september 2006 1 policy #97 conflict of interest and conflict of commitment & filing online in...

September 2006 http://www.universitycounsel.ubc.ca/coi1

Policy #97

Conflict of Interest and Conflict of Commitment

&

Filing Online in RISe

http://www.universitycounsel.ubc.ca/coi

T H E U N I V E R S I T Y O F B R I T I S H C O L U M B I A


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


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.


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.


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


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


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)


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.


Role of COI Committee

• Only deals with COIs, not COCs• Will assess disclosures where Initial

Reviewer (and, where applicable, Faculty-Based Process) was not satisfied

• Will hear appeals from decisions of Initial Reviewer or Faculty-Based Process

• Will conduct random audits• Will undertake education program


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/


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


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


Table: Who needs to file and when?

Annually : At least annually counting from the last disclosure report filing [s5.2 COC, s6.4 COI ]

X X

Change : Whenever there is a material change from those disclosed in last disclosure report [s5.1 & 5.2 COC, s6.3 & 6.4 COI ]

X X X X X

Before starting a research project [s6.2 COI ] X X X X

PTF* CF* PI / R*

* PI 's & Recipients of Tri-Council funding or from other agencies requiring annual/ regular disclosure

STAFF*

Annual Filing Obligation

File I F/ WHEN COI / COC Arises or Changes

X X X X X

FTF*

I f COI / COC Arises : Before acting in conflict (outside of an approved Management Plan) if the activity may give rise to:>a Conflict of Commitment [s5.1 COC]>a potential, actual or apparent Conflict of I nterest (or file ASAP if impossible beforehand) [s.6.3 COI ]

File When:Refer to Policy #97 for the authoritative text

* staff - Full-time and Part-time

Note: This table may not identify all people or requirements.

* Full time Faculty

* Part time Faculty

* Clinical Faculty (if not FTF or PI / R)


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.


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.


Disclosing- Conflicts 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 Non-

University Activities.


Recognizing Conflicts of Interests4.1 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.


Conflict of Interest Examples

• 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.

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. …


Conflicts by Type – One Conceptual ViewConflict 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)


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 Reviewer and any affected parties:– COIs relating to specific research projects– Activities that may create a COI or COC– 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.

In Advance

ASAP

Annually -if full-time faculty or

grant recipient


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.

Conflicts Timeframe (Window) of Filing


Assessing DisclosuresPolicy #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.


Identifying and Neutralizing Conflicts

1. Identify the parties and relationships.

2. 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.

3. 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

4. Develop/assess neutralization of each conflict corresponding to the actual risk and skeptic’s view


Management Plans (management protocols)

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. Commitment to normal recusal from participation in discussions and decision-making where in conflict

3. Nothing extra– recognition and declaration sufficient (Please still document in Management Plan section)

3. DISCLOSE – Disclosure to:– to all affected parties (mandatory to the other side of the conflict)

– in publications & presentations [See CME/CPD policy]

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:


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


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


• Faculty member files COI/COC on-line

• Management Plans and other documents may be easily attached to the declaration

Online Processes – Major (1/3)


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


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.


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


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


Questions & Answers

http://www.universitycounsel.ubc.ca/coi


Students4.1.1 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


Research4.1.2 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


Business Relationships4.1.3 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.


Hiring Decisions4.1.5 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.


Solicitation4.1.6 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.


Confidential Information4.1.7 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.


Board Positions4.1.8 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.

Gifts4.1.9 Where a Member accepts tokens of appreciation with a value of $250 or more in connection with his or her position at the University.


Non-University 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.

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

september 2006 1 policy #97 conflict of interest and conflict of commitment & filing online in...

Documents

uglygood conflict

management plan policy

new policy

amendmentsrevised policy

optional facultybased

coi review committeea

research context

sideaddress management