Conflict of Interest and Commitment Christy Hooper, CPA Assistant Vice Chancellor for University Affairs and Athletics Shannon Ontiveros, MS Director, Faculty Training and Compliance Programs Vanderbilt School of Medicine

Objectives 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

The Belmont Report, published in 1979 Basic Ethical Principles 1. Respect for Persons 2. Beneficence 3. Justice C. Applications 1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects The Belmont Report, published in 1979  http://www.hhs.gov/ohrp/policy/belmont.html

Bayh-Dole Act of 1980 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

Existence of a “Conflict” of Interest 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

Potential Conflicts of Interest: Non-Financial Considerations 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: Financial Interests Payments for professional services Equity holdings IP, Patents, Licenses, Royalties Service on Boards Gifts Reimbursements

Documents Influencing Conflict of Interest Policies and Procedures at Vanderbilt 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)

Vanderbilt COI/COC Policy 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 Policy Article IV: Disclosure

Requirements for Disclosure Disclosures required by 100% of Faculty and Staff Annually During submission of a Research Proposal Updated as circumstances change

Highlights of COI/COM Policy 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

Review and Mgmt Plan Process 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

Reviews by UCC 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

Amended PHS Regulations Overview So, What’s New? Amended PHS Regulations Overview

FCOI: The NIH View “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

PHS Funded Investigators 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.

Key Changes 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

Responsibilities Investigator or Key Study Personnel 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.

Institutional Responsibilities 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.

Definitions 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.

Example 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?

Answer 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.

Example Timeline for Existing SFI Faculty discloses consulting agreement Annual Disclosure Process Submit Grant Application & Complete PEER COI Disclosure Consulting contract signed by faculty* Grant funds may be dispersed JIT or NOGA Received Investigator Action Institutional Response COI Eliminated or Managed Annual report to NIH Submitted with Progress Report Review Process - MCCOIC and/or UCC (If required) Review Process - Department Chairs Review Process - MCCOIC Chair &/or Full Committee Review Process - Scientific Review Management Plan reported to NIH *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.

Example Timeline for New SFI Faculty discloses consulting agreement Annual Disclosure Process Submit Grant Application & Complete PEER COI Disclosure Consulting contract signed by faculty* Disclosure must be made within 30 days of new relationship Grant funds may be dispersed JIT or NOGA Received Investigator Action Institutional Response COI Eliminated or Managed Annual report to NIH Submitted with Progress Report Review Process - MCCOIC and/or UCC (If required) Review Process - Department Chairs Review Process - MCCOIC Chair &/or Full Committee Review Process - Scientific Review Management Plan reported to NIH *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.

Key Take Away Points! 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.

Contact Information Faculty in Schools of Medicine & Nursing University Faculty and ALL Staff Shannon Ontiveros, M.S. Director, Faculty Training and Compliance Programs Office of Faculty Affairs, School of Medicine 615.322.8384 shannon.ontiveros@vanderbilt.edu Christy Hooper, CPA Assistant Vice Chancellor University Affairs and Athletics 615.322.2401 christy.hooper@vanderbilt.edu Alison R. Cooper, J.D. Manager, Office of Conflict of Interest and Commitment Vanderbilt University 615.322.8363 alison.r.cooper@vanderbilt.edu Submit your questions - coi@vanderbilt.edu

Disclosure Systems & Policies 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_interest_policy.pdf (COI Policy) https://medschool.vanderbilt.edu/faculty/sites/medschool.vanderbilt.edu.faculty/themes/tao/pdfs/vumc-coi-policy.pdf (VUMC Policy)