Research- Controlled Substances
Technology Commercialization
School of Dentistry (billing compliance)
Student Finance
Tax Management
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The University Core Compliance Program
Compliance Partners are identified for each compliance area.
Reporting process occurs twice annually.
Compliance Partners submit written summary of identified risks, related risk management approaches, and the identification of trends.
In person meetings/conference calls are held.
Significant risks/areas of emphasis are identified through this process and other information gathering for focus during next reporting period.
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The University’s Core Compliance Program – Current Emphasis
The Conflict of Interest (COI) Program
Identifying COIs
Management plan follow-up
Coordination with the Office of Technology Commercialization (OTC)
Development of a revised COI Policy to address University-industry relationships
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Occupational Health and Safety
Personal Protective Equipment (PPE)
Research Outreach Centers
Research Lab Safety
OHS Training

Disability Services
Consistency in the delivery of DS services across all campuses
Accessibility of educational materials
Full access to:
sporting events
buildings

International Programs
Tracking students, staff and faculty traveling abroad outside of programs offered through the Office of International Programs.

Human Resources
Several new laws increase compliance responsibilities
Americans with Disabilities Act (ADA)
American Recovery & Reinvestment Act (ARRA)
Family Medical Leave Act (FMLA)
Electronic I-9 Employment Eligibility Verification
Lily Ledbetter Fair Pay Act

HIPPA/Data Security
Effective encryption systems are now in place
Focus is on ensuring that identifiable health information is stored in protected information systems

The University’s Core Compliance Program - UReport
UReport is a web-based and call center reporting service
To report violations or suspected violations of local, state, and federal laws and University polices
Provides for anonymous reporting
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The University’s Core Compliance Program - UReport
Metrics:
Approximately 150 reports submitted annually
Nearly 90% are submitted on-line
The majority of the reporters prefer to remain anonymous
Approximately 20% are deemed to be credible reports of a violation of law or policy
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Compliance Committees/Groups
Compliance Partners
Executive Oversight Compliance Committee (EOCC)
Research Compliance Committee
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Membership on Faculty Committees
CRAD
Senate Research Committee
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The University Policy Program
This program manages the process of policy development, revision, maintenance and retirement.
The Policy Advisory Committee (PAC) ensures that policies are needed and aligned with institutional mission, goals, and priorities.
The President’s Policy Committee (PPC) provides final institutional review and approval.
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The University Delegations Management Program
BOR policy:
Reserved several authorities to itself.
Delegated general executive management and administrative authority to the President and to further delegate that authority to other executive officers and employees.
Formerly managed by OGC.
Currently reviewing the existing electronic tracking system for possible modifications.
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The Conflict of Interest Program
Effective September 1, 2008, the Conflict of Interest Program was transferred from OVPR to OIC.
The University evaluates both individual and institutional COIs.
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What is an individual COI?

A situation that compromises a covered individual’s professional judgment
In carrying out University teaching, research, outreach, or public service activities
Because of an external relationship that directly or indirectly affects a business or significant financial interest of the individual, an immediate family member, or an associated entity.

Conflict of Interest Program
What is an institutional COI?
A situation in which the research, teaching, outreach, or other activities of the University
May be compromised because of an external financial or business relationship held at the institutional level
That may bring financial gain to the institution, its units or University Officials.

Multiple Committee Process
Institutional COI Committee (Dan Feeney, Chair)
AHC Committee (Bob Cipolle, Chair)
Provost Committee (Art Erdman, Chair)
Each has an executive and a full committee
Resolution is by peer review

Conflicts of interest are referred via:
REPAs
IRB
IACUC
PRFs
OTC
Individual referrals

Review process
Executive Committee
Full Committee
Outcomes
No COI
No current COI but guidance letter is needed
COI exists - management plan developed

Conflict of Interest – the Focus on Physicians’ Relationships with Industry
Scrutiny by the FederalGovernment – numerous “kickback” cases
The Pharmaceutical Industry
Serono - $567 million in part for kickbacks paid to physicians
TAP Pharmaceutical - $559 million in part for kickbacks paid to physicians
Bristol Myers Squib - $515 million in part for kickbacks to physicians
Smith Kline Beecham - $325 million in part for kickbacks to physicians
AstraZeneca Pharmaceuticals - $266 million in part for kickbacks to physicians
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Conflict of Interest – the Focus on Physicians’ Relationships with Industry
The Device Industry:
Settlement of claims against 5 orthopedic companies in September 2007 for $311 million (Stryker, DePuy, Zimmer, Smith & Nephew and Bionet)
Fall 2005 Department of Justice subpoenas served on Medtronic, St. Jude and Guidant (now Boston Scientific).
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Conflict of Interest – the Focus on Higher Education
By Congress: Re Alleged Inadequate Disclosures in Higher Education:
Harvard: Senator Charles Grassley (IA) alleged that two Harvard faculty/physicians failed to report $1.6 million in consulting fees to their institution.
Stanford: Senator Grassley alleged that the Chair of the Department of Psychiatry failed to report $6 million in ownership interest in stock in a company involved in a government-funded study that the physician oversees.
Emory: One of the nation’s most influential psychiatrists is alleged to have earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, but failed to report at least $1.2 million of that income to his university and violated federal research rules.
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In August of 2008, the media reported that Senator Grassley sent letters to several institutions of high education seeking information about the quality of the reporting system by which academic researchers report their outside income to their institutions.
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In July of 2009, Senator Grassley’s focus moved to the University of Minnesota

Senator Grassley’s concerns:
That colleges and universities often do not monitor or audit the information that researchers report so the only person who knows if the reported income is accurate is the person who is receiving the money.
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Conflict of Interest- The Focus on Higher Education
The University is currently engaged in a process to revise its current Individual COI Policy to address relationships with industry

Conflict of Interest – The University’s Current Focus
The Conflict of Interest Program is enhancing its approaches to:
REPA reporting
Reporting of COIs and
Monitoring of management plan compliance
COI training