Clinton Schmidt, J.D. COI Program, Office for Research Protections Health & Human Development Information Sessions February 27 & 29, 2012

Required Annual Financial Disclosures Who How Federally Required Changes to RA20 New requirements Revisions Provisions to be applied to PHS-sponsored investigators only Conflict Of INterest System (“COINS”) Implementation Questions & Answers

RA20 – current requirements Revised RA Regulatory Changes Annual Disclosures for All “Investigators” Beginning March, 2012 for all PHS/NSF “Investigators” 3 Year Staggered Implementation Schedule 2012 – approximately 1300 (not including Hershey) 2013 – Engineering, HHD, Science, EMS, ARL, and Ag By 2014 – all other colleges and campuses Due end of April, 2012 Failure to comply can impact research funding and/or require additional COI training Required to disclose “Significant Financial Interests” (“SFI”) – Investigator, spouse and dependent children

Updates To Disclosure As Necessary Are Required Throughout the Year At Proposal Time for Related Research Within 30 days of acquiring new SFI Within 30 days of sponsored or reimbursed travel “COINS” – beginning in March You will receive further instructions on the listserv – DO NOT LOG IN YET “Smartform” – data saved from year-to-year and with each update

Financial Conflict of Interest Training Incorporated into the Disclosure Form No quizzes or questions Nothing to upload or print off At least every 4 years – COINS will know when you need it again Training also required when: Investigator is new to Penn State Non-compliance with RA20 or Federal Regulation is Found Policy changes

Lower Thresholds For Disclosure – RA20 no more strict than federally required All “SFI” reasonably related to “institutional responsibilities” must be disclosed Institutional responsibilities defined as: Research Teaching University Service (committee memberships, panels) Outreach

SFI = Four Basic Categories (include spouse and dependent children) Compensation Equity (e.g., stock, stock options, partnership percentages, etc.) Intellectual Property which produces income Travel Sponsored or Reimbursed by an outside Entity

SFI: Thresholds for disclosure Publicly-traded Entities (i.e., listed on stock exchange) Compensation + Equity value > $5,000 Non-publicly-traded Entities (e.g., “start-ups”) Compensation > $5,000, OR ANY Equity interest, regardless of value Intellectual Property: (includes patents, copyrights, licensing royalties) >$5,000 in revenue/income Does NOT include income (e.g. royalties) received from Penn State or the Penn State Research Foundation (PSRF) or intellectual property owned by PSRF Sponsored or Reimbursed Travel $0 threshold – all must be disclosed

New Category of SFI Sponsored or Reimbursed Travel: Sponsored = Travel paid on behalf of and not directly to the Investigator $0 – one area that revised RA20 could change depending on expected guidance from NIH Does NOT include travel of spouse or dependent children Does NOT include travel paid by the University or covered by a sponsored award through the University

Exclusions – what is NOT an SFI (you do NOT need to disclose the following): Income (i.e. royalties, supp pay) received from Penn State or PSRF Intellectual property owned by PSRF Income from “passive investments” (e.g., mutual funds, retirement accounts) Any income, reimbursement, or sponsorship of travel by a government agency, American institution of higher education, academic teaching hospital, medical center, or research institute affiliated with an institution of higher education

Non-Profits are no longer excluded Any income, reimbursement, or sponsorship of travel by a non-profit entity that is related to an Investigator’s institutional responsibilities must be disclosed This is a change to the new RA20 and the new federal regulation Includes professional societies Includes foreign institutions of higher education and foreign governments Includes travel paid by non-profits The Institution (i.e., Penn State) is charged with determining which non-profits are independent, charitable organizations and which ones are industry- controlled interest groups

Provisions to be applied to PHS-sponsored Investigators only Public Accessibility Identified Conflicts related to PHS-sponsored research will need to be made publicly accessible Respond to written request within 5 business days with detailed information (including name of Investigator, nature and value ranges of SFI, management provisions, etc.) Sub-recipient requirements Retrospective Review/Mitigation Plan for Non-compliance If Investigator fails to timely disclose (within 30 days) or University fails to timely review (within 60 days) or if Investigator fails to comply with COI Management Plan, then University will need to review related PHS research for bias

Updating disclosures At Proposal Time for Related Research Within 30 days for new SFI Is the SFI “related” to Institutional Responsibilites? University must manage any identified conflict of interest (COI) before research funds can be expended Investigators and COI Program/Committee work cooperatively to expedite review Investigators must comply with all provisions of RA20 and COI Management Plan

Electronic Disclosure and Management System Do not log in until March when Form and training are ready You will receive further communication from the ORP

Draft has been reviewed and approved by the Provost and the VP For Research Draft is now being reviewed by legal counsel (Reed Smith) March, 2012 – Annual Disclosure and COI training process begins for PHS and NSF Investigators Comprehensive implementation plan calls for complete implementation by August 24, 2012

Adobe Connect Recording on web after February 16 th coming-in-2012 (may want to bookmark it!) coming-in-2012

Debra Thurley, J.D., Assistant Director Clinton Schmidt, J.D., COI Coordinator Susan Seman, COI Assistant