The group shall be known as the International PSC Study Group (hereinafter referred to as IPSCSG). IPSCSG is an international, non-governmental, non-profit and not registered scientific organization based on voluntary participation by providing a platform for carrying out project based collaborations on PSC and PSC-related diseases.
The main objective of the IPSCSG is to contribute to the advancement of scientific knowledge and clinical management of the rare autoimmune liver disease primary sclerosing cholangitis (PSC) and related diseases by undertaking a small number of carefully defined collaborative projects which benefit maximally from the high quality of the IPSCSG’s members competency and which any independent group would be unable to achieve.
The IPSCSG has to this date been managed in a friendly and collegiate spirit. In many respects this has been the secret of its success. We should work to maintain this spirit of collaboration for the benefit of the field. The group is international and should seek balance for geographical representation and location of meetings at all times.
The IPSCSG as an organization will not engage in independent projects. All projects will have to be run by their respective primary investigators (PI) who form thematic working groups (WG) when needed to maximize synergy and collaboration whilst still maintaining the integrity of the independent project.
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 IPSCSG projects. Equity and recognition of contribution are important principles of the IPSCSG and the number of authorship slots and positions will be proportionate to the size 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 and no IPSCSG directed template will apply.
The principal tasks of the IPSCSG, by which the aforementioned objectives are to be achieved, are:
i) Organize two annual meetings of shorter duration during the main European (EASL) and American (AASLD) liver conferences;
ii) Organize biennial meetings over two days at one of the member institutions. These meetings should normally not be held on the same continent for more than two (2) consecutive events;
iii) Identify synergies and collaborations which necessitates the establishment of WGs;
iv) Facilitate contact between PSC researchers;
v) Facilitate contact between PSC 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 PSC related research projects.
Any physician and/or scientist working with PSC and related diseases can become member of the IPSCSG. Membership is based on active participation in at least one on-going IPSCSG project.
The IPSCSG is a voluntary, project-based network of scientists and does not have a formal organizational structure to minimize bureaucracy but a Steering committee (SC). The SC acts as the governing organ of the IPSCSG. The committee has six (6) members and a Secretary who is the formal head of the committee. The SC must contain representatives from both US and European regions at all times, and should also consider representation from other regions.
The Secretariat is appointed by the SC among its members for a period of four (4) years with the possibility of prolongation for a maximum of 2 (two) years. During rotations the previous Secretary will stay on the SC for the subsequent two years as Past Secretary (PS) to allow for transition of practical working tasks and continuity of affairs.
To allow for more redundancy the secretariat is relocated every four (4) years to a site rather than to a single person. Requirements for a site to qualify for the Secretariat are:
- longstanding (>5 years) track record of PSC research at the site;
- a minimum of two (2) senior PIs, of which at least one has served on the steering committee;
- active participation of the researchers from the center in all past three IPSCSG bienneal meetings.
The SC members are elected from all members of the IPSCSG. Nominations shall have to be provided to the SC at least four (4) weeks prior to the vote. Members are elected for a period of four (4) years with the possibility of re-election for another two (2) year’s period. Elections are to be carried out during the biennial meetings and members are to be informed prior to the meeting about the election.
Re-elections to any position within the governance structure of IPSCSG is possible four (4) years after exiting previous positions.
The SC, represented by the Secretary, has the responsibility to i) represent the IPSCSG in all official settings; ii) to establish and manage all official documents the IPSCSG 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 program 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, CRFs/databases; viii) make sure that the group’s webpages are updated at all times; ix) make sure that the member list is updated at all times, x) prepare an IPSCSG Annual report.
The SC members as of 2018 are:
- Professor Cyriel Ponsioen, Academic Medical Center Amsterdam, the Netherlands (Secretary) (since 2016)
- professor Ulrich Beuers, Academic Medical Center Amsterdam, the Netherlands (Secretary) (since 2018)
- Professor Annika Bergquist, Karolinska Institute Stockholm, Sweden (since 2018)
- Professor Chantal Housset, University of Pierre and Marie Curie, France (since 2018)
- Professor Christoph Schramm, Hamburg, Germany (since 2016)
- Professor Christopher Bowlus, University of California Davis Medical Center, USA (since 2014)
- Professor Cynthia Levy, University of Miami Miller School of Medicine Miami, Florida, USA (since 2016)
- Professor Tom Hemming Karlsen, University of Oslo, Norway (Past secretary) (since 2010)
This section of the statutes will be updated by the Secretary following each biennial meeting with elections.
Working groups (WG)
WGs are defined as a number 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 on one of the yearly meetings.
As of 2016 the IPSCSG has the following WGs:
- Natural history & Database
- Clinical trial design
- Imaging studies
- Animal and cellular models & pathophysiology
The WG structure should be updated biennially in conjunction with the biennial IPSCSG meetings.
Any member of the network can propose and initiate projects to be carried out within the IPSCSG. A project may or may not be associated with a particular WG.
For each project a PI should be clearly identifiable who has the overall responsibility to carry out the project.
The PI is responsible for providing information on the project (protocols and updates) to all members of the IPSCSG on the website and, if needed, in conjunction with the IPSCSG meetings. In case the project is associated with a WG, the WG leader should be notified on major updates, cancellation and publication of projects. WG leadership does not qualify to co-authorship unless justified by scientific contribution.
IPSCSG is not a legal entity. The IPSCSG does not have any independent income. Membership is free of charge.
Members carry their own costs in connection with the biannual meetings. At the biennial meetings the local organizer will normally carry the cost of accommodation, whereas travel costs will be covered by the individual participants. The Norwegian PSC Research Center will cover expenditures related to meeting room rental at the annual meetings organized in conjunction with the EASL (spring) and AASDL (autumn) conferences as long as the Norwegian PSC Center exists.
All projects are financed by external funding.
IPSCSG 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 and SC members should disclose financial and other conflicts of interests on the IPSCSG webpage. The relationship between the pharmaceutical industry and the individual members of the IPSCSG needs no disclosure unless otherwise required (e.g. in conjunction with publications).
The Norwegian PSC Research Center (NoPSC) voluntarily provides the IPSCSG with a biennial award (The IPSCSG Accomplishment Award) for a young and talented investigator of EURO 5.000,-. This award shall exist as long as NoPSC exists and will be given during the biennial meetings.
The following rules related to authorship, acknowledgements and sponsors for the IPSCSG are based on the 1991 guidelines for the International Committee of Medical Editors (1), modified by a New English Journal of Medicine editorial and correspondence (2), and a Lancet editorial (3), and will be applied to the IPSCSG publication plan.
1) Any publication generated with or using data from the IPSCSG (either the complete IPSCSG data or any subset of data having been collected in a project officially affiliated with the IPSCSG) or using IPSCSG as a named author or the IPSCSG banner authorship MUST be submitted to the SC at least four (4) weeks prior to submission for approval of authors’ list and scientific content prior to any submission (abstract or 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 in a case to case basis.
2) Draft manuscripts are to be sent to named IPSCSG partners or authors affiliated with an IPSCSG 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 appointed by the SC.
IPSCSG authorship rules
Two categories of articles will be generated from the IPSCSG:
General papers: these include clinical and biological data generated by a majority fraction of the group, including, but not restricted to papers deriving from the IPSCSG affiliated clinical database(s)
Local specific papers: these papers will be initiated by any member of IPSCSG and will focus on a specific question on a defined subset of samples or data from a few IPSCSG partners.
Every article will include an ‘Acknowledgements’ section in which any financial or scientific support will be acknowledged.
Authorship rules for general papers:
The author list of general 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 IPSCSG 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 + one representative of the coordination center.
– 1 to 5 senior authors, i.e. partners who led the work, participated in design and organization, and in the writing of the article.
– Followed by ‘on behalf of the IPSCSG’. The IPSCSG banner list should be circulated along with the manuscript to named authors and authors listed in the banner for confirmation of authorship.
Authorship rules for local specific papers:
These papers are initiated locally by one or several of the IPSCSG members and focus on specific issues. The publication rules are those of any scientific papers, i.e.:
– The authors are those who have actually done the work in the involved laboratories and/or the representatives of the clinical centers that specifically recruited patients for this paper.
– Their order is defined by the senior author, according to their respective contributions.
– The senior corresponding author(s) will be the first or the last author(s).
– No ‘clinical list’ and no authors who are not directly related to the work must appear.
– The International PSC study group should appear as one of the named authors before the last author(s), but without a banned with named authors.
International Committee of Medical Journal Editors. Style matters: Uniform requirements for manuscripts submitted to biomedical journals. BMJ 1991;302:338-41.
Kassirer JP, Angel M. On authorship and acknowledgments. N Engl J Med 1991;325:1510-2 and 1992; 326: 1084-8 (correspondence).
Olivir MF. Al or the anonymity of authorship. Lancet 1995;345:668.
These statutes can be subject to amendments at the instigation of any of its members. Proposed amendments shall be communicated to the SC which has the power of attorney to introduce changes if considered necessary. Amendments will be voted at the biennial IPSCSG meetings before put in action.
In the event of the IPSCSG purpose coming to an end the IPSCSG network shall be wound up by giving written notice to all its members.
Until this point the network shall continue its existence.
Disclosures Steering Committee Members (as of 2016)
Dr. Ponsioen received research grants from Takeda, advisory board fees from Takeda, Abbvie and Pliant, and speaker’s fees from Takeda, Tillotts and Abbvie.