Debra Thurley, J.D. Clinton Schmidt, J.D. Susan Seman COI Program, Office for Research Protections Information Session – February 16, 2012

Required Annual Financial Disclosures Who How Other Federally Required Changes to RA20 New requirements Revisions Provisions to be applied to PHS-sponsored investigators only Conflict Of INterest System (“COINS”) Short demonstration 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 COM) By 2014 – approximately 4000 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 for new SFI Within 30 days for new sponsored or reimbursed travel Failure to update in a timely fashion will require a review of PHS research for bias &/or additional training “COINS” – beginning in March You will receive further instructions on the listserv – DO NOT LOG IN YET Currently making updates to the Form Awaiting clarifications from NIH that can impact the Form “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 Immediately 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 = (include spouse and dependent children) Compensation/remuneration: >$5,000 – publicly-held companies (compensation plus value of equity) or non-publicly-held companies (compensation only) Equity: (includes ownership, stock, stock options, etc.) $0 – non-publicly-held companies (any equity interest needs to be disclosed) >$5,000 – publicly-held companies (value of equity plus any compensation) Intellectual Property: (includes patents, copyrights, licensing royalties) >$5,000 in revenue/income Does NOT include income (i.e. royalties) received from Penn State or the Penn State Research Foundation (PSRF) or intellectual property owned by PSRF

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 sponsored or reimbursed 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, higher education institution, academic teaching hospital, medical center, or research institute affiliated with a higher education institution

Special Note regarding non-profit entities (e.g., professional societies) 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

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 Non-compliance by non-PHS Investigator handled appropriately (e.g., further COI training, stop research funds, recommendations related to HR)

Updating disclosures At Proposal Time for Related Research Within 30 days for new SFI Is the SFI “related” to University research? University must manage any identified conflict of interest (COI) before research funds can be expended Investigators should cooperate with COI Program and COI Committee 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 is ready You will receive further communication on listserv Short Demo – first time user (Investigator)

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 the entire University Comprehensive implementation plan calls for complete implementation by August 24, 2012

February 7 (T): 4:00pm-5:00pm 110 Wartik Lab February 16 (Th): 12:00pm-1:00pm 112 Forestry Resources Building Approximately 140 seating capacity – first come basis Adobe Connect Recording on web after February 7 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