conference for effective compliance in · overview: university of minnesota’s conflict of...
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SCCE Conference for Effective Compliance Systemsin Higher Education
June 2009Lynn Zentner, Director
Office of Institutional Compliance
The Focus for TodayDisclosing, Identifying, and Managing Individual Conflicts of Interest in Higher Education
Disclosing, Identifying, and Managing Institutional Conflicts of Interest in Higher Education
Developing Standards to Govern Relationships between Institutions of Higher Education and Industry
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Overview: University of Minnesota’s Conflict of Interest Program
In operation for more than 15 years1994: Board of Regents policy on individual business or financial conflict of interest adopted2005: Board of Regents policy on institutional conflict of interest adoptedPolicies and procedures implemented through a three‐committee structureUniversity‐wide application (5 campuses and greater than 30,000 employees)
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Definition: Individual Business or Financial Conflict of Interest (COI)
(as defined in Board of Regents policy)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.
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Individual Conflict of Interest Policies: Board of Regents Policy
Delegates authority to the President to:establish an oversight process and administrative policies and procedures to address individual conflicts of interest;implement a plan to manage, reduce or eliminate individual conflicts of interest; andensure that the University’s oversight process, policies and procedures conform to federal regulations related to conflict of interest and objectivity in research.
Provides for an annual reporting process requiring covered individuals to complete a report of external and professional activities.
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Individual Conflict of Interest Policies: Administrative Policy
Policy adopted in 2005 which:defines covered individuals;defines role of unit heads and deans;provides for two COI review committees; anddefines “financial interest” and “significant financial interest”.
Three administrative procedures govern COI disclosures, the evaluation and management of them, and how to avoid conflicts in special situations.
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Institutional Conflict of Interest Policies: Board of Regents Policy
Institutional COI definition:“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.”
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Institutional Conflict of Interest Policies: Board of Regents Policy
Defines “institutional official”Establishes guiding principlesReserves to the Board of Regents the authority to evaluate and manage significant institutional conflicts of interestDelegates certain authorities to the President or the President’s designee to:
establish an oversight process to identify and manage institutional COIs and ensure compliance
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Institutional Conflict of Interest Policies: Administrative
One administrative policy and six administrative procedures developed to identify and manage institutional COIs, and address conflicts arising in the context of:
giftsinvestmentslicensing and technology transferpurchasinghuman subjects research
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Internal Disclosure, Review, Resolution and Management Processes
Three avenues for disclosure Multi‐level review and resolution processWritten management plans
May include sanctions for non‐compliance
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Internal Disclosure of Conflicts of InterestThree avenues:Report of External Professional Activities (REPA)
Annual reporting requirement forAll paid faculty and professional and administrative (P&A) staff All individuals with research responsibilities (design, performance, or reporting of research) to include unpaid academic employees and adjunct faculty
Additional reporting obligations if circumstances change
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Internal Disclosure of Conflicts of InterestThree avenues (continued):
Financial disclosure by “university officials”Annual reporting requirementRequires disclosure of significant financial interests and business and community relationshipsMust describe how those interests relate to the individual’s institutional responsibilities.“University officials” includes
President, president’s chief of staff, chancellors, vice chancellors, deans and associate deans, division I athletic director, provost (vice and associate), all vice presidents, andothers as designated by the President
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Internal Disclosure of Conflicts of InterestThree avenues (continued):
Report of Outside Consulting and Other CommitmentsRequired for each external professional activity engaged in for more than an average of one day per month in any single term of University appointment.Typically this information has already been reported on the REPA.
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Internal Disclosure of Conflicts of InterestAdditional avenues of disclosure when:
submitting a proposal for a sponsored project; and/orsubmitting a new application or continuing review form to the IRB, the IACUC, or the IBC involved with technology transfer .
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Internal Review ProcessesThree committees:The Institutional COI Review CommitteeIndividual COI Review Committees
Academic Health Center Provost
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Internal Review Process: Committee Composition
Individual COI committeesAppointed by senior leadershipRepresentative from each college invited to participateCommunity representativesP&A staff Voting members: ¾ are faculty and ¼ are community representatives and P&A staffNonvoting members: e.g., Sponsored Projects Administration (SPA), Office of the General Counsel (OGC), Office of Institutional Conflict (OIC), Office of Technology Commercialization(OTC), Research Subjects Protection Program (RSPP)
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Internal Review Process:Committee Composition (continued)
Institutional COI CommitteeAppointed by senior leadershipSenior leader representatives from all of the campusesUniversity AuditorDirector of Intercollegiate AthleticsDirector of the Office of Research Integrity and OversightThe University controllerDirector of RSPPDirector of OTCAssociate VP for SPATwo members from the communityChairs of the two individual COI review committeesOGC and OIC representatives are nonvoting members
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Internal Review Process
Three levelsAdministrative reviewExecutive committee reviewFull committee review
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Administrative review covers:matters with pre‐existing management plans and no modification needed;outside consulting activities only with no relationship to University activities;a faculty member’s Scientific Advisory Board position with a commercial entity that sponsors his/her research; where the faculty member agrees to recusal re that research; andactivities that are exempt from COI disclosure.
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Internal Review Process
Internal Review ProcessExecutive committee review covers:
a determination that no potential or actual COI exists;matters that involve “minimal to moderate” potential for COI, no human subjects involved, individual agrees to proposed management plan; andthose that involve minor revisions to previously developed plan and individual agrees to the revisions.
Balance of the matters are prepared for full committee review.The plan going forward is to use a consent agenda process.
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Internal Review ProcessFull committee review covers:
any high visibility matter;those with “moderate to high” potential for a COI;those that involve substantial non‐compliance with a previously issued management plan; andrequests by a staff or faculty member for a full committee review.
Individual whose potential COI is under review is invited to participate.
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Conflict of Interest Resolution: Management Plans
Are addressed to the deans (for faculty) or appropriate management (staff)Are signed by the Committee Chair and the Director, OICGoing forward, will be agreed to in writing by the employee
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Conflict of Interest Resolution: Management Plans (continued)
Provide a summary of the factual backgroundIdentify the nature of the COISet forth the elements needed to eliminate, reduce or otherwise manage the COIGoing forward, will be monitored annually
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Conflict of Interest Non‐ComplianceCOI non‐compliance includes:
failing to file a REPA;filing an incomplete, erroneous, or misleading disclosure form;failing to provide requested information; orfailing to follow an approved management plan.
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Conflict of Interest Non‐compliancePotential sanctions include but are not limited to:
letter of admonition;ineligibility for grants and participation in human subjects research;suspension;non‐renewal of appointment; ordismissal.
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Special Considerations ‐Technology Transfer and Institutional Conflicts of Interest
COIs arise in the context of technology transfer (TT) when:
the University is receiving royalties or holding equity in a start‐up and University researchers continue to conduct research sponsored by the company or have some other financial interest, orthere is knowledge that the University stands to gain financially from the successful development of a licensed technology.
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Special Considerations – Technology Transfer and Institutional Conflicts of InterestWhere the University has a royalty or “other income”interest:Identify the potential COI:
IRB applications ask whether the proposed study evaluates a University invention. If so, the matter is forwarded to the COI Program for review.At least annually, OTC identifies all companies that paid more than $100,000 the prior year to the University, identifying the units and faculty that received a share of the revenue. That list is compared to databases identifying research sponsors, principal investigators (PIs) and potential vendors.
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Special Considerations – Technology Transfer and Institutional Conflicts of Interest
If the financial arrangement could affect or appear to affect
human subjects research, orUniversity teaching, research, outreach or other activities
the matter is referred to the Institutional COI Committee for review and resolution.
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Special Considerations – Technology Transfer and Institutional Conflicts of InterestWhere the University has or is contemplating an equity interest in a start up:
A COI review is required if the equity interest is 5% or greater or if human subjects research is involved ($0.00 threshold). If the University already holds an equity interest above the threshold, equity‐related information is insulated from the research enterprise. If Asset Management is asked to vote on a matter in which the University holds an equity interest in excess of the threshold or involving human subjects research, the matter will be addressed with the Institutional Conflict Review Committee.
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Special Considerations – Technology Transfer and Institutional Conflicts of Interest
In either circumstance:a royalty or “other income” interest exists, orthe institution is contemplating an equity interest in the start up,
where a COI is found to exist, a management plan is developed and, in certain circumstances, Board of Regents review may be required.
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Relationships With Industry and How to Manage Them
Many institutions of higher education are developing standards and principles to govern relationships with industry.These collaborative relationships offer value to the general public by bringing to the market place the innovations that result from academic research, education and outreach.However, we risk the loss of the public trust.Management of these relationships is the key.
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Relationships With Industry and How to Manage Them
Institutions of higher education are under scrutiny by:The general public (whistleblowers)The mediaThe Department Of JusticeCongressState legislatures
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Relationships with IndustryThe Enforcement Landscape: Federal Government
The Pharmaceutical Industry Serono ‐ $567 million in part for kickbacks paid to physiciansTAP Pharmaceutical ‐ $559 million in part for kickbacks paid to physiciansBristol Myers Squib‐ $515 million in part for kickbacks to physiciansSmith Kline Beecham‐ $325 million in part for kickbacks to physiciansAstraZeneca Pharmaceuticals‐ $266 million in part for kickbacks to physicians
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Relationships with IndustryThe Enforcement Landscape: by Federal Government
The Device Industry:Fall 2005: Department of Justice subpoenas served on Medtronic, St. Jude and Guidant (now Boston Scientific) September 2007: Settlement of claims against 5 orthopedic companies for $311 million (Stryker, DePuy, Zimmer, Smith & Nephew and Bionet)
Scrutinized consulting agreements for legitimacy and $$ paidDeferred prosecution agreementsOn‐site monitors
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Relationships with IndustryThe Enforcement Landscape: by Whistleblowers
September 2008: Whistleblower suit reported by the Minnesota media regarding alleged receipt of kickbacks by local physicians for prescribing the off‐label use of a biologic marketed and sold by Medtronic.
The federal government declined to interveneMarch 2009, case was dismissed by a federal district court judge in Massachusetts
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Relationships with IndustryThe Enforcement Landscape: by CongressAlleged Inadequate Disclosures in Higher Education:Harvard: Two Harvard faculty/physicians failed to report $1.6 million in consulting fees to their institution.Stanford: 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: A nationally recognized psychiatrist 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.
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Relationships with IndustryThe Enforcement Landscape: by Congress
In early August 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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Relationships with IndustryThe Enforcement Landscape: by CongressSenator Grassley’s concerns:
That colleges and universities may not have good systems to verify the accuracy of the outside income reported by the person who is receiving the money.The Senator’s focus is on issues of transparency and accountability, and not on the appropriateness of industry/higher education relationships.
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Relationships with IndustryThe Enforcement Landscape: by 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.
Minnesota Senator Amy Klobuchar is a co‐sponsor.
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Relationships with IndustryThe Enforcement Landscape: by Legislation
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.”
The AMA, the Association of American Medical Colleges, AdvaMed, PhRMA, Medtronic, and Merck have endorsed the legislation.
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Relationships with IndustryThe 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)VermontMaineDistrict of ColumbiaWest VirginiaMassachusetts
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Relationships with Industry:Principles and Standards
Many institutions of higher education have or are developing principles and standards to govern relationships with industry.A few key questions:
What societal benefits result from the higher‐education/industry collaboration? What disadvantages result from restricting this collaborative process?How do we strike the appropriate balance?
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Relationships with Industry: Principles and Standards (continued)Key questions (continued):
Should such standards apply University‐wide or only with respect to health sciences?How important is transparency and in what areas is transparency key?Should compensation resulting from industry/higher ed collaborations be posted on public websites? Actual dollar amounts? Incremental dollar amounts? A “more than” amount?
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Relationships with Industry:Principles and Standards (continued)Key questions continued:
Should written consulting agreements be required? If so, should each consulting agreement contain certain essential elements?Should consulting arrangements require prior review and approval?Should we restrict industry presence on campus?
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Relationships with Industry: Principles and Standards (continued)Categories to consider:
Internal reporting of income earned from industry relationshipsDisclosure of financial relationships to patients, students, colleagues, professional journalsConsulting arrangements and agreements
required provisionsprior approvalprohibited consulting activities
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Relationships with Industry:Principles and Standards (continued)
Gifts and other items of valueIndustry‐sponsored recreation and entertainmentOwnership interest in a commercial companySpeakers bureausGhostwritingRepresentations made on behalf of the institutionEndorsements/product promotionsIndustry sponsorship of activities
Meals – on and off campusEducation, Training and CMEsResearch and educational grants and charitable contributions
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Relationships with Industry:Principles and Standards (continued)
Sales, promotional, and other business meetingsIndustry‐developed patient education materialsIndustry‐sponsored marketing surveysCommercially‐sponsored journals
Industry presence on campus (industry representatives, products and logos)Off‐site interactions with industryInvolvement in purchasing decisions where financial relationship with commercial entity existsIndustry provision of samples and demonstration products
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Closing
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