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

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Presentation on theme: "Clinton Schmidt, J.D. COI Program, Office for Research Protections Health & Human Development Information Sessions February 27 & 29, 2012."— Presentation transcript:

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

2 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

3 RA20 – current requirements Revised RA20 - 2011 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

4 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

5 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

6 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

7 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

8 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

9 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

10 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

11 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

12 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

13 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

14 Electronic Disclosure and Management System https://coins.psu.edu Do not log in until March when Form and training are ready You will receive further communication from the ORP

15 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

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17 Adobe Connect Recording on web after February 16 th http://www.research.psu.edu/orp/coi/changes-to-coi-policy- coming-in-2012 (may want to bookmark it!) http://www.research.psu.edu/orp/coi/changes-to-coi-policy- coming-in-2012

18 Debra Thurley, J.D., Assistant Director 865-2955 djd116@psu.edu Clinton Schmidt, J.D., COI Coordinator 865-5437 cls65@psu.edu Susan Seman, COI Assistant 865-0000 sls426@psu.edu


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