1. JUNE 19, 2012 PAUL MURPHY, JD DIRECTOR, RESEARCH ADMINISTRATION SERIES 2, SESSION 7 APPLICANTS & ADMINISTRATORS PREAWARD LUNCHEON SERIES Public Health Service (PHS) Financial Conflict of Interest (FCOI) Regulations The “New Rule”

2. Topics to be Covered Current Situation FCOI Regulations Definitions Major Changes to Regulations Examples Proposed Courses of Actions for Tufts Discussion/Questions/Comments

3. Current Situation Department of Health and Human Services (HHS) revised the regulations on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors Federal Register publish date: August 25, 2011 Implementation no later than 365 days after publication of the final rule in the Federal Register, i.e. August 24, 2012. 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

4. FCOI Regulations HHS is the only agency that has the Code of Federal Regulations governing financial conflicts of interest of extramural investigators (other agencies have policies). First promulgated in 1995 42 CFR Part 50 Subpart F (PHS-funded grants and cooperative agreements) 45 CFR Part 94 (PHS-funded contracts) These regulations promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

5. Definitions Significant Financial Interest (SFI) is a financial interest of the Investigator (and those of the Investigator’s spouse and dependent children) that:  Reasonably appears to be related to the Investigator’s institutional responsibilities (the Investigator’s professional responsibilities on behalf of the Institution) and;  Consists of one or more of the interests identified as a Significant Financial Interest in the regulations. This includes anything of monetary value, such as (but not limited to):  Salary or other payments for services (e.g., consulting fees or honoraria)  Equity interests (e.g., stocks, stock options or other ownership  interests)  Intellectual property rights (e.g., patents, copyrights and royalties from such rights) Current policy asks whether the SFI reasonably appears to be affected by this research project.

6. Definitions (con’t) Institutional Responsibilities (proposed) means an Investigator's professional responsibilities on behalf of Tufts University. That is, all activities that derive or descend from the investigator’s standing or expertise and are tied to those responsibilities and activities the investigator was hired to perform and for which the investigator is paid by the University.  Some examples are, research, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. Financial Conflict of Interest (FCOI) is an Investigator’s SFI that the Institution determines could directly and significantly affect the design, conduct, or reporting of PHS- funded research.

7. Major Changes Significant Financial Interest (SFI)  Minimum threshold of $5,000 generally applies to payments and equity interests (currently $10,000 or 5% and less equity interest).  Includes any equity interest in non-publicly traded entities  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.  Excludes 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. Investigator Disclosure  All SFIs related to Investigators’ institutional responsibilities.  Institutions responsible for determining whether SFIs relate to PHS- funded research and are FCOI (currently, the Investigator makes the determination). New rule will require additional knowledgeable people including the investigator to make the determination.

8. Major Changes (con’t) Disclosure of Travel (currently not required) Investigators also must disclose the occurrence of any reimbursed or sponsored travel ( i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by:  Federal, state, or local government agency, an;  Institution of higher education as defined at 20 U.S.C. 1001(a), and;  Academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The details of this disclosure will include, at a minimum, the:  Purpose of the trip  Identity of the sponsor/organizer  Destination  Duration.

9. Major Changes (con’t) Reporting to PHS Awarding Component (NIH) –Previous requirements, (grant/contract number, name of PD/PI, name of Investigator with FCOI) with new rule, add:  Name of the entity with which the Investigator has a FCOI  Value of the financial interest  Nature of FCOI, e.g., equity, consulting fees, honoraria  A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research  Key elements of the Institution’s management plan Public Accessibility (currently not required)  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 within 5 days of the request.  A decision needs to be made on whether to have a public accessible website or via a request. Investigator Training (currently required for training grants and others, but not all)  FCOI training required for Investigators before engaging in PHS-funded research, every four years thereafter, and immediately under designated circumstances.

10. Major Changes (con’t) Policy Applies to Subrecipients (currently required, except for not having the subrecipient subject to Tufts’ policy if the sub doesn’t have a policy) If an Investigator through the University carries out PHS-funded research through a subrecipient, the University as the awardee Institution will take reasonable steps to ensure that any subrecipient Investigator complies with this policy by:  Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution (Tufts) or that of the subrecipient will apply to the subrecipient's Investigators. If the subrecipient does not have a policy, then they will be subject to Tufts’ policy and complete a financial disclosure form. In the event of a FCOI, Tufts will be the organization that manages, eliminates or reduces the conflict

11. Major Changes (con’t) Retrospective Review (currently not required) Whenever :  a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the University to constitute a financial conflict of interest;  failure by the University to review or manage such a financial conflict of interest; or  failure by the Investigator to comply with a financial conflict of interest management plan: The University will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

12. Examples An Investigator was instructing other physicians about the use and benefits of a drug and being paid by the maker of that drug.  The Investigator determined that this income was not related to his/her NIH grant so did not disclose the income.  The revised regulations require disclosure of all SFI related to the Investigator’s institutional responsibilities, regardless of relationship to a specific grant. The Institution determines relatedness to the NIH- funded research. An Investigator failed to disclose financial relationships with drug companies to his/her Institution.  When these relationships came to light, the Investigator claimed no knowledge of the disclosure requirements.  The revised regulations include a training requirement to ensure that Investigators are aware of their responsibilities.

13. Examples (con’t) An Investigator received PHS funding for a conference on a specific disease and gave a talk at the conference about the use of a drug, while receiving funding from the maker of that drug  The Investigator did not disclose the funding with the rationale that it was not related to his/her research per se.  The requirements in the revised regulations are not limited to research grants, and would cover such a case. In a case in which public postings by a pharmaceutical company did not match the disclosures, it turned out that the discrepancies were due in part to travel reimbursements reported by the company but not disclosed by the Investigator.  After this case came to light, the Institution considered including travel reimbursement in their disclosure requirements.  Information on travel reimbursements and sponsored travel are included in the disclosure requirements in the revised regulations to clarify this point.

14. Proposed Course of Action 1. Have two polices: a. The new rule PHS policy covering only federal proposals. b. Apply the current policy, based on the 1995 PHS regulations, to all non-federal sponsors.

15. Discussion Discussion/Questions/Comments