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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
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