Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest UT HOP UT HOP The University of Texas at Austin RC 410 Financial Conflict of Interest Training for Non-UT Covered Individuals The Office of Research Support Slides Effective 1/2013

Training Overview Completion of this Financial Conflict of Interest (FCOI) training module will satisfy the regulatory and policy requirements for FCOI Training. FCOI training is required once every four years. Throughout the training you will be provided links to related sections of the University policy to refer you to more detailed information about the topic under review. This detailed information is critical to your understanding of your responsibilities as a “covered individual” and any relevant information you are required to submit in order to meet those responsibilities. The Office of Research Support Slides Effective 1/2013 Slide 2 of 14

Federal Regulation The University policy on objectivity in research (HOP ) delineates requirements for the disclosure of financial interests that comply with the disclosure requirements of federal regulations of the U.S. Public Health Service (PHS). The federal regulation, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors” (42 CFR Part 50 Subpart F), establishes standards to be followed by Institutions that apply for or receive research funding from PHS awarding components, which includes the National Institutes of Health (NIH) and several other entities. The primary goal of the federal regulation is to promote objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest. The Office of Research Support Slides Effective 1/2013 Slide 3 of 14

University Policy; HOP Unlike the PHS policy, the University policy applies broadly to research performed at, or on behalf of the University, without regard to whether the research has external funding, and if externally funded, regardless of the funding source. The University policy and federal regulations require completion of training (every 4 years) and submission of a financial interest disclosure statement by all covered individuals at least annually. If the research does not involve human subjects research, a Covered Individual is an individual who is responsible for the design, conduct or reporting of research. If the research involves human subjects, the definition is broader and Covered Individuals are individuals that are involved in the design, conduct, or reporting of research. The Office of Research Support Slides Effective 1/2013 Slide 4 of 14

Grants, Cooperative Agreements, and Research Contracts Neither the University nor a covered individual may expend research funds unless the COI Official has determined that no financial conflict of interest exists or that any financial conflict of interest is manageable in accordance with the terms of a management plan that has been adopted and implemented. For more information regarding the University processes for proposals and award actions, visit: The Office of Sponsored Projects: The Office of Industry Engagement: The Office of Research Support Slides Effective 1/2013 Slide 5 of 14

Key Terms and Definitions Below are key terms for understanding the University policy, applicable federal regulations, and your responsibilities as a covered individual.  Covered Family Member  Covered Individual  Institutional Responsibilities  Research  Financial Interest  Financial Conflicts of Interest  Management Plan See Section IV, Definitions of HOP Section IV, Definitions The Office of Research Support Slides Effective 1/2013 Slide 6 of 14

Disclosure Requirements You must report significant financial relationships or interests, aggregated for you and all covered family members, in the preceding 12 months that reasonably appear to be related to your institutional responsibilities. These interests include the following:  Receipt of payment(s) from and/or held any equity interest in a publicly traded entity that when aggregated exceed $5,000;  Receipt of payment(s) from a non-publicly traded entity that when aggregated exceed $5,000;  Held any equity interest (no minimum threshold) in a non-publicly traded entity  Intellectual property rights held and/or receipt of royalty payments  Travel with sponsored expenses and/or receipt of a travel reimbursement payment from an applicable entity  Receipt of a single gift or multiple gifts from a single entity that when aggregated exceed $250  Involvement with a for-profit or non-profit entity including a position as a member of board of directors, an officer, or other executive or management position, for which any form of remuneration or reimbursement for expenses was received. See Section VII, Chapter 2 (Sections ), Disclosure of Significant Financial Interests Related to Institutional Responsibilities of HOP Section VII, Chapter 2 (Sections ), Disclosure of Significant Financial Interests Related to Institutional Responsibilities The Office of Research Support Slides Effective 1/2013 Slide 7 of 14

Exclusions The following are specifically excluded from disclosure in the PHS regulations and University policy and need not be disclosed on financial interest disclosure forms.  Salary, royalties, or other remuneration paid by the University to the covered individual, if the covered individual is currently employed or otherwise appointed by the University;  Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;  Income from service on an advisory committee or review panel for a federal, state, or local government, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;  Income from investment vehicles, such as mutual funds or retirement accounts, as long as the covered individual does not directly control the investment decisions made in those vehicles; or  Travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. See Section VII, Chapter 2 (Sections ), Disclosure of Significant Financial Interests Related to Institutional Responsibilities of HOP Section VII, Chapter 2 (Sections ), Disclosure of Significant Financial Interests Related to Institutional Responsibilities The Office of Research Support Slides Effective 1/2013 Slide 8 of 14

Review and Management Each financial interest disclosure will be reviewed by the Conflict of Interest Official (COI Official) to determine if a financial conflict of interest exists that is related to the research in which the covered individual is engaged. A financial conflict of interest exists if the COI Official reasonably determines that a financial interest could reasonably appear to affect the design, conduct, or reporting of the research. If it is determined that a financial conflict of interest exists, the COI Official, in collaboration with the covered individual and other appropriate university officials, will develop a management plan to reduce or eliminate the conflict of interest. See Section VII, Chapter 3 and 4, Conflict of Interest Official; Disclosure Statement Review and Management of Financial Conflicts of interest of HOP Section VII, Chapter 3 and 4, Conflict of Interest Official; Disclosure Statement Review and Management of Financial Conflicts of interest The Office of Research Support Slides Effective 1/2013 Slide 9 of 14

Availability and Retention of Information For each financial conflict of interest in PHS-funded research that is found to exist, the University will make specific information available to the public through a web site. For each financial conflict of interest in research not funded by PHS that is found to exist, the University will centrally retain and make specific information available to the public, upon request under the Texas Public Information Act (Chapter 552, Government Code.) Records regarding the disclosure of financial interests and the management of a conflict of interest and other records of University actions will be retained in a central repository. See Section VII, Chapter 5 and 8, Web Posting of Financial Conflict of Interest Information and Administration of Conflicts Policies; Records of HOP Section VII, Chapter 5 and 8, Web Posting of Financial Conflict of Interest Information and Administration of Conflicts Policies; Records The Office of Research Support Slides Effective 1/2013 Slide 10 of 14

Enforcement, Certification and Report Timely, complete, and accurate disclosure of activities and financial interests consistent with the University policy is a condition of employment at the University. For a covered individual who is not an employee of the University, compliance with this policy is a condition of participating with the University in the capacity that qualifies the person as a covered individual. The University will comply with all federal regulations that require certifications and reporting. Each application for funding to the PHS will include specific certifications and agreements with regard to the policy and financial conflicts of interest. See Section VII, Chapter 6 and 7, Certification and Reports; Enforcement of HOP Section VII, Chapter 6 and 7, Certification and Reports; Enforcement The Office of Research Support Slides Effective 1/2013 Slide 11 of 14

Responsibilities of the Covered Individual As a covered individual, your responsibilities include:  Completion of FCOI training once every four years  Annual submission of a financial interest disclosure (FID) statement  Updating your FID statement within 30 days of acquiring a new financial interest that requires disclosure  If applicable, compliance with all terms of the management plan The Office of Research Support Slides Effective 1/2013 Slide 12 of 14

Resources  Office of Research Support (ORS) Phone: (512) Website:  PHS Regulation: pdfhttp:// pdf  NIH FAQs: The Office of Research Support Slides Effective 1/2013 Slide 13 of 14

Certification You should now be familiar with the University policy, your responsibilities as a covered individual, and what types of financial interests or relationships need to be reported for you and/or your covered family members. To receive credit for this module you must certify your understanding of the material. View the next slide for instructions on how to receive credit for completing this module. The Office of Research Support Slides Effective 1/2013 Slide 14 of 14

How to Obtain Credit Send an to with “FCOI Training Certification” in the subject line and 1.Your certification statement: “I certify that I have reviewed the Financial Conflict of Interest training materials and understand The University of Texas at Austin policy for Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest.” 2.Your guest UT EID One business day after you send your certification, you will receive an from regarding submission of the financial interest disclosure The Office of Research Support