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NHS R&D Forum News

Title: Newsletter April 2012
Date: 14/05/2012
News:

News from the NHS R&D Forum

April 2012

1. News from the Forum

1.1 Annual NHS R&D Management Forum - Prospering in the evolving NHS R&D landscape

28 & 29 May 2012 at Hilton Birmingham Metropole

Final plans are now underway for this years' R&D Forum with 400 delegates now booked to attend and an astonishing 330 for the drinks reception and dinner. There are still places available for the conference and although our 300 bedroom allocation has been used we've requested a small number of rooms to be held at the Hotel for late bookings.

You should now have received your final delegate reminder and dinner tickets by email. If you have booked and have not yet received them please contact events@blueberrybusiness.co.uk

For the full programme and the event webpage:

http://www.rdforum.nhs.uk/004c.asp?entryid=946

1.2 Forum Training Courses

Dates are being planned for the autumn courses. As soon as the dates are finalised they will be posted on the website.

1.3 News from the Interim Board

The Interim Board has met twice and has reviewed plans to modifying the management of the R&D Forum and its activities to further strengthen its ability to support people involved in R&D in the NHS as we move, yet again, into another period of significant change in the NHS. The Forum Advisory Group has given feedback on the general direction of travel and will continue to be involved as we progress this work over the summer. We will be reviewing working groups to most effectively deliver what members want to help them access professional development opportunities and guidance.

The Health Research Authority (HRA) consultation on shaping an effective national role for the HRA to provide a unified approval process and to promote proportionate standards for compliance and inspection has now closed. Look out on their website for further updates at the end on May on their website http://www.nres.nhs.uk/hra/. The Forum looks forward to opportunities to work with HRA and our members to facilitate implementation of the outputs of their work.

2. News from DH/NIHR

2.1 CSP Module version 1.4 successfully released

Version 1.4 was completed ahead of schedule on 13 April. This release included some detailed technical changes to address issues raised through the Helpdesk and identified through review of the system. The following elements will be of particular interest to users:

  • Revised R&D Forms for legacy studies can now be handled correctly in CSP Module allowing sites to be created following the manual submission of the form. Please ensure that all revised R&D forms for legacy studies are now forwarded to the CSP Unit (crncc.cspunit@nihr.ac.uk) for manual submission, instead of uploading them as documents.
  • Information in Study View about number of sites with permission and PICs with agreement should now be accurate
  • Information in Study View for new studies should now accurately determine the commercial/ non-commercial status. Any errors relating to historic data should be reported to the Helpdesk.
  • It is now possible to view the study-wide governance comments in full from the local governance tasks.
  • Downloaded pdf files will retain the correct file name
  • Links to view documents from certain tasks are fixed
  • There is an additional Governance Report in pdf format available from the local governance section of Study View that includes all the components originally specified. This will report all current governance activity and documents.
  • You can now access the current Module User Guide, Reporting User Guide and CSP Operating Manual from the Help menu of CSP Module

Further information:

http://nihr.enewsplus.co.uk/cm/public/enews/news.php?newsid=864&templateid=96&ticketid=CI2P8CZYIV&mm=55839

2.2 Update of Eligibility Criteria Implementation and Management of Jointly-Supported Studies guidance documents

The application of the DH policy document Eligibility Criteria for Clinical Research Support (Feb 11) is supported by an Eligibility Criteria Implementation Guidance Document and supporting annexes.

The new business process for determining eligibility of non-commercial studies for consideration for NIHR CRN support was implemented across all eight Networks from 02 April 2012. In order to reflect the changes in business process the guidance document and annexes have been updated (version 3, April 2012).

In addition, the guidance document 'Management of Jointly Supported Studies' has been updated to take into account the changes to the non-commercial eligibility and adoption process. Version 2 of this guidance (April 2012). Please destroy all earlier versions of these documents.

Email: joanna.knee@nihr.ac.uk

DH policy document Eligibility Criteria for Clinical Research Support (Feb 11): http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_eligibility

2.3 Information for Networks and Trusts on accepting assurances and NHS permission

Local networks and Trusts may be aware of, or involved in, a number of local initiatives to maximise the opportunity to accept assurances from others in order to minimise duplication and speed up the review of studies prior to issuing NHS permission for research. The following information may be helpful in local discussions.

  • The ability of Trusts to accept assurances from others in the set up and delivery of research studies is key to improving the overall research agenda for the UK
  • NIHR CSP relies on a single study-wide review of study-wide issues, allowing the local review to focus on local arrangements and implementation
  • The CSP Operating Manual (v5.1) makes this distinction very clear and provides a clear mechanism for a single review of study-wide issues to minimise duplication, and a single point of resolution of study-wide issues to provide consistent set up of a study across the NHS
  • Historically many Trusts have struggled with the balance between their own liability and responsibility and the assurances they feel able to accept from others
  • Feedback indicates that frequently concern about accepting assurances from the study-wide review is raised by departmental managers e.g. data protection officers
  • Feedback also indicates that study set up is swifter and more consistent where R&D staff are empowered to make pragmatic and proportionate decisions and judgements without needing every study to be reviewed by large numbers of internal staff 
  • Trusts need to empower their staff to accept standard national processes as a guarantee of high quality, low risk delivery of studies instead of relying on internal processes of variable (and potentially unknown or inexperienced) quality by individual staff using internal processes and standards

Trusts may be aware of the Mutual Recognition Alliance pilot which replicates CSP for non-CSP studies. Trusts are encouraged to consider how to adopt the principles and standards of CSP for studies not eligible for the NIHR portfolio to support the delivery of the 70 day benchmark. The 70 day benchmark currently applies to all research undertaken by Trusts with specific contracts for NIHR funding that include this as a contractual term. It should be noted that delivery against this benchmark is a matter between Trusts and DH and is not a responsibility of the NIHR CRN. However, delivery of CSP studies to the existing targets for study-wide and local review will support Trusts in achieving the benchmark.

The NIHR RSS framework includes an Operational Capability Statement that allows the Trust board to demonstrate that it is managing its R&D activity, standard templates for SOPs so Trusts can review their SOPs for consistency with national standards, a planning template to ensure appropriate senior and experienced review of studies at an early stage, and a competency framework to ensure R&D staff are appropriately trained. This activity sits alongside the CRN systems for robust feasibility to enable site selection, performance management for delivery to time and target, and coordination of network support.

The focus of Trusts should be on ensuring that they adhere to national standards and systems, that they collaborate with neighbouring Trusts to improve consistency and share learning, that senior experienced people are involved at an early stage of study review (in accordance with RSS principles), and that staff involved in study set up and delivery are appropriately trained and resourced (in accordance with the RSS competency framework). The developing Academic Health Science Networks can support this for example by ensuring appropriate deployment of R&D expertise to ensure that Providers are able to minimise duplication whilst supporting the full life cycle of research activity.

NIHR CRN CC welcomes suggestion on how to maximise the opportunities for accepting assurances from others to support further development of the Operating Manual for CSP, but they are keen to emphasise the importance of local R&D staff working on behalf of the Provider in the local review of studies to support research teams setting up studies locally to ensure delivery to time and target. Feedback on delivery of NIHR CSP may be sent to crncc.csp@nihr.ac.uk.

2.4 UK Clinical Trials Gateway update launched 

The NIHR has launched an update to the UK Clinical Trials Gateway significantly improving the information available to patients, clinicians and the public about Clinical Trials. The Gateway brings together information about current health research trials from a variety of sources which can then be searched to find out more about the trials that are taking place in the U.K. The latest update increases the amount of simple and easy to understand summary information describing each trial.

Versions of the UK Clinical Trials Gateway are also now available for the iPhone, iPad and Android devices.

Further information: UK Clinical Trials Gateway 

2.5 Calls for Proposals

The latest Calls for Proposals can be viewed at:

http://www.nihr.ac.uk/proposals/Pages/default.aspx

3. News from other organisations

3.1 Measuring the return on investment of research

The Medical Research Council (MRC) has launched a new funding initiative to identify rigorous, quantitative and qualitative methods to analyse the contribution research makes towards economic growth and wider societal impact.

Pilot and feasibility studies will be supported with the aim of providing practical policy recommendations relevant to medical research funding strategy in the UK. The studies should allow funders to better estimate the return on investment from research, and identify key factors that influence impact.

Funding will be available for up to one year initially. Awards will be made in September 2012 and progress with the work will be reviewed in May 2013.

3.2 Academy of Medical Sciences Strategy published

The 2012 -16 Strategy of the Academy of Medical Sciences has just been published and is available to download from their website.

Founded in 1998, the Academy of Medical Sciences is the independent body in the UK representing the diversity of medical science. It's vision is to improve health through research with the mission to promote medical science and its translation into benefits for society.

http://www.acmedsci.ac.uk/p29.html

3.3 European Federation of Pharmaceutical Industries and Associations (EFPIA) supports a Europe-wide approach to increase transparency of clinical data

The European Medicines Agency released guidance on increased transparency and access to information included in companies' applications for marketing authorisation. EFPIA, the voice of the research-based pharmaceutical industry, welcomes all moves to remove perceived secrecy, as long as legitimate trade secrets are protected.

Further information: http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=12805

3.4 Clinical Practice Research Datalink launches to improve health research

The Clinical Practice Research Datalink (CPRD) - a world-class e-health secure research service - that will help improve public health, develop new treatments for patients faster and attract investment in the UK's life sciences sector and economy has been launched and is hosted and managed by MHRA.

The CPRD is a key part of the government's Plan for Growth and will enable health researchers to have better access to anonymised NHS data from patients suffering with particular health conditions like cancer and diabetes. This will help researchers to better understand the causes of illness and protect public health while ensuring that the UK is the place for new health research projects. All patient data is anonymised, robustly protecting people's confidentiality. Patients can opt-out if they wish by speaking to their doctor.

This collaborative approach will be at the forefront of delivering a world-class health research service by allowing life science researchers to draw on the power of large linked anonymised data sets on an unprecedented scale. It will also provide novel and powerful ways in which clinical trials can be undertaken.

Further information: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON146890

3.5 Human Tissue Authority announces licence fee reductions for a second year running and further efficiency savings

The Human Tissue Authority (HTA) has announced its licence fee structure for 2012/13 which will see a drop in fees for the vast majority of its stakeholders across 800 establishments for a second year running -

The licence fees for 2012/13 come into force on 1 April 2012.

Further information can be accessed at:

http://www.hta.gov.uk/newsandevents/htanews.cfm/1050-Human-Tissue-Authority-announces-licence-fee-reductions-for-a-second-year-running-and-further-effici.html

3.6 UK Biobank opens to researchers

Researchers from the UK and abroad will be able to apply for access to use data from the world's largest and most detailed resource for health research in the world. UK Biobank has been funded by the Medical Research Council (MRC), the Wellcome Trust, the Department of Health, the British Heart Foundation and the Scottish and Welsh Governments. It has been designed to allow scientists to examine the complex interaction of genes, lifestyle and other environmental factors in causing a wide range of different diseases.

Further information: http://www.mrc.ac.uk/Newspublications/News/MRC008546

3.7 INVOLVE has published its' Strategy for 2012 -2015: Putting people first in research

INVOLVE's strategy for 2012 - 2015 sets out the overall direction for their work over the next few years. It will inform not only the development of their annual priorities but also the way in which they work with their partners in the interests of research for public benefit.

INVOLVE's Vision -a dynamic partnership between the public, researchers and others, to advance NHS, public health and social care research and improve the health and well being of the population:-

  • leading on public involvement across the National Institute for Health Research (NIHR)
  • building and sharing the evidence base
  • developing capacity and capability for public involvement in research
  • influencing research policy and practice

Further information can be accessed at:

http://www.invo.org.uk/wp-content/uploads/2012/04/INVOLVEStrategy2012-15.pdf

3.8 Guidance on collaboration between healthcare professionals and the pharmaceutical industry

The guidance was produced by the Ethical Standards in Health and Life Sciences Group. This Group is made up of senior representatives from the pharmaceutical industry and the healthcare community, and is supported by the major professional associations.

The guidance offers essential, highly practical "dos and don'ts" for both pharma industry and healthcare professionals to promote successful collaborative relationships.

Further information can be accessed at:

http://www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-guidance.aspx

4. Updating R&D office contact details

The NHS R&D Forum maintains the R&D office contact database on the website as a service to researchers (see Contacting R&D Offices).  We are increasingly receiving requests where the Trust R&D contact is out of date. We rely on people in post to keep the lists up to date so please check the details for your organisation now.

The R&D Forum website allows you to login and update the contact details we have for your R&D Department. If you have lost your login details or you encounter any difficulties, please contact the Forum.

 

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