Conflicts of Interest in Sponsored research PHS 2011 updates to 42 CFR Part 50, Subpart F & 45 CFR 94 May, 2012

Office of Research Compliance (ORC) Leadership: John Bixby, PhD, Vice Provost for Research Staff: Lory A. Hayes, PhD, Associate Director Jerry Engel, Esq., Compliance Specialist Taimania Matthews, Compliance Specialist Phone: Fax: ‘Cane Watch Compliance website: Websites: uresearch.miami.edu/complianceuresearch.miami.edu/compliance uresearch.miami.edu/coi/phs uresearch.miami.edu/coi/phs (website with details about regulation changes)

New Conflict of Interest (COI) regulations from the PHS: Highlights institution, not investigator, bears primary responsibility for determination, management, reporting lower threshold for significance of financial COI travel reimbursement must be reported investigators must be trained in COI information on COI must be publicly available

FCOI Responsibilities Investigator : disclosure of SFI compliance with institutional policy Institution:  institutional policy development and implementation  evaluation of SFI  identification of Financial Conflict of Interest (FCOI)  management of FCOI  reporting to NIH NIH: oversight

Major Changes to the Regulations Significant Financial Interest (SFI) minimum threshold of $5,000 (from $10K) any equity interest in non-publicly traded entities excludes income from seminars, lectures, etc, and service on US government panels, or from US universities, teaching hospitals, medical centers, or research institutes affiliated with universities excludes income from mutual funds and retirement accounts if Investigator does not directly control decisions

Major Changes to the Regulations Investigator Disclosure all SFIs related to institutional responsibilities institutions responsible for determining whether SFIs relate to PHS funded research and are FCOIs Philosophical shift – institution bears more responsibility in connecting the SFI to the proposed work Investigator Training FCOI training required for Investigators before engaging in PHS- funded research, every 4 years thereafter, and immediately under designated circumstances (e.g., policy change).

Public Accessibility FCOI policy must be available via a publicly accessible web site (or available to requestor within 5 business days). Before spending funds for PHS-supported research, Institution must make public information on SFIs that it has determined are related to the PHS-funded research and are FCOI Major Changes to the Regulations

“Retrospective” reviews if an interest is not disclosed and reviewed within 60 days, regardless of reason Reporting to PHS Awarding Component (NIH) previous requirements, (grant number, name of PD/PI, name of Investigator with FCOI) plus: o name of the entity with which the Investigator has a FCOI o value of the financial interest o nature of FCOI, e.g., equity, consulting fees, honoraria o how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that it is a FCOI o key elements of the Institution’s management plan Major Changes to the Regulations

Office of Research Compliance policy review, update formation of COI Advisory Committee provide advice to administration on policy IT project to implement new policy UM Response to new COI Regulations

COIC Advisory Committee Cynthia Augustyn, Asst. Vice President, Deputy General Counsel David Birnbach, Vice Provost for Faculty Affairs John Bixby, Vice Provost for Research Barbara Cole, Assoc. Vice President, Research Administration Dalton Dietrich, Sr. Assoc. Dean for Discovery Science (Miller School) Kenneth W. Goodman, Professor and Director, Bioethics Program; Co-Director, Ethics Programs Lory Hayes, Associate Director, Office of Research Compliance Norma Kenyon, Chief Innovation Officer Jennifer McCafferty, Chief Med. Compliance Officer Victoria Mitrani, Assoc. Dean for Research; Nursing and Health Studies John Newcomer, Sr. Assoc. Dean for Clinical Research (Miller School) Pedro Salas, Professor of Cell Biology Helena Solo-Gabriel, Assoc. Dean for Research; Engineering William O’Neill, Executive Dean for Research and Research Training; Miller School of Medicine Rod Wellens, Chair of Psychology

system(s) assessment, plan for implementation advice to VPR, Office of Res. Compl., COI Advisory Committee timeline: begin Fall 2011, complete Summer 2012 full implementation August 24, 2012 IT Working Group for COI Policy Implementation Mark Ager, Information Technology Project Manager John Bixby, Vice Provost for Research Bob Burns, Assistant Director, Information Technology Stephen DeGennaro, Manager, Applications Systems Development Mariano L. Estrada, Business Systems Analyst Lory Hayes, Associate Director, Office of Research Compliance David Seo, Director, Research Strategic Planning

Note: Investigator--everyone involved in design, conduct or reporting of research/sponsored scholarly activities, including subcontractors Investigators must complete training on COI policy initially, and every 4 years Investigators must disclose financial and obligatory interests (including spouse/dependents) related to their institutional responsibilities at least annually Interests disclosed: compensation (incl travel) > $600; any equity in a privately held company; any IP interest updated within 30 days if new interests arise UM’s proposed policy

VPR will review disclosures and determine if related to sponsored work, and will conduct retrospective reviews when necessary UM will report FCOIs of key/senior personnel on all sponsored work via website Reporting to awarding entity will be FI >$5,000, and only if required by entity