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Research Governance Guidelines

Contents

Published: 10 June 2022

Version: 3 - January 2023

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Please contact your nominees before you give us their names, to ascertain their availability and willingness to be appointed.

Trial Steering Committees and Study Steering Committees

All projects with an element of primary research are required to establish a Steering Committee. The following lists provide guidance on its role, constitution, composition, meeting requirements and primary reporting line. This information can be used as a template terms of reference.

The role of the Steering Committee

The role of the Steering Committee is to provide overall supervision for a project on behalf of the study's Sponsor and Funder and to ensure that it is conducted to the rigorous standards set out in the UK Policy Framework for Health and Social Care and the Guidelines for Good Clinical Practice.

The day-to-day management of the study is the responsibility of the Chief Investigator, and as such the Chief Investigator may wish to set up a separate Study Management Group to assist with this function.

The main features of the Steering Committee are as follows:

  • To provide advice, through its Chair, to the study's funder, sponsor, Chief Investigator, host institution, and contractor
  • To concentrate on the study's progress, adherence to the protocol, and patient safety (where appropriate), and to consider new information of relevance to the research question
  • To uphold the rights, safety and well-being of the participants: these are the most important considerations and should prevail over the interests of the research
  • To ensure appropriate ethical and other approvals are obtained in line with the project plan
  • To agree proposals for substantial protocol amendments and provide advice to the sponsor and funder regarding approvals of such amendments
  • To provide advice to the investigators on all aspects of the study

Constitution of a Steering Committee

  • The relevant NIHR Programme Director will review the nominees and appoint the Chair and members
  • Independent members must make up a minimum of 75% of the Committee membership (see definition of independence below)
  • The minimum quoracy for any Steering Committee meeting to conduct business is 67% (two thirds) of the appointed membership
  • Only appointed members will be entitled to vote (irrespective of their level of independence) and the Chair will have a casting vote
  • The Chair and members must sign and maintain a log of potential conflicts and/or interests
  • Attendance at Steering Committee meetings by non-members is at the discretion of the Chair
  • The primary Steering Committee reporting line is via the Chair to the relevant NIHR Programme Director; however, communication is likely to be between the Chair and the NIHR Research Manager who has day to day responsibility for the study.

Please note: We advise you to keep the number of members on your Steering Committee to an easily manageable number, but preferably to no more than eight members in total.

Composition of the Steering Committee

  • An Independent Chair (holding a substantive UK based appointment), the Steering Committee Chair does not need to be a study-specific content expert but needs to ensure that sufficient content expertise is available for the group to perform its oversight function effectively.
  • An independent statistician or other person with expertise in the main methods used in the study
  • At least one public member, preferably independent
  • Others with clinical or other expertise relevant to the project, such as in health economics, social care, public health etc.
  • Ideally, the Steering Committee should invite observers, including representatives of the sponsor and research network to meetings
  • Justification for proposing members based overseas should be provided when you submit nominations

Steering Committee meetings

  • Although there may be periods when more frequent meetings are necessary, the Steering Committee should meet at least annually
  • Where a Data Monitoring and Ethics Committee (DMEC) is required, Steering Committee meetings should be scheduled to follow shortly after their meetings so that reports from the DMEC can be considered if appropriate
  • Minutes of meetings should be sent to all members, the sponsor, and the funder, and be retained in the study master file

The responsibility for calling and organising Steering Committee meetings lies with the Chief Investigator, in association with the Chair.

The NIHR reserves the right to attend any meeting, therefore should be included in relevant invitations. In exceptional circumstances there may be occasions when the study Sponsor or NIHR will organise and administer these meetings.

The Role of the Chair of the Steering Committee

The Chair of the Steering Committee is directly answerable to the relevant NIHR programme, as funder. The Chair’s responsibilities include:

  • Liaising with the Chief Investigator to arrange a meeting to finalise the protocol and to set up a schedule of meetings to align with the project plan
  • Establishing clear reporting lines to the Funder, Sponsor, etc.
  • Being familiar with relevant guidance documents and with the role of the DMEC if appropriate.
  • 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 Steering Committee to provide regular, impartial oversight of the study, especially to identify and pre-empt problems
  • Ensuring that changes to the protocol are debated and endorsed by the Steering Committee; letters of endorsement should be made available to the study team when requesting approval from the funder and sponsor for matters such as changes to the protocol
  • Being available to provide independent advice as required, not just when Steering Committee meetings are scheduled
  • Commenting on any extension requests and, where appropriate, providing a letter to the funder commenting on whether the extension request is supported or otherwise by the independent members of the Committee.
  • Commenting in detail (when appropriate) regarding the continuation, extension or termination of the study.

Data Monitoring and Ethics Committee (DMEC)

The formation of a Data Monitoring and Ethics Committee (DMEC) is needed when there are particular risk factors involved in a study.

Most studies with an element of primary research are required to establish a DMEC. The following provides guidance on the role, constitution, composition and meeting requirements for a DMEC. This information can be used as a template terms of reference.

The role of the DMEC

The Data Monitoring and Ethics Committee's main role is as follows:

  • In the case of a study with blinded/masked data, the DMEC is the only body involved that may have access to the unblinded comparative data. For other study types it has oversight of any primary data collected from participants, including qualitative data
  • The role of DMEC members is to monitor these data and make recommendations to the Steering Committee on whether there are any ethical or safety reasons why the study should not continue
  • The DMEC should uphold the safety, rights and well-being of the study participants: these are paramount considerations
  • The DMEC should consider the need for any interim analysis advising the Steering Committee regarding the release of data and/or information
  • The DMEC may be asked by the Steering Committee, Study Sponsor or Study Funder to consider data emerging from other related studies
  • There are also rare occasions when the DMEC chair might be asked by the Study Funder, through the chair of the Steering Committee, to provide advice based on a confidential interim or futility analysis if serious concerns are raised about the viability of the study or if the research team are requesting significant extensions
  • Criteria should be agreed (where appropriate) relating to the point at which continuation of the study is considered futile, and in the case of a randomised trial, the DMEC would only indicate if these had been passed or not as this would limit the potential for un-blinding.

Constitution of a DMEC

  • The relevant NIHR Programme Director will review the nominees and appoint the Chair and members
  • Only appointed members will be entitled to vote and the Chair will have a casting vote
  • The minimum quoracy for a meeting to conduct business is 67% (two thirds) of appointed members
  • The Chair and members must sign and maintain a log of potential conflicts and/or interests
  • Attendance at DMEC meetings by non-members is at the discretion of the Chair
  • The primary DMEC reporting line is via the Chair to the Steering Committee.

Composition of a DMEC

  • All DMEC members are to be independent (with at least one member being UK based and/or holding a substantive UK based appointment)
  • Membership of the DMEC should be small (3- 4 members) and comprise experts in the field, e.g. a clinician with experience in the relevant area and expert statistician. Membership might, on occasion, include members of the public.

DMEC meetings

  • Responsibility for calling and organising DMEC meetings lies with the Chief Investigator, in association with the Chair of the DMEC. The study team should provide the DMEC with a comprehensive report, the content of which should be agreed in advance by the Chair of the DMEC
  • The DMEC should meet at least annually, or more often as appropriate, and meetings should be timed so that reports can be fed into the Steering Committee
  • Minutes of meetings should be sent to all members, the sponsor, the funder, and the Steering Committee, and a copy should be placed in the study master file. It should be noted that the minutes may have ‘in camera’ items redacted from some copies.

Independence

Independence (for both the Steering Committee and the Data Monitoring and Ethics Committee) is defined as follows:

  • Not part of the same institution as any of the applicants or members of the study team
  • Not part of the same institution that is acting as a recruitment or investigative centre, including Patient Identification Centres (PIC), identifying and referring patients to a recruitment or investigative centre
    (In both cases above ‘not part of the same institution’ means holding neither a substantive nor honorary contract or title with said institution)
  • Not related to any of the applicants or study team members
  • No other actual or perceived conflicts of interest
  • For the Chair only; where competing bids for the same NIHR call were head to head the chair cannot have been an applicant on one of the competing applications

It is recognised that independence status of individual members of the above committees may change during the duration of the project, for example, a member may move from one institution to another, meaning that they would no longer be independent. It is the responsibility of the Chief Investigator to ensure that the funder is notified of such changes, and that the committees maintain the necessary level of experise and independence.