ISARIC Working Groups are investigator-led and represent the constituent units of the Consortium. They generate ideas, concepts, study protocols and related documents, including applications for funding for specific projects. In the first instance, the Consortium is expected to include the following four Working Groups:
• Working Group 1: “Inter-pandemic clinical trials”
• Working Group 2: “Global data collection and collation”
• Working Group 3: “Genomics, Pathogenesis and Pharmacology”
• Working Group 4: “Changing Clinical Research paradigms for rapidly emerging public health threats”
The scope of planned activities for these four Working Groups is outlined in Appendix II. Within a Working Group, individual project teams are responsible for the delivery of these activities, including the development of specific protocols to be submitted to funding agencies. The number and topic focus of Working Groups is expected to change as the Consortium evolves. The Council or Executive Committee can propose the establishment of additional Working Groups. New Working Groups or major changes in their terms of reference have to be ratified by the Executive Committee before activities on behalf of ISARIC can commence. Working Groups can be disbanded by a majority vote (i.e. > 50%) of its members or by a majority vote (i.e. > 50% of all members) of the Council. In the latter case, Working Groups retain the right of appeal against this decision.
Composition of the Working Groups
Each of the Working Groups includes members, a Chair and Vice-Chair, a representative to the Executive Committee (who has one vote on the Council, and who may also be the Chair or Vice-Chair), and project team leads. For efficient working the anticipated size of the Working Groups will be approximately 10-20 members. The size of project teams will be at the discretion of the Working Group members.
Working Groups are composed of ISARIC research network representatives, as well as invited investigators who are not affiliated with a particular ISARIC member network. Invitations to individual investigators can be issued by the Chair of the Working Group or the Head of the Secretariat upon recommendation by the Working Group and endorsement by the Executive Committee.
Unless specified otherwise, Working Group membership will remain open and individuals will be able to become a member or leave a Working Group at any stage. If it serves the best interest of the Consortium, any member may be removed by a majority vote of the Working Group but retains the right to appeal to the Council. No investigator should be member of more than two Working Groups at any one time, and no research networks should provide more than three representatives across the four Working Groups.
All members have the freedom to carry out other research projects, and ISARIC membership does not limit any other activity outside of the Consortium.
Chair and Vice-Chair
Each Working Group has a Chair and Vice-Chair who are elected by a majority vote of the Group and accountable to the Executive Committee. The Chair leads the Working Group, organises and runs its meetings, and assigns and coordinates activities within the Group. The Vice-Chair will perform these activities in the absence of the Chair or as requested by the Chair.
The term of office for the position of Chair and Vice-Chair is for two years in the first instance and renewable once. The Chair or Vice-Chair may resign from office at any time by giving notice in writing to the Working Group and the Head of the Secretariat. If it serves the best interest of the Consortium, the Chair or Vice-Chair may be removed by a majority vote of the Working Group.
Representatives to the Executive Committee and Council
Each Working Group has a voting representative on the Executive Committee and Council who is elected by a majority vote of the Group. The representative is responsible liaises with the Working Group Chair and Vice-Chair to maintain an overview of the activities within the Group, provides regular progress reports to the Executive Committee and Council, and represents the interests of the Group at meetings of the Executive Committee and Council. The representative to the Executive Committee and Council may be the Chair or Vice-Chair of the Working Group or a project team leader.
The term of office for the position of representative to the Executive Committee and Council is for two years in the first instance. The representative may resign from office at any time by giving notice in writing to the Working Group and the Head of the Secretariat. If it serves the best interest of the Consortium, the representative may be removed by a majority vote of the Working Group.
Project team leads
Project team leads are responsible for leading individual project team activities within a Working Group. They are accountable to and appointed by the Working Group based on their specific expertise and contributions to developing individual projects and protocols.
The tenure of project team lead is determined by the project requirements and is not time-limited. Project team leads may resign at any time by giving notice in writing to the Working Group. If it serves the best interest of the Consortium, the project team lead may be removed by a majority vote of the Working Group.
Conduct of business and accountability
Each Working Group project team establishes its own rules for conduct of business and work plan (including goals, objectives, timelines, critical milestones, monitoring and evaluation plans). In the absence of a contrary provision by the Executive Committee, a majority (i.e. > 50%) of all members of each Working Group present at a Working Group meeting constitutes a quorum for the transaction of a business.
Working Groups are accountable to the Executive Committee and Council. They report to the Executive Committee and the Council through their representatives and to the rest of the Consortium through a semi-annual report. Progress of Working Group activities is monitored by the Executive Committee and the Stakeholder Advisory Board. Working Group Chairs and representatives may be invited to report directly to the Stakeholder Advisory Board.
Endorsement of Working Group outputs and outward-facing activities
Protocols, documents for public posting, and manuscripts for publication generated by a Working Group need to be ratified formally by the Executive Committee in order to qualify for official endorsement as ISARIC output. At the discretion of the Executive Council, a publishing subcommittee can be formed to review manuscripts to be submitted in the name of ISARIC, and to address authorship questions.
Any documents submitted by a Working Group for ratification will be circulated to all members of the Council for comments. The decision of whether or not to ratify a submitted document will take into consideration those comments received in timely fashion from members of the Council. It is expected that the time from submission to initial feedback by the Executive Committee will be no longer than 4-6 weeks. Only outputs ratified by the Executive Committee can be published in the name of an ISARIC Working Group or the Consortium as a whole.
Any other outward-facing activities proposed by a Working Group (e.g. scientific colloquia, workshops) need to be formally ratified by the Executive Committee in order to qualify for official endorsement as ISARIC activity.
All members are free to publish without official endorsement any documents that encompass their own data and are not in the name of ISARIC. Likewise, outward-facing activities not endorsed by the Consortium are not limited by ISARIC membership.
Authorship on Working Group publications
Group authorship is the preferred form of authorship for manuscripts submitted in the name of the Consortium, for example:
• “The Inter-pandemic Trials Working Group on behalf of ISARIC”
• “Investigators of the ISIG study/project team”, with contributions from individual ISARIC investigators and member networks acknowledged.
Ownership of samples and results remain with the individual investigators and networks.
Working Groups meet in person or via teleconference as required, but at least on a bi-monthly basis. Minutes of each meeting of the Working Groups are kept and are submitted to the Executive Committee. The Stakeholder Advisory Board can request to view these minutes if this is in the best interest of the Consortium.