Policies and Processes for Limiting Conflict of Interest Patrick N. Breysse, PhD, CIH Johns Hopkins University Bloomberg School of Public Health Vice-Chair, ACGIH ®

Background 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 (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 (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

Membership Regular member –professional whose primary employment is with a government agency or an educational institution Associate member Student member Retired member Organizational member

Associate 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 and Procedures Development 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 (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.

BIAS 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 (NAS definition) Any financial or other interest which conflicts with the service of an individual because it: (1) could impair the individuals objectivity, or (2) could create an unfair competitive advantage for any person or organization.

Conflict of Interest Basis for Conflicts of Interest: –Employment –Financial benefit –Personal –Professional Avoid perceived as well as real conflict of interest

Conflict 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 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

COI Process at ACGIH ®

Conflict 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 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 Interest It is each Members 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 Conflict 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 Conflict (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 Conflict 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 Conflict 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 Conflict 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 Conflict Examples (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 Conflict 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 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