News

This page contains news items relevant to NHS R&D. Don't forget to check the Home Page for other updates to the website.

New Social Care REC

A new Social Care Research Ethics Committee (SCREC) has been established and will be operational from June. The REC will operate within the framework of the National Research Ethics Service and will provide for review of certain categories of social care research. For details of projects that can seek review from the new REC please see http://www.scie.org.uk/networks/screc/index.asp. There will shortly be a specific application form for SCREC in IRAS, but in the meantime applications on the existing REC form in IRAS are now being accepted for the first meeting on 5 June. For dates of meetings, deadlines for submission and submission instructions see the link above.

7 May 2009

 

Call for registered medical practitioners and members of the public to join a GMC Reference Community

The General Medical Council (GMC) is setting up a Reference Community of 25 public members and 25 registered medical practitioners from England, Wales, Scotland and Northern Ireland. The Reference Community is designed to help inform and influence the policies and decisions of the GMC by giving personal and professional opinions on a range of topics. People from a wide variety of backgrounds, locations, and medical specialisms are needed. Since the GMC already has ways to engage with professional bodies and interest groups, members should bring only their own opinions and not represent those of a particular organisation.

There are a variety of ways to contribute, including commenting on draft publications, replying to a poll or questionnaire, and attending occasional meetings that can fit around personal or professional commitments. Ideally, each member will give around 20 to 30 hours per year, but this could vary according to individual circumstances. For more information and the application process, visit www.gmcappointments.org.uk. The deadline for applications is 18 May 2009.

7 May 2009

 

The latest information and evidence about treatment and interventions for influenza

The latest information and evidence about treatment and interventions for Influenza from the Centre for Reviews and Dissemination (CRD) and the Cochrane Collaboration can be sourced via the NIHR home page.

The CRD has collated the evidence from its internationally renowned databases focusing on the effectiveness of two drugs used to prevent and treat influenza - oseltamivir (tamiflu) and zanamivir (relenza). The International Cochrane Collaboration has reviewed and published the evidence relevant to different aspects of the prevention and treatment of influenza.

7 May 2009

NRES publications

NRES has published its review of 2008-9 and its plan for 2009-10. The documents are available from the NRES website.

7 May 2009

 

New R&D approval system for primary care in Wales

A new centralised Streamlined NHS Permissions Approach to Research – Cymru (SPARC) system was launched 1 April 2009. The new system is designed to provide a streamlined and consistent process for obtaining NHS permission for primary care research studies in Wales. It is intended that all new primary care studies requiring NHS permission from this date shall be processed through the system. More information at www.primarycarermg.wales.nhs.uk.

2 April 2009

 

Q&A on Mental Capacity Act

New guidance, in the form of Questions and Answers on the Mental Capacity Act 2005, has been published on the NRES website. The purpose of this guidance is to assist researchers with the sorts of questions that might arise in relation to research projects which fall under the Mental Capacity Act 2005.

2 April 2009

 

Update on IRAS Developments

IRAS was updated on 1 April to reflect the transfer of Site-Specific Assessment (SSA) to R&D offices for NHS sites. There is now no need to submit SSI Forms to RECs for any NHS sites. SSI Forms must be submitted as part of the R&D application for all NHS sites for all study types. For further information see the bulletins.

From 1 April 2009, the NRES on-line application form will not be available for new applications to Research Ethics Committees. REC applications not yet submitted can be completed and submitted until 1 September 2009. Researchers can continue to access locked forms in the NRES on-line form system and generate Site-Specific Information (SSI) Forms to apply for R&D approval at NHS sites for studies that are already underway. More information.

From 1 April, IRAS has been designated as the preferred method of application to the review bodies included in IRAS.

1 April 2009

 

Update on transfer of SSA to R&D - final bulletin

The NHS R&D Forum and the National Research Ethics Service (NRES) have jointly published a third bulletin with final information for R&D staff and RECs across the UK about the arrangements for Site-Specific Assessment. Download the bulletin.

The bulletin also includes separate information for applicants.

25 March 2009

 

IRAS now includes full functionality for studies involving investigational medicinal products (IMPs)

From 09 March 2009 all the data that are required to make an application to the Medicines and Healthcare products Regulatory Agency (MHRA) for authorisation of a clinical trial of an Investigational Medicinal Product (IMP) can now be completed within the Integrated Research Application System (IRAS). Previously IRAS only collected information about the IMP that was also required by other review bodies. That meant that although information could be imported and exported between IRAS and EudraCT, further information also needed to be completed in EudraCT before an application to the MHRA could be made. Now through IRAS all the information about a study can be entered in one place and researchers need only to go to EudraCT to obtain their EudraCT number. IRAS contains extensive guidance to support researchers in completing their application form. Additionally, it is now possible to generate the application form to the MHRA in the appropriate formats directly from IRAS.

9 March 2009

 

Update on transfer of SSA to R&D - second bulletin

The NHS R&D Forum and the National Research Ethics Service (NRES) have jointly published a second bulletin providing further important information for R&D staff and RECs across the UK about plans for new arrangements for Site-Specific Assessment. Download the bulletin.

6 March 2009

 

NCIN response to the consultation on access to samples and data for cancer research

The National Cancer Intelligence Network (NCRI), in collaboration with the National Cancer Intelligence Network and onCore UK, ran a consultation on access to sample and data for cancer research. A summary document detailing the range of opinions expressed, highlighting areas of general consensus, and of difference is available from the NCRI website.

23 February 2009

 

NHS R&D Forum Annual Conference open for booking

The Annual Conference will be held on 12-13 May at the Heathrow Marriott. Booking is now open. Click here for full details of the programme and to access the online booking form. Information for organisations and companies interested in sponsorship and exhibiting is also available.

6 February 2009

 

R&D reports to DH for 2009

The 2009 R&D Annual Report Guidance is now available on the DH website. Any R&D office in England in receipt of transitional funding should have received information about the annual report, if not please contact DH.

6 February 2009

Update on transfer of SSA to R&D

The NHS R&D Forum and the National Research Ethics Service (NRES) have jointly published a bulletin with important information for R&D staff and RECs across the UK about plans for new arrangements for Site-Specific Assessment. Download the bulletin.

21 January 2009

 

Publication of NHS Constitution

The NHS Constitution and Handbook have been published following public consultation. Both the Constitution and Handbook confirm the core role of research in achieving the highest standards of excellence and professionalism in the NHS. See the NHS website.

21 January 2009

 

New NIHR CRN CC website

The National Institute for Health Research Clinical Research Network Coordinating Centre website has been launched at www.crncc.nihr.ac.uk. This follows the recent change of name from UK Clinical Research Network Coordinating Centre (UKCRN CC) to reflect the coordinating centre's role as part of the NIHR.

21 January 2009

 

Pilot Voluntary Harmonisation Procedure for multinational clinical trials in Europe

In order to support the harmonisation objectives of the EU Clinical Trials Directive, proposals are being developed for a harmonised procedure for assessing multinational clinical trials by the National Competent Authorities in the EU. The procedure is being piloted with certain types of multinational clinical trials, in particular those in specific patient groups or novel drugs. Details of the proedure are available via the Clinical Trials Facilitation Group.

21 January 2009

 

Update from PIAG

The Patient Information Advisory Group (PIAG) has now been replaced by the National Information Governance Board for Health and Social Care (NIGB) for England.

Applications under Section 251 (originally Section 60 of the Health & Social Care Act 2001 - to set aside the common law duty of confidentiality where anonymised data will not suffice and consent is genuinely not practicable) in England and Wales will be considered by the new Ethics and Confidentiality Committee (ECC).

The Database Monitoring sub-Group (DMsG) will continue to operate under the ECC and review applications relating to Hospital Episode Statistics (HES) and Central Register data. The SCAG and ONS Advisory Group for Medical Research have been wound up. HES applications and applications under Section 251 are part of IRAS at www.researchproject.org.uk. For Central Register Data applications, guidance is available at The Medical Research Information Service (MRIS), which is now part of the NHS Information Centre, at www.ic.nhs.uk/mris. There are plans to integrate a revised MRIS form into IRAS.

For more details about the NIGB go to www.NIGB.nhs.uk.

21 January 2009

Access to NIHR Programmes in Wales

An agreement has now been reached with DH England on the Wales Office for R&D (WORD) contribution to the NIHR programmes managed by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC). This means that Wales-based researchers will have access to the NIHR HTA Programme (including HTA Clinical Evaluation and Trials), the NIHR Public Health Research Programme, the NIHR Health Services Research Programme, and the NIHR Service Delivery and Organisation Programme. Wales-based researchers already have access to the Efficacy and Mechanism Evaluation Programme, which is managed by the NIHR and funded by the MRC.

This agreement does not include NIHR support for CTUs, which is infrastructure-related, and therefore remains the responsibility of individual administrations.

The agreement covers the period up to the end of the financial year 2011. All funding commitments made in that period but which run beyond 2011 will be met by WORD.

21 January 2009

 

Government response to the Data Sharing Review Report

The Data Sharing Review Report, on the use of personal information in the public and private sectors, was published in July 2008. Its recommendations focused on cultural changes; changes to the legal framework, regulatory body changes, research and statistical analysis, and safeguarding and protecting personal information held in publicly-available sources. The Government’s response to the Review has now been published and sets out the government’s way forward. The sections relevant to research are covered in recommendations 15 to 17.

21 January 2009

 

Distinguishing different types of monitoring and audit

The NHS R&D Forum has produced a document which considers the different types or monitoring and audit - organisation-wide and study-specific. The resource has been produced in response to queries during the monitoring courses being run with the ACRP. Members’ feedback on the document is welcomed to allow us to refine it and make it clearer.

22 December 2008


Model Agreement for Non-Commercial Research in the Health Service

The model agreement for non-commercial research (mNCA) has been published by UKCRC. The mNCA is a template for documenting the relationship between and the responsibilities of the non-commercial sponsor(s) of a research study and the Health Service organisation where the study takes place.

The mNCA is intended for use in non-commercial research studies carried out in Scotland, Wales and Northern Ireland. It can also be used for non-NIHR portfolio studies in England. Usage of the mNCA in this way is supported by the UKCRC Partners.

The mNCA has been developed as a single agreement that ensures compliance with the applicable UK law and institutional arrangements. The clauses in the main body of the Agreement are intended to be used without modification or negotiation whilst the Schedules will need tailoring to the specific research situations.

Please email feedback on your experience of using this template agreement. This feedback will be used for inform activities to further streamline the R&G environment.

18 December 2008

 

Integrated Research Application System (IRAS) - Version 2.0

The Integrated Research Application System (IRAS) has been updated on 18 December to Version 2.0. The main enhancement in Version 2.0 is a system of electronic authorisation as an alternative to ink signature for most declarations required in IRAS. A number of other changes have been made to IRAS in response to issues reported by users and review bodies during the initial consultation-in-use phase. These are mostly related to improved functionality and guidance for users. A full summary of the changes is available on the IRAS site.

Further clarification of any of the changes in Version 2.0 may be sought from the IRAS Project Team by writing to iras@nres.npsa.nhs.uk. The Project Team continues to welcome all feedback on IRAS and will consider the need for further changes as experience with IRAS increases.

18 December 2008

 

Annual Conference 2009

The NHS R&D Forum Annual Conference 2009 will be held on 12-13 May at the Heathrow Marriott. In response to feedback, we are extending the conference to 1 1/2 days. The main conference presentations will be held on the afternoon of 12 May and parallel sessions will take place on 13 May. Our keynote speaker on 13 May is Simon Denegri, Chief Executive of the Association of Medical Research Charities. Further details will be made available in January but get the date in your diary now!

15 December 2008

 

Application process opens for Academic Health Science Centre designation

The Department of Health has begun the process to select new Academic Health Science Centres (AHSC). The NHS Next Stage Review announced the Government’s commitment to fostering AHSCs in England. The designation process will allow the Government to identify the University and NHS partnerships best able to realise the synergies between research, education and health services to deliver better patient care. An international panel chaired by Sir Ian Kennedy will offer a “peer review” of the bids for designation and will identify the organisations best placed to compete alongside leading AHSCs elsewhere in the world. Closing date for first stage applications is Friday 16 January 2009.

08 December 2008

 

Report reveals financial benefits of medical research

Medical Research: What's it worth? Estimating the economic benefits from medical research in the UK provides the first quantitative estimates of the economic benefits of public and charitably funded medical research in the UK. The work demonstrated that the health (using quality adjusted life years) and economic (GDP) gains to the UK attributable to public and charitable funding of research (and 'spillovers' to the private sector) represent a substantial rate of return. The researchers estimate that the time lag between research expenditure and eventual health benefits is around 17 years. The work raises a number of questions about how to assess, for example, the economic impact of non-disease-specific research, the impact of international research on the UK, and the time lag between research the development of treatments - finding ways to shorten the time lag between research and health impact is likely to improve the rates of return from research investment.

08 December 2008

 

Revised guidance on NHS permission

The DH has published a second edition of Research governance in health and social care: NHS permission for research and development involving NHS patients. The document clarifies what primary care trusts and NHS trusts need to consider before granting permission for research that involves NHS patients. The only substantive change in this revised version is a reference to NIHR CSP.

08 December 2008

 

REC fast track review of minimal risk studies

In response to recommendations of The Report of the Ad Hoc Advisory Group on the Operations of NHS Research Ethics Committees the National Research Ethics Service (NRES) conducted an internal review of applications to Research Ethics Committees (RECs) which indicated there were many studies that carried no risk and would be no or minimal intrusion on subjects. NRES has explored the ethical dimensions of “fast track” review by shadowing suitable applications (around 40% of applications) in four RECs. The report shows that "fast track" is both feasible and suitable where there is minimal risk and no material ethics issues. Based on these findings there will now be a pilot of fast track review in South London in early 2009. The reports can be found on the NPSA website.

08 December 2008

 

Updated Research Governance Documentation and Information Guide

The NHS R&D Forum and the Primary and Social Care Working Group are pleased to announce an updated version of the Research Governance Documentation and Information Guide, which has been developed by Gill Sarre with Trent RDSU. The guide, available as a downloadable Word document or as an online resource, provides a comprehensive summary of the current regulations, guidance and information relating to Research Governance, plus full reference details of how these documents can be accessed electronically. It will prove indispensable to all R&D managers within the NHS and to everyone planning to undertake health-related research.

24 November 2008

 

NIHR Coordinated System for gaining NHS Permission

The National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) came into effect on 18 November 2008 for NIHR Clinical Research Network Portfolio studies in England.

The Integrated Research Application System (IRAS) is the single gateway for NIHR CSP. IRAS can be accessed at https://www.myresearchproject.org.uk. Data cannot be transferred from the NRES on-line form to IRAS. Researchers wishing to apply to NIHR CSP must therefore use IRAS for their ethics and R&D applications.

All enquiries about NIHR CSP should be directed to the CSP Unit at csp@ukcrn.org.uk.

Researchers who have submitted an application for NHS Ethical Review via the NRES on-line application form (i.e. not via IRAS) should continue to seek permission directly from the NHS Trusts involved in the study.

Researchers who have started to complete applications in IRAS but have not yet made applications to R&D offices should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance

Investigators based in Scotland, Wales or Northern Ireland and conducting a study with sites in England should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.

18 November 2008

 

Involvement portfolio

The NHS R&D Forum Service User and Carer Working Group has published the Involvement Portfolio to coincide with the INVOLVE conference. The portfolio is a tool for those using health and social care services who are involved in voluntary or involvement activities such as consultation, committee membership, research and development, to record and
provide evidence of their activities. Much of this involvement goes unrecognised although the participants are
gaining valuable skills and experience as well as contributing their experience and expertise. The Involvement Portfolio provides a mechanism to record the skills and experience gained through involvement and voluntary activity to allow it to be recognised in applications to undertake new activity, for educational or vocational courses, or to find employment.

13 November 2008

 

Important changes to RECs recognised to review Clinical Trials of Investigational Medicinal Products

NRES has announced some important changes to the number and type of Committees which are recognised by the United Kingdom Ethics Committee Authority (UKECA) to review CTIMPs in England, Northern Ireland and Wales. There are no changes in Scotland. These changes take effect for new applications booked after 1 November 2008. For details see the NRES website.

13 November 2008

 

Guidance on Professional Legal Representatives

Updated guidance on who can be identified as a Professional Legal Representative (PrLR) and their role in Clinical Trials of Investigational Medicinal Products has been produced by the NHS R&D Forum Research Governance Working Group.

The Medicines for Human Use (Clinical Trials) Regulations 2004 profoundly changed the legal basis for consent for vulnerable subjects (minors and incapacitated adults) in clinical trials of investigational medicinal products (CTIMPs). The document defines a Personal and Professional Legal Representative. It then clarifies in a question and answer format issues such as how a PrLR should be nominated, their role, how they should make their decision and their indemnity.

The guidance gives useful links to regulatory documents and the NRES guidance on informed consent in Clinical Trial.

13 November 2008

 

Launch of model Clinical Investigation Agreement (mCIA)

The UK Clinical Research Collaboration (UK CRC) has launched the model Clinical Investigation Agreement (mCIA). This has been designed in collaboration with the DH and the Association of the British Healthcare Industry (ABHI).

Use of the mCIA is not mandatory for either NHS hospitals or member companies of either the ABHI or other medical technology trade associations but it is intended that the model would be widely adopted and carry an authority equivalent to that of the ABHI Form of Indemnity. Its routine use is strongly commended by the UK Departments of Health in England and the devolved administrations of Wales, Northern Ireland and Scotland; and the ABHI. These bodies recommend that no modifications are made to the agreement, other than those necessary to correctly identify the investigation, the contracting parties, and the investigator, and set out the financial terms and clinical investigation subject recruitment arrangements. Its use removes the need for company-by-company, investigation-by-investigation and site-by-site legal review of contract terms.

Copies of the mCIAs for England and each devolved administrations plus the Guidance can be found on the UKCRC website.

7 November 2008

 

Information on NIHR CSP in NHS Chief Executive Bulletin

The launch of the new NIHR Coordinated System for gaining NHS Permission (CSP) in England was highlighted in David Nicolson’s (NHS Chief Executive) recent Bulletin as a one-stop shop shared information system which will be the standard method of providing and checking information on studies for adoption into the NIHR Portfolio.

NHS Research and Development offices and applicants should be using it as a matter of routine from 18 November. CSP aims to reduce the bureaucracy burden in research for studies intended for the NIHR Portfolio. The CEOs monthly Bulletin can be found on the DH website.

Please note that:

  • Applications for NHS Permission through NIHR CSP must be made via the Integrated Research Application System (IRAS) at the following link: www.myresearchproject.org.uk

  • The eligibility criteria for inclusion of studies on the NIHR Clinical Research Network Portfolio can be found on the UKCRN website.

  • Initially, NIHR CSP will not be available for studies not included in the NIHR Clinical Research Network Portfolio. Researchers whose study is not eligible for the Portfolio should continue to seek permission directly from the NHS Trusts involved in the study.

7 November 2008

 

Deadline for inclusion of ongoing studies in CCRN topics into the NIHR Clinical Research Network Portfolio

The NIHR have announced that the system for adding ongoing studies to the Portfolio, which has been open for 18 months, will be closing on 30 November 2008. Ongoing studies are defined as those that are open to recruitment and have actually recruited participants since April 2008. Due to the low rates of new submissions it has been concluded that all ongoing studies have been registered.

If any investigator has overlooked the submission of an ongoing study then they should contact the CRN CC as a matter of urgency and submit a completed Initial Study Registration Proforma before the deadline of 30th November, as no further ongoing studies will be accepted using this route after that date.

Those already submitted for processing will continue to be processed however a time limit on any outstanding information requests has also been announced. These must be supplied within six months of the request being made.

7 November 2008

 

Workshops on use of patient information for research

Places are still available at a workshop that forms part of the Connecting for Health consultation on the wider use of patient data. The workshop for researchers and R&D staff is at the Manchester Conference Centre on 6th Nov at 1.30 pm - contact Christina Brand on 07717881633 or email christina.brand@tribalgroup.co.uk. http://www.connectingforhealth.nhs.uk/susconsultation.

2 November 2008

 

New website of UKCRC-registered Clinical Trials Units

A new website has been developed to help researchers and funders identify Clinical Trials Units (CTUs) in the UK with expertise in centrally coordinating multicentre clinical trials from design and development, through to data management, and final analysis. The CTUs listed on the website have all achieved UKCRC Registration status. It will allow users to find suitable CTUs by disease research areas (e.g. diabetes, mental health), methodological research areas (e.g. economic evaluation, systematic reviews and meta-analysis) or specific types of clinical research study (e.g. surgical trials, trials of investigational medicinal products). See www.ukcrc-ctu.org.uk

29 October 2008

First Stage of NRES Research Summary Database Underway

The first stage of an initiative by the National Research Ethics Service, to publish research summaries is now underway. This is the first step in developing a transparent and open system of NHS ethics review where research summaries can be accessed and viewed by all interested parties. Publication of the summaries will be an ongoing process and feedback forms will soon be available on the website. Further information about this initiative is available in the news announcement on the NRES website.

27 October 2008

 

New Declaration of Helsinki

The World Medical Association has published a new version of the Declaration of Helsinki. The 2008 version is now the only official one; all previous versions have been replaced and should not be used or cited except for historical purposes.

27 October 2008

 

Important Changes for Researchers from 18 November

The new National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permissions (NIHR CSP) is being introduced in the NHS in England from 18 November 2008 for NIHR Clinical Research Network Portfolio studies.

NIHR CSP will streamline the processes by which NHS Trusts provide permission (sometimes known as R&D approval) for new research and reduce duplication in NHS review processes. NIHR CSP will have a single entry point, via the Integrated Research Application System (IRAS), so that researchers will be able to apply for permission from all NHS sites in England through a single gateway.

Researchers wishing to gain NHS permissions from 18 November 2008 should note the following important changes:

1. From 18 November, researchers submitting a new application for NHS permission for a study that is automatically eligible for the NIHR Clinical Research Network Portfolio, or that requires formal consideration prior to acceptance on the Portfolio, should apply for NHS permissions via NIHR CSP.

2. Initially, NIHR CSP will not be available for studies not included in the NIHR Clinical Research Network Portfolio. Researchers whose study is not eligible for the Portfolio should continue to seek permission directly from the NHS Trusts involved in the study.

3. The eligibility criteria for inclusion of studies on the NIHR Clinical Research Network Portfolio have been set out by the Department of Health - see the UKCRN website.

4. Applications for NHS Permission through NIHR CSP must be made via the Integrated Research Application System (IRAS) at the following link: www.myresearchproject.org.uk

5. Further information on NIHR CSP is available at: www.ukcrn.org.uk. Please email queries to csp@ukcrn.org.uk

Please note:

Researchers who have submitted an application for NHS Ethical Review via the NRES on-line application form (i.e. not via IRAS) should continue to seek permission directly from the NHS Trusts involved in the study.

Researchers who have started to complete applications in IRAS but have not yet made applications to R&D offices should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance

Investigators based in Scotland, Wales or Northern Ireland and conducting a study with sites in England should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.

23 October 2008

 

NRES updated guidance - Approval of research involving ionising radiation

NRES has published a revised version of its guidance on the approval of research involving ionising radiation, in reponse to developments in approval systems and feedback from users. The document is a comprehensive guide on the approval of research involving ionising radiation, developed by a working party including the NHS R&D Forum. For details of the main changes in this version and to download the document, see the NRES website.

16 October 2008

 

HTA summary inspection report

The Human Tissue Authority has produced a summary inspection report on research. The report summarises the key learning points from a range of information that the HTA holds about the establishments that it regulates. The aim is to allow lessons to be learnt and standards improved. See the HTA website.

16 October 2008

 

NHS R&D Forum - new staff

The NHS R&D Forum is delighted to announce the appointment, with immediate effect, of two secondees to support the work of the Forum. Sylvia Westrup, a freelance research facilitator in London and the South East, will be R&D management and governance advisor and Allyson Bailey from the Forth Valley R&D office in Scotland will be project manager. They will each work approximately one day a week for the Forum, supported by our existing admin support from Angie Major at Blueberry Business Support Services. These secondments will allow Janet Messer to fully take up her 3 day a week secondment to NRES as Policy Associate for IRAS, as announced in August. Janet will remain as the primary point of contact for all enquiries and advice for the Forum.

16 October 2008

 

Clinical Trials Issues for Pharmacy

3 November
Nottingham City Hospital

A conference for pharmacy clinical trials staff, NHS and university R&D staff and clinical trials unit staff on GCP, QP and Quality Management Systems in pharmacy. The event is organised jointly by ACRP and NHS R&D Forum. The registration charge is only £25 per person. For more details and to book click here.

26 September 2008

 

Monitoring courses - November and December

The NHS R&D Forum/ ACRP course on monitoring skills for non-commercial trials will be running in Liverpool, Edinburgh and Oxford. Details and online booking are available here.

18 September 2008

 

Consultation on use of patient information for research

NHS Connecting for Health has launched a 12-week consultation to allow the public and healthcare professionals to have their say on the wider use of patient data. The results of the consultation will be used to shape how information held in the NHS Care Records Service is used other than for the purpose of providing direct care to patients. A series of workshops across England are also planned. See http://www.connectingforhealth.nhs.uk/susconsultation. Consultation closes 10 December 2008.

17 September 2008

 

Review of the GMC’s confidentiality guidance

The GMC is reviewing its guidance to doctors, Confidentiality: Protecting and providing information (2004) and the accompanying Frequently Asked Questions. A consultation on revised guidance is taking place. See http://www.gmc-uk.org/confidentiality/index.asp. Consultation closes 28 November 2008.

17 September 2008

 

NHS European Office

The NHS European Office has recently been established to represent NHS organisations in England to EU decision makers. The Office is part of the NHS Confederation and is funded by the Strategic Health Authorities. The Office can assist NHS organisations wishing to access EU funding. In particular, the NHS European Office can help NHS organisations in:

  • obtaining further information on the FP7 and its calls for proposals, as well as the organisation of relevant information events.

  • liaising with the European Commission to discuss possible plans for a project proposal and whether the ideas correspond with the Commission’s priorities for funding.

  • finding a consortium that is currently being established around a specific topic of interest.

  • identifying a European partner to cooperate with in developing in a project proposal.

For further information see the briefing note.

15 September 2008

 

Reminders to REC applicants

NRES has noticed a significant increase in researchers booking in applications for single site studies outside the Strategic Health Authority boundaries. Details of when specific types of research need to be booked via the central allocation system are given on the NRES website. If your research does not fall within one of these categories, single site research should be booked to your local REC within the SHA boundary.

Researchers sending in applications to RECs for Site-Specific Assessment (SSA) via IRAS are reminded to submit Parts A & B of the ethics form along with the SSI form and CV. This requirement is in the submission instructions for SSI Forms and only applies until transfer of SSA to R&D offices is completed.

15 September 2008

 

HTA codes of practice consultation

The Human Tissue Authority is conducting a consultation on the HTA revised codes of practice. This includes a new code of practice on research. For more information see the HTA website. Consultation closes 14 November 2008.

12 September 2008

 

Launch of procedure for investigating research misconduct

The Procedure for the Investigation of Allegations of Misconduct in Research has been published by the UK Panel for Research Integrity in Health and Biomedical Sciences.

The procedure provides researchers’ employers with standards for conducting investigations into misconduct that are thorough and fair to all parties. For a copy of the procedure and more information about the UK Panel, visit www.ukrio.org.

12 September 2008

 

DH Guidance note: Security of NHS patient data shared for research purposes

Following a Cabinet Office review of public sector data handling, NHS guidance for the protection of patient information has been extended and strengthened. A document has been published with guidance on appropriate information security standards for handling patient information for research. Information is most at risk when it is in transfer. In line with the Cabinet Office requirements for the public sector, the transfer of unencrypted person identifiable information on electronic media is now prohibited. The guidance is available on the Information Governance Toolkit.

12 September 2008

 

Meeting for NHS-University Joint R&D offices

10am - 3pm
8 September 2008
Nowgen Centre, Manchester

This meeting will provide an opportunity for those actively working towards establishing joint offices, and those currently working in joint offices to explore models for developing a successful arrangement and to explore issues and share experiences in a workshop format. For more information see the events page.

13 August 2008

 

Call for Expressions of Interest: NHS R&D Forum secondment posts

Expressions of interest are invited for one or more secondment opportunities at the NHS R&D Forum. The current Deputy Director, Dr Janet Messer, has been asked to undertake a part-time secondment of one year to support further development of the Integrated Research Application System (IRAS). In order to support the management of the NHS R&D Forum during this time, secondment opportunities are being offered to undertake one or more roles in the management team.

Three specific roles are available, which may be undertaken by one or more individuals up to a maximum of 0.6 FTE. Secondees will report to the Deputy Director. Location of the secondments is flexible with home-working or current office location both possible. Further details are available here. Closing date 29 August.

8 August 2008

 

Consultation on access to samples and data for cancer research

The NCRI, in collaboration with the National Cancer Intelligence Network and onCore UK, is soliciting views on the elements of policies and agreements for access to samples and data for cancer research. The aim is to develop a template list of terms for an access policy for a specific collection of data or samples, and a template Data and Material Transfer Agreement (MTA). For more information see the NCRI website. Closing date 19 September. If you would like to contribute to a response from the NHS R&D Forum please contact the Forum.

8 August 2008

 

NRES guidance on ethical review of research databases

IRAS contains a specific application form for voluntary ethical review of a research database. Organisations responsible for the management of research databases anywhere in the UK may apply for ethical review of their arrangements for collection, storage and use of data, including arrangements for release of anonymised or pseudonymised data to external researchers. NRES has now published interim guidance for NHS /HSC Research Ethics Committees on policy and procedures for review of database applications.

8 August 2008

 

IRAS well-received by research community

The consultation-in-use phase for IRAS (Integrated Research Application System) finished at the end of June and received very positive feedback. Researchers using IRAS to submit their applications to the various regulatory bodies were encouraged to give feedback on their experiences with the system. Many suggestions were received and either have been, or will be, incorporated into the system.

Further improvements and functionality are being added to IRAS on an ongoing basis. This includes the remaining data fields for full European Clinical Trials Database (EudraCT) functionality.

Researchers are strongly urged to begin new applications on IRAS to take advantage of the increased functionality and benefits of the integration the system offers. IRAS will be the entry point to systems including the National Institute for Health Research Coordinated System for Gaining NHS Permission (NIHR CSP) in England, so researchers and research managers are strongly encouraged to familiarise themselves with the system and start using IRAS now.

For more information, see the UKCRC website.

24 July 2008

 

Monitoring course - September

The NHS R&D Forum/ ACRP monitoring course will be running in Birmingham on 25-26 September. Booking has now opened. Details of the course and plans for future locations are available here.

23 July 2008

 

Consent to medical research: GMC consultation

The General Medical Council is seeking views on the scope and content of the guidance they give to doctors about obtaining consent for research. The GMC’s current guidance on research, "Research: The Role and Responsibilities of Doctors" was published in 2002. It sets out the principles governing research practice together with detailed advice on putting those principles into practice. The GMC has also recently published new guidance on consent issues, "Consent: patients and doctors making decisions together". The GMC intends to produce a shorter, more focused research guidance document to supplement the Consent booklet. The consultation will help the GMC clarify the main issues facing doctors involved in obtaining consent to research, and identify the areas where guidance from the GMC would be most helpful. Guidance on issues relating to confidentiality and probity in research is being developed separately and there will be a formal consultation on these issues towards the end of 2008 or in early 2009.

Closing date for comments 11th of August 2008. If you would like to contribute to a response from the NHS R&D Forum please contact the Forum.

For more information see
https://gmc.e-consultation.net/research/

Update - The NHS R&D Forum's response is available here.

23 July 2008

 

Data Sharing Review Report

The Report of the Data Sharing Review undertaken by Richard Thomas, the Information Commissioner, and Dr Mark Walport, the Director of the Wellcome Trust has been published. The report includes specific recommendations relevant to clinical research - see recommendations 15 - 17. The report has attracted a range of responses from commentators.

23 July 2008

 

Launch of the NIHR Invention for Innovation (i4i) Programme

The NIHR Invention for Innovation (i4i) Programme has been launched. i4i will fund future product development through New and Emerging Applications of Technology (NEAT), Health Technology Devices (HTD), Pilot Healthcare Technology Co-operatives (HTCs) and partnership under the i4i Challenge Fund for Innovation. For more information see the NIHR website.

20 July 2008

 

PIAG response to draft NHS constitution

The Patient Information Advisory Group has published an initial response to the draft NHS constitution. See the PIAG website.

20 July 2008

 

EU Commission update

Update to the European Commission Guidance on Clinical Trials (Volume 10) website.

Public consultation on the list of fields for paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA). Deadline for comment 30 September 2008.

Regulation (EC) No 1394/2007 on advance therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidance on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance. Deadline for comment 15 October 2008.

20 July 2008

 

IRAS update

The consultation-in-use phase of IRAS ran from January to June 2008. This phase has now closed. Thank you to the many of you who took the time to give feedback on IRAS. Many of the suggestions received will be or have already been incorporated into IRAS.

Researchers are strongly urged to begin new applications on IRAS now to take advantage of the increased functionality and benefits of the integration IRAS offers. As data cannot be transferred from the old ethics and R&D on-line application forms to IRAS, and as IRAS will be the entry point to other systems including the National Institute for Health Research Co-ordinated System for Gaining NHS Permission (NIHR CSP) in England, researchers and research managers are strongly encouraged to familiarise themselves with and start using IRAS now.

IRAS can be accessed at www.myresearchproject.org.uk.

9 July 2008

 

Concordat to support career development of researchers

A new Concordat to support the career development of researchers has been launched by Iain Pearson, the Minister for Science and Innovation. The Concordat to Support the Career Development of Researchers sets out the expectations and responsibilities of researchers, their managers, employers and funders. This meets the principles of the European Charter and Code of Practice for the recruitment of researchers. For more information see http://www.researchconcordat.ac.uk. The Department of Health is a signatory to the concordat.

9 July 2008

Declaration of Helsinki revision

The World Medical Association is consulting on draft revisions to the Declaration of Helsinki “Ethical Principles for Medical Research Involving Humans”. The latest revisions to the Declaration have been agreed with the aim of identifying gaps in the content while avoiding a complete re-opening of the document. The WMA is planning for the agreed revision to be adopted in October 2008. The draft and consultation information is available at http://www.wma.net/e/index.htm. Comments on this consultation should be emailed to secretariat@wma.net. The Department of Health would like to receive copies of any comments so please copy any feedback to the R&D Forum and we will collate it. Deadline for comments is 21 August 2008.

8 July 2008

 

Secretary of State for Health makes research commitment to NHS patients

The Government has announced that it will aim to inform all patients throughout the NHS of research that is relevant to them so that, if suitable, they can be offered the opportunity to take part in it.

Speaking at a summit hosted by the Prime Minister on 28 June 2008 to commemorate 60 years of NHS research, Alan Johnson, Secretary of State for Health, underlined the huge importance of research to the NHS, and how it has made unparalleled advances in medical science and healthcare since it was founded in 1948.

He stated that every patient in the NHS should have the right to take part in approved medical research that is appropriate for them, and set out the measures that will be introduced to deliver this commitment. This will help transform the healthcare and well-being of the nation and enable eligible patients who wish to take part in research to do so swiftly and easily.

Further details can be found by viewing the Secretary of State's statement on the NIHR website along with information about the consultation on the draft constitution. Consultation closes 17 October 2008.

8 July 2008

 

NIHR publishes "60 years of research in the NHS benefiting patients"

The Prime Minister hosted a summit on 25 June celebrating 60 years of NHS research. The report which was launched at the meeting summarises some of the great research discoveries which have been made in the NHS. Plans for ten Academic Health Science Centres and to improve the opportunities for patients to take part in research were also announced. See the NIHR website.

25 June 2008

 

Survey on the Impact of the EU Clinical Trials Directive

ICREL (Impact on Clinical Research of European Legislation) is a one-year EU FP7 project that aims to analyse the impact of the Clinical Trials Directive 2001/20/EC on clinical research in Europe. The outcomes of the ICREL project are likely to contribute to suggestions for possible changes to the current EU legislative framework. ICREL has launched a survey giving stakeholders (commercial and non-commercial sponsors, ethics committees and competent authorities) the opportunity to contribute to this project. The survey and more information can be found at www.eortc.be/icrel. The deadline for responses is 20 July 2008.

25 June 2008

 

Monitoring course - Nottingham

The NHS R&D Forum/ ACRP monitoring course will be running in Nottingham on 22-23 July. Booking has now opened. Details of the course and plans for future locations are available here.

23 June 2008

 

Human Tissue Authority - Licensing of procurement organisations

The Human Tissue Authority has announced that all establishments procuring tissues and cells for human application must apply for an HTA licence or have a third party agreement in place with an HTA licensed establishment by 5 July 2008. For more information see the HTA website.

16 June 2008

 

New NIHR School for Social Care Research

A National Institute for Health Research School for Social Care Research has been established. The aim of the new School is to improve the quality of care services for all those who use them, concentrating on social care practice and encouraging active collaboration with service users and their carers. For more information see the NIHR website.

16 June 2008

 

Monitoring course open for booking

The NHS R&D Forum/ ACRP monitoring course has opened bookings for the first course. Details of the first course and plans for future courses are available here.

5 June 2008

 

New NIHR Research Collaborations for Health

Seven new NIHR Collaborations for Health Research and Care have been announced. Each Collaboration will bring together universities and their surrounding NHS organisations to research new treatments and new ways of working in specific clinical areas and to improve care. Details of the new collaborations are on the NIHR website.

28 May 2008

 

Update from the Research Capability Programme

The Research Capability Programme was set up to take forward the recommendations in the 'Report of Research Simulations' produced by the UK Clinical Research Collaboration's Advisory Group to NHS Connecting for Health. It aims to develop the capability of NHS IT Systems to enable research and analysis aimed at improving the quality and safety of care. Professor Sir Alex Markham, Chair of the Research Capability Programme, has published the programme's first update with information about the progress of the initiative. For more information see the NHS Connecting for Health website.

28 May 2008

 

New NIHR Public Health Research Programme

A new Public Health Research (PHR) Programme has been established by the NIHR to provide new knowledge on the benefits, costs, acceptability and wider effect of non-NHS interventions. Following the Cooksey review recommendation for more public health research, the Government has awarded the NIHR additional money to set up this new programme. The NIHR PHR Programme will mainly work in responsive mode, taking applications for both primary and secondary research and assessing them at regular intervals. The programme will look to fund primary research at all phases but especially pragmatic evaluation studies. The first call for research proposals will be taking place in November 2008. For more details visit http://www.phr.nihr.ac.uk

28 May 2008

 

R&D annual reports for 2008

The Department of Health expects all trusts in England who received Transition R&D Funding in the last financial year (2007-08) to complete an annual report. See the DH website.

Guidance on the 2008 Annual Report was published on 23 April and an e-mail was sent to all reporting organisations on 16 May with a link to the on-line reporting system http://www.dhreports.org.uk. If nobody in your R&D department has received these details, please contact DH using either RD2008.AnnualReports@dh.gsi.gov.uk or 020 7972 4065.

All sections of the electronic copy of the Annual R&D Report must be completed no later than mid-day on Tuesday 1 July 2008 using the web-based pro-forma. No other form of submission will be accepted.

28 May 2008

 

Launch of UKCRN Costing Template

UKCRN has published the Costing Template, developed on behalf of the National Institute for Health Research (NIHR). The UKCRN Costing Template has been developed to speed up the initiation of industry contract trials by reducing the time required for site-by-site negotiations. It is based on the principles articulated in the NHS Finance Manual and is intended to provide transparency, greater consistency and predictability on costing for companies.

The Template and supplementary information about its development, constituent elements and use of the tool is available to download through the UKCRN website at www.ukcrn.org.uk/index/industry/costing

The Template has been developed and piloted through a collaborative process involving the NHS, including the NHS R&D Forum, and industry stakeholders. It will be reviewed and updated, as required, in the light of broader experience.

28 May 2008

 

Leaflet on NIHR CSP

UKCRN have published a leaflet which gives details about the development and implementation of NIHR CSP. It can be downloaded from the UKCRN website.

28 May 2008

 

Annual Conference Presentations

Copies of the presentations given at the Annual Conference are now available here.

22 May 2008

 

UKCRC endorsement of Research Passport

The UKCRC partners have issued a statement strongly advocating the routine use of the Research Passport for issuing honorary research contracts in the NHS and the Research in the NHS – HR Good Practice Resource Pack as the definitive guidance on sharing pre-engagement checks across sectors and between NHS organisations. The Research Passport now forms part of the Research in the NHS – Human Resources Good Practice Resource Pack (October 2007) issued for use by all NHS organisations in the UK. The Research Passport is the new standard approach to issuing NHS honorary research contracts to those, with no contractual relationship with the NHS, wishing to conduct studies in the NHS. The Resource Pack additionally contains clear guidance regarding the use of pre-engagement checks for those already in a contractual relationship with the NHS: i.e. with either a substantive employment contract or honorary clinical contract - and who wish to conduct research across several NHS organisations. The NHS R&D Forum played a key part in the development of the guidance. For more information on the implementation of the system across the UK, and to view the statement, see the UKCRC website.

8 May 2008

 

Publication of lay summaries by NRES

From 1 May 2008, lay summaries from all research ethics applications will be published on the NRES website no earlier than three months after the committee’s final opinion has been issued or the application is withdrawn. This initiative will improve transparency in research, and will ensure compliance with GAfREC and the Clinical Trials Regulations. The declaration on the ethics form has been amended to include the intention to publish lay summaries and the ethics form has been revised to include provision of a lay summary.

8 May 2008

 

Mental Capacity Act 2005 – transitional arrangements

Researchers are reminded that they have until 1 October 2008 to obtain approval for any research project which requires approval under Section 30 of the Mental Capacity Act 2005. This applies to “intrusive research” in England or Wales involving participants who are unable to consent for themselves where the research project started with ethics committee approval before the Act came into force, i.e. prior to 1 October 2007. Researchers to whom this applies should submit their applications to NHS RECs no later than 1 June 2008, in order to ensure that final approval can be given before 1 October 2008. Any intrusive research continuing after 1 October 2008 without Section 30 approval will be unlawful.

8 May 2008

 

Medical devices research guidance

The National Research Ethics Service has published two guidance documents on medical devices research:

  • Approval of medical devices research - This is an updated version of a document originally published in draft for use and comment in December 2006, setting out comprehensive guidance on arrangements for approval of medical devices research in the UK.

  • Communications on medical devices research - This document describes agreed arrangements for communications between NHS RECs and the MHRA in relation to clinical investigations of non-CE marked medical devices subject to the Medical Devices Regulations 2002.

Both guidance documents have been developed by the Medical Devices Research Collaboration Group, which includes the NHS Research & Development Forum. For more information and to download the documents, see the NRES website.

8 May 2008

 

IRAS updated to include EudraCT import/ export function

IRAS has been further developed to incorporate applications to MHRA Medicine (Investigational Medicinal Products). From 6 May 2008, IRAS includes a simple mechanism to export data into the format required by EudraCT or alternatively import data to IRAS from EudraCT.

Applicants can enter information into IRAS and export a .xml file to EudraCT to avoid the need to duplicate information on Investigational Medicinal Products in several applications. Alternatively, the data can be imported from the EudraCT application form into IRAS. This first stage covers data on the Investigational Medicinal Products. The remaining data fields will be added in Summer 2008. For more information on IRAS click on the link in the menu on the left.

7 May 2008

 

UKCRC Microbiology and Infectious Diseases Report

The UKCRC has published the report of a strategic planning group whose work led to a new funding initiative to strengthen microbiology and infectious diseases research.

The report documents the activities of the UKCRC Strategic Planning Group which reviewed the microbiology and infectious diseases research area in the UK. Based on the group’s findings, seven funding organisations came together to commit £16.5 million to the UKCRC Translational Infection Research Initiative, which was launched in June 2007. For more information see the UKCRC website.

7 May 2008

 

Increased NIHR funding for academic training

The NIHR Fellowship and Clinician Scientist Research Training Schemes are to be given substantial new funding to support a greater number of researchers and will now include support for research and training by the NIHR. In response to the Review of UK Health Research Funding Report (Cooksey Report) and the recent Comprehensive Spending Review, additional funding has been made available for extra applied Research Training Fellowships and Clinician Scientist Fellowships for doctors and dentists. These awards form part of the career pathway recommended in the Walport Report and will support trainees emerging from Academic Clinical Fellowships and Clinical Lectureships. For more information see the NIHR website.

7 May 2008

 

NIHR Flexibility and Sustainability Funding allocations

The NIHR Flexibility and Sustainability Funding allocations for 2008/09 have been announced. This is a new funding stream that will provide funding for some or all the research-related component of an NIHR Faculty member's salary where that component is not already provided by other research funding sources. For more information see the NIHR website.

24 April 2008

 

UKCRN costing initiative for commercial studies

UKCRN will be launching a new national costing process at the end of April. The process will give companies and the NHS a clear and consistent method for calculating the costs associated with running a commercial clinical study in the NHS.

The process has been developed by the UK Clinical Research Network in close consultation with key stakeholders from industry, the NHS and the research community, including the NHS R&D Forum. It aims to tackle the problem of inconsistent costing of studies and to ensure that NHS Trusts are fully reimbursed for the services they provide. For more information see the UKCRN website.

22 April 2008

 

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941)

Statutory Instrument 2008/941 has been laid before Parliament and comes into force on 1 May 2008. This instrument amends the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Clinical Trials Regulations) in order to:

  • enable children to take part in emergency care trials when there would be no time to seek initial consent before administering the medicine;

  • allow the Gene Therapy Advisory Committee to notify UKECA that its advice is not required on routine gene therapy trials and for applications to be transferred to another recognised ethics committee (EC) for an opinion;

  • and modify the procedures for operation of ECs to widen the available expertise, reduce administrative burden and rationalise the documents an applicant must submit for an opinion.

This instrument also amends the Blood Safety and Quality Regulations 2005. These amendments are not relevant to research.

The Regulations and explanatory information can be accessed at http://www.opsi.gov.uk/si/si200809.

NRES has issued amendments to SOPs, standard letters and standard approval conditions to implement these amendments. For details of the changes see the NRES website.

18 April 2008

 

Advanced Therapy Medicinal Product Regulations

The HTA has issued a joint statement with the Medicines and Healthcare products Regulatory Agency (MHRA) on the relationship between the Advanced Therapy Medicinal Product (ATMP) Regulations 2007 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The statement aims to clarify when treatments involving tissues and cells are regulated by the MHRA, and when they are regulated by the HTA. For more information see the HTA website.

17 April 2008

 

NIHR Biomedical Research Units

Details of the new NIHR Biomedical Research Units are on the NIHR website.

17 April 2008

 

UKCRC Update

The UK Clinical Research Collaboration has published its Spring Update. It includes information about the new Public Health Research Centres, UKCRC Experimental Medicine Resources, and work on e-health records research. See the UKCRC website.

17 April 2008

 

Important update on NIHR Coordinated System for gaining NHS Permission

UKCRN aimed to launch NIHR CSP this month. After consulting CLRN staff to test readiness, NIHR announced today that they are allowing more time for preparation. NIHR plan to launch NIHR CSP as soon as they are confident it will deliver a high quality service. Building on all the groundwork so far, there will now be a period of communication, engagement, testing and training before NIHR brings the new system into general use. A revised implementation plan has been issued. More information.

7 April 2008

 

NIHR College of Senior Investigators

The National Institute for Health Research has announced the first Senior Investigators of the NIHR Faculty. More information.

7 April 2008

 

The Integrated Research Application System: Webinar for R&D staff

The NHS R&D Forum and ACRP are collaborating to hold a webinar for NHS R&D staff on IRAS. It will be held on 17 April, 3-4.30pm. IRAS is currently available for use and consultation at www.myresearchproject.org.uk. As part of the consultation, this event is being held to provide an opportunity for discussion and feedback with staff in R&D offices in NHS organisations.

The deadline for registration is 10th April 08. For more information click here.

19 March 2008

 

NHS R&D Forum Annual Conference open for booking

The NHS R&D Forum Annual Conference will be held on 12-13 May in Newcastle. Booking is now open. Click here for more information.

10 March 2008

 

NRES project to improve public reporting of clinical trials

In response to recent publicity about public registration of research, NRES is leading a collaborative project to reconcile the Research Ethics Database (RED), with the two public clinical trial registers (International Standard Randomised Controlled Trial Number Register and ClinicalTrials.gov). More information.

10 March 2008

 

Update on NIHR CSP

UKCRN have published further information about the NIHR Coordinated System for gaining NHS permission (NIHR CSP). Details of how CSP will work and the timetable for implementation are now available - see the UKCRN website. A new link to the information is also now in place from the main UKCRN home page.

6 March 2008

 

2008/09 NHS R&D transitional funding allocations

The Department of Health has announced the transitional R&D funding allocations to NHS organisations for 2008/9. The total sum available for Transitional Funding is related to the pace of implementing Best Research for Best Health research strategy. The 2008/09 allocations represent 42.1% of pre-Best Research for Best Health allocations in cash terms. 2008/09 is the final year of Transitional R&D Funding. An increasing amount of NHS research funding is being provided through the new NIHR schemes and through activity-based NHS R&D support funding, via the Comprehensive Local Research Networks.

28 February 2007

 

Guidance on nominating a consultee for research involving adults who lack capacity to consent

The Department of Health has published new guidance that sets out how to identify an appropriate consultee for the purposes of section 32 of the Mental Capacity Act (MCA).

This guidance applies to research in England and Wales that involves adults lacking capacity to consent (other than clinical trials under the Clinical Trial Regulations). The Act requires the researcher to take reasonable steps to identify a person who, as a result of an existing relationship with the person who lacks capacity, can advise the researcher about that person’s participation in the project. Where no such person can be identified, the Act requires another person who can provide this advice to be appointed in accordance with guidance. Download guidance.

The R&D Forum's guide to the MCA has been updated to reflect this new information.

27 February 2008

 

Healthcare Technology Co-operatives

The Department of Health has launched a pilot initiative that will bring patients with debilitating diseases such as incontinence or renal failure together with doctors, scientists and manufacturers to help develop new technology and healthcare products in these areas. The two pilots, called Healthcare Technology Co-operatives, will each receive £275,000 a year for the first two years, with the potential for further funding if successful. More information.

27 February 2008

 

IRAS - update to guidance for R&D offices

The guidance pack for R&D offices on IRAS has been updated to reflect guidance issued recently to RECs. The guidance includes a log of additions in this version. Updated details include important information about student applications.

18 February 2008

 

Joint DH/ABPI UK Regional Workshop Programme

The Department of Health and the ABPI are running a programme of Regional Workshops to promote clinical research in the NHS in partnership with the pharmaceutical and biopharmaceutical industry. The workshops aim to provide researchers and research managers from NHS bodies, pharma/biopharmaceutical companies, CROs and Medical Schools with the opportunity to discuss the model Clinical Trial Agreements and other tools developed to facilitate more rapid clinical trial set-up and initiation, and to discuss the problems faced by companies sponsoring trials in the UK. For more information click here.

18 February 2008

 

IRAS launched

The Integrated Research Application System (IRAS) was launched on 29 January 2008. IRAS provides an integrated system for applying to a wide range of regulatory and governance bodies, in which the applications cross-populate. IRAS is available for optional use from 29 January. Applicants and review bodies are encouraged to provide feedback so that it can be revised before becoming a mandatory system later this year. The NRESform system continues to be available for REC and R&D applications during the consultation-in-use phase of IRAS. More information.

Go to IRAS - www.myresearchproject.org.uk
Download IRAS brochure
See UKCRC Press Release

29 January 2008

 

IRAS - guidance for R&D offices

The NHS R&D Forum has produced a guidance pack for R&D offices on IRAS. This provides an explanation of what IRAS aims to achieve, how it was developed and how it works. R&D offices requiring a copy of the XML schema to support the export of data from IRAS to R&D management systems should contact the Forum. For more information see the IRAS section of the website.

28 January 2008

 

MISG report on earlier access to medicines

The Ministerial Industry Strategy Group (MISG) has published a report of discussions about making medicines available to patients at an earlier stage of their development. The report recommends conditional licensing of new drugs at an earlier stage in the development process. A programme of work by the MISG will explore the possibility of developing a regime that would provide earlier access to medicines under certain
circumstances in the UK. More information.

28 January 2008

 

UKCRC Centres of Excellence

The UKCRC has announced the award of £20m funded by a partnership of funders, to establish five Centres of Excellence across the UK to strengthen research into complex public health issues such as obesity, smoking and health inequalities. The successful Centres are based in Newcastle, Cardiff, Belfast, Cambridge and Nottingham. Each will receive up to £5m over 5 years to create posts and support infrastructure. More information.

28 January 2007

 

NIHR Progress Report

The National Institute for Health Research has published its first progress report, two years after the implementation of Best Research for Best Health. To coincide with the publication, a new health research feature has been added to the NHS Choices website to give patients and members of the public more information about how to get involved in clinical trials. Download the report
View NHS Choices website

28 January 2008

UKCRC Experimental Medicine Resources website

UKCRC has launched a web resource to help industry and academic investigators seeking information about experimental medicine facilities in the UK. It contains up-to-date information on available expertise, resources, techniques and technologies in experimental medicine. The UKCRC Experimental Medicine Resources website can be found at: http://www.ukcrcexpmed.org.uk/

28 January 2007

 

Integrated Research Application System (IRAS) to be launched

The Integrated Research Application System (IRAS) will be launched on 29 January 2008. For updated information see the IRAS section of this website.

17 January 2008

 

NIHR Coordinated System for gaining NHS Permission

UKCRN has published information on the coordinated system it is developing for handling NHS permission for research in England from April 2008. The system will integrate with other developments to simplify applying for NHS permission (R&D approval). Key features include: a single point for applications to all NHS organisations, coordination and standardisation of the review of applications by CLRN-funded R&D staff in NHS organisations, coordination of provision of permission from all the relevant NHS organisations for a study. For details see http://www.ukcrn.org.uk/index/clinical/r_management.html.
More information will be provided through this link in due course. The NHS R&D Forum is continuing to work closely with UKCRN on this development.

9 January 2008

 

NIHR IS Programme – Progress Report January 2008

An update on the development of NIHR Information Systems has been published on the NIHR website. It provides updates on the NIHR Portal, the R&D Management Information System, and systems to support the NIHR Coordinated System for gaining NHS Permission, Biomedical Research Centres, and NIHR Faculty. See the NIHR website.

9 January 2008

 

Information on MHRA Inspections

MHRA have updated their online information about GCP inspections. New information includes definitions of GCP findings classifications and outputs from the update meeting in September 2007. See the MHRA website. GCP inspections of clinical laboratories involved in analysis of samples from trials have recently started. For more information see MHRA events.

9 January 2008

 

NRR archive

The National Research Register has now closed down. Existing data on the NRR can now be accessed from the NIHR portal at http://portal.nihr.ac.uk/ but no new data will be added to the NRR. New arrangements for registering studies are being put in place in each of the UK nations.

9 January 2008

 

Archive News 2007

Archive News 2006