Policies and Processes for Limiting Conflict of Interest Patrick N. Breysse, PhD, CIH Johns Hopkins...
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![Page 1: Policies and Processes for Limiting Conflict of Interest Patrick N. Breysse, PhD, CIH Johns Hopkins University Bloomberg School of Public Health Vice-Chair,](https://reader035.fdocuments.net/reader035/viewer/2022070306/55163d67550346a2308b6515/html5/thumbnails/1.jpg)
Policies and ProcessesPolicies and Processes for for
Limiting Conflict of InterestLimiting Conflict of Interest
Patrick N. Breysse, PhD, CIHJohns Hopkins University
Bloomberg School of Public HealthVice-Chair, ACGIH®
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BackgroundBackground• Historical Perspective
– assumed membership limited to government and academics controlled conflicts of interest
– industry involvement as consultants, and as providers of data both formally and informally.
• Industry representatives could be non-voting members of ACGIH® as of 1992
• Voting rights granted in 2000
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Background Background (cont.)(cont.)
• The OSHA proposal to re-adopt the TLVs® as PELs resulted in increased scrutiny of the TLV® process and the role of “guidelines”
• In the late 1980s and early 1990s ACGIH® was criticized as being “industry influenced” and for not limiting conflicts of interest
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Background Background (cont.)(cont.)
• As a result of these events and other factors the ACGIH® began, in the mid-1990s, to:– Review of the TLV® process – Reevaluate of the role of industry
membership– Reevaluate conflict of interest policies and
procedures
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MembershipMembership
• Regular member– professional whose primary employment is
with a government agency or an educational institution
• Associate member• Student member• Retired member• Organizational member
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Associate MemberAssociate Member• Not eligible for Regular membership
• Eligible to serve as voting members of appointive committees
• May hold elective office as a Director-at-Large on the Board of Directors, and may vote on committee matters and ACGIH® elections.
• May not vote on amendments to the Bylaws, serve as an officer on the Board of Directors, or as Chair of an appointive Committee or as a member of the Nominating Committee.
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Conflict of Interest Policy Conflict of Interest Policy and Procedures and Procedures
DevelopmentDevelopment
• Reviewed COI policies of numerous groups• Use the National Academy of Sciences model
as the starting point• Held extensive discussions with TLV®
committee and Board of Directors• Adopted COI Policy on September 17, 2000
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BIAS BIAS (NAS definition)(NAS definition)
“Views stated or positions taken that are largely intellectually motivated or arise from close identification or association of an individual with a particular point of view or the positions or perspectives of a particular group.”
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BIASBIAS
• NAS position– Must create a committee with a balance of
potentially biasing backgrounds or professional or organizational perspectives
• TLV® Committee approach– Attempt to create a balance of opinions
and views by maintaining a diversity of professional affiliations, disciplines and activities among its membership
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Conflict of Interest Conflict of Interest (NAS definition)(NAS definition)
“Any financial or other interest which conflicts with the service of an individual because it: (1) could impair the individual’s objectivity, or (2) could create an unfair competitive advantage for any person or organization.”
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Conflict of InterestConflict of Interest
• Basis for Conflicts of Interest:– Employment– Financial benefit– Personal– Professional
• Avoid perceived as well as real conflict of interest
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Conflict of InterestConflict of Interest
• Committee members serve as individuals– they do not represent organizations and/or
interest groups
• Members are selected based on expertise, soundness of judgement, and ability to contribute
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Conflict of InterestConflict of Interest
• NAS position:– Significant conflict of interest will disqualify
an individual
• TLV® Committee approach:– Try to minimize or eliminate its effects
while allowing member to participate as fully as possible in Committee activities
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Full d isclosure ofpossib le conflicts of
in terest
D iscussion with in fu llcom m ittee andsubcom m ittees
M anagem ent ofperceived and
real CO Is
C om m itteeand
subcom m itteechairs
Bo
ard
of
Dir
ect
ors
Ove
rsig
ht
COI Process at ACGIHCOI Process at ACGIH®®
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Conflict of InterestConflict of Interest• Annual discussion of conflict of interest in full
committee– Definitions– Case studies
• Annual declaration by each member– Professional employment background– Current professional activities– Consulting– Research funding– Financial holdings
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Conflict of InterestConflict of Interest
• Subcommittee– Subcommittee Chair will discuss and
remind as new substances are taken up– Subcommittee Chair will work with
individual members to minimize conflicts:• Authorship?• Co-author or external review?• Voting?
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Conflict of InterestConflict of Interest
• It is each Member’s responsibility to ensure they have considered and addressed any conflicts
• Failure to report conflict of interest can result in immediate termination of membership on the Committee
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High Degree of High Degree of ConflictConflict
• Requires “direct” and substantial personal, professional and/or financial involvement with the substance
• In most cases the member should:– not author the Documentation– not participate in discussions about the
recommended TLV®
– should abstain from voting on the TLV®
• The member may discuss matters of science and express opinions about individual studies
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High Degree of High Degree of Conflict Conflict (cont.)(cont.)
• In some cases it may be possible for the member to participate in authorship of the Documentation as a co-author (following full discussion with and approval from the subcommittee and committee chairs)– they should not participate in drafting or
discussing the TLV® Recommendation or value, however
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High Degree of High Degree of Conflict ExamplesConflict Examples
• A member working with a regulatory agency who plays a role in developing regulations for the substance
• A member affiliated with an academic institution and their research forms the central basis for the TLV®
• A member who works for a company that is a major producer and who plays a direct role in the development of internal exposure levels
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Medium Degree of Medium Degree of ConflictConflict
• Based on “indirect” and modest personal, professional and/or financial involvement with the substance
• The matter should be carefully discussed with the subcommittee chair and members and appropriate steps taken to mitigate the conflict– Typically this will mean assigning a co-author or a
reviewer for the Documentation– In some cases, abstention from voting on the TLV®
is also appropriate.
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Medium Degree of Medium Degree of Conflict ExamplesConflict Examples
• Member who works for a regulatory agency that regulates the chemical substance, does not have a direct role in developing regulations but may be concerned with enforcing regulations
• Member who works for an academic institution and their research may be concerned with the chemical substance but is not central to the determination of a TLV®
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Medium Degree of Medium Degree of Conflict Examples Conflict Examples (cont).(cont).
• Member employed by a company that is a major producer of the chemical substance but who plays a minor role in the internal development of exposure levels
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Low Degree of Low Degree of ConflictConflict
• The member is affiliated with an organization that has a financial or other interest in the substance but has a very minor or nonexistent role with respect to the substance – In most cases, simply informing the
subcommittee and committee members about low level conflicts is all that is needed
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Continuing EvolutionContinuing Evolution
• The implementation of the COI Policy requires constant re-evaluation of conflicts, their impacts and management strategies
• We are learning as we go
• Developing implementation guidelines that are appropriate for each committee