office of institutional compliance

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Office of Institutional Compliance

Presentation to the Provost’s Department Chairs Leadership Program

October 8, 2009Lynn Zentner, Director

Office of Institutional Compliance

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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

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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

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Conflict of Interest – the Focus on Physicians’ Relationships with Industry

Scrutiny by the Federal Government – 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

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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