Code for the Assessment and Management of Conflict of Interest

Purpose and Application

Complex relationships with for-profit and not-for-profit organizations and entities may by their existence present a perceived or real conflict with the missions and values of the AASLD. In as much as the existence of real or perceived conflicts of interest serves to undermine the stature, integrity, creditability and function of the AASLD, AASLD must insure that its membership, leadership and the public-at-large understand the importance it places on identification and resolution of conflicts. The independence and the credibility of AASLD require implementation of a clear policy that can be enacted in a practical, fair and transparent manner.

Conflicts of interest are defined as any circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. 1 Primary interests are those associated with the stated mission of the AASLD. Secondary interests may be financial or non-financial in nature. (e.g. intellectual conflict of interest,2 membership in other organizations, or institutional or corporate associations).

Application of this policy is to be temporally phased in with the addition of new members and reappointments. Further, the degree of permitted associations will be regulated in a fashion that is commensurate with the influence that the individual has in the creation, implementation and/or execution of AASLD functions. Since the AASLD plays roles of advocacy for clinical care, education and research in liver diseases, the policy shall cover all individuals who participate at any level in those functions. The definition of conflict, review of disclosures and the adjudication and resolution of conflicts requires a multi-layer effort that is charged to the Ethics committee. The policy outlined will require diligent interpretation in complex cases, with the goal of providing clarity for members as they engage in their functions. The overriding goal is to provide objective conflict management. The application of this Code is not intended to be punitive to the member. The process is by its nature fluid and ongoing reporting and review will be necessary.

Definitions 3

The following terms are defined for purposes of this Code:.

Company: A Company is an entity that develops, produces, markets, or distributes drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions and whose interests could reasonably be seen to overlap with the interests, missions and values of the AASLD. This definition is not intended to include entities outside of the health care sector, or entities through which physicians provide clinical services directly to patients.

Direct Financial Relationship: A Direct Financial Relationship is a compensated relationship with a Company held by an individual that should generate an IRS Form W-2, 1099 or equivalent income report. All direct financial relationships that are in effect, or had been in effect, any time within the 12-month period preceding the date of disclosure must be reported.

Educational Grant: An Educational Grant is a sum awarded by a Company, typically through its grants office, for the specific purpose of supporting an educational or scientific activity offered by the recipient. Educational Grants awarded by a Company to support a CME activity are referred to in the ACCME Standards for Commercial Support as “Commercial Support” of CME. An Educational Grant may also be “in-kind.”

Gifts "in kind:" Compensation in goods or services rather than money; non-monetary gifts of valued consideration (e.g. access to advisory or consultant services, specific resource allocation or access).

Research Grant: For purposes of this Code, a Research Grant is an award that is given by a Company or other funding agency to an individual, institution, or practice to fund the conduct of scientific research. Companies may provide an individual, institution, or practice with programmatic support (e.g., an Educational Grant) designated for the specific purpose of funding Research Grants.

Principles and Practice

1.Independence

AASLD will develop all educational activities, scientific programs, products, services and advocacy positions aligned with the mission of the Association, independent of external influence, and will develop and adopt policies and procedures that foster this independence. AASLD will separate their efforts to seek Educational Grants, Corporate Sponsorships, Charitable Contributions, and support for Research Grants from their programmatic decisions. The initial step in program development is the independent assessment by AASLD that a program is needed (e.g., to address gaps in care or knowledge). Once AASLD determines that a program is needed, it is permissible to assess the availability of funds.

A. The Ethics Committee of AASLD will be responsible for evaluating and adjudicating conflicts of interest and guiding the interactions of AASLD, and its Members, and monitoring the compliance with this Code. (See Appendix C).

B. Approval of a motion involving identification or management of a conflict of interest by the Ethics Committee requires a two-thirds majority of voting members.

C. The President and President-elect, Chair of the Ethics Committee, and Chairs and Chairs-elect of the CME, Practice Guidelines and Practice Metrics Committees may not have Direct Financial Relationships with Companies during his or her term of service.

AASLD will require that a majority (based on simple numerical majority) of CME Committee members are free of conflicts of interest.

D. Other AASLD Governing Board members, Committee Chairs, Committee members and Editors- in-Chief of AASLD journals are permitted to have Direct Financial Relationships with Companies up to $10,000 per company per year and must disclose any such Relationship and indicate whether it is in excess of $10,000 per year.

Journal Editors are required to recuse themselves from involvement with any manuscript funded by or impacting companies with which they have personal financial relationships. These manuscripts should be assigned to and handled by a non-conflicted Deputy or Associate Editor, with no input from the Editor. These recusals must be documented and tracked.

E. Governing Board members and Journal Editors-in-Chief (a) should not serve on industry speakers’ bureaus, (b) should not participate in industry-sponsored satellite symposia at DDW or The Liver Meeting®, and (c) should not participate in programs conducted by vendors contracted by AASLD.

Membership as an officer or member of the governing board of a related professional association or editor or associate editor of a competing journal are not allowed.

F. Nominees for Councilor will be informed that they will be required to terminate any Direct Financial Relationships with Companies prior to their term as President-elect.

G. The President and President-elect, and Chair of the Ethics Committee and Chairs and Chairs- elect of the CME and Practice Guidelines Committees may provide uncompensated service to Companies and accept reasonable travel reimbursement in connection with those services. The President and President-elect and Chair of the Ethics Committee and Chairs and Chairs-elect of the CME, Practice Guidelines and Practice Metrics Committee may accept research support as long as grant money is paid to the institution (e.g. academic medical center) where the research is conducted, not to the individual or to a practice. Research support, uncompensated services and other permitted relationships must be disclosed to the AASLD, regardless of any monetary value or its equivalent. AASLD does not consider research funds provided to a member’s institution as a conflict of interest.

Membership as an officer or member of the governing board of a related professional association and appointment as editor or associate editor of a competing journal are not allowed.

H. Committee Chairs and members are required to recuse themselves from decisions that could result in direct/indirect financial benefit or could reasonably be perceived as a conflict of interest, even if these activities have not been specifically precluded by AASLD COI policy.

2. Transparency

AASLD will make their conflict of interest policies available to their members and the public. AASLD, through the Ethics Committee, will manage conflicts of interest in a variety of ways. This may include, but is not limited to, disclosure, recusal, divestiture, or AASLD-independent review. The Ethics Committee will select conflict of interest management mechanisms that are appropriate for the activity, type of relationship and role of the individual under consideration (see Appendix C).

A. AASLD, through the Ethics Committee, will provide written disclosure forms to individuals who serve on behalf of the AASLD (see Appendix D), and will use the disclosed information to manage conflicts of interest in decision-making. AASLD will require volunteers to update disclosure information at least annually and whenever material changes occur.

B. AASLD will disclose all Direct Financial Relationships and uncompensated relationships held by the President and President-elect making this information available to their members and the public.

C. Disclosure forms obtained during any nominating process shall not be included as part of the review of the candidate by the Nominating Committee. The disclosures of the finalists selected by the Nominating Committee shall be reviewed by the Ethics Committee prior to review by the Governing Board.

3. Clinical Practice Guidelines / Guidances and Quality Measures

AASLD will base Clinical Practice Guidelines/Guidances and Quality Measures on scientific evidence and will follow a transparent Guideline/Guidance and Quality Measure development process that is not subject to Company or other external influence. AASLD will publish a description of their Guideline/Guidance and Quality Measures development processes, including their process for identifying and managing conflicts of interest on AASLD websites and in AASLD journals.

A. AASLD will not permit direct Company support of the development of Clinical Practice Guidelines/Guidances, Guideline/Guidance Updates and Quality Measures.

B. Permitted relationships and their disclosure for Clinical Practice Guidelines/Guidances and Quality Measures Committee members and Chairs are outlined in Appendix A.

C. AASLD will require that a majority (based on simple numerical majority) of Guideline/Guidance or Quality Measures development writing panel/group members are free of conflicts of interest relevant to the subject matter of the Guideline/Guidance or Quality Measures during the period of Guideline/Guidance or and Quality Measures development. Writing Panel/Group members without conflicts will be expected to remain conflict-free during their term of service on the Writing Panel/Group.

For the minority of writing panel/group members who are not free of conflicts, AASLD will apply procedures for conflict of interest management developed in accordance with Section 2.

As soon as a violation of COI policy is identified, the specific Committee or Writing Panel/Group member who was identified to be in violation would immediately lose voting and authorship privileges. These privileges can be reinstated after the conflict is rectified in a satisfactory manner, as adjudicated by the Ethics Committee.

D. AASLD will require the writing panel/group chair(s) to be free of conflicts of interest and to remain free of conflicts of interest during Guideline/Guidance or Quality Measures development up to the time of publication of the Guideline/Guidance or Quality Measures.

E. Clinical Practice Guidelines/Guidances and Quality Measures Committee members and Chairs, as well as assigned Administrative Staff are expected to possess a sound knowledge of COI requirements for their respective Committees/Groups and to promptly report changes in COI. Once the composition of a Committee/Writing Group has been reviewed by the Ethics Committee and approved by the Governing Board, the AASLD administrator assigned to each committee/group will be responsible for monitoring new conflicts and bringing any non-permitted conflict to the attention of the relevant Committee Chair and to the Ethics Committee. This specifically includes the reporting of any new conflict submitted by a non-conflicted Writing Group member that would cause the Writing Group to exceed the 50% threshold for non-conflicted members.

F. AASLD will require that Guideline recommendations, Guidance statements or Quality Measures be subject to multiple levels of review, including rigorous peer-review by a range of experts. AASLD will not select as reviewers individuals employed by or engaged to represent a Company.

G. AASLD will publish Guideline/Guidance or Quality Measures development writing panel/group members’ disclosure information adjacent to each Guideline/Guidance or Quality Measures and will identify voting members.

H. AASLD will require all Guideline/Guidance or Quality Measures contributors, including expert advisors or reviewers who are not officially part of a Guideline/Guidance or Quality Measures development writing panel/group, to disclose financial or other substantive relationships that may constitute conflicts of interest.

4. Adherence to the Code

Adherence to this Code will be promulgated by AASLD. All Members of the AASLD will be encouraged to adopt the principles of this Code and their application.

For AASLD officials, Committee Chairs and members, willful non-reporting or withholding of COI information with the intention to conceal ongoing or planned non-permitted activities and/or failure to respond to AASLD requests to complete or clarify COI reporting and/or to divest from specific non-permitted activities in a timely manner may result in disciplinary action by the Governing Board. These actions may include reprimand, removal from current Committee position(s), exclusion from future service on Committees, and/or suspension of membership in the AASLD.

Appendix A

Conflict of Interest: Special Considerations for Practice Guidelines Committee and Practice Metrics Committee Chairs, Committee Members and Writing Group Members Disclosures

Disclosures must be made at least annually and when material changes occur.

Download Appendix A [PDF].

Appendix B

Conflict of Interest: Special Considerations for Governing Board, Journal Editors-in-Chief, and Committees

Disclosures must be made at least annually and when material changes occur.

Download Appendix B [PDF].

Appendix C

Policy and Criteria for Assessment of Conflicts of Interest by the Ethics Committee

The Ethics Committee will employ a policy of evaluating conflicts of interest that embodies the criteria of proportionality, transparency, accountability and fairness. Proportionality requires a policy to address the most important conflicts (i.e. direct financial relationships or financial relationships in-kind); the disclosure forms will reflect this policy. Transparency dictates that the policy be available and understood by the affected parties; this code and the attached appendices (outlining the criteria that will be employed for the assessment of conflicts) will be posted for all members to review and disclosure forms will be accompanied by clear instructions to allow members to understand the specific information required to fulfill full and accurate disclosure. Accountability requires divulging the details of who will be responsible for assessment and enforcement; this is reflected in the code stating that the Ethics Committee will be responsible for the assessment of conflicts and that enforcement of the management of conflicts will be via relevant sections of the Association’s By-laws and the joint actions of the Ethics Committee and the Governing Board. Fairness requires that a policy for the evaluation of conflicts apply to all relevant parties with equal measure; this criterion is met by the statement in this code indicating that the criteria employed to assess conflicts of interest will be independent of the individual or groups to whom they are applied but rather will vary by the set of circumstances around which a conflict arises.

Criteria for Assessment of Conflicts of Interest

Conflicts of interest are rarely, if ever, “absent” or “clearly present”, but rather vary in their severity and relevance to a particular circumstance. Accordingly, the Ethics Committee will assess potential conflicts from the perspectives of the chance that a conflict will impair impartial decision-making and the degree of harm that would arise from such impairment. Based on this Code’s definition of a conflict of interest as any circumstances that create a potential risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest, the Ethics Committee will use the following criteria when assessing a conflict:

What is the financial value of the secondary interest involved?
What is the scope of the relationship(s) of the individual being assessed, with the party or parties associated with the secondary interest?
Is the circumstance one involving sole discretion of the particular individual being assessed?
What is the value (either direct financial or “in-kind”) to the AASLD of the interest that could be affected by a conflict?
What is the scope of the consequence to the AASLD resulting from public disclosure of the conflict?

Questions 1, 2 and 3 evaluate the potential that a conflict could impair impartial decision-making, while questions 4 and 5 assess the degree of harm that could result from an impairment.

After review and discussion of an individual’s potential conflict(s) of interest and its (their) severity, the Ethics Committee will, by voting according to this Code, determine that a conflict exists and that the severity of the conflict rises to the point that management of the conflict requires more than simple disclosure. Based on the criteria outlined above, the Ethics Committee, by a two-thirds majority vote, will request recusal, withdrawal of consideration for a nominated position, AASLD-independent review, divestiture or any other appropriate management of the conflict. The recommendation of the Ethics Committee will be forwarded to the Governing Board for its approval and enforcement. If the matter involves an individual who is a Member of the Governing Board, that Member will recuse themselves from any deliberations involving that matter.

Appendix D

AASLD members may complete their disclosure of potential conflicts of interest online by updating their member profile here: AASLD Conflict of Interest Disclosure Form.

Footnotes

Conflict of interest in medical research, education and practices.
Guyatt G, Aki EA, Hirsh J, et al. The vexing problem of guidelines and conflict of interest: a potential solution: Ann Intern Med 2010;152:738-41
Modified from Council of Medical Specialty Societies, 230 E Ohio St. Suite 400 | Chicago, IL 60611