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®

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

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

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

MembershipMembership

• Regular member– professional whose primary employment is

with a government agency or an educational institution

• Associate member• Student member• Retired member• Organizational member

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.

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

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.”

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

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.”

Conflict of InterestConflict of Interest

• Basis for Conflicts of Interest:– Employment– Financial benefit– Personal– Professional

• Avoid perceived as well as real conflict of interest

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

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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COI Process at ACGIHCOI Process at ACGIH®®

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

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?

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

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

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

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

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.

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®

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

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

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