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Good practice guidelines on the recruitment and involvement of public members on Trial Steering Committees (TSCs) / Study Steering Committees (SSCs)

Contents

This guidance is for use by researchers, public members and TSC/SSC chairs and members. It provides definitions of research oversight groups including TSC/SSCs, describes the public member role and expectations and outlines good practice for recruitment and involvement of public members on TSC/SSCs.

Definition of a public member

The public members of TSCs/SSCs are ideally people who have lived experience of the subject being researched, or who have other relevant experience that will add value to the conduct of the study. This may include people who have experience of a particular condition or service as a patient or a carer, or members of the public who are affected by the issues being researched. Public members should not be patients of a clinician on the research team or TSC.

Research Oversight Committees or Groups

For clarity, this guidance is for research steering committees. There are three main types of research oversight committees or groups and steering committees are just one of them. The groups are defined below and further details are available in NIHR's Research Governance Guidelines. For a diagram of the oversight committees and reporting routes  see the diagram showing the Oversight Committee Structure. 

Please note: Not all studies report via a Clinical Trials Unit (CTU). CTUs are specialist units which have been set up with a specific purpose to design, conduct, analyse and publish clinical trials and other well-designed studies. The Trial Management Group may liaise directly with both the Trial Steering Committee (TSC) and the Data Monitoring Committee. Not all studies which are required to have a steering committee will be clinical trials. Hence there is the term Study Steering Committee (SSC) which refers to studies with different designing to a trial but require an oversight committee.

Trial Steering Committees (TSCs) / Study Steering Committees (SSCs)

A Trial or Study Steering Committee (TSC/SSC) has a supervisory and advisory role. It has overall oversight of the trial or research study and provides advice to the study/trial management group, funder and sponsor of the research.

Membership of the TSC/SSC includes both independent* members and members of the research team.

*Independence is defined as follows:

  • 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, 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 or honorary contract with said institution).
  • Not related to any of the applicants or project team members.
  • No other perceived conflicts of interest. 
  • For the Chair only; not an applicant on a rival proposal.
  • It is recognised that independence status may change during the duration of the trial.

The TSC/SSC consider the study from the perspective of the participants, the public affected by the issues being researched, research team, the funder and the sponsor.

Roles of the TSC include:

  • To monitor the progress of the trial
  • To monitor adherence to the protocol
  • To consider recommendations from the Data Monitoring Committee (DMC)
  • To make recommendations to the Trial/Study Management Group (T/SMG).
  • To make recommendations to the trial Sponsor
  • To consider new information as it becomes available.

Public role: There is usually a public member on a TSC/SSC and we recommend at least two public members.

It is desirable that the public members should not have been involved in designing the trial or applying for funding. However, it is essential that the independent members are not involved in the routine management of the trial or other study committees/groups.

Trial Management Group / Study Management Group (TMG/SMG)

The Trial or Study Management Group (TMG/SMG) is responsible for the set-up, routine running and analysis of the research and is usually made up of the research team.

The TMG/SMG meet regularly, typically monthly, and review the ongoing progress and conduct of the trial including:

  • Progress of study and site opening
  • Recruitment rate (actual versus predicted)
  • Site issues
  • Data quality and return rate
  • Protocol amendments
  • General research study issues

Public role: The SMG/TMG may have a public member who is a member of the research team and has research management responsibilities. They may also have been a public co-applicant on the research funding application.

There may be other members of the public involved in the undertaking of the research in advisory or research activity role.

Data Monitoring Committee (DMC)

The Data Monitoring Committee (DMC) is responsible for safeguarding the interests of study participants and for assessing both, how safe and how effective the treatments/therapies being studied are. The DMC also review overall progress and conduct of the trial. Not all studies have DMCs. They are most common in clinical trials.

The members of the DMC are independent and not involved in the study in any other way. Whilst the trial is running, the DMC may be the only committee that sees the study data. They will then report back on this to the TSC/SSC.

Public role: There may be a public member on a DMC who considers the safety of study participants.

Public Membership on TSC/SSCs

Having a public member on a TSC/SSC can provide a unique stakeholder perspective. Using their personal experience they could contribute by:

  • considering the perspective of a potential study participant assisting with recruitment and retention plans
  • providing a fresh ‘critical friend’ perspective on the feasibility (practicalities and acceptability) of study design and
  • offering advice on the planned Patient and Public Involvement (PPI) in the study including adherence to protocol and milestones.

The role of the public TSC/SSC member is explained further in the role description. View our Public TSC / SSC Member Role Description document.

There may be occasions where a public member is not appropriate such as studies focusing on health professionals as the end user. Careful thought should be given to what perspective will be gained through public membership.

UK Standards for Public Involvement

The approach of the TSC/SSC to public involvement should be in keeping with the National Standards for Public Involvement. An evaluation of the involvement against the standards is recommended.

National Standards for Public Involvement as applied to TSC/SSC activity

Standard 1: Inclusive Opportunities - The public role is accessible and the opportunity reaches people and groups who have lived experiences of the service / condition or are affected by the issues being researched.

Standard 2: Working Together - The TSC/SSC work together in a way that values all contributions and that builds and sustains mutually respectful and productive relationships.

Standard 3: Support & Learning - The TSC/SSC and research team offer and promote support and learning that builds confidence and skills for public involvement in research. Specifically, the study and research or medical terminology should be explained. Public members should also be directed to appropriate learning resources.

Standard 4: Communications - The TSC/SSC and research team use plain language for timely, accessible, two way and targeted communications, as part of involvement plans and activities.

Standard 5: Impact - To drive improvement, the TSC/SSC and research team should aim to capture and share the difference that public involvement makes to research. For suggested tools, see further resources.

Standard 6: Governance - By involving the public on TSCs/SSCs the public are involved in governance and leadership with the aim that the decisions made promote and protect the interests of the people who have lived experiences of the service / condition or are affected by the issues being researched.

Good practice for the recruitment of TSC/SSC public members

  • We recommend routinely recruiting two public members to provide more than one perspective and for peer support / development.
  • Examples of advertising opportunities include relevant charities, community groups, social media and People in Research website. It is also worth seeking advice from your local Research Design Service (RDS) about local public involvement networks.
  • Recruitment should be an open process as an inclusive opportunity. This could safeguard against the overuse of known public members and conflicts of interest. Whilst there are no limits to the number of oversight committees an individual can sit on including a wider range of public members will provide different viewpoints and reduce the potential for conflicts of interest and ‘tunnel vision’.
  • Developing and using a role description as part of the recruitment process helps to clarify the public member role expectations and to recruit the right people.
  • The monitoring and oversight role of the TSC/SSC and the complexity and variety of the issues commonly raised means that it may be desirable to recruit an experienced public member. One who has been involved in research study conduct and has an understanding of the research lifecycle. However, a less experienced public member could be recruited with appropriate support and development and with the mentoring of an experienced public member.

Good practice for committee meeting involvement

The research team and TSC/SSC Chair have a duty of care to the public member. Mechanisms of support should be in place.

Prior to the first meeting

  • Ensure the public member is clear on their role and the role of the TSC/SSC.
  • Ensure that the access and support needs of the public member are known and accounted for. View and download the Access and Communication Meeting Requirements form (Word Document).
  • Agree any reward or payments including expenses, ensuring that reimbursement processes are shared. The National Institute for Health Research (NIHR) provide guidance on payments and rewards including an advice on tax and for those in receipt of benefits.
  • Discuss possible and acceptable methods of communication and practicalities such as meeting timings, venues, paper circulation with advice on which sections to focus on, methods of feedback etc.
  • Ensure that the public member has a named main contact for all TSC/SSC arrangements and to manage the expectations of their role.
  • Although formal training is challenging to provide for individual public members, do direct them to learning and development resources (for example see the Learning for Involvement website). It is equally important to take time to explain the study and any research or medical terminology in plain English.
  • Consider providing a mentor to support the public member.
  • If using technology such as Skype, Hangouts or teleconferences provide a full explanation of the process and ensure the public member has support as well as access.

First meeting

  • The first few meetings are vital to relationship building. Try to make the first meeting face-to-face so that members have a chance to meet each other. This can be costly but if budgeted for it will facilitate effective future working relationships.
  • Prior to the first meeting take time to get know your public member by an informal pre-meet or lunch for example. Building a personal relationship with the public member will increase their confidence and hence ability to contribute.
  • Make sure the public member is well briefed on the role and membership of the TSC/SSC and its relationship with other study groups. If necessary, give a Plain English explanation of each member’s professional role e.g. health economist, oncologist etc. This is likely to benefit all members.

During meetings

  • Meetings may be face-to-face, via tele or video conferencing so ensure the public member is supported to contribute.
  • Good chairing skills which facilitate participation are key:
    • inviting the member to voice their opinion or raise questions (particularly important if meeting via tele/video conference)
    • to recognise when members look confused and respond
    • to notice body language
    • to allow time for all to speak
  • Although public members are equal participants throughout the meeting, the committee may wish to consider having a specific PPI item on the agenda to facilitate participation.
  • Check that your public member understands the issues raised. Explain complex issues and technical language.

After meetings

Accountability and reporting

The research team are usually responsible for the recruitment of a public member to the SSC/TSC. A nominated research team member should act as the point of contact for the recruitment of the public member and ongoing relationship.

Any issues the public member wishes to raise should be initially with the Chair of the TSC/SSC.

Further resources

Payments

Tools for reporting and evaluating PPI

PPI learning and development

Plain English

Acknowledgements

Some content is attributed to:

  • Keele Clinical Trials Unit’s ‘Trial Steering Committee (TSC) Patient and Public Involvement and Engagement (PPIE) member- Remit & role description’
  • Keele University’s ‘Sitting on a Research Steering Group, Research User Group Guide’

Guidance development group members

Heidi Surridge (lead), Doreen Tembo, Eleni Chambers, Amanda Roberts.

With special thanks to the following for reviewing later drafts: Steven Blackburn, Andy Gibson, Martin Lodemore, Richard Stephens, Jennifer Cook, Katie Porter and Silvia Bortoli