TH E U N IVE RSITY O F BR ITI SH C OLU MB IA
Policy #97
Conflict of Interest and
Conflict of Commitment
&
Filing Online in RISe
http://www.universitycounsel.ubc.ca/coi
September 2006
http://www.universitycounsel.ubc.ca/coi
1
Conflicts:
The Good, The Bad and The Ugly
• Good - Conflict of interest and conflict of commitment can
naturally arise from being active in research, industry, and
community. These may be good, even desired, activities
and the mere existence of a conflict is not necessarily
improper.
• Bad - Impropriety arises from inattention to risk & failure
to
– Recognize
– Disclose [to UBC and other side]
– Address [Management Plan: recuse, neutralize or divest]
• Ugly - Failure to comply may harm both UBC’s & Faculty
member’s
– Integrity / Reputation
– Funding
September 2006
http://www.universitycounsel.ubc.ca/coi
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Need for Policy & 2005 Review
• Increased scrutiny and public expectations
of ethical conduct and conflict of interest
issues over the last ten years.
(e.g. Enron, Gelsinger {U Penn 1999} gene “therapy” death)
• Increased research activity means increased
potential for conflict of interest claims.
• New requirements and obligations imposed
by Canadian and American government
research agencies.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Approval & Implementation
• Policy approved 1992, updated over time, and then
revised in March 2005
• Fully compliant with latest recommendations and
requirements of:
– Tri-Council granting agencies
– U.S. Department of Health & Human Services.
• Much greater attention given to conflicts arising in
the research context.
• New Policy is easier to read and only 2/3 the length
of the previous version.
• Unified on-line disclosure system launched Faculty
by Faculty: Sept 2005 - Sept 2006.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Policy 97 - 2005 Amendments
• Revised Policy incorporates “best practices”
• General principles:
– Recognition
– Disclosure
– Removal or management/neutralization of
conflicts (other than inconsequential conflicts)
– Assessment and Approval
• Detailed examples in guidance documents instead
of Policy
• Flexible enough to accommodate needs of
different Faculties
• Conflict of Interest Committee established
September 2006
http://www.universitycounsel.ubc.ca/coi
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Structure of Policy Document
• Initial Reviewer assesses a Member’s form &
may require a Management Plan for any:
– Conflict of Commitment (COC)
– Conflict of Interest (COI)
• A Reviewer may refer a form to the Dean or an
optional Faculty-Based Review if required by
disclosure volume and/or a specialized
academic/professional discipline
[Medicine has a COI Review Committee]
• A form may be referred for final decision to the
COI Committee
September 2006
http://www.universitycounsel.ubc.ca/coi
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Role of Initial Reviewer on COCs
Authorized to grant approval of COCs:
• Based on consideration of whether activity
interferes with duties owed to UBC
• Even if activity interferes, provided the
contribution to UBC warrants the
interference (offsetting benefit)
September 2006
http://www.universitycounsel.ubc.ca/coi
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Role of Initial Reviewer on COIs
• May determine that activity is:
– Permissible as-is
– Permissible only with Management Plan
(Policy 97 uses the term“management protocol”)
– Prohibited
• May refer matter for further consideration
to next level:
– Faculty-Based Review where this process is
developed by the dean and the University
Counsel; or
– COI Committee.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Role of COI Committee
• Only deals with COIs, not COCs
• Will assess disclosures where Initial
Reviewer (and, where applicable, FacultyBased Process) was not satisfied
• Will hear appeals from decisions of Initial
Reviewer or Faculty-Based Process
• Will conduct random audits
• Will undertake education program
September 2006
http://www.universitycounsel.ubc.ca/coi
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Role of University Counsel
• Will provide advice to:
– Administrative Heads of Unit [Deans,
Heads/Reviewers]
– COI Committee
• Responsible for overall management of
COC/COI process
University Counsel as a website with general
advice and FAQs:
http://www.universitycounsel.ubc.ca/coi/
September 2006
http://www.universitycounsel.ubc.ca/coi
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Why Comply?
• Policy protects both UBC and its faculty
members
• Government Agencies require:
– Audits by UBC
– Breaches to be reported by UBC (penalty for
failure to report breaches)
• Government Agencies may:
– Conduct audits at UBC
– Require return of any/all grant funds even if
already spent
– Halt certain grants or all grants
September 2006
http://www.universitycounsel.ubc.ca/coi
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Scope/People
-Who Needs to File a COI/COC Declaration?
• Policy applies to all full-time and part-time
members of UBC faculty and staff and any
person who is teaching, conducting research, or
otherwise working under UBC’s auspices
(including students and visiting professors) .
• All these people must complete a Conflict of
Interest / Conflict of Commitment declaration:
– Some must file yearly
– Some only when conflicts arise
– All must file when there is a change in circumstances
creating or altering a conflict
September 2006
http://www.universitycounsel.ubc.ca/coi
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Table: Who needs to file and when?
File When:
Refer to Policy #97 for the authoritative text
FTF*
Annual Filing Obligation
Annually : At least annually counting from the last
disclosure report filing [s5.2 C OC , s6.4 C OI]
File IF/WHEN COI/COC Arises or Changes
Change : Whenever there is a material change from
those disclosed in last disclosure report [s5.1 & 5.2
C OC , s6.3 & 6.4 C OI]
PTF*
CF*
X
PI/R*
STAFF*
X
X
X
X
X
Before starting a research project [s6.2 C OI]
X
X
X
X
If COI/COC Arises : Before acting in conflict (outside
of an approved Management Plan) if the activity may
give rise to:
>a C onflict of C ommitment [s5.1 C OC ]
>a potential, actual or apparent C onflict of Interest (or
file ASAP if impossible beforehand) [s.6.3 C OI]
X
X
X
X
X
X
*Full time Faculty
*Part time Faculty
*Clinical Faculty (if not FTF or PI/R)
*PI's & Recipients of Tri-Council funding or from other agencies requiring
annual/regular disclosure
*staff - Full-time and Part-time
Note: This table may not identify all people or requirements.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Recognizing Conflicts of Commitment
“Conflict of Commitment” occurs :
• Where Non-University Activities are so
distracting (e.g. time or attentiveness) that
they adversely affect the discharge of a
Member’s UBC duties.
• Where UBC resources are used (other than
inconsequential) for Non-University
Activities.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Conflict of Commitment- One Description
Conflict of Commitment usually involves time
allocation to fulfill academic obligations.
A faculty appointment confers the privilege &
obligation to pursue teaching, research,
scholarship, service and, in some faculties,
clinical care, requiring a significant presence on
campus in order to:
– Fulfill these primary obligations to UBC
– Be accessible to students, staff, administrators,
and affiliates.
September 2006
http://www.universitycounsel.ubc.ca/coi
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DisclosingConflicts of Commitment, &
Outside Professional Activities / Resource Use
• As COCs Arise (“If/When arising”) -All
Members must:
– disclose the COC
– obtain written approval (prior/ASAP)
• Annually - Some Members must disclose
in the online form all COCs arising from:
– Outside Professional Activities
– Use of UBC resources for NonUniversity Activities.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Recognizing Conflicts of Interest
s4.1 Members must conduct themselves at all times
with the highest ethical standards in a manner that
will bear the closest scrutiny.
…
• “Conflict of Interest” occurs where Member (or Related
Party) can potentially, actually or apparently influence
decisions to advance his/her own interests to detriment of
UBC’s interests, integrity, or mission.
• Also occurs in research context when personal
considerations may appear to compromise Member’s
judgment in conducting or reporting research.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Conflict of Interest Examples
s4. 1 As each situation depends upon its specific facts, the University has not
attempted to develop an exhaustive list of Conflicts of Interest. … Conflicts of
Interest will arise in the following situations. …
• Policy contains 9 common examples where COIs arise.
–
–
–
–
–
–
–
–
Students uncompromised, unimpeded by COI
Research Financial Interest in the outcome (>$10,000 or >5% ownership )
Business Relationship “business” includes non-profits but excludes a medical practice
Hiring Decisions Personal Benefit, Financial Interest, personal relationship (> colleague)
Solicitation use of position to solicit for Non-University Activities
Confidential Information use of UBC owned or protected information without authority/rights
Board Positions duty owned to business with UBC dealings or research connection
Gifts $250 aggregated from COI common source. Honouraria is usually a “Financial Interest” not a gift.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Conflicts by Type – One Conceptual View
Conflict of Commitment
(@UBC re time/attentiveness/use of resources)
Conflict of Interest (Self or Related Party) [5 classes- descriptive only, not in policy]
– Conflict of Duty
– Conflict of Educational Mission
The mission includes:
–
–
–
–
–
–
Protection of the academic interests of students (and postdoctoral fellows)
Academic freedom
Advancing the range & depth of knowledge of the natural world & the human condition
Open and timely dissemination of knowledge
Protecting the appearance and actual integrity and objectivity of research, instruction, and
public service (may be Research Integrity)
Safety of patients and research participants
– Conflict of Financial Interest (>$10,000 annually or >5% ownership)
– Conflict of Personal Benefit (may be Financial Interest)
•
•
•
Non-financial or indirect benefit
Competing interest
Direct status benefit
– Conflict of Research Integrity
(also: Policy 85 - Scholarly Integrity
Policy 87 – Research)
September 2006
http://www.universitycounsel.ubc.ca/coi
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Disclosing Conflicts is KEY!!!
Scope/Standard of Filing - The form only asks for
disclose of facts/circumstances that would cause a skeptical and
not fully informed observer to reasonably question whether a
potential, actual, or apparent conflict exists.
Scope/Frequency - Members must disclose, to Initial
In Advance
Annually if full-time
faculty or
grant
recipient
Reviewer and any affected parties:
– COIs relating to specific research projects
– Activities that may create a COI or COC ASAP
– Financial Interests in their UBC work (by Member or Related Party)
– COCs arising from Outside Professional Activities*
– Use of UBC resources for Non-University Activities (always
a potential COC)
*At annual performance review all Outside Professional Activities must be
disclosed in order to comply with s5.2. – This may be moved to this online
system.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Conflicts Timeframe (Window) of Filing
Declarations are to cover activities within a
window looking backward 12 months and forward
12 months i.e. activities:
– Engaged in since last filing
– Anticipated to be engaged in before next filing
FYI
– JAMA requires looking back 5 years for Financial Interest &
at all time for any other conflict of interest.
– American Society of Clinical Oncology looks at all time and
requires disclosure of any conflict over $100.
– Many mandate that a PI may not be involved in any research
where there is any conflict of interest.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Assessing Disclosures
Policy #97 Procedures
2.2
Without limiting the discretion of a person assessing a
disclosure to consider all relevant factors, the following factors
must be considered in assessing a disclosure:
2.2.1. the impact on the Member’s ability to satisfy his or her
obligations to the University;
2.2.2. the degree to which the proposed action will be
detrimental to the interests of the University, or in the
research context, the degree to which it may compromise
an investigator’s professional judgment in conducting or
reporting research; and
2.2.3. the extent to which the proposed action or activity may be
managed through an appropriate protocol.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Identifying and Neutralizing Conflicts
1.
2.
3.
4.
September 2006
Identify the parties and relationships.
For each relationship identify the conflict type and
each party affected by the conflict (which may
extend beyond those ID’d above) as viewed by the
skeptic.
For each combination of party, relationship, and
conflict heading assess the magnitude of each
specific conflict by actual risk and the opportunity
for skeptical query
Develop/assess neutralization of each conflict
corresponding to the actual risk and skeptic’s view
http://www.universitycounsel.ubc.ca/coi
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Management Plans (management protocols)
The reviewer of a COI/COC Declaration may require a Management Plan to
neutralize a COI or manage a COC by various combinations of the
following:
1.
SEVER - Resignation, Divestiture or other means of severance
from the conflict on one side or the UBC side– e.g. from the a position
of influence/decision-making regarding certain business, students, contracts, or
research; or reduction of Financial Interest by disposal of shares (total or to below
threshold) or limiting consulting etc.
2.
MINIMIZE –
1.
Appointment of an independent to control, monitor, and/or
periodically report on area of concern – e.g. Have co-PI, or independent with
oversight &/or veto control over various combinations of research area(s) - design, data
collection, testing, analysis, publication.
2.
3.
3.
DISCLOSE – Disclosure to:
–
–
September 2006
Commitment to normal recusal from participation in discussions and
decision-making where in conflict
Nothing extra– recognition and declaration sufficient (Please still
document in Management Plan section)
to all affected parties (mandatory to the other side of the conflict)
in publications & presentations [See CME/CPD policy]
http://www.universitycounsel.ubc.ca/coi
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Filing Online –Research Information Services RISe
• Online filing (vs paper filing) thru RISe is
required of Researchers and everyone entitled
to do research (i.e. almost all faculty - see list
or have staff get paper forms at:
www.universitycounsel.ubc.ca/coi/file.html)
• RISe is “Researcher Information Services” an
online system that enables researchers to easily
and securely submit and manage:
– COI/COC declarations
– Animal care ethics applications
– Applications for research with human subjects
September 2006
http://www.universitycounsel.ubc.ca/coi
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Filing Online –RISe Management and Access
• With RISe, users can track their COI
declarations and ethics applications through the
approval process, as well as manage
amendments, renewals, & user information/
profile.
• Almost everyone with a CWL may access RISe
directly at http://rise.ubc.ca
• If you don’t have CWL (or are insufficiently
identified) go to
http://www.it.ubc.ca/cwl/homelink.shtml
September 2006
http://www.universitycounsel.ubc.ca/coi
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Online Processes – Major (1/3)
• Faculty member files COI/COC on-line
• Management Plans and other documents
may be easily attached to the declaration
September 2006
http://www.universitycounsel.ubc.ca/coi
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Online Processes – Major (2/3) - Medicine
• Review is prompted by email notice to Reviewer
(Notice sent to access RISe – The form is not sent)
• Review Steps (minimum):
– 1st Review = Initial Reviewer, usually a Dep. or
Div. Head*
– Referral/Appeal Review = Medicine COI
Review Committee* (if referred or appealed)
– Final Review/Appeal = UBC COI Committee
(if referred, appealed, or audited)
*Set by Dean & Office of University Counsel
and includes oversight by Dept and/or Dean
September 2006
http://www.universitycounsel.ubc.ca/coi
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Online Processes – Major (3/3)
• E-mail notification to targeted people when
activity is required from them (Notices only files
are not emailed)
– Notice to Reviewer
– Notice to Member of COI/COC declaration
approval or escalation for appeal/additional
review
– E-mail notification and prompts on yearly
COI/COC expiration
• Information disclosed in on-line Research Ethics
Board conflict of interest disclosures will also be
available to Initial Reviewers.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Approved COI Declaration
• Faculty member will update to renew
the declaration when required (yearly)
• Amendments can be made when the
faculty member’s situation changes
and a potential COI or COC could
exist
• Approved amendments reset the
yearly expiration
September 2006
http://www.universitycounsel.ubc.ca/coi
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Printing & Reporting
• COI declarations can be printed
• Reports are accessible to department
reviewers (usually heads & deans are set
up as reviewers).
• Reports show compliance per
department and faculty, depending on
the state “Approved”, “Dean review”
etc.
• Drill-down will provide specific person
data
September 2006
http://www.universitycounsel.ubc.ca/coi
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Questions & Answers
http://www.universitycounsel.ubc.ca/coi
September 2006
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Students
4.1.1 Where a Member’s responsibility to instruct and
evaluate students in a fair, unbiased and effective
manner is or appears to be impeded or compromised.
The inherent power imbalance that exists between a
Member and a student must not be used for personal
benefit. A Conflict of Interest exists where a Member
receives a personal benefit when dealing with
students.
4.1.6 Where a Member uses his or her position with
the University to solicit students, fellow Members,
government agencies, private companies, or members
of the public for Non-University Activities
September 2006
http://www.universitycounsel.ubc.ca/coi
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Research
4.1.2 Where a Member (or a Related Party of the Member) has a Financial
Interest in the outcome of his or her research. In the area of research,
vigilance is required. The University’s commitment to liaise with industry
and to transfer technology, the growth of industry sponsored research, and
the substantial increase in the University’s interactions with outside
organizations generally all lead to a corresponding increase in the
potential for Conflicts of Interest. In addition, various governmental and
other agencies that fund research are imposing increasingly stringent
Conflicts of Interest requirements on investigators and institutions
applying for research funding. A Member must comply with this Policy
and any applicable Conflicts of Interest policies imposed by other
organizations, agencies or institutions.
2.6 Where the Committee determines that a Conflict of Interest exists, the
Committee will:
…
2.6.2 disclose the existence of the Conflict of Interest to a funding
agency where relevant to an application for research funding to that
agency
September 2006
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Business Relationships
4.1.3 Where a Member has influence over a decision about a proposed relationship
between the University and a Business in which the Member or his or her Related
Party has a Financial Interest or holds an Executive Position.
4.1.4 Where a Member or his or her Related Party obtains a Financial Interest or an
Executive Position in a Business with which the University has an existing
relationship and the Business is related to the Member’s work at the University.
[Also Board Positions]
4.1.8 Where a Member’s obligations to a board of directors, advisory boards, or the
like of an outside organization interfere with or compromise the Member’s
obligations to the University.
12.2 “Business” means a corporation, partnership, sole proprietorship, firm,
franchise, association, organization, holding company, joint stock company,
receivership, business or real estate trust, or other legal entity organized for profit or
charitable purposes, but excluding the University, an affiliated Hospital, a private
medical practice, or other entity controlled by, controlling, or under common control
with the University or an affiliated Hospital.
September 2006
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Hiring Decisions
4.1.5 Where a Member is in a position to influence human
resource decisions (such as recruitment, offer of employment,
evaluation of performance, promotion, granting of tenure, or
termination of employment) or admission decisions with respect to
a person with whom the Member has a personal relationship that
might reasonably be construed as a Conflict of Interest.
September 2006
http://www.universitycounsel.ubc.ca/coi
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Solicitation
4.1.6 Where a Member uses his or her position with the University
to solicit students, fellow Members, government agencies, private
companies, or members of the public for Non-University
Activities.
Overriding Rule:
4.1 As each situation [Recognizing COI] depends upon its specific facts,
the University has not attempted to develop an exhaustive list of Conflicts
of Interest. Rather, Members must conduct themselves at all times with
the highest ethical standards in a manner that will bear the closest
scrutiny. Conflicts of Interest will arise in the following situations.
September 2006
http://www.universitycounsel.ubc.ca/coi
37
Confidential Information
4.1.7 Where a Member uses information that is acquired as a result
of his or her relationship with the University and not in the public
domain for Non-University Activities unless the Member has
proprietary rights (usually enforceable through copyright) to that
information. Members should also be aware that insider trading
restrictions may also apply to them.
[Also Business Relationships]
4.1.4 Where a Member or his or her Related Party obtains a
Financial Interest or an Executive Position in a Business with
which the University has an existing relationship and the Business
is related to the Member’s work at the University.
September 2006
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Board Positions
4.1.8 Where a Member’s obligations to a board of directors,
advisory boards, or the like of an outside organization interfere
with or compromise the Member’s obligations to the University.
Gifts
4.1.9 Where a Member accepts tokens of appreciation with a value
of $250 or more in connection with his or her position at the
University.
September 2006
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Non-University Activity
12.10 “Non-University Activity” means any activity outside a
Member’s scope of work with the University and includes Outside
Professional Activities.
Outside Professional Activity
12.11 “Outside Professional Activity” means any activity outside a
Member’s scope of work with the University that involves the
same specialized skill and knowledge that the member utilizes in
his or her work with the University and includes the operation of a
Business, consulting or advisory services and speaking
engagements.
September 2006
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