1. Office of Institutional Compliance Presentation to the Provost’s Department Chairs Leadership Program October 8, 2009 Lynn Zentner, Director Office of Institutional Compliance
2. Office of Institutional Compliance Office – Four Components The Core Compliance Program University Administrative Policies Delegations Management Conflict of Interest Program 2
3. 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 3
4. 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 4
5. 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 5
6. 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. 6
7. 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 7
8. The University’s Core Compliance Program – Current Emphasis Occupational Health and Safety Personal Protective Equipment (PPE) Research Outreach Centers Research Lab Safety OHS Training
9. The University’s Core Compliance Program – Current Emphasis Disability Services Consistency in the delivery of DS services across all campuses Accessibility of educational materials Full access to: sporting events buildings
10. The University’s Core Compliance Program – Current Emphasis International Programs Tracking students, staff and faculty traveling abroad outside of programs offered through the Office of International Programs.
11. The University’s Core Compliance Program – Current Emphasis 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
12. The University’s Core Compliance Program – Current Emphasis HIPPA/Data Security Effective encryption systems are now in place Focus is on ensuring that identifiable health information is stored in protected information systems
13. 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 13
14. 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 14
17. 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. 17
18. 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. 18
19. 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. 19
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21. In carrying out University teaching, research, outreach, or public service activities
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23. The Conflict of Interest Program 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
24. The Conflict of Interest Program Conflicts of interest are referred via: REPAs IRB IACUC PRFs OTC Individual referrals
25. The Conflict of Interest Program Review process Executive Committee Full Committee Outcomes No COI No current COI but guidance letter is needed COI exists - management plan developed
26. 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 25
27. 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). 26
28. 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. 27
29. Conflict of Interest – the Focus on Higher Education 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. 28
30. Conflict of Interest – the Focus on Higher Education In July of 2009, Senator Grassley’s focus moved to the University of Minnesota
31. Conflict of Interest – the Focus on Higher Education 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. 30
32. 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
33. 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
