Transcript NIH Policy Changes for Financial Conflict of Interest

Clinton Schmidt, J.D.
COI Program, Office for Research Protections
Health & Human Development Information Sessions
February 27 & 29, 2012
 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
 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
 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
 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
 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 = 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 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
 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
 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 industrycontrolled interest groups
 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
 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
 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
 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 Director
865-2955
[email protected]
 Clinton Schmidt, J.D., COI Coordinator
865-5437
[email protected]
 Susan Seman, COI Assistant
865-0000
[email protected]