In4Kids

TERMS OF REFERENCE

1.       Introduction:

In4kids is the HRB Irish Network for Children’s Clinical Trials, supporting researchers in Ireland to develop and deliver a portfolio of high-quality clinical trials that will benefit children’s health. Clinical trials in children are more challenging than those in adults and the pool of eligible children for trials is often small, making collaboration crucial. Children must have at least the same rights as adults regarding access to high quality and evidence-based medications, interventions, and health care services.

In4kids is also the Irish National Hub on the c4c-S (conect4children-stichting), an innovative pan-European paediatric clinical trial network of high-quality, trial-ready sites, and multidisciplinary experts.

In4kids is building on existing national and EU investment and works closely with the Clinical Research Facility infrastructure, Children’s Health Ireland, the HRB Trial Methodology Research Network (TMRN) and the national Public and Patient Involvement (PPI) network to build a sustainable clinical trial network to support a portfolio of research for children.

The network is integrating a strong education and training programme, a young person’s advisory group providing a voice for children and a robust public engagement platform.

The Network is led by Professor Geraldine Boylan and co-lead, Professor Eleanor Molloy and an executive team of Principal investigators, supported by a dynamic operations team which includes a Network Manager and Public and Patient Involvement Officer.

In4kids Vision: Transforming child health in Ireland through innovative research and clinical trials.

In4kids Mission: To deliver high quality clinical trials for children in multiple sites across Ireland through a collaborative national network.

The main strategic objectives of In4kids are:

  • To increase the quantity and quality of paediatric clinical trials in Ireland by focusing on areas of national and global importance in child In4kids is ideally placed to achieve this goal by acting as the primary contact point for all enquiries, national and international, considering its strategic alliance with the pan-European c4c-S.
  • To maintain and strengthen existing collaborations in paediatric clinical trials nationally and internationally and increase the scale, quality, and integrity of research assets. To build on existing relationships with established networks like PEDCRIN Enpr-EMA, ECRIN and c4c-S.
  • To establish best-practice in Public & Patient Involvement. We are involving Children and Young Patients (CYP) through the forum of a Young Person’s Advisory Group (YPAG) and aligning with the European Young Persons Advisory Group Network.
  • To grow a dynamic and sustainably resourced and funded national network with international reach and impact

2.       INTERNATIONAL ADVISORY BOARD TERMS OF REFERENCE

About In4kids International Advisory Board

The International Advisory Board (IAB) will provide independent oversight of the network.

The role of the IAB is as an advisory body to support and where possible, strengthen the work of the Network. The board will provide advice and guidance to the Executive Management Committee (EMC), comprised of Principal Investigators in the Network.

Composition

  • Chair – Prof Susa Benseler,Chief Academic Officer and Head of Paediatric Health Affairs,Children’s Health Ireland
  • Prof Geraldine Boylan, in4kids Professor of Neonatal Physiology. INFANT Centre Director
  • Prof Eleanor in4kids Co-Lead. Consultant Neonatologist. Professor and Chair of Paediatrics, Trinity College Dublin.
  • Dr Fionnuala Director of Operations, RCSI Clinical Research Centre
  • Ms Beth Programme Manager and PPI Rep at Trinity College Dublin
  • Dr Damian O’Connell, CEO of the Experimental Drug Development Centre, Singapore
  • Professor Tobias Consultant Neonatologist. Department Head, The Kids Research Institute, Australia.
  • Prof Thomas University of Bergen. Director NorPedMed

Quorum: The Quorum for meetings of the International Advisory Board shall be three plus the Chair.

Term of Membership: Membership applies for the duration of the current award (2021-2026). New members may be co-opted on to the Advisory Committee as required.

Roles & Responsibilities

  • Provide oversight on the progress of the vision and mission of the In4kids Children’s Clinical Trials Network
  • Monitor and advise on the strategy of the in4kids
  • Advise on current and future policy developments that relate to the
  • Advise on future research priorities and identify opportunities for new areas of research.
  • Advise on funding opportunities at both national and international level that might support the sustainability and aims of the Network.
  • To act as ambassadors for the Network, highlighting its activities and any relevant achievements to other key stakeholders.
  • Provide advice and collaboration with developing links with similar International Research
  • Maintaining oversight and management of risk in relation to the Network including review and final approval of the risk management plan.
  • To attend in4kids I AB meetings and provide feedback in circulated minutes of the meeting for record.

Meetings

  • Meetings will take place biannually,
  • A provisional agenda will be drawn up by the Chair in consultation with the lead PI and Network Manager and circulated 2 weeks in advance of the meeting.
    • Meetings will be recorded and an agreed written record of each meeting will be taken and maintained by the Network Business Manager.
    • Minutes will be circulated for approval no later than four weeks after the meeting has taken place, and a final approved version will be shared with the IAB.
    • A copy of these minutes will be kept on
  • The final agenda and any papers will be circulated at least a week in advance of each All Committee members are welcome to suggest agenda items.
  • Where possible, decisions will be taken collectively, taking full account of the views of all
  • The Network Manager is responsible for the provision of administrative support to the meetings.
  • The role of an IAB member is unpaid, but the programme will reimburse members for all reasonable costs that they incur in fulfilling their roles on the board and which cannot be recovered from their own organisation.
  • The business conducted at the International Advisory Board meetings and actions required will be recorded and then signed off by the Chair.

Conflicts of Interest

A member of the International Advisory Body shall not participate in any IAB discussion where a situation or circumstance of personal or professional nature can compromise his/her ability to provide advice and recommendations in the interest of best performing his/her objectives and tasks.

 

3.       EXECUTIVE MANAGEMENT COMMITTEE TERMS OF REFERENCE

About in4kids EMC:

The In4kids Executive Management Committee (EMC) is constituted as a committee of the In4kids Clinical Trial Network. The In4kids EMC is made up of the Lead, co-Lead, co-applicants, PPI representative and the network manager.

Purpose

EMC is responsible for the operation of the network, meeting the deliverables and milestones of the projects and scientific and financial reporting. EMC will provide oversight to the network managed by the Operations Committee.

Membership:

The EMC will comprise of:

  • Geraldine Boylan, In4kids Lead
  • Eleanor Molloy, In4kids co-lead
  • Imelda Coyne, In4kids co-applicant
  • Mandy Daly, In4kids co-applicant & PPI representative
  • Eugene Dempsey, In4kids co-applicant
  • Declan Devane, In4kids co-applicant
  • Prof Jonathan Hourihane, In4kids co-applicant
  • Prof Paul McNally, In4kids co-applicant
  • Prof Deirdre Murray, In4kids co-applicant
  • Prof Colm O’Donnell, In4kids co-applicant
  • Prof Mark Turner, In4kids co-applicant
  • Network Manager

Roles and Responsibilities

EMC will develop and make all decisions relating to the strategy of the network. EMC will oversee the management the work package (WP) activities described in Business Plan of the network. Each member of the EMC will be responsible for one or more activities or element of strategy and will be supported by collaborators of the In4kids network.

EMC sets policy for trial operations, including adoption. EMC will review the allocation of network resources quarterly.

The membership of the EMC will commit to:

  • attending all scheduled EMC meetings
  • wholeheartedly championing the network within and outside of work areas
  • sharing all communications and information across all Network/Advisory Group members
  • making timely decisions to efficiently advance the project
  • notifying members of the EMC, as soon as practical, if any matter arises which may be deemed to affect the development of the Network

Members of the EMC will expect:

  • that each member will be provided with complete, accurate and meaningful information in a timely manner
  • to be given reasonable time to make key decisions
  • to be alerted to potential risks and issues that could impact the project, as they arise
  • open and honest discussions, without resort to any misleading assertions
  • ongoing ‘health checks’ to verify the overall status and ‘health’ of the

Meetings

All meetings will be chaired by the in4kids Lead partner.

Decisions will be made by consensus (i.e. members are satisfied with the decision even though it may not be their first choice) provided a minimum of 5 members were present for the discussion. Voting rights are restricted to Network Leads & Co-applicants.

Meeting agendas and minutes will be provided by the In4kids Network manager.

Meetings will be held biannually for 1 hour using Teams. If required, subgroup meetings will be arranged outside of these times at a time convenient to subgroup members.

 

 

4.       IN4KIDS OPERATIONS COMMITTEE

About in4kids Operations Committee (OC)

This group will be responsible for the day-to-day operations of the network,

Membership: comprises of the Network lead, co-lead, Network Manager, Trial Liaison Officer, PPI coordinator,

Meetings:

To take place biweekly and to manage the day-to-day operations which might include but not limited to the following:

  • Day to day management of the network
  • Communications and outreach
  • Event planning and management
  • Public Patient Involvement Partnerships and collaborations
  • Governance policies and practices
  • Researcher Education and Training
  • Budgets and funding
  • HR matters

 

 

5.       Public and Patient Involvement Steering Committee 

The In4kids PPI Steering Committee led by Prof Eleanor Molloy is set up to oversee the HRB funded joint work package on Public and Patient Involvement (In4kids WP3, CHI WP1). These Terms of Reference (ToR) sets out the working arrangements for the steering committee and lists important information about the purpose, structure, roles and responsibilities and meeting schedule.

 

Purpose

The Steering Committee is responsible for the operation of the Joint WP and meeting the deliverables and milestones of the projects and scientific and financial reporting. It is accountable to the In4kids EMC and CHI Director of Research & Innovation.

Term

This Terms of Reference is effective from September 2023 and will be ongoing until terminated by agreement between the parties. Membership of the committee will last two years, and will automatically rollover to a second year, unless a member notifies the chair of a desire to step down after one year.

Membership

The Steering committee will comprise of:

  • Eleanor Molloy, In4kids co-lead (Chair)
  • Imelda Coyne, In4kids co-applicant
  • Mandy Daly, In4kids co-applicant & PPI representative
  • Clodagh O’Gorman, In4kids co-applicant
  • Peter McCarthy, CHI representative
  • Michael Barrett, CHI representative
  • Orla Killeen, CHI Representative
  • Shirley Bracken, CHI representative
  • Barry Linnane, In4kids co-applicant
  • Sonia Lenehan, PPI Coordinator
  • Mary Costello, CHI Research Programme Manager
  • Sharon Rafferty PPI Coordinator
  • Cameron Keighron, PPI Representative

The steering committee may invite/co-opt additional members as needed to enhance the work of the committee or to replace outgoing members.

Responsibilities

The Steering Committee will help guide Joint PPI WP activities which are led by Prof Eleanor Molloy with the support for committee.

The steering committee will oversee the development of a strong, sustainable PPI framework for paediatric Clinical trials in Ireland. They will also oversee the setup of the young children’s advisory group (YPAG) and the parental advisory group (PAG).

 

The membership of the steering committee will commit to:

  • attending all scheduled steering committee meetings, endeavour to attend 70% of meetings in a calendar year.
  • wholeheartedly championing the network within and outside of work areas
  • sharing all communications and information across all Network/Advisory Group members
  • making timely decisions and acting to not hold up the

Members of the steering committee will expect:

  • that each member will be provided with complete, accurate and meaningful information in a timely manner
  • to be given reasonable time to make key decisions
  • to be alerted to potential risks and issues that could impact the project, as they arise
  • open and honest discussions, without resort to any misleading assertions
  • ongoing ‘health checks’ to verify the overall status and ‘health’ of the

Meetings

All meetings will be chaired by Prof Eleanor Molloy. Decisions will be made by consensus (i.e. members are satisfied with the decision even though it may not be their first choice) provided a minimum of half (50%) of committee members are present for the discussion.

Meeting agendas and minutes will be provided by one of the PPI Coordinators.

Meetings will be held every month (more or less frequently as deemed necessary for the committee) for 1 hour using Teams. If required, subgroup meetings will be arranged outside of these times at a time convenient to subgroup members.

6. Review of Terms of Reference

 These terms of reference will be reviewed every two years with input and approval from each of the committees

7.       Abbreviations:

C4c-S conect4children Stichting

ECRIN European Clinical Research Infrastructure Network,

EPTRI European Paediatric Translational Research Infrastructure

Enpr-EMA European Network of Paediatric Research at the European Medicines Agency

HRB – Health Research Board

PEDCRIN: Paediatric Clinical Research Infrastructure Network