Transcript Conflicts of Interest in Research and Scholarly Activities: Federal Regulations, UM Policy and the Disclosure Profile System September, 2012

Conflicts of Interest in
Research and Scholarly
Activities:
Federal Regulations, UM Policy
and the Disclosure Profile System
September, 2012
Office of Research Compliance (ORC)
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Leadership: John Bixby, PhD, Vice Provost for Research
Staff:
Lory A. Hayes, PhD, Associate Director
Jerry Engel, Esq., Compliance Specialist
Taimania Matthews, Compliance Specialist
Phone:
305-243-4054
Fax:
305-243-6160
DPS helpline: 305-243-0877 uresearch.miami.edu/DPS
‘Cane Watch Compliance website: www.canewatch.ethicspoint.com
Websites: uresearch.miami.edu/compliance
uresearch.miami.edu/coi/phs (website with details about regulation
changes)
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COI, Regulations and Disclosures at UM
• Definitions
• Regulations
– UM’s COI policies
– Federal regulations
– Responsibilities under PHS Regulations
– Major changes to the PHS regulation
• UM’s updated COI in research policy
• Proposal submission process
• Disclosure Profile System (DPS)
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Conflict of interest (COl)
an actual or potential interest that could directly and substantially affect the
outcome of:
– funded research, or of
– scholarly and/or educational activities funded under external grants,
contracts or cooperative agreements.
**COls can be financial (FCOI) or obligatory (OCOI) in nature.
Significant COIs: above a certain financial threshold where
disclosure/reporting is required
– Disclosure threshold – above $600, must disclose to UM.
– Reporting threshold – may have to be reported to the funding entity.
• valued above a significant threshold, (for PHS funding $5,000)
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Types of Interests that pose potential COI:
•Individual Interests:
• Financial
• Income, gifts, loans – salary, consulting fees, honoraria, travel expenses,
gifts-in-kind and equity interests (e.g., stocks, stock options (received
and/or exercised), warrants or other ownership interests).
• Proprietary interests
• All intellectual property rights (e.g., patents, copyrights and royalties from
such rights) that would reasonably appear to be affected by or affect the
work proposed.
• Obligations
• Consultant, lecturer (educational or promotional), speakers bureau,
trustee, employee, advisory board of an entity, etc. that would reasonably
appear to be affected by or affect the work proposed.
• Institutional Interests
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Definitions:
Investigator– PD/PI, co-PI, trainees, staff, students,
subcontractors and any other person who could be
responsible for the design, conduct, or reporting of
I) research irrespective of funding source, or
2) scholarly and/or educational activities funded under external grants,
contracts or cooperative agreements.
** for disclosure purposes, this includes spouse and dependent
children.
Research – means a systematic investigation, study or
experiment designed to develop or contribute to
generalizable knowledge.
• encompasses basic "bench," "clinical" or applied research (e.g., a
published article, book or book chapter),
• product development (e.g., IP, device, drug or diagnostic test), and
• any scholarly or educational activity for which external funding is
available through a contract, grant or cooperative agreement.
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COI, Regulations and Disclosures at UM
• Definitions
• Regulations
– UM’s COI policies
– Federal regulations
– Responsibilities under PHS Regulations
– Major changes to the PHS regulation
• UM’s updated COI in research policy
• Proposal submission process
• Disclosure Profile System (DPS)
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COI in Research: UM Policies
Faculty Manual
• “University faculty members undertaking or engaging in sponsored
work, who have a
• significant financial interest in, or a
• consulting arrangement with a private business concern,
must avoid conflicts of interest between their sponsored University
research obligations and their outside interests and other obligations.”
UMMG Policy
• Interaction with Health Industry Entities
Sponsored Programs Policies
• Updated June 2012
• C: Non-financial Compliance Issues Policy
• C8: Conflict of Interest
• Mandates disclosure of COI to the Vice Provost for Research
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Federal Regulations: sponsored research
Food and Drug Administration (FDA)
• 21 CFR 54
• “Financial Disclosure by Clinical Investigators" (FDA 2000; new
draft guidelines currently open for comment)
National Science Foundation (NSF)
• 510 Conflicts of Interest Policies (NSF 05-131 July 2005)
update anticipated Oct 2012
Public Health Service (PHS)
• 42 CFR Part 50, Subpart F & 45 CFR 94
• “Responsibility of Applicants for Promoting Objectivity in Research
for which PHS Funding is Sought” (PHS 1995; PHS 2011)
• “Responsible Prospective Contractors” (PHS 2004; PHS 2011)
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Responsibilities under PHS Regulations
Investigator:
• complete training
• disclosure of significant financial interests (SFI)
• compliance with institutional policy
Institution:
institutional policy development and implementation
l evaluation of SFI
• identification of Financial Conflict of Interest (FCOI)
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Philosophical shift – institution bears more responsibility in
connecting the SFI to the proposed work
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management of FCOI
reporting to NIH
NIH: oversight
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PHS regulations
Timing of disclosures hasn’t changed
• At the time of application:
• The Institution must be aware of interests that pose potential
COIs (Investigator disclosures).
• Prior to the expenditure of funds:
• The Institution must report an identified significant COI to the NIH
and assure that it has been managed.
• FCOI identified after the initial report:
• The Institution must report to the NIH within 60 days of
identification and assure that it has been managed.
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Major Changes to the PHS Regulations
1. Investigator Training
2. Investigator Disclosure
3. Reporting to PHS Awarding Component
(NIH)
4. Reporting Significant Financial Interest
(SFI) threshold
5. Public Accessibility
6. Retrospective Reviews
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COI, Regulations and Disclosures at UM
• Definitions
• Regulations
– UM’s COI policies
– Federal regulations
– Responsibilities under PHS Regulations
– Major changes to the PHS regulation
• UM’s updated COI in research policy
• Proposal submission process
• Disclosure Profile System (DPS)
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UM’s updated COI policy
1. Investigator Training
Investigators must complete training on COI policy initially,
and every 4 years
CITI: Collaborative Institutional Training Initiative
“Conflict of Interest Course”
1.“Financial Conflicts of Interest: Overview, Investigator
Responsibilities, and COl Rules”
2.“Institutional Responsibilities as They Affect Investigators”
3.“The University of Miami Conflict of Interest Review: Policy
and Process”
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UM’s updated COI policy
2. Investigator Disclosure
• Investigators must disclose financial and obligatory
interests (including spouse/dependents) related to their
institutional responsibilities
• Institutional responsibilities (IRs) – an Investigator’s
professional responsibilities on behalf of the Institution,
such as
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research,
teaching,
professional practice,
institutional committee memberships, and
service on panels such as Institutional Review Boards or
Data and Safety Monitoring Boards.
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UM’s updated COI policy
2. Investigator Disclosure (cont)
• Interests disclosed:
• Disclosure threshold for compensation (incl travel), or
equity in public entity > $600;
• any equity in a privately held company;
• any IP interest;
• at least annually (in order to be compliant with federal regs)
• updated within 30 days if new interests arise
• If PHS-funded (at the time of disclosure) must disclose
the occurrence of any reimbursed or sponsored travel
related to Institutional Responsibilities
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UM’s updated COI policy
2. Investigator Disclosure (cont)
• Includes interests with not-for-profit organizations
• Excludes:
• income from seminars, lectures, etc, and service
on US government panels, or from US universities,
teaching hospitals, medical centers, or research
institutes affiliated with universities
• income from mutual funds and retirement accounts
if Investigator does not directly control decisions
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UM’s updated COI policy
3. SFI reporting threshold
• PHS SFI change to $5,000; others may vary
4. Reporting to Awarding Component
• Only SFIs will be reported to the awarding entity, and only if
required by entity
5. Public Accessibility
• the updated UM policy must be posted on website
• will report FCOIs of key/senior personnel on all sponsored
work via website
6. Retrospective Reviews
• VPR will review disclosures and determine if related to
sponsored work, and will conduct retrospective reviews when
necessary
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COI, Regulations and Disclosures at UM
• Definitions
• Regulations
– UM’s COI policies
– Federal regulations
– Responsibilities under PHS Regulations
– Major changes to the PHS regulation
• UM’s updated COI in research policy
• Proposal submission process
• Disclosure Profile System (DPS)
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Proposal submittal process
• PD/PIs will certify that they have, and that they
have reminded their team to complete
requirements
• Accomplished by a checkboxes on the PT
• Office of Research Administration (ORA)
determines if the PD/PI is compliant by checking
the COI Compliance System for name or C#.
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Imminent funding process
• When award is imminent, the PD/PI will enter
the project/award/contract into the DPS
– including a list of team members
• The COI Compliance System will
– confirm the compliance status of each team member
– alert the Office of Research Compliance (ORC) of
• non-compliant individuals and
• flag FOIs that may be pertinent to the proposed work
• NO new accounts will be opened until all members of
the team have completed requirements.
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Notice of Award process
• Prior to release of funds, ORA will access the COI
Compliance System and search for a specific InfoEd
number. Funding is approved for release if:
– The PD/PI inserted the study in the DPS
– Each team member is compliant with the regulations
• If not cleared, ORA will escalate the InfoEd number to an
ORC worklist indicating
– award received, but
– project/award/contract not approved for funding release.
• ORC contacts individual; initiates a COI review if necessary
• COIC reviews for potential COI
• ORC registers result in COI Compliance System
• ORA releases funding
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COI, Regulations and Disclosures at UM
• Definitions
• Regulations
– UM’s COI policies
– Federal regulations
– Responsibilities under PHS Regulations
– Major changes to the PHS regulation
• UM’s updated COI in research policy
• Proposal submission process
• Disclosure Profile System (DPS)
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Disclosure Profile System (DPS)
• Information repository used to make UM
compliant with federal regulations
• Streamlined to combine
– Faculty Disclosure Forms (FDF),
– Financial Interest Declaration (FID), and
– Individual Interest Disclosure (IID)
• Annual disclosures are retained and
relationships can continue over multiple years
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DPS sections
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Outside Professional Activities (OPAs)
Institutional Responsibilities
Financial /Obligatory Interests
Travel
– Sponsored or reimbursed
– PHS-funded Investigators only
• Sponsored Project/Award/Contract tracking
– When funding for a project is imminent, PI adds team
members to the project in DPS
– Triggers review for potential COIs of team members
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DPS: who discloses?
• Casts a “wide net” to include everyone who could
be involved in the design, conduct and reporting of
sponsored work
• Questionnaire: 4 questions with pre-filled answers:
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Faculty?
Research?
Sponsored educational activities?
PHS funded?
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Disclosure Profile System (DPS)
Direct link: http://www.miami.edu/dps
MyUM: under the “Payroll, HR, Misc” tab
DPS web page: uresearch.miami.edu/DPS
Includes:
•Overview
•Instructions via funding and position at UM
•Non-Sponsored: faculty (OPAs) vs non-faculty;
•Sponsored: PD/PI, Team member or Subcontractor
•FAQs
•Glossary and Acronyms
•Link to CITI COI Training
•Link to the UM updated policy on COI in sponsored research
(avail Aug 24th)
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Office of Research Compliance (ORC)
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Leadership:
Staff:
John Bixby, PhD, Vice Provost for Research
Lory A. Hayes, PhD, Associate Director
Jerry Engel, Esq., Compliance Specialist
Taimania Matthews, Compliance Specialist
Phone:
305-243-4054
Fax:
305-243-6160
DPS helpline: 305-243-0877
‘Cane Watch Compliance website: www.canewatch.ethicspoint.com
Websites: uresearch.miami.edu/DPS
uresearch.miami.edu/compliance
uresearch.miami.edu/coi/phs (website with details about regulation
changes)
UMMG Executive Office
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Policy on Industry Interactions
Phone:
305-243-7100
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Disclosure Profile System
DPS, Questionnaire
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Disclosure Profile System
OPA introduction
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Disclosure Profile System
OPA submission
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Disclosure Profile System
IR screen
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Disclosure Profile System
FOI introduction
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Disclosure Profile System
FOI submission
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Disclosure Profile System
Travel introduction (PHS-funded only)
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Disclosure Profile System
Travel submission
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Disclosure Profile System
Sponsored Projects/Awards/Contracts intro
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Disclosure Profile System
Projects/Awards/Contracts submission
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Disclosure Profile System
Projects/Awards/Contracts Roster
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Disclosure Profile System
Projects/Awards/Contracts submission
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Disclosure Profile System
Summary
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