Conflict of Interest and Commitment

Christy Hooper, CPA Assistant Vice Chancellor for University Affairs and Athletics

Shannon Ontiveros, MSDirector, Faculty Training and Compliance Programs

Vanderbilt School of Medicine

Background on Conflict of Interest Guiding Principles Process of Review at Vanderbilt Recent changes to COI regulations for PHS

funded Investigators & Key Study Personnel Questions

Objectives

 http://www.hhs.gov/ohrp/policy/belmont.html

The Belmont Report, published in 1979

Designed to promote use, development and

promotion of technology invented with federal funding.

Recipients of federal funding have the right to retain ownership to inventions developed with federal funding.

Recipient must share royalties, or other income, derived from the invention with the inventor(s).

Resulted in dramatic increase in patents issued and royalty payments to Universities

Bayh-Dole Act of 1980

Describes a situation Not a judgment regarding behavior or motives Often the result of desirable activities Usually concurrent with confluence of interest Often results from convergence of several

types of relationships, with each individual activity being appropriate

Process for evaluation and management of COI should not be adversarial

Existence of a “Conflict” of Interest

Desire for career advancement Competition for sponsored research funds Pursuit of accolades from peers Receipt of prestigious prizes Improvement of the human condition Advancement of discovery and knowledge

Potential Conflicts of Interest:

Non-Financial Considerations

Payments for professional services Equity holdings IP, Patents, Licenses, Royalties Service on Boards Gifts Reimbursements

Potential Conflicts of Interest:

Financial Interests

NIH Proposed Guidelines for Policies on Conflicts of Interest

(September 15, 1989) AMA Conflicts of Interest in Medical Center/Industry Research

Relationships (December, 1989) AAMC Guidelines for Dealing with Conflicts of Commitment

and Conflicts of Interest in Research (February 1990) Conflict of Interest Hearing-Clinical Evaluation of Products, NIH

(November 30, 1990) AAMC Principles and Recommendations for Oversight of An

Institution’s Financial Interests in Human Subjects Research (October, 2002)

Financial Relationships and Interests in Research Involving Human Subjects Protections, DHHS (May 2004)

Amendments to 45 CFR 50, Subpart F and 45 CFR 94 (2011)

Documents Influencing Conflict of Interest Policies and Procedures at Vanderbilt

Duty to Disclose

“In order to identify and review conflicts of interest or commitment, and the appearance of conflicts of interest or commitment, members of the University community must disclose in advance all outside activities and financial interests that create or have the appearance of creating conflicts of interest to the appropriate University officials…[who] will review the disclosures to determine whether a conflict of interest exists and what conditions or restrictions, if any, should be imposed in order to manage, reduce or eliminate the conflict of interest.”

Vanderbilt University Conflict of Interest and Commitment PolicyArticle IV: Disclosure

Vanderbilt COI/COC Policy

Disclosures required by 100% of Faculty and

Staff• Annually• During submission of a Research Proposal• Updated as circumstances change

Requirements for Disclosure

Personal Interests in Vanderbilt Activities Business Relationships with Vanderbilt Gifts and Contributions University Assets Research Activities Healthcare Industry Activities Student Activities Family Members Conflict of Commitment

Highlights of COI/COM Policy

Initial Review by Supervisors, Deans, and/or

Department Chairs Second Review Performed:• By SOM Office of Faculty Affairs (VUMC Faculty) • By Office of Conflict of Interest and

Commitment Mgmt (all VU and VUMC staff, and VU Faculty)

Third Review may be Necessary by UCC

Review and Mgmt Plan Process

When Second review Committee cannot

determine a Management Plan When the University also is a party

(institutional conflict) Involving Human Subjects Research Where an individual has a financial interest in

a company that contracts with the University

Reviews by UCC

So, What’s New?

Amended PHS Regulations Overview

“The NIH is committed to preserving the public’s trust that the research supported by us is conducted without bias and with the highest scientific and ethical standards. We believe that strengthening the existing regulations on managing financial conflicts of interest is key to assuring the public that NIH and the institutions we support are taking a rigorous approach to managing the essential relationships between the government, federally-funded research institutions, and the private sector.”

http://grants.nih.gov/grants/policy/coi/index.htm

"The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.”

Dr. Francis Collins, Director, NIH

FCOI: The NIH View

In August 2011, the Department of Health and

Human Services, acting through the Public Health Service (PHS), issued its final rule amending the regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR 50, Subpart F) and Responsible Prospective Contractors (45 CFR 94).

All changes to be implemented before the August 25, 2012 deadline and applied to all Notice of Grant Awards issued after this date.

PHS Funded Investigators

The Significant Financial Interest (SFI) threshold has

been reduced from $10,000 to $5,000 annually and includes any equity holding in a non-publicly traded company.

All reimbursed or sponsored travel related to “institutional responsibilities” must be disclosed to Vanderbilt regardless of the amount. Same exemptions apply as in SFI definition.

All federally funded investigators and key study personnel must complete training initially upon submission of a grant application and every four (4) years following.

Key Changes

Vanderbilt is required to complete a scientific

review for each award to determine whether any SFI constitutes a Financial Conflict of Interest (FCOI), and if so, how this will be managed or eliminated. Management plans must be reported back to the awarding agency, before grant funds are spent, and updated at least annually.

Key Changes

Vanderbilt is required to respond to requests

for information from the public to include disclosure of:• The conflicted investigator/key study

personnel’s name• Title of the sponsored project• Entity in which there is a FCOI• Nature of the financial interest (e.g., consulting,

board service, royalties, etc.)• Value of the interest

Key Changes

Faculty & Staff must disclose all outside

business and other relationship to Vanderbilt at least annually, as required by Vanderbilt policy. This requirement is not new.

Disclosures must be updated within 30 days of the acquisition of a new financial interest by personnel receiving PHS support. This requirement is new.

Responsibilities Investigator or Key Study Personnel

Investigators and Key Study Personnel must

affirm at least annually and upon each submission of a federal grant, their understanding of and agreement to follow Vanderbilt's Conflict of Interest and Commitment Policy.

Investigators and Key Study Personnel must complete training on the topic of Conflicts of Interest.

Responsibilities Investigator or Key Study Personnel

Maintain a Conflict of Interest Policy that is in

compliance with the federal regulations and publically available for review via the VU and VUMC Compliance Office websites.

Maintain records of all COI documentation of review and actions related to conflicts of interest for at least three years from the date of submission of the final expenditures report.

Institutional Responsibilities

Review all disclosures and determine whether

relationships reaching the level of a significant financial interest constitute a Financial Conflict of Interest (FCOI), and if so:• Develop a management plan• Provide management plans to PHS awarding

agent prior to the expenditure of funds, within 60 days of identifying a new FCOI, and annually

Institutional Responsibilities

• Make available at the public’s request the

following: Investigator/KSP’s name and title Role within the funded project(s) (e.g., PI) Name of entity with FCOI Nature of FCOI (e.g., payments for consulting) Approximate dollar value of the FCOI in ranges

(e.g., $0-$4,999) or a statement that the value cannot be readily determined.

Institutional Responsibilities

Significant Financial Interest (SFI) A financial interest consisting of one or more

of the following (included are any financial interests of one’s spouse and dependents):• the value of any remuneration from and/or

equity interest in a single entity exceeding $5,000 (previously $10,000) in aggregate, when received in the twelve months preceding

• any equity interest in a non-publicly traded company

• royalties not paid through Vanderbilt

Definitions

Exclusions from the SFI determination:

• Salary or other income paid by Vanderbilt• IP income distributions paid through Vanderbilt• Income from mutual funds and similar investments so

long as no direct control over investment decisions• Income from seminars, lectures, teaching, service on

advisory committees or review panels, for a federal, state or local governmental agency, institution of higher education (as defined by 20 USC 1001(a)), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

Definitions

Financial Conflict of Interest (FCOI) A significant financial interest that could

directly and significantly affect the design, conduct, or reporting of research.

Definitions

Dr. Smith has a consulting relationship with a

healthcare industry company. He was paid $12,000 in the prior year and was reimbursed travel expenses for two trips related to this consulting at a value of $3,000 per trip.

Dr. Smith is proposed as PI on a grant application being submitted to the NIH for funding. The Specific Aims of this study overlap topically with the consulting work he is doing with the company.

Under Vanderbilt’s Conflict of Interest and Commitment Policy, what must Dr. Smith do?

Example

Dr. Smith must disclose this consulting relationship

business on his annual Conflict of Interest Disclosure Form, including the travel reimbursements.

When submitting the grant to the NIH, Dr. Smith must affirm that he disclosed this relationship in his annual form and make any needed amendments to the disclosure.

Upon receipt of the NOGA, Dr. Smith and Vanderbilt must verify that a COI review has been completed and any needed management plan established BEFORE expending funds from the grant.

It will be Dr. Smith’s responsibility to follow all stipulations of any needed COI management plan.

Answer

Example Timeline for Existing SFI

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*All relationships must be in compliance with the University and VUMC COI Policies. Your Department Chair should approve all activities prior to its initiation.

This review is a new requirement.

Investigator ActionInstitutional Response

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*All relationships must be in compliance with the University and VUMC COI Policies. Your Department Chair should approve all activities prior to its initiation.

This review is a new requirement.

Investigator ActionInstitutional Response

Annu

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to N

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Subm

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with

Pro

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The threshold for SFI has been reduced from $10,000 to $5,000

and includes any interest in a non-publicly traded company. There is a paradigm shift in determining whether the potential for

bias exists. Investigators must disclose relationships to Vanderbilt. Vanderbilt must determine whether any SFI is a Financial Conflict of Interest and if so, take steps to eliminate or manage the FCOI.

Management plans must be reported to NIH upon initial NOGA, before expenditure of funds. Updates will be required annually to the NIH.

If one develops a new SFI which is a potential FCOI, you must disclose this to Vanderbilt within 30 days.

All FCOIs for PHS funded personnel will be subject to public disclosure.

COI training mandatory.

Key Take Away Points!

Contact Information

Faculty in Schools of Medicine & Nursing

Shannon Ontiveros, M.S.Director, Faculty Training and Compliance ProgramsOffice of Faculty Affairs, School of Medicine615.322.8384shannon.ontiveros@vanderbilt.edu

University Faculty and ALL Staff

Christy Hooper, CPAAssistant Vice ChancellorUniversity Affairs and Athletics615.322.2401christy.hooper@vanderbilt.edu

Alison R. Cooper, J.D.Manager, Office of Conflict of Interest and CommitmentVanderbilt University615.322.8363alison.r.cooper@vanderbilt.edu

Submit your questions - coi@vanderbilt.edu

https://webapp.mis.vanderbilt.edu/coi/ (VUMC Staff, VU

Staff and Faculty) https://medapps.mc.vanderbilt.edu/coi (VUMC Faculty) http://www.vanderbilt.edu/compliance/html/conflict_of_i

nterest_policy.pdf (COI Policy)

https://medschool.vanderbilt.edu/faculty/sites/medschool.vanderbilt.edu.faculty/themes/tao/pdfs/vumc-coi-policy.pdf (VUMC Policy)

Disclosure Systems & Policies