To strengthen and assure research governance arrangements in line with the UK Policy Framework for Health and Social Care Research, the NIHR requires that research funded through its Programme Grants for Applied Research (PGfAR) Programme is overseen by a Programme Steering Committee (PSC). The remit and practical arrangements for PSCs outlined below are modelled on clinical trial steering committees as first established by the Medical Research Council and subsequently adapted by the NIHR Health Technology Assessment Programme.
Investigators are reminded that the minutes of PSC meetings must be sent to representatives of the PGfAR Programme.
Role of PSCs
The main roles of PSCs are to:
- Provide expert advice during the conduct of a programme that is independent of the Investigators.
- Supervise the overall programme, on behalf of NIHR and the Sponsor1. Day to day management of the programme is the responsibility of the Chief Investigator1 and coinvestigators and management structures, such as programme management groups, should be set up, as deemed most appropriate.
- Have a membership limited to an independent* Chair, three independent members one of whom should be a statistician and one of whom should represent the interests of patients and the public, and up to three members of the research team, including the Chief Investigator. Representatives of the PGfAR Programme and of the Sponsor must be invited to all meetings. Additional members of the research team may attend meetings at the discretion of the PSC Chair and additional independent members may also be appointed if deemed necessary. We would encourage teams to consider the diversity and representativeness of steering committee members when making nominations for members.
- Meet at least annually, and more frequently if judged necessary – as a general rule, responsibility for calling and organising meetings rests with the Chief Investigator1 but the PGfAR Programme or the Sponsor have the right to convene a meeting in exceptional circumstances. It is recommended that a first meeting is held early in the programme to allow an overview of the planned research and agree milestones. Every effort should be made to ensure that all independent members attend meetings - at least two independent members, including the Chair, must be present for a meeting to be quorate
- Monitor progress - against pre-agreed milestones (such as recruitment and follow-up rates), adherence to the agreed programme and any more detailed protocols, measures of patient safety, and any new evidence from the programme or externally. It is the responsibility of the Chief Investigator to bring all relevant information to the attention of the PSC
- Advise on proposed changes to the programme’s plans in light of new evidence or other unanticipated development
- Provide advice to the Investigators, the PGfAR Programme, the research sponsor, the host institution, and the contractor on appropriate aspects of the programme; in practical terms, this would be through reports or minutes, formally agreed by the PSC Chair following each meeting of the PSC or by direct communication from the Chair. Serious concerns or disagreements should be brought to the urgent attention to the PGfAR Programme, and to other parties as appropriate.
- Decide whether a further independent Data Monitoring Committee (DMC) is needed for any aspects of the programme, such as randomised controlled trials; if so, to liaise with the PGfAR Programme to suggest and agree membership and subsequently to receive any reports from the DMC and act on any advice
- Provide written evidence to support any requests for additional funding or time extensions, indicating that all practical steps have been taken by the investigators to achieve targets and/or that changes to the planned work are fully justified
- Encourage appropriate efforts to disseminate the programme’s findings, including through timely provision of the final report for later publication in the NIHR Journals Library.
IMPORTANT: NIHR approval must be obtained for any significant changes to the research programme even if they have been endorsed by the PSC.
Successful applicants will be asked to suggest independent PSC members. If and when a Programme Grant for Applied Research is approved for funding, the Chief Investigator will be notified whether or not these suggestions are acceptable to NIHR.
It is appropriate to approach potential members informally to ascertain their willingness and availability to serve on the PSC, while making it clear that formal appointment will be made by the NIHR.
Appointment of PSC members from outside the UK will only be agreed in exceptional circumstances.
The PGfAR Programme must be apprised of any changes to the independent membership of the PSC because new members will need to be approved by the Programme Director. Once deemed acceptable, a formal appointment letter will be issued.
Travel expenses and other justifiable costs related to membership of a PSC are reimbursable. No other payments or rewards should be given to professional members. Honoraria may be paid to lay members. All justifiable costs should be included within and met from the budget for the programme.
The Role of the Chair of PSC
The Chair of the PSC is directly answerable to the NIHR PGfAR programme, as funder. The Chair’s responsibilities include:
- Establishing clear reporting lines – to the Funder, Sponsor, etc.
- Being familiar with relevant guidance documents and with the role of the DM(E)C
- Providing an independent, experienced opinion if conflicts arise between the needs of the research team, the funder, the sponsor, the participating organisations and/or any other agencies
- Leading the PSC to provide regular, impartial oversight of the programme, especially to identify and pre-empt problems
- Ensuring that changes to the protocol are debated and endorsed by the PSC; letters of endorsement should be made available to the programme team when requesting approval from the funder and sponsor for matters such as changes to protocol
- Being available to provide independent advice as required, not just when PSC meetings are scheduled
- Commenting on any extension requests and, where appropriate, providing a letter of recommendation to accompany such a request
- Commenting in detail (where appropriate) regarding the continuation or termination of the programme
Model terms of reference
It is NIHR policy that all research undertaken through its Programme Grants for Applied Research (PGfAR) programme should be overseen by a Programme Steering Committee (PSC) with the following terms of reference:
- To meet at least annually, with a minimum of two of the four independent members present at each meeting
- To identify and agree milestones, and to monitor and supervise the progress of the programme against these
- To consider and advise on the implications for the programme of any new evidence from both within the programme and other sources, or of any proposed changes to the programme
- If the programme includes one, consider reports from any separate independent data monitoring committee
- To provide independent advice to the investigators, the NIHR PGfAR Programme, the research sponsor, the host institution, and the contractor on appropriate aspects of the programme
- To report to the NIHR PGfAR Programme following meetings through annual progress reports to be signed off/approved by the independent Chair and in addition (if necessary) by direct communication from the independent Chair, bringing serious concerns or disagreements to the urgent attention to the PGfAR Programme, and to other parties as appropriate.
- Not part of the same institution as any of the applicants or members of the project team
- Not part of the same institution that is acting as a recruitment or investigative centre
- Not related to any of the applicants or members of the project team
- For the chair only – not an applicant on a rival proposal
- Not previously a member of the project team, for example, during a preceding Programme Development Grant award (or otherwise).