Clinton Schmidt, J.D.

COI Program, Office for Research ProtectionsHealth & Human Development Information Sessions

February 27 & 29, 2012

Required Annual Financial DisclosuresWhoHow

Federally Required Changes to RA20New requirementsRevisionsProvisions to be applied to PHS-sponsored

investigators onlyConflict Of INterest System (“COINS”)ImplementationQuestions & Answers

RA20 – current requirementsRevised RA20 - 2011 Regulatory Changes Annual Disclosures for All “Investigators”

Beginning March, 2012 for all PHS/NSF “Investigators”

3 Year Staggered Implementation Schedule2012 – approximately 1300 (not including Hershey)2013 – Engineering, HHD, Science, EMS, ARL, and AgBy 2014 – all other colleges and campuses

Due end of April, 2012Failure to comply can impact research funding and/or

require additional COI trainingRequired to disclose “Significant Financial Interests”

(“SFI”) – Investigator, spouse and dependent children

Updates To Disclosure As Necessary Are Required Throughout the YearAt Proposal Time for Related ResearchWithin 30 days of acquiring new SFIWithin 30 days of sponsored or reimbursed travel

“COINS” – beginning in MarchYou 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 TrainingIncorporated into the Disclosure Form

No quizzes or questionsNothing 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 StateNon-compliance with RA20 or Federal Regulation is

FoundPolicy 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:

ResearchTeachingUniversity 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 disclosurePublicly-traded Entities (i.e., listed on stock exchange)

Compensation + Equity value > $5,000 Non-publicly-traded Entities (e.g., “start-ups”)

Compensation > $5,000, ORANY Equity interest, regardless of value

Intellectual Property: (includes patents, copyrights, licensing royalties)>$5,000 in revenue/incomeDoes 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 SFISponsored 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 childrenDoes 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 onlyPublic 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 requirementsRetrospective Review/Mitigation Plan for Non-

complianceIf 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 disclosuresAt Proposal Time for Related ResearchWithin 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 Systemhttps://coins.psu.edu

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 16th

http://www.research.psu.edu/orp/coi/changes-to-coi-policy-coming-in-2012 (may want to bookmark it!)

Debra Thurley, J.D., Assistant Director865-2955djd116@psu.edu

Clinton Schmidt, J.D., COI Coordinator865-5437cls65@psu.edu

Susan Seman, COI Assistant865-0000sls426@psu.edu