NEW PHS COI REGULATIONS CRITICAL CARE MEDICINE DECEMBER 4, 2012 University of Pittsburgh Conflict of Interest Office David T. Wehrle, CPA, CFE, CIA Director Khrys X. Myrddin, MPPM Associate Director Benjamin T. West Compliance Coordinator

New PHS COI Regulations Effective August 24, 2012 University policy Conflict of Interest Policy for Faculty, Researchers, Scholars, Research Staff/Coordinators revised to reflect the changed regulations Summary of changes available on COI website:

Administration for Children and Families (ACF) Administration on Children, Youth and Families (ACYF) Administration for Community Living (ACL) Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) National Cancer Institute Substance Abuse and Mental Health Services Administration (SAMHSA) Agencies of the Public Health Service (PHS)

The PI, project director, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, including collaborators and consultants. Definition is based on individual’s role in the research; can include undergraduate and graduate students and staff. Definitions – Investigator

An Investigator’s professional responsibilities on behalf of the University of Pittsburgh, including activities such as research, teaching, professional practice, institutional committee memberships, service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards, and other administrative activities. Definitions – Institutional Responsibilities

Significant Financial Interest (SFI): a financial interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities Definitions – SFI (PHS)

Aggregated remuneration from and equity in any publicly traded entity exceeding $5,000 in value; Remuneration from a non-publicly traded entity in the 12 months preceding the disclosure exceeding $5,000, or any equity interest in such an entity; Being the inventor of a technology that has been patented, copyrighted, or optioned/licensed to an external entity, and on which research is continuing; Any reimbursed or sponsored travel related to Institutional Responsibilities, except travel that is reimbursed or sponsored by Exempt Institutions. Definitions – SFI (PHS) cont’d

The term SFI does not include salary or supplementary payments from the University of Pittsburgh, University of Pittsburgh Medical Center (UPMC), University of Pittsburgh Physicians (UPP), or Veterans Administration Pittsburgh Healthcare System; income from seminars, lectures, or non-promotional engagements sponsored by Exempt Institutions; income from service on advisory committees or review panels for Exempt Institutions; royalties, milestone payments, or licensing fees paid through the University of Pittsburgh; income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles. Definitions – SFI exclusions

A federal, state, or local government agency; A domestic Institution of Higher Education; An academic teaching hospital; A medical center; or A research institute that is affiliated with an Institution of Higher Education Definitions – Exempt Institutions

A Significant Financial Interest determined to be related to a PHS-funded research project and that could directly and significantly affect the design, conduct, or reporting of the research. Definitions – Financial Conflict of Interest (FCOI)

COI training ( Investigators currently engaged, or who anticipate engaging, in PHS-supported research must complete the CITI (Collaborative Institutional Training Institute) COI Training Module; The University will not submit a proposal to any PHS agency until the PI/PD and all Senior/Key Personnel complete the CITI PHS COI Training Module; PHS-funded researchers are required to complete the CITI COI Training Module every three years thereafter. Investigator responsibilities – Training (PHS-funded)

Investigators who do not work on any PHS-funded projects should complete the Internet-based Studies in Education and Research (ISER) Conflict of Interest Module if they: Plan to submit a proposal through the Office of Research for funding from a non-PHS funding source; or Disclosed outside financial interests on the University’s Faculty/Researcher form; or Have been directed by their supervisors to complete COI training. Completion of the CITI Training module will also fulfill the COI training requirement for non-PHS investigators. Investigator responsibilities – Training (non-PHS funded)

Individuals conducting research without any external funding, and Individuals who do not conduct any research do not need to complete either training module. Investigator responsibilities – Training (others)

Investigators engaged in research funded by a PHS agency, or who plan to apply for funding from PHS, must complete the new PHS Faculty/Researcher form that reflects: new disclosure thresholds; disclosure of income from non-exempt not-for-profit organizations; and sponsored/reimbursed travel. Applies to all Investigators engaged in the funded research; not limited to only PI/PD and Senior/Key personnel on the grant. New SFIs must be disclosed within 30 days. Investigator responsibilities – Disclosure

Who must complete this form? ALL employees, regardless of title, who participate in the design, conduct, and reporting of PHS-funded research. Students and trainees must complete this form and the CITI COI Training module if their involvement with a research project is substantial enough that they fall under the PHS definition of an “Investigator.” If you complete the PHS form, you do NOT have to additionally complete a “regular” Faculty/Researcher form. PHS Faculty/Researcher form

Value of equity and remuneration from publicly-traded companies combined (Q1) Remuneration from nonprofit entities included (Q2) Disclosure of reimbursed or sponsored travel (Q4) PHS Faculty/Researcher form –- Significant changes

Answer this question ONLY if the answer to questions 1, 2a, 2b, 4, or 6 is “yes”; Include ALL grants that are funding ANY research project on which you serve as an Investigator, regardless of whether or not you are listed on the grant; Include ONLY protocols on which you are an Investigator; Indicate if you believe you have an FCOI with the research; if not, explain why. Is the research evaluating or developing any IP of which you are an inventor or that is owned by an entity in which you disclose an SFI? Is any entity in which you disclose an SFI providing funding or materials (e.g., drugs, devices) for the study? PHS Faculty/Researcher form –- Question 8 PHS Funded Research

Review PHS-specific Faculty/Researcher COI form; Complete a PHS-specific Management Reporting Form (MRF): determine whether an SFI in the $5,001-$10,000 range gives rise to an FCOI (i.e., the SFI is related to the PHS- funded research and could directly and significantly affect the design, conduct, or reporting of such research); if it does not, explain why; or state that there is an FCOI, indicate how it will be managed, and send a copy of the COI form and the MRF to the COI Office. Supervisor responsibilities

If an FCOI has been identified, the conflict management plan (CMP) must include at least the following elements: Investigator must disclose SFI in relevant abstracts, presentations, press releases, publications, and in proposals/applications for research funding; Other students, staff, faculty engaged in the research must be notified of the Investigator’s SFI through the use of a standard notification form; Students must have approval of their department chairs or deans to be engaged in the research project. Other optional management techniques: data steward or oversight committee; prohibiting individual from serving as PI, or other limits on his/her role in the research project. Supervisor responsibilities cont’d

The COIC, in consultation with department chairs and investigators, will review SFIs greater than $10,000, ownership interests in nonpublic companies, and technology transfer activities to determine whether they constitute FCOIs with PHS-funded research. If they do, the COIC will manage the FCOIs. COI Committee (COIC) responsibilities

Investigator responsibilities – Disclosure NEW – COI Declaration Form for research protocol applications IRB (OSIRIS), IACUC (ARO), IBC/rDNA, hSCRO, CORID Two versions: one for protocols funded by PHS agencies and another for all others. PI is responsible for ensuring that the relevant SFIs of ALL Investigators on the study are reported on the form. ALL Investigators on studies supported by PHS agencies must complete CITI COI training module and have a current PHS Faculty/Researcher COI form on file.

Submissions: the Office of Research will verify that PI/PD and all Senior/Key personnel have PHS Faculty/Researcher forms on file & have completed the CITI PHS COI Training module. Awards: the Office of Research will refer to the COI Office those awards on which Investigators have reported outside financial interests on their PHS Faculty/Researcher forms. Important changes in Office of Research review of PHS-funded research

The COI Office will determine whether it has a PHS MRF from the supervisor that includes the relevant award If it does not, the COI Office will write to Investigator and request review from department chair or division chief; If disclosed SFIs require COIC review, the COI Office will forward materials to the COIC Chair for final FCOI determination. COI Office Review of PHS grants

Office of Research will determine whether the subrecipient Institutions have PHS-compliant policies; If not, those Institutions will rely on Pitt’s policy, and Investigators at the subrecipient Institutions must complete: CITI COI Training module Pitt’s “Subrecipient Disclosure of Significant Financial Interests” paper form Important changes –- Subrecipient Monitoring

If a contract provides for more than $5,000 annually or stock/stock options in a nonpublic company and the individual is engaged in PHS-funded research, the supervisor will be asked to conduct an FCOI review; If a contract provides for more than $10,000 annually or stock/stock options in a nonpublic company, an FCOI review by the COI Committee is required. Additional implications –- Consulting Contract Review

To comply with PHS regulations, the following information concerning FCOIs held by an Investigator on a PHS- funded project will be posted on the COI website: Name, title, and role of investigator on the research project Name of entity in which interest is held Nature of the SFI Approximate dollar value of SFI within a defined set of ranges, where possible Applies to grants with a Notice of Award after August 24, Public disclosure of FCOIs

If identification or management of an FCOI was delayed, or the Investigator failed to comply with a plan to manage his or her FCOI, the COIC must complete a retrospective review to determine whether any PHS-funded research was biased in the design, conduct, or reporting of such research performed during the period of non-compliance. PHS FCOI Retrospective Reviews

COI Web site: See section for PHS-Funded Researchers & Supervisors Jerome L. Rosenberg, PhD (Chair, COIC): David T. Wehrle: Khrys X. Myrddin: Benjamin T. West: For access to the COI database, contact Hannelore Rogers (Office Coordinator): To view completed ISER/CITI Training modules, contact Erin List (Center for Continuing Education/Health Sciences); ) For more information/assistance