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.