Statutes of the International Autoimmune Hepatitis Group (IAIHG)

Name

The group shall be known as the International Autoimmune Hepatitis (AIH) Group (hereinafter referred to as IAIHG). IAIHG is an international, non-governmental, non-profit and not registered scientific organization based on voluntary participation, providing a platform for carrying out project-based collaborations on AIH and AIH-related diseases.

Objectives

The main objective of the IAIHG is to contribute to the advancement of scientific knowledge and clinical management of the rare autoimmune liver disease AIH and related diseases by undertaking carefully defined collaborative projects, which benefit maximally from the high quality of the IAIHG’s members competency and which any independent group would be unable to achieve.

Principles

The IAIHG is international and should seek balance for geographical representation and location of meetings at all times. The IAIHG as an organization will not engage in independent projects. All projects will have to be run by their respective primary investigators (PI), who will form thematic working groups (WG) when needed to maximize synergy and collaboration whilst still maintaining the integrity of the independent projects. Management of individual authorship is agreed upon for each individual project and is the responsibility of the PI. The PI and co-authors also hold ownership of any intellectual property rights arising from IAIHG projects. Equity and recognition of contribution are important principles of the IAIHG and the number of authorship slots and positions will be proportionate to the size/importance of a contribution in terms of participation in the project and the production of a manuscript. For further details on manuscript handling principles, see separate section. Should any project need material or data sharing between the collaborating partners, this will have to be governed by independent Material or Data Sharing Agreements signed by the involved parties. The format of these agreements will be dictated by the PI or collaborator institutional requirements, not by an IAIHG directed template. For the retrospective and also the prospective collection of clinical data in registries, a data sharing agreement will have to be signed between the contributing centre and the site/PI storing and handling the data.

Tasks

The principal tasks of the IAIHG to achieve the aforementioned objectives are: i) Organize two annual meetings of 1-2 hour duration during the main European (EASL) and American (AASLD) liver conferences ii) Organize biennial 2-day meetings at one of the member institutions; iii) Identify synergies and collaborations which necessitate the establishment of WGs; iv) Facilitate contact between AIH researchers; v) Facilitate contact between AIH researchers and other stakeholders like the pharmaceutical industry, regulatory authorities, funding agencies and patient organizations; vi) Serve as a platform for grant applications within the EU and NIH funding systems; vii) Provide standards for data and material collection in AIH related research projects.

Members

Any physician and/or scientist working with AIH and related diseases can become member of the IAIHG. Membership is based on active participation in at least one on-going IAIHG project/task and attendance of at least 50% of the meetings.

Organization

The IAIHG is a voluntary, project-based network of scientists and does not have a formal organizational structure to minimize bureaucracy. The Steering Committee (SC) acts as the governing body of the IAIHG. The committee has seven (7) members and 2 Secretaries who will act as the formal head(s) of the committee. The Secretary(ies) is/are appointed by the SC among its members for periods of two (2) years with the possibility of prolongation for further two (2) years for a maximum of four (4) years. When the Secretary position rotates, the Secretary will stay on the SC as one of the two Secretaries for the subsequent two years as Past Secretary (PS) to allow for transition of practical working tasks and continuity of affairs. The SC members are elected from all active members of the IAIHG. Nominations shall have to be provided to the SC at least four (4) weeks prior to the vote. SC members are elected for a period of four (4) years with the possibility of re-election for another two (2) years. Elections are to be carried out during the meetings and members are to be informed prior to the meeting about the election. Re-election to any position within the governance structure of IAIHG is possible 4 years after exiting previous positions. The SC, in the person of the Secretary, has the responsibility to i) represent the IAIHG in all official settings; ii) establish and manage all official documents the IAIHG needs; iii) invite members to the annual meetings which are held within the framework of the European (EASL) and American (AASLD) liver congresses; iv) assist the local organizers in preparing the programme and invitations for the biennial meetings; v) coordinate efforts to provide funding from non-commercial entities; vi) provide written minutes from meetings; vii) provide access to and dissemination of study protocols, Case Report Forms/databases; viii) make sure that the IAIHG webpage is updated at all times; ix) make sure that the member list is updated at all times.

Working groups (WG) WGs are defined as a group of PIs and associated researchers working within the framework of one particular scientific area/topic. Each WG has its coordinator who reports once a year to the SC through presentation at one of the yearly meetings.

Projects

Any member of the group can propose and initiate projects to be carried out within the IAIHG after an application to and approval by the SC. The proposed project may or may not be associated with a particular WG. For each project a PI should be clearly identifiable, who carries the overall responsibility to see the project to completion.

Financing

IAIHG is not a legal entity. The IAIHG does not have any independent income. Membership is free of charge. Members carry their own costs in connection with the biannual meetings. All projects are financed by external funding. IAIHG as a group should not hold formal contractual agreements with the pharmaceutical industry. However, individual projects and PIs can, if relevant, seek industrial funding. The Secretary(ies) and SC members should disclose financial and other conflicts of interests on the IAIHG webpage. The relationship between the pharmaceutical industry and the individual members of the IAIHG needs no disclosure unless otherwise required (e.g. in conjunction with publications).

Authorship

The following rules relating to authorship, acknowledgements and sponsors for the IAIHG are based on the 1991 guidelines for the International Committee of Medical Editors (1), modified by a New England Journal of Medicine editorial and correspondence (2), and a Lancet editorial (3), and will be applied to the IAIHG publication plan.

  1. Any publication generated with or using data from the retrospective or prospective IAIHG registries other than the center´s own data or any subset of data having been collected in a project officially affiliated with the IAIHG, such as position statements, or using IAIHG as a named author or the IAIHG banner authorship MUST be submitted to the SC at least four (4) weeks prior to submission for approval of authors’ list and scientific content (full length publication). Exemption from the four (4) weeks rule can be given by the SC in cases of rapid communications, but approval of the publication will still be needed in due time determined on a case to case basis.
  2. Draft manuscripts are to be sent to named IAIHG partners or authors affiliated with an IAIHG banner for critical review. The draft is accompanied by a letter asking the partner to describe his contribution and that of his co-workers in relation to authorship; the partner can also add comments and indicate specific conditions to be considered for making the authorship list.
  3. Any contest or conflict between investigators on authorship issues should be submitted to the SC. Conflicts between investigators and the SC should be solved with the help of outside advisers agreed upon by both parties

Every article will include an ‘Acknowledgements’ section in which any financial or scientific support will be acknowledged.

Authorship rules for IAIHG papers: The author list of papers with contribution of the IAIHG (e.g. with data from registries or position papers) will contain the following names, in order:

  • The authors, who did the work, i.e. collected, generated and/or analyzed the presented results and participated in the writing of the manuscript.
  • The IAIHG banner list, including an a priori assigned number of representatives per contributing center, for clinical contributions in order of decreasing number of patients included in the center
  • Followed by ‘on behalf of the IAIHG’. The IAIHG banner list should be circulated along with the manuscript to named authors and authors listed in the banner for confirmation of authorship.

References

  1. International Committee of Medical Journal Editors. Style matters: Uniform requirements for manuscripts submitted to biomedical journals. BMJ 1991;302:338-41.
  2. Kassirer JP, Angel M. On authorship and acknowledgments. N Engl J Med 1991;325:1510-2 and 1992; 326: 1084-8 (correspondence).
  3. Oliver MF. AI, or the anonymity of authorship. Lancet 1995;345:668.

Amendments

These statutes can be subject to amendments at the instigation of any of IAIHG members. Proposed amendments shall be communicated to the SC, which has the power to introduce changes if considered necessary. Amendments will be voted at the IAIHG meetings before being actioned.

Termination

In the event the IAIHG reason of existence should end, the IAIHG network shall be terminated by giving written notice to all its members.