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NHS R&D Forum News

Title: Newsletter November 2010
Date: 30/11/2010
News:

1. News from the Forum

1.1 Sponsor Fees: Meeting the costs of undertaking activities to fulfil the role of sponsor for non-commercial NHS research

The cost of undertaking activities to fulfil the role of sponsor for non‐commercial NHS research is classified as a research cost. In September 2010, 191 NHS R&D Forum members responded to an online survey regarding fees charged.

The full report is available here: Survey Report October 2010

1.2 Two new Research & Innovation course dates

Creating Innovative NHS Organisations - 3 March 2011

Course aims:

  • To provide delegates with an overview of the innovation landscape and how organisations can capitalise on recent policy opportunities
  • To explore the relationship between innovation, quality and productivity
  • To improve understanding of the different domains of innovation and to develop processes for capturing and managing it
  • To help delegates develop a business case for innovation
  • To provide a foundation for taking steps to embed innovation in the organisation

Key knowledge and skills the attendees will take back to their organisations

  • How to use innovation to improve quality and productivity
  • How to develop a business case to support innovation
  • Understanding of the innovation pathway and the different innovation domains
  • An understanding of how to identify and manage innovation
  • How to identify and use evidence to support innovation

Course feedback

"Would definitely recommend.  Exceeded my expectations"

"A very useful day!  Has helped me enormously.  Many thanks"

"An interesting and thought provoking day"

Further details

Leading and Delivering Research and Innovation in the NHS - 4-6 April 2011

The Programme will:

  • Consider the latest policy developments around research & innovation in the NHS
  • Enable participants to develop a strategy to meet current challenges
  • Review organisation partnerships and communication strategy

A central theme will be 'embedding research and innovation into the culture of the NHS'.

Key knowledge and skills the attendees will take back to their organisations

  • How to develop a research and innovation strategy
  • Understanding of the innovation pathway and the different innovation domains
  • How to use innovation to improve quality and productivity
  • How to work with industry more effectively in both research and innovation

Course Feedback

"Absolutely brilliant.  So inspiring and insightful"

"This has been the best course I have done in a very very long time.  It far surpassed what I expected and has given me the knowledge to start implementing an innovation plan." 

"Excellent course leaders - all with very relevant and recent experience in the NHS"

"I found it incredibly useful.  Very thought provoking, lots of ideas to take back to my work place"

Further details

For further details and to book a place on either course please visit http://www.researchandinnovation.co.uk/courses.asp


1.3 NHS R&D Forum/ACRP Joint Training Courses

Course dates for Jan - April will be published on the Forum website shortly:

  • Skills for Monitoring Non-Commercial Clinical Trials
  • Preparing Sites for GCP Inspections
  • Fundamentals of Clinical Research

Please sign up for 'Watch this Page' to receive alerts when web pages are updated. www.rdforum.nhs.uk/events.htm


1.4 NHS R&D Forum Annual Conference & Exhibition

This annual event will be held 16-17 May 2011 at Bristol City Centre Marriott. Bookings will open mid-December so keep watching the website for details.

Anyone interested in exhibiting or sponsoring should contact Angie Major: angie.major@rdforum.org.uk

1.5 Forum discussion board

Please help answer questions raised on the Forum discussion board and share your experiences relating to R&D Management. This tool is provided to support the R&D Community and is great way to help others in R&D.

Primary Care R&D Approval

Our PCT receive an increasing number of non-portfolio projects where the research site is secondary care however researchers wish to collect additional data from patient records (with patient consent) or where primary care involvement is limited to blood test or additional investigations in GP practice etc.

What level of scrutiny do other Trusts give to such projects? Are they considered for full R&D approval or a 'lighter touch' where you agree to the arrangements. What level of paperwork would you require?

Log on to post your view:  http://rdforum.willco.com/forum/forum/read.php?i=85921

You do not have to be a member of the NHS R&D Forum or set up a user account to post messages. Calls for Papers and Fellowships can be added on the Discussion Board too.

2. DH/NIHR Update

2.1 NorthWest Exemplar Project - meeting summary

A meeting in snowy Manchester on 2nd December (Commercial Research in the NHS; NoW open for business) heard about the initial outcomes of the NorthWest Exemplar Project. This was presented in the context of the whole infrastructure available to facilitate good research. Presentations described the CRNs, (NIHR Clinical Research Networks) BRCs, (Biomedical Research Centres), WTCRF (Welcome Trust Clinical Research Facility) and MAHSC (Manchester Academic Health Science Centre) focussing on how all parts of the system work in collaboration and how this facilitates commercial research.

Natalie Goulden (project manager for the exemplar project) then described the background to the project, how it was progressed and some initial outcomes. By bringing together all components of the NIHR system, working closely with Industry and NHS organisations improved clinical trials performance was seen. The project demonstrated improved set-up times with 18 out of 20 studies on or ahead of recruitment trajectory and 7 having enrolled the first patient globally. 

'Capturing the Learning', a qualitative project to establish the factors resulting in successful set-up and delivery and issues presenting problems, will provide valuable knowledge to allow the lessons learned to be rolled-out across England. Look out for the full report due in the first week of January.

The exemplar project built on the existing Northwest infrastructure and culture of collaboration and communication and their success will be difficult to replicate where these elements are not present. While it may be regarded as lucky, for those driving the project, that all these things exist in the Northwest it is not impossible to build similar collaborations across communities and many have made huge progress in doing so. As Samuel Goldwyn said ' The harder I work, the luckier I get'.

2.2 Current NIHR calls for proposals

NIHR Public Health Research - Commissioned Research

The NIHR Public Health Research (PHR) programme invites outline research proposals in the following areas:

  • Community Farms, Gardens and Allotments
  • Emotional and social wellbeing of primary school children
  • Promotional mental health and wellbeing in the workplace
  • Interventions for preventing uptake of smoking in school aged children.

The closing date for applications is 8 December 2010, 1.00 pm.

Link: NIHR PHR

NIHR SDO programme - NHS Evaluations funding stream

The NIHR SDO programme invites outline proposals for promising local innovations in healthcare delivery in the NHS. Proposals require a partnership between healthcare organisations and health service researchers with expertise in evaluation, and should have all or most of the following characteristics:

  • Promising innovations in healthcare delivery that have a substantial potential benefit and could be applied more widely in the NHS.
  • Being piloted, tested or implemented in a number of healthcare organisations.
  • Involving the application of ideas or technologies introduced or transferred from other countries, sectors or settings.
  • Focused on service delivery and management issues in healthcare organisations.
  • In addition, have not already been well explored and tested through research.

The deadline for outline proposals is 16 December 2010.

Link: SDO programme - NHS Evaluations funding stream

NIHR HTA - Commissioned Research

The NIHR Health Technology Assessment (HTA) programme invites research proposals on the following topics:

Primary Research (outline proposals):

  • The whispered voice test for triage of hearing impairment
  • Whole body physiotherapy package for hypermobility
  • Physiotherapy for osteoporotic vertebral fracture
  • Cognitive Behaviour therapy in treatment-resistant schizophrenia
  • Supported self management of diabetes in people with learning disability
  • Use of mood stabilisers in borderline personality disorder

Evidence Synthesis (outline proposals)

  • A clinical decision rule to help decide on cessation of anticoagulant therapy
  • Management of thoratic aortic aneurysm

Evidence Synthesis (full proposals)

  • The cost effectiveness of genetic markers for antibiotic resistance in tuberculosis

The closing date for submissions is 13 January 2011, 1pm.

Link: HTA - Commissioned Research

3. News from other organisations

3.1 Update to IRAS

The EudraCT Annex 2 form for notification of substantial amendments and the National Offender Management Service (NOMS) form have been added to IRAS. In addition some minor changes have been made to the National Information Governance Board (NIGB) form and the REC Form submission guidance. Please see the IRAS Updates page for details: https://www.myresearchproject.org.uk/Help/Updates.aspx.

3.2 Changes to MHRA SUSAR reporting and End of Trial notification

MHRA have announced changes to reporting arrangements. SUSAR reporting must now be done electronically to the MHRA - full details of the process and e-SUSAR website can be found at: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting-SUSARsandASRs/index.htm

End of Trial notifications now only need to be submitted to the Competent Authority for international trials when the trial has ended globally. In the UK however the MHRA CTU would encourage sponsors to continue to send in a notification to them when the UK aspect of the trial has ended. This can take the form of a letter rather than the Annex 3 form if reported prior to the global end of the trial. Until an end of trial notification is received by the MHRA the annual service fee for the CTA will continue to be charged to the Sponsor.

3.3 Draft consolidated UK medicines regulations

The MHRA has published a working draft of the consolidated UK medicines regulations.  As announced previously, the MHRA is undertaking a consolidation and review of medicines legislation, to ensure that the legislative framework for medicines is comprehensive, comprehensible and fit for current purpose.  The project has two phases, consolidation and review.  This draft is published to provide an update on the progress of the consolidation. This is not a formal consultation. The MHRA will, in consultation with interested parties, be carrying out a significant amount of further work on the review phase of the project. This will be followed by a formal consultation in early 2011 on the draft consolidated legislation and proposals for substantive change. phase and to obtain informal views and comments. 

3.4 People in Research website re-launched

The new site aims to help research organisations and researchers find members of the public to get actively involved in their work by enabling them to advertise their opportunities. Members of the public can search the opportunities database to see if there is any work that they are interested in getting involved in. They can also find out more about getting involved in research and the different ways that they can become involved by viewing and listening to videos of the experiences of others.

3.5 EMA Regulatory and Procedural Guideline

The EU GCP Inspectors Working Group have produced a reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.  This reflection paper outlines the current opinion of the EU GCP Inspectors Working Group on the use of electronic data capture in clinical trials and on related inspections.

3.6 Outcome of Non-Departmental Public Body Review for the NIGB

As result of the Government's Review of Arms Length Bodies, the NIGB will be abolished as a Non-Departmental Public Body.  Subject to legislation, the statutory functions of the NIGB are to be transferred to the Care Quality Commission and its advisory role will return to the Department of Health or be given to other bodies.

3.7 Revision of the NRES SOPs

A further announcement about the revision of the NRES SOPs has been placed on the NRES website at http://www.nres.npsa.nhs.uk/news-and-publications/news/revision-of-standard-operating-procedures/

The summary of issues we propose to address in this revision of the SOPs has been updated to include further proposals emerging during the consultation period.  These include plans for the Gene Therapy Advisory Committee (GTAC) to be incorporated into NRES and to adopt the NRES SOPs, following the outcome of the Department of Health's Review of Advisory Non-Departmental Public Bodies.  The Review concluded that GTAC no longer needed to provide advice directly to Ministers and that responsibility for supporting its statutory functions as an ethics committee should be transferred to NRES.  

GTAC already operates to similar standards to those of other RECs, for example using the same application form in IRAS and RED.   To enable GTAC to adopt the NRES SOPs in full, some adaptation will be required to reflect the special provisions for trials of medicinal products for gene therapy under the Clinical Trials Regulations. 

The closing date for the consultation on the SOPs has been extended to 31 December 2010. 

3.8 New Human Tissue Authority Directions

The Human Tissue Authority issued new Directions on 12 November to consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007. Under the Human Tissue Act, the HTA has the power to issue its expected standards (or Directions) to establishments. The requirements of Directions 003/2010 are set out in the "Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment" which forms the Annex to these Directions. The Guide will be the primary reference for establishments and will be subject to periodic updates. Overall the requirements set out in the Guide are not intended to place additional requirements on licensed establishment and third parties; instead the Guide more clearly reflects guidance already issued to establishments in the course of inspections.

4. Updating your membership details

We are tidying up the membership database. Please log in to your membership record and make sure your details are up to date. Go to: http://web.rdforum.nhs.uk/manage/member_details.php

There is a password reminder if you've forgotten or mislaid it.

 

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