1. News from the Forum
1.1 Skills for Monitoring Non-Commercial Clinical Trials
The R&D Forum with the Association of Clinical Research Professionals (ACRP) run a training course for monitoring clinical trials of medicinal products in the non-commercial sector. The following courses are opened to bookings – Preston (6-7 October 2009) and Bristol (28-29 October 2009).
This two-day course provides an introduction to the skills required for monitoring of clinical research trials of medicinal products in the UK non-commercial sector. The course is designed for all staff involved in monitoring, or supervising monitoring of clinical research e.g. R&D Managers, research governance staff, study coordinators, and investigator site staff. More details can be found at http://www.rdforum.nhs.uk/events.htm
1.2 NHS R&D Forum Annual Conference Slides
Slides of the presentations given at the Forum's Annual Conference on 12 and 13 May 2009 are now available at: http://www.rdforum.nhs.uk/080.asp
2. DH/ NIHR Update
2.1 Letter to NHS Chief Execs re research
A letter has been sent to NHS Trust Chief Executives from Professor Dame Sally Davies drawing their attention to recent policy statements and operational requirements regarding research in the NHS. She reminds CEOs that the NHS is committed ‘to the promotion and conduct of research’ (NHS Constitution), and ‘that the national ambition is to double the number of patients taking part in clinical trials’ (NHS Operating Framework). Trusts will be asked ‘to set goals for research in their organisation’, ‘to publish the average time it takes for the local research approval process to be completed’ and ‘to ensure that they use the NIHR CSP system and that they do not develop unnecessary additional activities or bureaucracies locally’.
The letter can be found at http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_102101
2.2 The Office for Life Sciences (OLS) BluePrint
The Office for Life Sciences (OLS), led by Lord Drayson, is proposing an "Innovation Pass", which will make it easier for companies to get their products to market, especially those for illnesses that affect only a small number of people. The OLS is a joint DH and Dept of Business Skills & Innovation (BIS) initiative dedicated to improving the operating environment for the pharmaceutical, medical biotech and medical devices sectors. Their Blueprint sets out to transform the UK environment for life sciences companies and ensure faster patient access to cutting-edge medicines and technologies. Details of the actions to be taken by Government to ensure this crucial industry is in the best possible position to drive future growth and prosperity as well as continuing improvements in healthcare is available at http://www.dius.gov.uk/ols
2.3 Expansion in the NIHR School for Primary Care Research
Dame Sally announced the NIHR School for Primary Care Research would expand from the five founding academic university departments to eight in August 2009 under the acting Directorship of Richard Hobbs, Professor and Head of Primary Care and General Practice at the School of Medicine, University of Birmingham. http://www.nihr.ac.uk/research/Pages/programmes_primary_care_research.aspx
2.4 NIHR Master Classes in Mental Health Research 21-25 September 2009
The NIHR has commissioned a week long series of Master Classes in Mental Health Research, to be delivered between 21-25 September at the Institute of Psychiatry in London. The programme is specifically designed for postgraduate clinician researchers and will be of interest to psychiatrists occupying NIHR supported Academic Foundation Posts, Academic Clinical Fellowships, and Clinical Lectureships. 30 fully funded places are available and early application is advised. Further details and registration
2.5 NIHR School for Social Care Research consultation on commissioning research
The NIHR School for Social Care Research (NIHR SSCR) undertakes and commissions research to improve adult social care practice in England. The SSCR is seeking contributions to develop the research agenda, its topics, methods and processes, which in turn may lead to research that makes a positive impact to care and support, and thereby to individual lives.
The SSCR want to hear your thoughts, views and ideas on any of the following:
- Topics in adult social care that need further research
- Specific research questions
- The methods needed to answer them
- The ways that research findings can be translated into a form that can aid the development of practice.
NIHR SSCR consultation on commissioning research
2.6 Publication of the NIHR Progress Report 2008/09 – Delivering Health Research
The National Institute for Health Research (NIHR) Progress Report for 2008/09 was launched at the NIHR West Midlands 10 July 2009 Regional Conference. The report gives an account of the NIHR’s achievements in developing the infrastructure, programmes and the systems to facilitate health research in England and re-states the government's commitment to making the NHS in England a centre of excellence for health research. The report can be found at http://www.nihr.ac.uk/files/pdfs/NIHR%20Health%20Report%20final.pdf
2.7 Dismantling the Barriers to Clinical Research Workshop
On 30th April 2009, NIHR hosted a workshop on Dismantling the Barriers to Clinical Research. The purpose of this Workshop was described as: to identify the specific barriers to clinical research in England and the work that needs to be done now, and by whom, to dismantle them. A report of the workshop has been published, including the action points and next steps that will be taken. An Implementation Plan will be available on the NIHR website before the end of July. To download the report go to http://www.nihr.ac.uk/events/Pages/Dismantling_Barriers.aspx.
2.8 Current NIHR calls for proposals
NIHR Programme Grants for Applied Research - Programme Development Grants
The NIHR Programme Grants for Applied Research invite proposals for Competition 2 of the NIHR Programme Development Grants. Programme Development Grants provide funding of between £20k and £100k over a period of 6-18 months to enable research teams to undertake the preparatory work that will position them to submit a successful Programme Grant application in a subsequent funding competition. The deadline for applications is Monday 30 November 2009. Programme Development Grants call for proposals
The NIHR Health Technology Assessment (HTA) programme
The NIHR Health Technology Assessment (HTA) programme invites proposals on various topics regarding Primary Research and Evidence Synthesis. The closing date for applications is 2 October 2009. HTA – standard call for proposals
The NIHR School for Social Care Research (NIHR SSCR
The NIHR School for Social Care Research (NIHR SSCR) invites outline proposals for research projects within its five core research programme areas. The NIHR SSCR is seeking proposals with a clear element of originality, which demonstrate relevance – and potential improvements - for adult social care practice in England. The closing date for applications is 25 August 2009. SSCR call for proposals
NIHR Capital Investment 2009/10 call for bids
The NIHR invites bids from research-active NHS organisations for capital funding in 2009/10, to ensure that the NHS has the capital resources it needs to deliver high quality research across all NIHR programmes, and that all NIHR funding streams are fully funded. Bids may include dedicated research facilities or equipment, trial pharmacies, refurbishments, or a share of capital assets commissioned for joint use (along side patient care and / or training). The closing date for applications is 5.00 pm on Monday 10 August 2009. NIHR Capital Investment 2009/10 call for bids
Health Innovation Challenge Fund - Advancing Genetic Discoveries
The Health Innovation Challenge Fund (HICF) - a partnership between DH and the Wellcome Trust – is allocating £20 million towards proposals that take into practical healthcare application the understanding of genetic variation on disease. UK Institutions, eligible companies, NHS Trusts and equivalent UK authorities are invited to submit a preliminary application including, diagnostic genetics; pharmacogenetics tests; point-of-care test and treatment technologies; medical devices for hospital-based or out-patient use; technologies to facilitate home-based disease monitoring, management or treatment and health informatics. Awards will normally be for a period of up to 3 years at which point development activity should be close to market introduction and adoption by healthcare providers and the NHS.
The closing date for preliminary applications is Friday 2 October 2009. Full applications, if invited, will be required by 14 December 2009 Health Innovation Challenge Fund - Advancing Genetic Discoveries
NIHR SDO on research utilisation and knowledge mobilisation by healthcare managers
The NIHR Service Delivery and Organisation programme (SDO) invites proposals on research utilisation and knowledge mobilisation by healthcare managers. The focus of this call is on managers’ use of research, and on how research interacts with other forms of knowledge within the organisational contexts in which managers work. This relates to managers’ own decision-making and to the ways in which managers support and encourage the use of research (including the implementation of clinical research evidence) by others in the organisation. Projects may be of up to three years duration and funded to a maximum of £450,000 per project.
The closing date for outline applications is 1pm on Thursday 20 August 2009. SDO call - Research utilisation and knowledge mobilisation by healthcare managers
NIHR SDO new responsive funding workstream
The NIHR Service Delivery and Organisation programme (SDO) new responsive funding workstream invites proposals for follow-on empirical studies, evidence synthesis, and scoping reviews for future research needs. This first call is constrained to proposals for projects of up to 12 months in duration, and up to £150,000 in cost. The closing date for outline applications is 1pm on Thursday 20 August 2009. SDO call - Responsive funding work stream
3 Information from other organizations
3.1 IRAS News
IRAS was updated on 3 July 2009 to Version 2.3. This version launches the application form for the new Social Care Research Ethics Committee. Some small changes to A64 and Part C have also been made. IRAS now includes a free, online e-learning module. For more information about this update please see the Help page.
Version 7 of EudraCT has been released. Applications to MHRA can continue to be prepared in IRAS as before. Applicants are advised that the MHRA does not require a validation document and there is no requirement for the files to be zipped together.
3.2 MHRA news
Alert: Impersonation of MHRA staff
The MHRA have become aware that there have been a number of calls made to companies recently from people purporting to be members of MHRA staff, but who do not work for the Agency. Although companies are generally alert to this type of activity please remind your staff to be vigilant. These callers often quote non-geographic numbers, such as those starting with 0871, which are not utilised by the agency. If you do not recognise the name of the caller, please do not hesitate to take their number and call our Central Enquiry Point on 020 7084 2000 to check whether the caller is genuine before you give them any information.
Draft guidance for comment on the UK's arrangements under the hospital exemption scheme for advanced therapy medicinal products
This draft guidance has been developed on the proposed UK exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (“the ATMP Regulation”). The question and answer document aims to clarify the specific areas where the MHRA can provide advice. A draft advice form has been developed which will replace existing arrangements for companies who wish to seek advice on the regulatory classification of a product. This form should only be used where advice is sought on product classification. An impact assessment formed part of the formal consultation package on the proposed implementation arrangements for the Regulation which was issued in July 2008.
The new hospital exemption scheme arrangements are expected to apply from around the autumn. The MHRA would welcome comments on the documents by 18 September 2009. http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/Othermedicinesconsultations/CON051874
3.3 General Medicine Council consultation on guidance about research
The GMC is holding a consultation to seek views on two short pieces of draft supplementary guidance about research. This includes:
a) Good practice in research, which provides advice on how to comply with the principles relevant to research set out in our core guidance Good Medical Practice (2006); and
b) Consent to research, which explains how the principles in our guidance Consent: patients and doctors making decisions together (2008) apply to research.
This updates their existing guidance Research: the role and responsibility of doctors (2002).
The consultation will interest individuals and groups involved in research and the wider research community. The consultation closes on 25 September 2009. For more details please visit https://gmc.e-consultation.net/econsult/consultation_Dtl.aspx?consult_Id=69&status=2
3.4 Managing clinical trials in the UK today: Challenging times - 9th September 2009 in London
This one day event will report the major results of a 2 year EPSRC funded research project which sought to identify the key challenges for managing different models of clinical research in the UK today. It will discuss the strengths of the UK clinical research base, along with the challenges that are currently encountered when conducting commercial and non-commercial trials, from the perspectives of the different stakeholders that are involved.
To book your place please contact: Ms Jodie Lyons J.Lyons@qmul.ac.uk
3.5 House of Lords Science and Technology Committee Genomic Medicine Inquiry
In 2008 The House of Lords Science and Technology Committee appointed a sub committee, chaired by Lord Patel, to look at genomic medicine. Its report has just been published and can be found at http://www.parliament.uk/parliamentary_committees/lords_s_t_select/genomic.cfm
The Committee identifies the state of progress in genomic medical research and makes a number of recommendations for translating human genomic research into clinical practice including informatics, public engagement and its implementation and service delivery in the NHS. It also makes a recommendation for a White Paper on genomic medicine as well as a number aimed at NICE and the NIHR.
3.6 Report on use of patient records for research
The Wellcome Trust hosted a meeting of invited delegates in 2008 to discuss the use of patient records from general practice for research with the aim of working towards consensus. Three overarching principles were agreed during the meeting:
- the overriding importance of safeguarding patient confidentiality and privacy, and the need to clearly define the processes and procedures for the use of data
- the role of the GP as the patient’s advocate
- the need to ensure transparency, and to improve public awareness and understanding about the use of patient records in research.
The report has been published and is available from the Wellcome Trust website.
3.7 UK Clinical Research Collaboration newsletter
The latest Update newsletter from the UK Clinical Research Collaboration is now available at http://www.ukcrc.org/publications/updates.aspx
3.8 Clinical Research Organisation model Clinical Investigation Agreement (CRO mCIA)
The Contract Research Organisation model Clinical Investigation Agreement (CRO mCIA) is a tripartite agreement between:
- The company sponsoring commercial research involving medical device(s)
- The contract research organisation (CRO) managing the research
- The NHS organisation where the research takes place.
The CRO mCIA is based on the bipartite model Clinical Investigation Agreement (mCIA), which is for use by NHS Trusts and the medical technology industry. This tripartite agreement can be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. It is tailored to be used without modification for CRO-managed clinical investigations of medical devices in patients in hospitals throughout the UK Health Service.
Four versions of the CRO mCIA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. All the model agreements can be found at http://www.ukcrc.org/regulationgovernance/modelagreements.aspx
4. Updating your membership or R&D office contact details
Membership contact details
If you change jobs or change your email address, please make sure you update your details for your newsletter subscription. Go to http://web.rdforum.nhs.uk/manage/member_details.php
Emails to R&D offices
NHS R&D office staff are reminded to ensure that at least one person from each office is subscribed to receive R&D office emails. These are an important route of communication directly to R&D staff. You are recommended to ensure that all relevant R&D staff are subscribed. Please log in to the website http://web.rdforum.nhs.uk/manage/member_details.php and update your subscriptions to include R&D office emails. This subscription category is only open to NHS (or joint NHS-university) R&D staff across the UK and to CLRN staff.
New RDForum website allows contact details to be updated
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). The new R&D Forum website now allows you to login and update the contact details we have for your R&D Department. Each Trust or PCT has been assigned a unique username and password and this has been emailed to the contact person on the R&D Forum website.
If you have not received an email from the Forum with your login details or you encounter any difficulties, please contact the Forum.