1. Conflict of Interest Victoria Tugade, COI Officer

2. Today we will cover… What's new? Why is this important? Important Definitions What do Investigators need to do? How is funding affected? What are the Institutions responsibilities? Where can we go for help?

3. 2011– DHHS announced new rules (effective August 24, 2012) relating to conflict of interest. New rules require organizations to have an enforced conflict of interest policy for individuals participating in research (Investigators) and require Investigators to complete training and disclosure prior to expenditure of any DHHS funds. November 2013 – NSF announced new rules (effective February 24, 2014) relating to conflict of interest. New rules require institutions to have an enforced conflict of interest policy for Investigators, requiring Investigators to be in compliance with the policy at the time of proposal submission. Code of Federal Regulations (cfr) 200.112 requires all federal agencies to have an enforced COI policy and to require all funding recipients to comply with said policy. What is new? Changes in federal regulations.

4. The conflict of interest requirements protect you, your research and the University from concerns relating to the intersection of research and personal financial interests. This is not a question of right or wrong, and having a financial interest is not inherently a bad thing. Issues arise when a financial conflict of interest is undisclosed and unmanaged. Why is this so important?

5. Very real consequences exist when conflicts of interest are not properly disclosed and managed. See Jesse Gelsinger case from 1999. Patient died while enrolled in a clinical trial where the Principal Investigator and the Institution had a financial interest. See Yudong Zhu FBI case from 2013. Principal Investigator and several Investigators on project failed to disclose financial interest and were found to be sending proprietary information from the project to their financial interest in China. Why is this so Important?

6. Investigator: Any person who is responsible for the design, conduct or reporting of Research under the auspices of the University. This includes, but is not limited to, the Principal Investigator (PI), Co-Investigator, Project Director (PD), Co- PD, Senior/Key Personnel and any other persons involved in the Conduct of Research, regardless of title or position. An individual’s position, title on the project, employment status (full or part-time), or percent of effort devoted to the project, pay, etc., do not factor into the definition of Investigator. The term “Investigator” is based upon the individuals independence in the design, conduct or reporting of the Research and students, trainees, collaborators, volunteers, and consultants may be considered an Investigator. The term, “Investigator,” does not include individuals whose performance within the Research is purely ancillary or occurs solely under immediate supervision. Important Definitions

7. Institutional Responsibilities: An Investigator’s Institutional Responsibilities may include, but are not limited to, the following activities, regardless of when and where the activities occur: Research Scholarship Teaching and instruction Development and commercialization of research results Administrative service to the University Membership on institutional committees All other work and activities that the University considers in its review of an individual’s performance in the course and scope of his/her University employment or other obligations Important Definitions

8. Financial Interest: Exists when the Investigator, the Investigator’s spouse or domestic partner, and/or dependent children, are financially invested in, and/or receive compensation from any of the following: Publicly traded entities Non-publicly traded entities Positions outside of University employment Intellectual Property rights or interest Important Definitions

9. Significant Financial Interest (SFI): Compensation and/or equity that is considered a financial interest and meets one of following three criteria: Remuneration from any publicly traded entity in the twelve months prior to disclosure; and/or (ii) ANY Equity Interest in the publicly traded entity as of the date of disclosure and the combined total of all such Remuneration and Equity Interests exceeds $5,000 in value. Remuneration from a non-publicly traded entity in the twelve months prior to a disclosure, and the value of all such Remuneration exceeds $5,000 when aggregated; or (ii) ANY Equity Interest in a non-publicly traded entity, regardless of the percentage of equity or value. Income related to intellectual property rights or interests (e.g., as owner of a patent or copyright or as a licensee of such rights) except for those interests determined to be Investigator’s Excluded Interests. Important Definitions

10. Excluded Interests: Under UA’s Conflict of Interest Policy, the following interests do not need to be disclosed: Salary, royalties or other Remuneration paid by the University to a current University employee or appointee; and Payments made by the University in exchange for the transfer of intellectual property rights assigned to the University and from agreements by the University to share any royalties related to such rights; and Important Definitions

11. Excluded Interests (continued): Income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by the investment managers within these funds or accounts; and Income from seminars, lectures, teaching engagements or service on advisory committees or review panels sponsored by: (i) a government agency (federal, state or local), or (ii) an institution of higher education as defined at 20 USC § 1001(a); or (iii) an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education. Important Definitions

12. Financial Conflict of Interest: Any Significant Financial Interest that is deemed to have potential to directly and significantly affect the design, conduct or reporting of research. Such determinations are made by the University’s Institutional Review Committee (IRC) for individual Investigator’s financial interests, and by the Executive Review Committee (ERC) for financial interests held by the University. Important Definitions

13. Training For University personnel, online training is available through D2L For Non-University personnel, online training is available through CITI Training must be completed once every 4 years (or more often if requirements change or the COI office determines that additional training is necessary) Disclosure On an annual basis between June 1 and June 30 of every year Within 30 days of a change to the existing disclosure (ex. acquiring a new SFI) With each new proposal and/or award for Investigators with one or more SFIs disclosed. What do Investigators need to do?

14. How is funding affected? Proposal stage: Proposal might not be submitted if everyone who is considered an Investigator is not up-to-date on training and disclosure requirements. Proposal might be delayed, or get stuck, in the routing process while those considered Investigators are completing training and disclosure requirements. Award Stage: New awards will be held until everyone who meets the definition of Investigator is up to date with their training and disclosure requirements. Note: If an Investigator discloses an entity and it is determined the project needs to be reviewed by the IRC, the funds will not be released until the IRC approves the project, or if necessary, the management plan.

15. What are the Institutions responsibilities? The Conflict of Interest Office: Provides oversight, management and training for COI policies and procedures related to research at the UA. Manages the committees that review disclosures. Manages and tracks training and disclosures relating to COI requirements. Committees: The Institutional Review Committee (IRC), comprised of faculty voting members and advisory non-voting members, reviews individual Investigator disclosures of Significant Financial Interests to determine if a financial conflict of interest exists. The Executive Review Committee (ERC), comprised of senior University Administrator voting members and advisory non-voting members, reviews financial interests of the Institution for potential conflicts

16. Where can we go for help? The Conflict of Interest Program Office is here to help. Please feel free to contact us at any time with questions or concerns: orcr-coi@email.arizona.edu Victoria Tugade Conflict of Interest Officer 520-626-8266, gibbinsv@email.arizona.edugibbinsv@email.arizona.edu Bethany Peters Program Coordinator Senior 520-626-7879, blpeters@email.arizona.edublpeters@email.arizona.edu To report suspected illegal or unethical conduct confidentially: 866-364-1908

17. Where can we go for help? COI Office Hours Every Tuesday and Thursday from 11 am – 1 pm Call: 626-7879 Stop by: 1618 E. Helen Street (SE corner of Cherry and Helen) E-mail: blpeters@email.arizona.edublpeters@email.arizona.edu IM via Lync: blpeters

18. Conflict of Interest Program Office