International Childhood Liver Tumour Strategy Group – SIOPEL Guidelines

22nd January 2008   v. 14.0

The following document represents formal guidelines for the conduct of the business of the International Childhood Liver Tumor Strategy Group, known as SIOPEL group.These guidelines are considered valid for a period of three years, after which they willbe reviewed and, if necessary, revised.

Article I – Name

The official name of this, previously informally constituted, research group isInternational Childhood Liver Tumour Strategy Group - SIOPEL. The acronymSIOPEL is derived from the following: SIOP (Société Internationale d’OncologiePédiatrique – SIOP) Epithelial Liver (Tumours). The group is constituted of international clinical research specialists. It was founded in 1988 under the umbrella of SIOP.

Article II – Mission

The mission of the SIOPEL group is:

•         To develop and conduct comprehensive clinical research programs on childhoodliver tumours;

•         To promote basic and translational research;

•         To promote world-wide cooperation with cooperative groups of similar interest;

•         To develop models to run clinical and translational research on rare tumours, and

•         To promote scientific and educational events in this field.

The SIOPEL group is committed to run its research activity according to the ICH GCP Guidelines, the Declaration of Helsinki and applicable regulatory frameworks. It will strive to develop its research strategy in collaboration with national pediatric oncology societies.

Article III – Membership

All professionals committed to pursue the missions of the SIOPEL group and serve it in one of the possible functions listed in these guidelines may become a SIOPEL group member. In order to be eligible to SIOPEL group membership, candidates must have attended at least one SIOPEL Annual Meeting. Upon formal written request addressed to the group chairman, it will be up to the SIOPEL Council to give membership approval during its meeting following recommendation from the Core Committee (see Article IV and V).

On an annual basis the SIOPEL Council (see Article IV) will prepare/update the list:  of the SIOPEL Group members,

-        of members of each of the committees and working groups, and

-        of the applicants to be approved by the SIOPEL Strategy Group.

Members who have not attended (for three consecutive years) the SIOPEL group meetings, will be removed from the SIOPEL membership list.

Article IV – The group structure

The structure of the SIOPEL  Group consists of:

•         Group chairperson;

•         The SIOPEL Council;

•         The SIOPEL Core Committee;

•         The study/project committees;

•         The discipline panels;

•         The biomedical research committee;

•         The publication committee.

•         Nominated Continental representatives

•         Nominated National representatives

•         Individual members

The SIOPEL Council is the supreme body of the group. The group is headed by the chairperson.

 

The members of the SIOPEL Council are:

•         the SIOPEL group chairperson

•         the chairperson of the SIOPEL trials office

•         CCLG trial coordinators

•         the SIOPEL statistician

•         the international trial chair for every active trial (up to publication)

•         discipline chairpersons

•         past group chairpersons

•         members appointed ad personam by the group Council

The SIOPEL Core Committee consists of

•         The SIOPEL group chairperson

•         The chairperson of the SIOPEL trial office,

•         Previous group chairperson (for one year after the election)

•         Two members elected by the SIOPEL Council for the 3-year term.

The SIOPEL Core Committee is chaired by the SIOPEL group chairperson.

Members of the Core Committee appoint among themselves (by agreement) the group’s treasurer and secretary.

The two elected members are any professionals who are recruited by the SIOPEL group to achieve specific aims directed towards accomplishing the group’s mission.

The SIOPEL Study/project committeesare made up of the SIOPEL members in charge of a specific study or project.

The SIOPEL discipline panels /chemotherapy, surgery, radiology, pathology, biology/are made up of all the sub-specialists joining the group according to specific specialty.

The SIOPEL Biomedical Research Committeeconsists of the chair of the pathology panel, the chair of the tissue bank, and one or more other members selected within the SIOPEL Council members.

The SIOPEL Publication Committeeis made up of four to five members of the SIOPEL group, including the group statistician.

Within the SIOPEL group members, national or continental representatives may be identified in order to facilitate the relationship with a specific nation or continent. Furthermore, it is accepted that some SIOPEL group members join the group as official representatives of a specific nation or continent.

The activity of the SIOPEL group is supported by one or more trial coordinators and a secretariat.

Article V – SIOPEL Group chair/committee responsibilities

The SIOPEL group chairperson has the responsibility (either directly or through delegation):

•         to call for the SIOPEL Core Committee, Council and Group meetings;

•         to prepare the working agendas;

•         to ensure that minutes of the meeting are kept;

•         to monitor that the actions decided by the SIOPEL Core Committee and the Council are realised in the timelines agreed;

•         to prepare a yearly report of the group activities published in a newsletter;

•         to represent the group.

The SIOPEL Core Committee has the responsibility:

•         to support the group chairperson in monitoring that the actions decided by the SIOPEL Council are realised in the timelines agreed;

•         to monitor the specific project plans;

•         to review group’s priorities and make recommendations on them;

•         to monitor the editorial plan

•         to handle the day-by-day issues related to the functioning of the group;

•         to monitor the financial situation of the group

•         to recommend new applications for membership to the Group

•         to ensure the list of the SIOPEL Group members, all the other committees/working groups and of all the applicants is updated;

•         to promote respect for the present SIOPEL guidelines

The Core Committee functions as a “facilitating and action monitoring body” for the group.

The SIOPEL Council has the responsibility:

•         to support the group chairperson in realizing the aims of SIOPEL;

•         to establish and approve the overall group research strategy;

•         to endorse strategic priorities of the group;

•         to develop editorial plans and approve editorial responsibilities;

•         to review and approve each the study/project committee’s progress reports and to provide recommendations;

•         to approve strategic decisions about basic and translational research and trials;

•         to approve clinical and biological projects of the group;

•         to delegate trial/project responsibilities to appropriate SIOPEL members and committees

•         to propose and finally approve SIOPEL trial/project chairmen;

•         to decide and approve any other activity regarding the SIOPEL group (e.g. cultural event, group participation to meetings and congresses, etc.)

•         to develop a financial strategy

•         to support the Group’s activities;

•         to ensure that the SIOPEL guidelines are respected and that assigned duties are fulfilled.

The SIOPEL trial/project committees have the responsibility

o To develop, conduct, complete and publish a specific trial/project and to provide yearly trial/project reports to the SIOPEL group members.

The Biomedical Research Committee(BRC) has the responsibility to implement basic and translation research projects and to foster cooperation with other research laboratories involved in the area of childhood liver tumors. It would also provide expert opinions to the SIOPEL Council regarding possible requests of having access to the material stored in the SIOPEL Tissue Bank.

The BRC should facilitate the incorporation of- and participation in biological studies integrated into clinical trials.

The Publication Committee has the responsibility

•         to ensure that the SIOPEL Group members reporting results related to Group activity follow the SIOPEL publication guidelines (Addendum 1)

Article VI - The group offices

The key elements composing the functional structure of the SIOPEL group are at present located in:

•         The SIOPEL Trials Office – United Kingdom Children’s Cancer Study Group Data Centre, Leicester United Kingdom;

•         The SIOPEL Biostatistical Office – IBCSG Coordinating Center, Bern, Switzerland;

•         The SIOPEL Telematic Communication Office: CINECA, Casalecchio di Reno, Bologna, Italy;

•         The SIOPEL Pathology Review Centre: Department of Surgical Pathology, Institute of Pathology, Berne, Switzerland;

•         The SIOPEL Radiology Review Centre: Department of Interventional Radiology, GOS, London United Kingdom;

•         The SIOPEL Tissue Bank: Department of Pediatric Oncology, Children’s Hospital, Zürich, Switzerland;

Article VII – Election of the SIOPEL officers

The SIOPEL group chairperson is elected by secret postal ballot among the members of the SIOPEL Council and serves the group for a three year period. The position may be renewed for at the most two terms. Subsequently, upon rotation, he/she can then be re-elected. The  three year term of office starts with the pertinent spring SIOPEL committee meeting.

The SIOPEL trial/project committee Chair is identified/selected by the SIOPEL Council and he/she will serve the group until completion of that specific project and publication of the data.

  • Discipline panel chairs are selected by the discipline members (panelists) by secret postal ballot unless a uniform agreement on a candidate is reached. Their term and re-election rules are identical to those for the chairperson.
  • For the SIOPEL group chair position an expression of interest will be required and circulated to all the members of the SIOPEL Council. The SIOPEL Council members who will have expressed an interest or nominees will form the list of candidates. The election will take place by secret postal ballot (or by anelectronic system upon availability). The voting members are the members of
  • the SIOPEL Council. The expression of interest will be required after the spring SIOPEL Group meeting of the year before completion of the term of office of the existing chairperson. The list of possible chairpersons will be completed by the autumn SIOPEL Council meeting and the election, if required, will have to be completed by the end of the year prior to the end of the outgoingchairperson’s term of office.

Article VIII – SIOPEL meetings and modality of communications

•         The SIOPEL group meets at least twice a year, once in the spring and once in the fall (usually but not necessarily at the time of the SIOP Annual Meeting).

•         The SIOPEL Council, meet at least 3 times a year (including 2 meetings on the occasions of the SIOPEL group meetings)

•         The SIOPEL Core Committee holds regular monthly teleconferences in order to monitor group activities. When teleconferences apply to specific trials/projects their chairpersons or, when not available, their deputies must be co-invited. Any Council member can put forward items for discussion. Minutes of the SIOPEL Core Committee teleconferences are circulated among all Council members and people concerned.

•         “Ad hoc” special meetings of the Core Committee or SIOPEL Council may be called by the group chairperson when needed.

•         The SIOPEL group sends out a regular e-mail bulletin to update all SIOPEL members on the activities and meetings of the group.

•         The SIOPEL group will publish regularly at least once a year its activity in the SIOP Europe newsletter.

•         A dedicated internet site is maintained to communicate with the SIOPEL group members.

Article IX – Guidelines for trials conduct

Specific guidelines for trial conduct, as well principal investigators’ responsibilities are included in Addendums No. 4 and No.5. They are subject to revision according to needs.

Article X – Guidelines for publications

The SIOPEL group publication guidelines are attached (Addendum No. 1).

Article XI – Financial support

There is no single source of funding for the SIOPEL trials or Group activity.

Responsibility for funding the SIOPEL activities is with a number of different parties, all of whom are responsible for ensuring that sufficient funds are available. The recipients of the grants are responsible for their budgets but will update the SIOPEL Core Committee, as well as the Council, regularly on the financial situation.

Article XII – Final provisions

Cooperation between SIOPEL Group and its Trial Office (CCLG), as well as Biostatistical office and CINECA as provider of internet based services, is regulated by separate written agreements. Strategic agreements with other study groups will be conceived to expand the research activity of the group.

Any member of the SIOPEL Group may suggest/propose amendments to the present guidelines which must then be approved by the SIOPEL Council. The list of the members of the SIOPEL group and of the various sub-committees for approval by the SIOP Council as of January 2007 is reported in a separate Addendums No. 2 and 3.