Introduction The primary mission of AASLD is to be the leading organization advancing the science and practice of hepatology, thereby promoting liver health and optimal care of patients with liver and biliary tract diseases.
AASLD may promote these goals by accepting external funds such as grants, sponsorships, or gifts in support of activities designed to meet the mission statement. One of the major sources of external funds over the past several years has been industry, and this has the potential to raise concern that the membership and leaders of our organization may perceive this as a potential area of conflict of interest. The AASLD ethics committee was requested to provide a written policy document that offers guidelines for the negotiation and acceptance of external funds to support AASLD’s mission. Individuals and groups which solicit funds on behalf of AASLD should not only be familiar with these guidelines but clearly work within the boundaries that are designated by this policy statement. This document represents the first statement of its kind for AASLD and may be amended by the ethics committee subject to final approval by the AASLD Governing Board.
Background
External funds may help AASLD pursue its mission in several ways. They may be offered to AASLD as either restricted (pass-through) or unrestricted grants. Examples include:
Unrestricted Funds
- To enable AASLD to undertake initiatives to promote patient care, teaching, and research in liver diseases beyond the capability of internal funds.
- To assist in improving the quality of AASLD meetings by allowing the Association to reimburse speakers, provide honoraria, furnish amenities, and support State-of-the-Art Lectures or Single Topic Conferences (STCs).
- To assist AASLD in providing services of value to members that advance the goals of the society, such as the website, that are currently beyond the capability of internal funds.
Restricted (Pass-through) Funds
These are funds offered to AASLD by industry in the form of grants to promote training of fellows, associates, etc. These funds are unencumbered in that they are under the exclusive control of AASLD.
While external, unrestricted funds potentially allow AASLD to pursue worthwhile activities that it might otherwise have to forego, any financial relationship with an external funder, particularly those developed in conjunction with the pharmaceutical industry, may create the appearance of a potential conflict of interest for AASLD. Regardless of whether or not the perceived conflict of interest results in inappropriate professional behavior, its appearance may be damaging to AASLD’s reputation. This is particularly true when external funding is from for-profit companies such as the pharmaceutical or medical device industries (or not-for-profit entities funded largely by for-profit companies such as medical communications companies); and when the amount of external funding, particularly when derived from a single source, becomes large enough to create dependence.
Guidelines for the Acceptance of External Funds
General Policy
AASLD may accept external funds for high quality projects that:
- Are consistent with its mission for research, education, and improved patient care,
- Are particularly well suited to be conducted by AASLD,
- Meet an education need currently unmet by limitations in internal funds, and
- Are free of commercial bias.
Limits to External Funding
“Internal” funds are considered revenues from dues, meeting and course registrations, serial publications (including subscriptions and royalties from HEPATOLOGY and Liver Transplantation), sales of products and services, return on financial investments, and donations from individuals. “External” funds are revenues from all other sources including industry sponsorship. Dependence is potentially created when AASLD’s core operations become too reliant on external funding. External, restricted funds that “pass through” AASLD to other individuals and groups for the accomplishment of specific projects do not necessarily create dependence, nor do funds that are saved for future disbursement for these purposes. It is the proportion of external, unrestricted funds that are used in support of administrative costs that if too high, raise concerns about dependence. In this context, it is recommended that external funds used specifically for AASLD administrative operations and included in the operating budget not exceed that section of the budget coming from internal funding during the term of any strategic planning period (customarily 5 years).
Educational Assurances
As required by the Accreditation Council for Continuing Medical Education (ACCME), AASLD must retain ultimate control over educational content, selection of speakers, review of educational materials, selection of research for presentation, or other public activities with scientific content that are financed with external funds. Courses, workshops, or other educational presentations at the Annual or other national meetings are considered educational projects from the perspective of this policy. AASLD’s educational projects comply with ACCME guidelines to ensure its independence from the interests of external funders.
Research Awards
AASLD Determines the process for the selection of award recipients and other activities for the conduct of research awards that are supported in part or entirely by external funding.
Training Awards
In like measure, AASLD retains control over selection of candidates for advanced hepatology fellowships and nurse practitioner/physician assistant fellowship awards.
Intellectual Property
When AASLD serves as the primary entity accepting external funds for a research or educational project, it reserves the right to all intellectual properties resulting from the project. When AASLD collaborates with another entity, such as a medical communications company that seeks funds for a project on behalf of AASLD, AASLD also retains all rights to the intellectual properties resulting from the project.
Budgets
When externally funded research or educational projects require using AASLD resources at the central office, a budget for those activities is negotiated between the AASLD Executive Director or their designee in conjunction with the AASLD Executive Committee and/or Governing Board to cover the direct costs of AASLD’s participation. The final budget for each project, including any deviations from the usual overhead rate, is approved by the AASLD Executive Committee and/or Governing Board.
Projects with an Internal Selection Process
When AASLD accepts external funds for research or educational projects that involve a competitive selection process with submitted proposals, the external funder has no input in the selection criteria for which proposals will receive funding, and receives information about which proposals did receive funding only after a decision has been made.
Awards
When AASLD accepts external funds for awards that reflect acknowledgement for work already completed, awardees are selected based on criteria established by AASLD. The sponsor has no input in the selection criteria or selection of the award recipient. The sponsor cannot impose obligations on the recipient of an award.
Access to AASLD Members
Access to its members is not a condition of support from an external funder, including access through discussions by representatives of the external funder at regional or national meetings.
Disclosure of Support
AASLD discloses all sponsored activities that are partially or completely financed by external funds, including but not limited to research awards, presentations, publications, and support of policy efforts (see subsequent section of procedures for disclosure). AASLD establishes levels of recognition based upon the magnitude of support that are consistently managed and based upon predefined criteria.
Business Relationships
AASLD may establish a business relationship with an individual, group, or organization for the development of journals, books, software, or other educational products. However, acceptance of any funds that come to AASLD from these relationships are governed by these guidelines for external funding of projects. It is appropriate that recognition be given to a sponsor for production and distribution of meeting bags and program books for the Annual Meeting, but under no circumstances is it allowable to use such devices to endorse, develop, distribute, or sell products such as pharmaceuticals, medical devices, diagnostics, or other products purported to have a direct health benefit to patients.
Acknowledgements
Tasteful acknowledgement of external funders is made in AASLD’s publications, meeting materials, or reports of project results, as appropriate. These acknowledgements do not advertise any products or services of the funder. Ultimate decisions about the tastefulness and appropriateness of any acknowledgements of external funding rest with AASLD.
Advertising
AASLD journals accept advertisements for medically-related products and services. Final judgment regarding the appropriateness and acceptability of advertisements rests with the journal’s editorial staff. Advertising in any other venues is approved by the AASLD Executive Committee and/or Governing Board.
Procedures for Reviewing External Funding
All AASLD members, staff, or consultants involved in negotiations with external funders should be familiar with this policy. The initiation of the approval process should begin early in any quest for external funding ideally when a member or group of members first conceives of a project requiring external funding, or when an AASLD member or group of members is first approached by an external funder about a potential project requesting AASLD’s participation. The AASLD President approves any quest for external funding, determines the appropriate level of funding for each project, and may consult the AASLD Executive Committee if a conflict of interest issue is perceived. Should the Executive Committee have any concerns about either a real or perceived conflict of interest issue, the Executive Committee may refer the issue to the AASLD ethics committee for further review.
Procedures for Disclosure of External Funding
When external funding supports presentations or awards at The Liver Meeting®, the program for the meeting indicates the source and nature of external support. As required by ACCME, speakers must disclose whether any part of their presentation resulted from external funding and whether they have any personal financial interest in the subject matter of the presentation.