NIH FINANCIAL CONFLICT OF INTEREST REGULATIONS – 2012 Office of Sponsored Programs Research & Graduate Studies

NIH STATEMENT “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. “

TIMELINE  Federal Register published August 25, Implementation no later than 365 days after publication of the final rule in the Federal Register, i.e., August 24, In the interim: –Institutions comply with 1995 regulations –Institutions revise policies, establish procedures for compliance, and train Investigators –NIH provides training materials for extramural community and NIH staff, expands FCOI reports database

INFORMATION FLOW

MAJOR AREAS ADDRESSED IN THE REVISED REGULATIONS  Definition of Significant Financial Interest (SFI)  Extent of Investigator Disclosure  Information Reported to PHS Awarding Component (e.g., NIH)  Information made accessible to the public  Investigator Training

DEFINITION OF SIGNIFICANT FINANCIAL INTEREST  Significant Financial Interest (SFI) Minimum threshold of $5,000 generally applies to payments and equity interests (changed from $10,000)  Includes any equity interest in non-publicly traded entities (de minimis $0)  Reimbursed or Sponsored travel – in any amount (de minimis $0)  Exclusions include :  Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education.  Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.  Travel reimbursed/sponsored by gov’t agency or institution of higher education

REGULATION APPLIES TO:  All university-employed Investigators (and spouse & dependent children)  ANY project personnel involved in the design, conduct or reporting of research funded by the PHS  Postdoctoral researchers (and spouse & dependent children)  Graduate students (and spouse & dependent children)  Subrecipients and collaborators (and their spouse & dependent children)  All PHS funding EXCEPT Phase I SBIR/STTR applications

INVESTIGATOR DISCLOSURE  All SIGNIFICANT FINANCIAL INTERESTS (SFI) related to Investigators’ institutional responsibilities  SFIs should be disclosed at the PROPOSAL STAGE – BEFORE proposal is submitted. If training is not completed by all affected individuals (including subrecipients), we cannot submit the proposal.  Disclosure (and training) will also be required for any investigators receiving continuing funding on a current NIH grant. Due at the time interim reports are filed.  Institutions are responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI)

WHAT TO DISCLOSE, WHEN, AND TO WHOM  What: investigators who are planning to participate in, or are participating in, NIH-funded research are required to disclose to the designated official(s) of the Institution a listing of Significant Financial Interests (and those of his/her spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.  When:  BEFORE time of application for NIH-funded research –two weeks before so that any SFI’s can be reviewed and managed  Within 30 days of discovering/acquiring a new Significant Financial Interest  At least annually, during the period of the award  To: Dr. Carol Brodie, Research/Graduate Studies

COVERED FINANCIAL INTERESTS  With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;  (ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); continued…….

ADDITIONAL COVERED FINANCIAL INTERESTS  Intellectual property rights and interests (e.g., patents) upon receipt of income related to such rights and interests  Paid authorship  Reimbursed or sponsored travel in any $ amount - related to affected personnel’s institutional responsibilities;  this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 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.  University’s FCOI policy specifies the details of this disclosure. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

FINANCIAL INTERESTS NOT COVERED  salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;  income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;  income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;  income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

NEXT STEP: DETERMINATION  Pacific will then determine if the Significant Financial Interest constitutes a Financial Conflict of Interest  Who determines? Associate Provost for Research, Sponsored Programs and Controller, along with ad hoc individuals as deemed necessary, e.g., Internal Audit, Dean, Department Chair, Legal Counsel, etc.  If it is decided that there is a Financial Conflict of Interest, next step is to advise the affected individuals, along with their chair and dean, and then develop a management plan.

MANAGEMENT PLAN  Examples of management strategies:  Public disclosure (presentations, publications, campus community)  For IRB – disclosure of FCOI to participants  Appointment of an independent monitor  Modification of research plan  Change of personnel or responsibilities  Reduce or eliminate the FCOI (e.g., sale of an equity interest)  Severance of relationships that create FCOI

WHAT MANAGEMENT PLAN MUST INCLUDE  Role and principal duties of the Investigator with FCOI  Conditions of the management plan  How the plan is designed to safeguard objectivity in the research project  Confirmation of the Investigator’s agreement to the plan  How the management plan will be monitored to ensure Investigator compliance; and,  Other information as the situation requires Plan is submitted to NIH

PUBLIC ACCESSIBILITY  Pacific’s FCOI policy will be made available via a publicly accessible Web site.  Before spending funds for PHS-supported research, an Institution shall ensure public accessibility of information on certain SFIs that the Institution has determined are related to the PHS-funded research and are FCOI, via a publicly accessible Web site or by a written response to any requestor.

INVESTIGATOR TRAINING  FCOI training required for Investigators before engaging in PHS-funded research, every four years thereafter, and immediately under designated circumstances.  Training (and disclosure) will also be required for any investigators receiving continuing funding on a current NIH grant. Due at the time interim reports are filed.