Technology Transfer TacticsAudio ConferenceOctober 14, 2010

Best Practices for Managing

Conflict of Interest in University Research

Bernadette M. Broccolo

McDermott Will & Emery, LLP

312-984-6911

bbroccolo@mwe.com

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Over the last decade, we have seen virtually relentless scrutiny of financial ties between drug

and device manufacturers and universities, providers and research institutes by federal and

state governments, courts, the public, professional associations and journals, pundits, watchdogs and

the media.

Focus of Today’s Discussion

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In the media…

“Patient advocacy groups…have long complained that drug companies exert undue influence on doctors…”

“[W]hen doctors are acting as researchers, they should not have money riding on the outcome…”

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In the media…

“But as the volume of disclosure rises, some fear the ritual will become a mere formality…”

“[T]he cozy relationship between prominent academics and the drug industry…”

“The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.”

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Focus of Today’s Discussion

Conflicts of interest in research arising from such relationships

Interplay with conflicts of interest in medical education and clinical care

Interplay with other compliance risks and challengesThe Laws and Regulations v. Industry Standards/ Emerging Best Practices

Provider and Industry Response to Scrutiny and Call for Reform

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Provider/Industry Relationship Puzzle

Pricing practices

Consulting Agreements

Scientific advisory board participation

Speakers Bureaus

Research sponsorship and grants arrangements

CME funding

Business entertainment, gifts, and travel reimbursement

Charitable Donations

Credit for published works

Recruitment bonuses

Individual and Institutional Royalty and Equity Interests in IP and Spin-Off Companies

Other Institutional Relationships

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Provider/Industry Relationship PuzzleEmerging Theme of Ethical, Legal and Safety Concerns

The concerns arising from all of these financial relationships are variations on a common theme: They create undue influence that can:

– Impair judgment in research resulting in risk to human subjects and unreliable data underlying new product development;

– Change medical prescribing behavior that can pose harm to patients; or– Diminish the objectivity and integrity of the content of medical educational

programs and materials.

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Historical Perspective:Where We Have Been

Federal policy beginning in 1980 (Bayh-Dole Act) – Encouraging institutions to seek private investment for research.– Allowing researchers and institutions to share in the financial return on

successful products/inventions. Well established bodies of law governing COIs in research are

inadequate to meet today’s needs.– Federal Common Rule and HHS Guidance on Conflicts, FDA, NIH/PHS– FDA/NIH/PHS– Focus only:

• Individual conflicts of PIs only (not other research team members)• Individual and not institutional conflicts of interest• Reporting (not assessment and management)

– Use dollar thresholds for disclosures of interests (“significant financial interest”)

– Relies primarily on the IRB and PIs to address conflicts of interest

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Historical Perspective:Where We Have Been

High profile cases of harm to clinical research subjects

– Put spotlight on financial interests of researchers and institutions.

– Increased focus on both individual and institutional COIs.

– Focus on injury/harm to human subjects.

– Myriad legal theories• Misrepresentation and fraud arising from failure to disclose COI.

• Breach of fiduciary duty implied under informed consent.

• Negligence, negligence per se.

• Violation of right to be treated with dignity.

• Assault/Battery (subject did not consent to research as conducted).

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Catalysts for Change:Where We Are Now

Widespread scrutiny– Industry and Professional associations– Courts and the plaintiffs bar– Regulators– Legislators (State and Federal)– Patient advocates– The Media (national, regional, local)

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Catalysts for Change:Where We Are Now

2004 guidance from HHS

Major Institutional Trade and Professional Associations (AAU, AAMC, AMA, IOM)

Related OIG guidance from OIG Major Manufacturer Trade Association Ethical Codes on Financial Interests between Providers and Industry

– PhRMA and AdvaMed Codes

• Both codes provide parameters for the full range of Interactions of their Members with Healthcare Professionals.

• Both codes were recently updated and contain tighter restrictions on industry interactions with healthcare professionals.

• The Codes provide some bright line standards that help guide Anti-Kickback Law compliance efforts.

• Compliance with the Codes, along with an active compliance program, may be viewed favorably by the OIG and other enforcement agencies.

ACCME Certification Standards

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Conflicts of Interest in Research:2008 Joint AAMC/AAU Report on COIs in Clinical Trials

Joint Committee of AAMC and AAU issued a report on Conflicts of Interest in Research (the “Report”) on 2/28/08.

Reinforces and supplements 2001 and 2002 reportsThe Report challenged institutions to take action within two years (2/28/10) to:

– Accelerate the development of COI policies that cover the financial interests of faculty, institutions and their officials, including deans, department chairs and division chiefs

– Implement a reporting, evaluation and management process for both individual and institutional financial COI, that includes a review system that involves a standing internal committee or an external review entity

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January 2008 OIG Report:NIH Conflicts of Interest in Extramural Research

Key Recommendations:– Increase oversight of grantee

Institutions to ensure compliance with Federal financial COI regulations

– Require grantee Institutions to provide details regarding the nature of COI and its management

– Require NIH to maintain all COI from the grantee Institutions in a database

Findings NIH could not provide an accurate count of grantee financial conflict-of-interest reports from 2004 through 2006.

NIH is not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported and most conflict-of-interest reports do not state the nature of the conflict.

Many Institutes’ primary method of oversight is reliance on grantee institutions’ assurances that financial conflict-of-interest regulations are followed.

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FDA Oversight of Financial Conflicts of Interest in Research:Report January 2009 OIG

Federal regulations require industry sponsors to collect and disclose certain financial interests of investigators that could create bias in the clinical research, such as serving as a consultant for the study sponsor or participating in the sponsor’s speakers bureau. 

January 2009 OIG report sharply criticizes FDA’s oversight of financial conflict of interest information submitted by investigators conducting clinical trials. 

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Findings:

One percent of clinical investigators disclosed a financial interest

FDA cannot determine whether sponsors have submitted financial information for all clinical investigators.

Forty-two percent of FDA-approved marketing applications were missing financial information.

FDA did not document a review of any financial information for 31 percent of marketing applications.

Neither FDA nor sponsors took action for 20 percent of marketing applications with disclosed financial interests.

January 2009 OIG Report: FDA Oversight of Financial Conflicts of Interest

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Industry Influence Over Medical Education:June 2008 AAMC Report

AAMC Report - Guidelines Addressing Gifts from Industry June 2008 Offers guiding principles and recommendations for how medical schools and teaching hospitals should govern student

and faculty interactions with industry. The report's objective is to prevent conflicts of interest that can distort therapeutic judgments and decision making. The AAMC's leadership urged all association members to implement policies and procedures, consistent with the report's guidelines, by July 1, 2009.

– Establish and implement policies that prohibit the acceptance of any gifts from industry by physicians, faculty, students and residents on- or off-site

– Eliminate the receipt of drug samples or manage their distribution via a centralized process that ensures timely patient access throughout the health care system

– Restrict access by pharmaceutical representatives to individual physicians by confining visits to non-patient areas and holding them by appointment only

– Set up a central continuing medical education (CME) office to receive and coordinate the distribution of industry support for CME activities

– Strongly discourage participation by faculty in industry-sponsored speakers' bureaus – Prohibit physicians, residents, and students from allowing presentations of any kind to be ghostwritten by industry

representatives

ACCME – (June 2008) Issued a Call for Comments seeking industry input on revised policy proposals, including a consideration that commercial support be eliminated from CME.

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Finance Committee Report Focuses on Drug Company Grants for Medical Education

Inquiry reveals educational grants as common business practice, but potential for

abuse remains

Industry Influence Over Medical Education:Congressional Focus on Educational Grants

The Senate Finance Committee and Senate Committee on Aging have launched formal probes of activities that could undermine the integrity of CME and research as well as clinical care.

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Industry Influence Over Medical Education:American Medical Student Association COI Policy Scorecard

Scorecard on conflict-of-interest policies at the 151 medical colleges and colleges of osteopathic medicine in the United States.

Assesses policies related to potential conflicts of interest created by industry marketing at the level of the individual physician and trainee.

Most recent results: of the 151 US medical schools, 8 received As (5%), 14 Bs (9%), 5 Cs (3%), and 24 Ds (16%). These totals include 11 institutions assessed since the original Scorecard release on May 30, 2008.

52 schools (34%) receive a grade of F. This includes 16 that either submitted policies graded as F or indicated they had no relevant policies, as well as 13 schools that declined to submit policies and 23 that did not respond to repeated attempts at follow-up.

September 2008 JAMA Commentary published in the Journal of the American Medical Association indicates that stricter conflict-of-interest policies adopted by academic medical centers has not apparently been detrimental to staff retention.

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Industry Influence Over Medical Education:Harvard Medical Students Express Concern

Just one day after the NYT article, Senator Grassley sent a letter to Pfizer requesting information regarding the nature and amount of payments made to 149 Harvard faculty members, such as honorarium or research support.

“Pfizer is attempting to intimidate young scholars from professing their independent views on issues that they think are critical to science, medicine, and the health and welfare of American taxpayers.”

March 3, 2009 New York Times Article Addresses Harvard medical student concerns regarding industry relationships with Harvard faculty.

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Institute of Medicine Report:COI in Medical Research, Education and Clinical Practice

Issued in late April 2009 by the Institute of Medicine of the National Academies

Comprehensive coverage of conflicts of interest arising from industry relationships in all three areas of concern

Reinforces the standards set forth by AAMC and AAU in earlier reports (2008, 2002 and 2001)

Recognizes the need for industry/provider collaboration to advance science

Reinforces that “disclosure” of interests is not enough to address the risk Calls for all the players to contribute to identifying and managing the conflict of interest risk arising from these relationships

Calls for uniform approach to transparency Urges a commitment to self-reform as the alternative to government prescribed reform

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June 2010 AAMC Report:COIs in Clinical Care

Reinforces and complements recommendations in prior reports on COIs in research and education

Uses IOM Report definition of clinical COI

A clinical COI occurs when a secondary financial interest creates the risk of undue influence in the exercise of the primary professional duty to the patient

Actual and Perceived Risk of Bias continues to be the standard

Financial interests only (not associational)

Heavier hand with regard to royalties

Patient Disclosure is Not Enough

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June 2010 AAMC Report 7 Recommendations Address Individual and Institutional Interests

Disclose Institutional Interests as a COI management step

The AAMC principles and standards should apply to all providers

AAMCs’ own compensation practices can create COIs

Involve patients in determining how to disclose COIs

No discussion of special challenges of disclosure, assessment and management in clinical care setting – but promise of future guidance

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Interplay with Other Laws and Standards

• Anti-Kickback Law (Federal and State)

• False Claims Act (Federal and State)

• FDA law and regulations concerning labeling, promotion and advertising

• Foreign Corrupt Practices Act

• Prescription Drug Marketing Act (PDMA) (samples)

• Medicare Marketing Guidelines

• State Consumer Protection Laws

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Pharmaceutical, medical device and biotech manufacturers have been and will continue to be the focus of the government’s intense and aggressive civil and criminal health care fraud and abuse enforcement initiatives.

Enforcement Activity

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Congress -Anti-Kickback Statute

-False Claims Act-MMA

Office of Inspector General

(OIG)- Civil Monetary Penalties- Exclusionary Authority

- Corporate Integrity Agreements

Centers for Medicare and Medicaid Services (CMS)-Reimbursement Regulations

Whistleblowers

Department of Justice

-Civil/Criminal Settlements

Food and Drug Administration (FDA)

-FDAMA-Off-Label Promotion

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Qui Tam (Whistleblower) Actions

False Claims Act cases brought by private citizens on behalf of the U.S. government

The qui tam relator receives 15 to 30 percent of the government’s recovery (can be reduced if the relator was culpable for the fraud)

Almost all fraud and abuse cases involving manufacturers have been brought as False Claims Act whistleblower cases

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GOVERNMENT V. PHARMA

Company $ Millions

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875

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248

355

614

430346

Allegations

Off-label marketing of human growth hormone Protropin

Illegal marketing and price manipulation of Lupron

Off-label marketing of Neurontin as a result of a Qui tam complaint

Misreporting “best price” for Cipro and Adalat CC

Free samples of Zoladex distributed to urologists with the understanding that they would bill for reimbursement

Misreporting “best price” and kickbacks for enteral products

Off-label marketing of Neurontin

Misreporting “best price” off-label promotion, managed care kickbacks for Claritin

Kickbacks to physicians, off-label promotion, off-label promotion via CME and educational programs

704

435 Off-label marketing of Temodar and Intron-A

Off-label promotion of Actimmune and misleading use of clinical trial results40

4252007

2009

2006

2005

2004

2003

2002

2001

1999

Off-label marketing of Bextra, Geodon, Lyrica, Zyvox

Off-label marketing of Actiq, Provigil, Gabitril

Off-label marketing of Xyprexa1400

2300

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Government v. Device2007 Hip and Knee Settlements: Allegations

“This industry routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products”

– “The financial inducements in the form of consulting agreements . . . in which physicians did little or no work for the financial inducements but did agree to exclusively use the paying company’s products.”

– “The physician consultants also failed to disclose the existence of these relationships with the companies to the hospitals where the surgeries were performed and, more importantly, to the patients that they treated.”

DOJ Press Release, 9/27/07

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Government v. Device2007 Hip and Knee Company SettlementsDeferred Prosecution Agreements (DPAs)

–Zimmer, Inc. ($169.5 million)–Depuy Orthopaedics, Inc. ($84.7 million)–Biomet Inc. ($26.9 million)–Smith & Nephew, Inc. ($28.9 million)

Non-Prosecution Agreement (NPA): –Stryker Orthopedics, Inc. (voluntarily cooperated first)

5-Year Corporate Integrity Agreements

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Government v. Device2007 Hip and Knee Settlements: TermsRetain a monitor to review all consulting arrangementsDisclosure of arrangements and amounts paid on company web pages

Disclosure of arrangements by physicians to patientsNeeds assessment to determine and document the reasonable need for consulting arrangements

Compensation of no more than $500 per hour for time actually expended (without FMV opinion and Monitor approval)

Invoices/documentation submitted prior to any paymentsProject manager must certify in writing that invoices reflect bona fide services provided by Consultant prior to payment

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Government v. DeviceOrthofix International2008: Guilty plea by physician

– “The federal case against Blackstone Medical of Springfield got a boost yesterday when an Arkansas neurosurgeon pleaded guilty to soliciting and accepting kickbacks from a salesman who worked for Blackstone's parent company, Orthofix International, based in Netherlands Antilles, as well as three other companies. Additional charges were dismissed in exchange for Dr. Patrick Chan's agreement to cooperate in the government's investigation into separate allegations that Blackstone and other companies defrauded the Medicaid and Medicare programs by paying illegal incentives to other doctors. Those allegations are contained in a whistle-blower's lawsuit.”

– “Chan also agreed to pay $1.5 million to settle allegations against him in the whistle-blower suit, which alleges Blackstone and another company provided kickbacks in the form of bogus consulting contracts, fake research studies, and gifts to Chan and doctors across the nation who agreed to use the companies' devices in back surgeries.” (Boston Globe, 1/4/08)

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Government v. PhysiciansHHS “Poster Child” Strategy

March 4, 2009 New York Times Article

Within a few months, federal officials “plan to file civil and criminal charges against a number of surgeons” who allegedly “demanded profitable consulting agreements from device makers in exchange for using their products.”

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it.”

Lewis Morris, Chief Counsel to the Department of Health and Human Services Office of Inspector General

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State Attorneys General v. Pharma

Use of consumer protection laws and unfair trade practices laws to pursue off-label promotion

For Lilly and Pfizer, state AG settlements preceded the federal settlements:

– Eli Lilly (October 2008) agreed to pay $62 million to 32 states and the District of Columbia to settle allegations of alleged off-label marketing related to its anti-psychotic drug Zyprexa.

– Pfizer (October 2008) agreed to pay $60 million to states as part of an $894 overall agreement to resolve a series of lawsuits involving allegations of an illegal marketing campaign that encouraged physicians, hospitals, and health plans to prescribe Bextra in higher doses for “off-label” uses after the FDA had rejected Pfizer’s applications seeking authorization to use Bextra at higher doses.

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Reporting and Disclosure Minefields

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Congressional Focus on Researchers’ Failures to Report Payments Senate Finance Committee and Senate Committee on Aging launched investigations of industry/academia/provider relationships that can affect quality and integrity of CME, clinical care and research (Grassley)

Two Phases: Began in certain cases with industry companies and led to institutions and prominent clinicians/researchers

– Harvard– Emory– CRF– University of Wisconsin

Developed support for “Sunshine” legislation and triggered self-initiated reform

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Congressional Focus on Researchers’ Failures to Report Payments

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Congressional Focus on Researchers’ Failures to Report Payments October 2008 Dr. Charles Nemeroff, Chair of the Emory University

psychiatry department stepped down as chair of the department after the congressional investigation determined that Nemeroff regularly exceed the $10,000 limit for significant financial interests and failed to fully disclose payments received from Glaxo while he was simultaneously conducting research into Glaxo Drugs

Emory Settlement– PI failure to fully disclose financial relationships with industry entities– Emory as large recipient of NIH grant funds undertook extensive internal investigation

that resulted in agreed-upon sanctions– PI permanently removed from Chair of Department– Tight restrictions on future participation in industry speaker bureaus, CME

presentations, and scientific advisory boards, whether paid or unpaid– No participation in NIH grant applications for 2 years

January 2009 Senator Charles Grassley wrote a letter requesting OIG of HHS to investigate Emory University over possible violations of NIH grant rules, government contract rules and other laws governing federally-funded research.

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The New TransparencyPublic Disclosure of Vendor/Provider Relationships

Disclosure of physician relationships–Disclosure alone implies a level of concern and potential

impropriety–Legitimate financial relationships vs. kickbacks

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State Sunshine Laws

Several states have enacted a sunshine law– Generally require pharmaceutical or medical device

manufacturers to report gifts or other economic benefits provided to prescribers or purchases or prescription drugs or devices (e.g., hospital, pharmacist, nursing home) and/or impose certain compliance or conduct requirements.

Massachusetts– First state to enact a law specifically requiring reporting by

medical device manufacturers.

– Recently survived a repeal attempt.

– More stringent than other states.

Vermont quickly followed suit.

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State Reporting and Compliance RequirementsState Sunshine Laws

• California – Comprehensive Compliance Program District of Columbia – Reporting • Louisiana - Sales activities as lobbying activities Maine – Reporting (Clinical Trial Posting) • Minnesota – Gift Restriction and Reporting• Massachusetts – Compliance and Reporting Nevada – Information regarding Code of Conduct Compliance Vermont – Reporting West Virginia – Reporting Ongoing activity in various other states!

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The “Grassley” Federal Sunshine Law

Senator Grassley’s relentless efforts resulted in adoption of federal sunshine law as part of “ObamaCare” (PPACA)

Requires annual reporting by manufacturers of drugs, devices, biologics and medical supplies on website and to HHS

– Transfers of value to physicians or teaching hospitals greater than $10 (unless $100 in aggregate)

• Various exclusions (e.g., patient samples, limited period device loans, in-kind charity care items, warranty replacements)

– MD ownership or investment interest in manufacturer or GPO (except publicly traded companies and holdings through mutual funds)

Delayed reporting for product R&D and clinical trials

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Federal v. State Sunshine Laws

Limited preemption of state law– State law prevails if it requires:

• Reporting of other payments/value transfers• Reporting by other entities• Reporting of payments/value transfers to other than physicians or teaching hospitals

Federal law does not include code of conduct such as MA sunshine law, PhRMA Code, AdvaMed Code

State law does not address “institutional interests”

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HHS Proposed Rulemaking:Conflicts of Interest in PHS-Funded Research

May 2009 HHS Notice of Proposed Rulemaking– Proposed regulations– Requests for comments on proposed rules and input on other

issues

May 2010 HHS Proposed Revised Regulations– Question Posed: “Is a more rigorous approach to investigator

disclosure, management of financial conflicts and federal oversight needed?”

– Comment period closed July 20, 2010

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HHS 2010 Proposed COI Rules:Definition of Interest “Significant Financial Interest”

– Any equity interest in non-publicly traded entities– Dollar threshold for other categories reduced from $10,000 to $5,000

• Value or potential value• Measured on prior year rather than coming 12 months• Includes payments for authorship and travel reimbursement• Includes royalties and royalty-sharing agreements• Excludes royalties from the institution to current employed/appointed investigators (policy v. license agreements?)

• Narrows exclusion for income from teaching etc. sponsored by public/nonprofit entities to sponsorship by government agency or institution of higher educations

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HHS 2010 Proposed COI Rules:Reporting and Assessment Investigator must report to Institution any “imputed institutional interests”

– SFIs that reasonably appear to be related to the investigator’s institutional responsibilities (e.g., research, teaching, professional practice, IRB membership)

Institution must Assess the Interest– Whether SFI is related to the research – Whether the relationship creates a COI– “Could the SFI directly and significantly affect the design, conduct or

reporting of PHS-funded research?”

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HHS 2010 Proposed Research COI Rules:Reporting to HHS Now: Only that institution identified a COI and managed, reduced or eliminated it

Proposed:– Report specifics such as investigator name, nature and value, basis for

determination that COI exists, key elements of management plan– Report anything internal policy requires even if policy is more stringent

than the regulations

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HHS 2010 Proposed Research COI Rules:Public Transparency

Now: No public reporting Proposed:

– Disclosure of details of the SFI on public website prior to any expenditure of funds

• Effectively increases institutions’ tracking and reporting burdens

– Posting of COI policies and procedures

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HHS 2010 Proposed Research COI Rules:Other Address only financial interests of investigators Do not address direct institutional interests

– Complexity– Seek public comment

Action required for new SFI that arose after research began Increased institutional burden regarding sub-recipients of PHS-funding

More stringent training requirements

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Today’s “Bottom Line”

The media, the public and regulators judge “yesterday’s practices” using “today’s standards” and based on appearance of conflict.

Good intentions and honesty of purpose are not enough to deflect scrutiny.

The IRB process clearly is not enough!

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Conflicts of Interest in Research:The Balancing Act

Balancing the desire to encourage innovation through

research and commercialization with emerging best practices concerning disclosure, assessment and

management of potential conflicts of interest

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May endanger Research Subjects’ safety and result in private claims for negligence, etc.

May reduce the public’s willingness to participate in research

May inhibit future discoveries if less support for research

Loss of federal funding

Sponsor’s inability to obtain FDA approval or exposure to withdrawal of approval

Conflicts of Interest in Research:A Review of The Potential Liabilities & Risks

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Conflicts of Interest in Research:A Review of The Potential Liabilities & Risks

Government investigations of research compliance generally

Suspension of research activities by IRB and/or government agencies

Individuals and institutions debarred from conducting federally-funded and FDA-regulated research

Perfect Storm: loss of reputation and public confidence in research, clinical care and education

Perfect Storm: criminal and civil liability (Anti-kickback statute, False Claims Act, FDA marketing and advertising laws, etc.)

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Institutional Provider ResponsePolicies/Code of Conduct on Financial Ties to Industry Broad and general policies on financial relationships with industry vendors Vendor access and certification policies Policy position vary in degree of conservatism A prophylactic approach is becoming more commonplace

– Yale School Of Medicine• Ban on gifts• Ban on industry-sponsored meals• Ban on drug samples for faculty/family• All industry-sponsored education must meet ACCME standards; faulty must

disclose and resolve Conflicts of Interest to participate

– Stanford• Ban on gifts• Ban on direct industry-sponsored meals• Educational grants must meet ACCME Standards for Commercial Support

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Institutional Provider ResponseVoluntary Exposure to the Sunshine

Other proactive measures: Harvard publishes some of the payments doctors receive from pharmaceutical and medical-device companies

The University of Pennsylvania School of Medicine and its health system launched a Web site of searchable information on all outside activities of its doctors and scientists

University of Wisconsin-Madison physician group is beginning a pilot effort notify interested patients as to how to obtain information about financial relationships their physician might have with private industry.

Cleveland Clinic discloses business relationships its 1,800 staff doctors and scientists have with drug and device makers through a database of payments of $5,000 on the clinic's website.

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Institutional Provider ResponseAdopt Emerging Industry COI Standards

Current legal and regulatory requirements no longer qualify as the minimum standard.

Standards exceeding those requirements have emerged from industry and government agency guidelines.

– Compliance with the guidelines is not mandatory.– The guidelines are not complete or entirely consistent.– Showing best efforts to implement the guidelines as appropriate for the

nature and extent of an organization’s operations, risks and resources (financial and personnel) is advisable.

– Must develop an approach that will be workable and effective for each entity.

– Art not science!

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The following definition of conflict of interest articulated in such guidelines should be viewed as the current industry standard, rather than as an industry best practice:

A conflict of interest is an Interest that has the potential to compromise or bias the professional judgment or objectivity of the holder of the Interest, or has the appearance of having the potential to compromise or bias the professional judgment or the objectivity of the holder of the Interest.

Use Today’s Industry Standards:Definition of Conflict of Interest

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Individual Conflicts of Interest = An Interest held by an individual, or that individual’s immediate family, that results in a Conflict of Interest

Institutional Conflicts of Interest = An Interest held by the institution directly or indirectly that results in a Conflict of Interest

Imputed Institutional Interest = An Interest held by an individual but that is imputed to the organization by virtue of that individual’s authority and decision-making capacity within the organization (these individuals are known as Key Officials).

Today’s Industry Standards:Types of Conflicts of Interest

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Today’s Industry Standards:Essential Components of a Conflicts of Interest Program

Competent Conflicts of Interest Committee oversees management All Interests must be reported by Covered Persons All Interests must be assessed to determine if they are Conflicts of Interest.

The assessment must follow pre-set criteria and must take into account whether the Holder is a key decision-maker or a member of the Research Team

Identified Conflicts of Interest must be reviewed by the appropriate Conflicts of Interest Committee to determine an effective management strategy or to determine that there is no effective management strategy available and the Conflict of Interest bars the holder from proceeding:

To whom should the Conflict of Interest be disclosed? What information regarding the Conflict of Interest should be

disclosed? Are changes in personnel or participation necessary? Chinese Wall? Does the make-up or nature of the Financial Interest need to change

The Conflicts of Interest Committee must maintain oversight of the Conflict of Interest to verify that the management strategy is implemented and remains sufficient to manage the Conflict of Interest

Reporting

Assessment

Management

Oversight

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Today’s Standards and Emerging Best Practices

Adopt some or all of the IOM-AAMC-AAU Recommendations

– Today’s COI programs must go beyond technical legal requirements.

Establish a Committee dedicated to overseeing COI.

– Define the relative role of COI Committee, Legal Counsel, Compliance Officer, Other Staff

– Sufficient, independent qualified personnel to assist in the assessment

– Limited role of Professional Staff

Clear separation of clinical and research administration and financial administration (e.g., formulary and device approval, technology licensing) within the institution

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Today’s Standards and Emerging Best Practices

Apply new rules to all research, not just federally funded research

Integrate the conflicts policies and disclosure processes for Governing body, senior officers, employees, professional staff, IRB, purchasing and formulary/device review process, fundraising, education, and tech transfer/commercialization function

Integrate conflicts policies with related policies such as vendor financial relationships, conflicts of commitment

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Today’s Standards and Emerging Best Practices: Reporting of Interests

More detailed reporting and disclosure of individual interests– Disclosure by all Research Team Members (endorsed in the AAMC

Report)– Disclosure of all “Interests” regardless of value (no thresholds) to address

clinical and research conflicts of interest (Beware of PHS Approach)– Eliminate judgment by disclosing party of whether Interest presents a COI– Consistency among COI Disclosure Forms for various constituencies

– Deadline for completing annual disclosure

– Obligation to update

– Need for cumulative disclosure

– Move to on-line disclosure

– Sanctions for late disclosure, incomplete disclosure, failure to disclose

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Today’s Standards and Emerging Best Practices: Assessment of Interests

All disclosed Interests must be assessed to determine if they give rise to a potential Conflict of Interest or appearance of a Conflict of Interest.

There are no absolute guidelines for when an Interest becomes a Conflict of Interest.

Some Factors to Consider include:

– Intensity of the Interest

– Control and knowledge of the Interest

– Variability of the Interest

– Fiduciary Duty of the Holder

– Extent of authority or influence of the Holder over the research

– Affect of the study results on the value of the Interest

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Today’s Standards and Emerging Best Practices

Higher Standard: Rebuttable Presumption against significant financial interests in human subjects research.

– Do not allow research to proceed where there are financial interests related to the research except in “compelling circumstances” and with appropriate management plans in place to assure that benefits of the research outweigh the conflicts of interest risk.

“ Compelling Circumstances” - Factors to Consider (endorsed in the Report):– The nature of the science (e.g., desperate need patient population).

– The nature of the interest.

– The degree to which the financial interest will be affected by the research results.

– How closely the interest is related to the research.

– The degree of human subject risk the research presents.

– Whether the researcher/institution is uniquely qualified to conduct the research and safeguard the welfare of the human subjects involved (e.g., unique expertise among faculty/nationally, special facilities or equipment, unique patient population, and experience and expertise of investigators (this latter factor should not dominate the assessment of the conflict)).

Overall Risk-Benefit Analysis– Determine whether the potential benefits of the transaction/study at issue outweigh the risks

presented by the conflict.

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Universal Database of Interests

Research Sponsors & Funders Fundraising

COI Reporting Forms

Formulary Drug Manufacturers

Pharmacy and Therapeutics Committee

All Purchasing Officials

Research Support Office/Division

Board of Directors or Trustees

The New Frontier:Universal Database of Interests

Functional Areas Across an Institutional Provider Need to Report Interests to Common, Integrated Databank

Vendors

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The New FrontierUniversal Database of Interests – Industry Entity

Universal Database of Interests

SalesGrant Agreements

Speaker Bureaus Institutional Relationships

Research Sponsorship Agreements

Advisory Boards

Grant Applications

Functional Areas Across an Industry Entity Need to Report Interests to Common, Integrated Databank while Maintaining Firewalls

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Institutional-Industry Cooperation

To effectively manage financial relationships, institutional providers and industry must work together to jointly track and monitor relationships, disclose relationships to one another to improve interest capture, and to assist one another in maintaining an entity-wide information system.

Technology Transfer TacticsAudio ConferenceOctober 14, 2010

Best Practices for Managing

Conflict of Interest in University Research

Bernadette M. Broccolo

McDermott Will & Emery, LLP

312-984-6911

bbroccolo@mwe.com