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Office of Institutional Compliance

Office of Institutional Compliance . Presentation to the Provost’s Department Chairs Leadership Program February 19, 2009 Lynn Zentner, Director Office of Institutional Compliance . Compliance Office – Four Components. The Core Compliance Program Conflict of Interest Program

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Office of Institutional Compliance

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  1. Office of Institutional Compliance Presentation to the Provost’s Department Chairs Leadership Program February 19, 2009 Lynn Zentner, Director Office of Institutional Compliance

  2. Compliance Office – Four Components • The Core Compliance Program • Conflict of Interest Program • University Administrative Policies • Delegations Management

  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

  4. The University’s Core Compliance Program – Subject Matter Areas • Athletics • Boynton Health Service • Community University Health Care Center • Conflict of Interest • 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

  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

  6. The University’s Core Compliance Program – Subject Matter Areas • Examples: • Research • Animal and human subjects safety and welfare • Protocol approval and adherence • Human Resources • FMLA • FLSA • New vacation policy

  7. The University’s Core Compliance Program – Subject Matter Areas Examples Continued: • Data Security/Privacy/HIPAA • Security of private data – employee, student, patient • Encryption • Occupational Health & Safety • Personal Protective Equipment (PPE) • Chemical storage and protection from flammables

  8. 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.

  9. The University’s Core Compliance Program – Current Emphasis • Occupational Health & Safety • AAALAC • Conflict of Interest Program

  10. The University Core Compliance Program • Occupational Health & Safety (OHS) • A few years ago, President Bruininks asked VPs Carol Carrier, Tim Mulcahy and Kathy O’Brien to form a Working Group charged with evaluating the then current status of the University’s OHS Programs.

  11. The University’s Core Compliance Program – Current Emphasis - OHS • Goals: • Develop an integrated and carefully coordinated program • Utilize the expertise that exists within the many departments within the scope of OHS • Close gaps that exist in services and training • Reduce redundancies regarding the same

  12. The University’s Core Compliance Program – Current Emphasis - OHS • External assessments are currently focusing on how to most effectively: • Integrate the operations of our current programs; • Identify, evaluate and manage all related risks; • Develop comprehensive standards, policies, and procedures; and • Establish a leadership model.

  13. The University Core Compliance Program –Emphasis – Animal Research • The Association for Assessment & Accreditation of Laboratory Animal Care (AAALAC) conducted accreditation site visits in early 2007 and again in February 2008. • AAALAC identified the following issues: • Strengthening the oversight, leadership and expertise of the membership of the IACUC

  14. The University’s Core Compliance Program – Emphasis – Animal Research • Developing greater consistency in the use of Personal Protective Equipment; and • Ensuring that certain biohazard containment practices are sufficient to properly contain the hazard and minimize risk to personnel. • The results of an external assessment are assisting the University in determining the most effective approaches to addressing the issues identified by AAALAC.

  15. The University’s Core Compliance Program – Emphasis – Conflict of Interest Program • The Conflict of Interest Program was transitioned to OIC effective September 1, 2008. • A time of transition often provides an opportunity to evaluate a current infrastructure, policies and procedures. • A process involving an internal self-assessment and an external evaluation are identifying ways in which we might modify our current infrastructure, policies and procedures.

  16. The University’s Core Compliance Program - UReport • UReport is a web-based and call center reporting service which: • Can be used to report violations or suspected violations of local, state, and federal laws and University polices; and • Provides for anonymous reporting

  17. The University’s Core Compliance Program - UReport 2008 metrics: • 161 reports submitted • 139 were submitted on-line; 19 were received via the call center, 2 were received via the mail and 1 was received “in person” • 29% were anonymous • 20% were deemed to be credible reports of a violation of law or policy

  18. The Conflict of Interest Program Program Purpose: • To ensure that the integrity of the work that we do here - our research, teaching and community outreach - is not called into question because of external relationships . To the extent that a business or financial relationship with an external entity might call into question the objectivity which we carry out our teaching, research and community outreach activities, the integrity of the University may be called into question.

  19. The Conflict of Interest Program • The University’s Conflict of Interest Program evaluates both individual and institutional COIs.

  20. The Conflict of Interest Program • An individual business or financial 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 covered individual, an immediate family member, or an associated entity as defined in related administrative policy.

  21. The Conflict of Interest Program • 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, any of its units, or the individuals covered by this policy.

  22. Conflict of Interest – the University’s Internal Disclosure & Review Process Policies and procedures: • Three administrative Policies – one to address individual conflicts and two to address institutional conflicts, and • Several procedures to address conflicts of interest arising out of gifts, licensing & technology transfer, purchasing, investments and conflicts that arise in the context of human subjects research.

  23. Conflict of Interest – the University’s Internal Disclosure & Review Processes Three Committees: • An Institutional COI Review Committee • Two Individual COI Committees: • AHC • Provost

  24. Conflict of Interest – the University's Internal Disclosure & Review Process The Disclosure Process: • REPAs • Annual financial disclosures by “University officials” • Proposal Routing Forms • ROCs

  25. Conflict of Interest – the University’s Internal Disclosure & Review Process Other avenues for disclosure: • When submitting new or continuing applications to the IRB, the IACUC or the IBC; • When receiving a contribution or gift which has the appearance of creating a conflict; and • When involved with technology transfer.

  26. Conflict of Interest – the University’s Internal Disclosure & Review Process Review and resolution: • Review by departments and colleges • COI program review and management • Executive Committee review • Full Committee review • Development of a Management Plan • Management Plan follow-up

  27. Conflict of Interest – Recent and Current Activities • Internal self-assessment and external evaluation conducted fall of ’08. • May result in the revision of current policies and procedures and modification of the current infrastructure. • Efforts underway to create a COI database. • A more comprehensive approach for management plan follow-up is being developed.

  28. Conflict of Interest – Recent and Current Activities • Development of standards to govern relationships with industry/external entities • The current landscape • Disclosure of failures in higher education • Senator Grassley’s “Sunshine” legislation • The Medical School Recommendations on the Oversight of External Relationships

  29. Conflict of Interest – Industry Relationships The Enforcement Landscape Scrutiny by the FederalGovernment: • 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

  30. Conflict of Interest – Industry Relationships The Enforcement Landscape The Device Industry: • Settlement of claims against 5 orthopedic companies in September 2007 for $311 (Stryker, DePuy, Zimmer, Smith & Nephew and Bionet) • Scrutinized consulting agreements for legitimacy and $$ paid • Deferred prosecution agreements • On-site monitors • Fall 2005 Department of Justice subpoenas served on Medtronic, St. Jude and Guidant (now Boston Scientific).

  31. Conflict of Interest – Industry Relationships The Enforcement Landscape By Whistleblowers: • September 2008 whistleblower suit reported in the local media regarding alleged receipt of kickbacks by local physicians for prescribing the off-label use of a biologic marketed and sold by Medtronic.

  32. Conflict of Interest – Industry Relationships The Enforcement Landscape 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, failed to report at least $1.2 million of that income to his university and violated federal research rules. • University of WI: An orthopedic surgeon is alleged to have received more than $19 million in royalty payments from Medtronic over a 4-year period. UW did not share in the payments. Researcher says that UW facilities were not used for the patent-related work.

  33. Conflict of Interest – Industry Relationships The Enforcement Landscape • In early 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.

  34. Conflict of Interest – Industry Relationships The Enforcement Landscape Senator Grassley’s concerns: • That colleges and universities often do not monitor or audit the information the researchers report so the only person who knows if the reported income is accurate is the person who is receiving the money. • Although he is not saying that there is something inherently wrong with accepting money from industry, for the sake of transparency and accountability, it is his view the American public should know who the physician is taking money from.

  35. Conflict of Interest – Industry Relationships The Enforcement Landscape Legislation • Federal: September 2007, Senators Grassley and Herb Kohl (WI) introduced legislation requiring manufacturers of pharmaceutical drugs, devices and biologics to disclose the amount of money they give to physicians through payments, gifts, honoraria, travel and other means. • Senator Amy Klobuchar is a co-sponsor.

  36. Conflict of Interest – Industry Relationships The Enforcement Landscape • Senator Amy Klobuchar’s comments on the proposed legislation: “This is a common sense legislation that helps ensure the integrity of our health care system. It is important to shed light on the millions of dollars these companies spend on marketing – money that could be put into research or lowering the cost of prescriptions.” • Letters of endorsement from the AMA, the Association of American Medical Colleges, AdvaMed, Pharma, Medtronic, and Merck.

  37. Conflict of Interest – Industry Relationships The Enforcement Landscape By States: • Several states and the District of Columbia have “sunshine laws” - some that provide public disclosure and others that do not; some that require disclosure by only the pharmaceutical industry and some that require disclosure by both the pharmaceutical and device industries: • Minnesota (the first) • Vermont • Maine • District of Columbia • West Virginia • Massachusetts

  38. The University Policy Office • Merged with OIC in 2007 • Michele Gross 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.

  39. 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.

  40. Questions? Lynn Zentner, Director Office of Institutional Compliance 612/626-7852 lzentner@umn.edu

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