Transcript NIH Policy Changes for Financial Conflict of Interest

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 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 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
 https://coins.psu.edu
 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 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 Director
865-2955
[email protected]
 Clinton Schmidt, J.D., COI Coordinator
865-5437
[email protected]
 Susan Seman, COI Assistant
865-0000
[email protected]