Debra Thurley, J.D.

Clinton Schmidt, J.D.

Susan Seman

COI Program, Office for Research ProtectionsInformation Session – February 16, 2012

Required Annual Financial DisclosuresWhoHow

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

investigators onlyConflict Of INterest System (“COINS”)

Short demonstrationImplementationQuestions & 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 COM)By 2014 – approximately 4000

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 for new SFIWithin 30 days for new sponsored or reimbursed

travelFailure to update in a timely fashion will require a review of

PHS research for bias &/or additional training

“COINS” – beginning in MarchYou will receive further instructions on the listserv –

DO NOT LOG IN YETCurrently 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 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

Immediately 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 = (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/incomeDoes 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 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-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 disclosuresAt Proposal Time for Related ResearchWithin 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 Systemhttps://coins.psu.edu

Do not log in until March when Form and training is ready

You will receive further communication on listservShort 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-1:00pm112 Forestry Resources Building

Approximately 140 seating capacity – first come basis

Adobe Connect Recording on web after February 7th

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