Board
Cover Sheet
Date of meeting:
25th October 2012
Agenda item:
18 – Attachment M
Title of paper:
HRA Collaboration and Development Steering Group Membership and Terms
of Reference
1. Background / Purpose
This paper sets out the background for the HRA Collaboration and Development Steering Group and
details the proposed terms of reference and membership group.
2. Reason for submission
For information
3. Details
As per the attached report
4. Recommendations / Proposed Action
The Board is invited to note the paper for information
Name: Janet Wisely
Job title: Chief Executive
Date: 24/09/2012
HRA Collaboration and Development Steering Group
- A UK wide group to lead on projects for improvement in the research journey
Background
The Health Research Authority (HRA) is tasked to deliver a unified approval process and to promote
proportionate standards for compliance and inspection. To do this effectively it will need to shape
this UK wide and work with others to implement shared solutions. This will build directly on the
success of the National Research Ethics Service (NRES) in creating the partnerships through which it
delivered the Integrated Research Application System (IRAS). The IRAS development was supported
by a NRES hosted UK wide steering group. This enabled early awareness of issues, buy in to
principles that underpinned solutions and ensured that when IRAS was delivered others beyond
NRES were willing and able to adopt it as the application system UK wide. The IRAS was developed in
2007, launched in January 2008 and by the end of that year was the preferred application system for
IRAS partners including NRES, MHRA (medicines and devices) and R&D permissions UK wide. It was
also successfully adopted by applicants and sponsors who were also engaged in development
through the steering group.
The same model is required now to support and steer key elements of HRA business that will be
delivered through defined project teams. There will be more than one deliverable and some projects
may be led by existing groups outside of the HRA. A key role for the HRA convened steering group
will be the oversight of the current improvement activity and work of a host of different groups that
exist at the moment.
The projects sitting under the steering group will include the current work on notification of changes
to R&D, the early adoption of the IRAS number, the implementation of a universal study title and will
include other system improvements such as the proposed review of application packages on IRAS
and consideration of a single legal review by HRA. A list of the projects sitting under the steering
group will be maintained by the HRA secretariat, essentially they will be projects where
implementation is required not just by HRA but by others as well. So it would not include, for
example, the advice project for HRA, HRA shared ethical debate etc. Although the steering group will
be a platform for updating and networking there are other forums for sharing information and the
focus will be the prioritisation and identification of projects, early agreement and buy in to principles
that need to be adopted in solutions to enable UK wide implementation to improve the research
journey in the UK.
The HRA Director of Communications and HRA Engagement Manager will attend the steering group
to ensure effective support and engagement, including Patient and Public Involvement (PPI) within
the wider HRA PPI strategy that will need to be embedded within the project teams as appropriate.
HRA Collaboration and Development Steering Group
- A UK wide group to lead on projects for improvement in the research journey
Draft terms of reference
A UK wide steering group for projects that will enable the implementation of a unified approval
process and will support the HRA in promoting proportionate standards for compliance and
inspection; specifically where implementation will be required not just by the HRA but by others as
well to improve the research journey in the UK.
The HRA is establishing a collaboration and development steering group, the remit of the group will
be to look for issues to be addressed, to consider wider changes that the HRA needs to be aware of
in considering solutions, judging priorities, agreeing common principles to underpin solutions and
monitoring implementation and improvement.
The steering group will:
Advise the HRA on issues that need to be addresses and that should be considered within
HRA business planning to improve the research journey in the UK
Comment on HRA priorities to improve the research journey in the UK
Discuss and agree key principles that would need wider adoption to enable the
implementation of HRA driven solutions
Endorse the principle of common formats and solutions for the HRA to implement
Actively support and promote the work of the HRA in improving the research journey in the
UK.
For example solutions may require agreement of common formats for reports, agreement on roles
in monitoring and reviewing research, wider support for adoption of a HRA provided project number
through IRAS etc. There are many areas where solutions can be provided but can only be
implemented if others agree to key principles that underpin them.
The steering group will meet quarterly, Chaired by the HRA Chief Executive.
The list (organisations) has been agreed with the HRA Chair and Devolved Administrations. Comment
is invited on individuals and if other organisations need to be included.
HRA CE (Chair)
Janet Wisely
HRA Chair
Jonathan Montgomery
Department of Health
Simone Bayes /
Bill Davidson
Devolved Administration leads
Michael Neely
Mike Stevens
Alex Newbury
HRA Director of Operations – NRES
Joan Kirkbride
Administration of Radioactive Substances Advisory Committee (ARSAC) Steve Ebdon-Jackson
Medicines and Healthcare Products Regulatory Agency (MHRA)
Rebecca Stanbrook
National Institute for Health Research (NIHR)
Jonathan Sheffield
Lynn Kerridge
Human Fertilisation and Embryology Authority (HFEA)
Peter Thompson
Human Tissue Authority (HTA)
Chris Birkett
Association of Medical Research Charities (AMRC)
Sharmila Nebhrajani
Cancer Research UK
Emma Greenwood
Medical Research Council (MRC)
Dr Catherine Elliott
Wellcome Trust
Dr Beth Thompson
NHS R&D Director
Professor Gary Ford
Head of Library and Knowledge Services Development
Louise Goswami
Academic researcher
Peter Brocklehurst
Committee on Publication Ethics (COPE)
CE or equivalent
Universities UK (UUK)
CE or equivalent
Higher Education
Nalin Thakker
Industry
Send to trade groups asking
for member nominations –
ABPI, EMIG
Academy of Medical Sciences
CE or equivalent
Secretariat – HRA to be confirmed
Dear ****
HRA Collaboration and Development Steering Group
- A UK wide group to lead on projects for improvement in the research journey
The HRA has set out an ambitious programme of work to make it easier to do good quality research
in the UK. Some of the work the HRA will need to lead and improve, continuing to work effectively in
collaboration with key stakeholders. Other areas will require the HRA to identify issues and options
for solutions, but implementation may not sit with the HRA alone. The HRA is committed to
maintaining a UK wide approach, that recognizes and respects where differences may be required
within an overall framework, building on the work of NRES and the IRAS partnership as well as the
early momentum gained from the HRA since it was established in December 2011.
The work will be managed through HRA project teams or current established groups as agreed by
the steering group. The HRA has issued a call for expressions of interest to work on these projects.
The HRA business plans that describe the identified areas for consideration can be found on the HRA
website at add link. An introduction to the group is attached, with draft terms of references that will
be discussed and agreed at the first meeting.
I would be pleased if you could join this group, the first meeting will be in November, I would be
grateful if you could indicate availability for the possible dates on the return below and also if you
are able to join the group to nominate a deputy to attend in your absence. The steering group is
expected to meet quarterly initially, although frequency may reduce once the identified projects
move in to implementation phases.
I would be grateful if you could confirm if you would wish to join this group to add details
BW YS etc
JW
Cc DH and DA
Name
Nominated Deputy
Date / Time
Monday 5th November 11.00 – 1.00
Monday 5th November 2.00 - 4.00
Monday 12th November 2.00 – 4.00
Tuesday 13th November 2.00 – 4.00
Availability
Member or Deputy?
HRA projects meeting
16th July 2012
Attended by HRA project team, HRA project workshop delegates and invited HRA staff
Janet Wisely
David Neal
Martyn Ward
Shaun Griffin
Rebecca Stanbrook
Sue Bourne
Jon Bell
Steve Tebbutt
Janet Messer
Hazel Gage
Joan Kirkbride
Alex Newbury
HRA project structures
1st Group – Name of the Steering Group
HRA Collaboration and Development Steering Group
- A UK wide group to lead on projects for improvement in the research journey
Implementation of these projects once identified would have a separate group within the
HRA.
Pick up on the term research journey throughout HRA.
Could create a graphic to show a research timeline.
2nd Group – Groups involved
Task groups
Human Tissue Collaboration Group
IRAS Board
UK Wide Compatibility Group for NHS permissions
Radiation Working group
COPE
Equator
MHRA risk adaptation consultative committee
Devices Working Group
Stakeholder groups or communication routes
GCP Consultative Committee
Research Support Services (RSS) Champion Group
Clinical trials collaboration group
commercial Clinical Operations Group (cCOG) / Corporation for Research and Education
Networking (CREN) / industry collaboration
Various industry groups – clinical
UK Clinical Research Collaboration Regulation and Governance Forum (UKCRC R & G Forum)
(Sub group but sub group on task)
R & D Forum Research Governance Working group
GCP Consultative Committee
NRES Human Tissue Authority collaboration group
3rd Group – Other groups to be included
Would depend on what the project was as to who is missing.
Some might not want to be part of it but would want to be informed.
HFEA
NIGB
Radiation
Industry – ABHI, ABPI
Universities
Charities
Funders
Opinion leaders
Royal Colleges
Commissioning board and CRGs
NHS R & D Forum
NHS Confederation – (Research)
Editors – Journals
NIHR – Central Portfolio Management System Team
Ministry of Justice
Ministry of Defence
Foundation Trust network
CQC
Trial registry
Registered UK CRC Unit
Biobanks
First meeting of steering group could identity which are tasks and which sub/communication.
Enabling people to be able to contribute
Who is on the steering group?
HRA – Chair role
Devolved Administrations
People to recruit
Focus on ‘buy in’
Secondment or fixed term
Programme manager + support
Then have project manager / business specialist for each of the projects
Tie down or ask people to be specific on areas of interest. Link to business plan
Need for agreement from line manager – sign off on application
Flexibility
Understanding of HRA
Backfill arrangements
Travel
Add those sources we would like responses from – not just R & D and RECs
Go out separately for Programme manager. Get in place for September time. 4 days a week.
2 year contract.
For other project managers – go out at same time but advise that may approach people for
certain smaller projects. Shorter contracts.
Communications
How to get the message out?
Use of:
Consultative committee
R & D forum
HRA news
HTA Bulletin
Clinical Research Network bulletin
Devolved nations will have a list.
ABPI
Systems
Rebecca has list from compliance workshop.