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MHRA has published a report on perceptions of the public and healthcare professionals about the risks and benefits associated with medicines and medical devices. It also sought views on how well these are regulated and on the communication of their risks and benefits. For further information visit the website.
The Government has published a White Paper on assisted human reproduction and embryo research. Proposals include increasing the scope of legitimate embryo research activities, subject to strict controls. It contains further details of the proposed new Regulatory Authority for Tissue and Embryos (RATE), which will replace the existing regulators the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). The Human Tissue Authority has written a HTA response to the white paper.
New guidance recommends that all xenotransplant procedures are carried out in a research context with appropriate approval from research ethics committee. For further information see the website.
MHRA (Devices); Association of the British Healthcare Industries (ABHI); Institute of Clinical Research (ICR); and COREC have collaborated to produce Guidance Notes for researchers, medical device industry applicants and REC members to assist in the understanding of the ethical review of trials of medical devices in the UK. The Guidance Notes have been issued in draft form for a period of around 6 months for use and comment. The guidance will be kept under review in the light of practical experience and feedback. Comments on the draft Guidance from users is welcomed and should be addressed to Sandra Tapping. A list of contact points for specific advice on medical devices is in section 11 of the document.
An up to date version of the Forum's handy timetable for all the NIHR funding schemes was published on 15 December.
Connecting for Health research simulations underway. There are currently a number of developments in the UK and elsewhere to create linked electronic patient records systems to support the delivery and management of health. In England this development is being managed by Connecting for Health. Data collected routinely as part of patient care, and now increasingly stored electronically, has added value for secondary uses such as research including surveillance of health, understanding effectiveness of interventions and knowledge of public health impacts on provision and use of healthcare services.The UKCRC is engaged in a programme of work with Connecting for Health to capture the issues of importance to the research community and ensure that these are fed into developments of the new Care Records Service. As a first step, a series of simulation projects are underway to help identify the technical, operational and governance issues that would need to be addressed to enable the Care Records Service to facilitate high quality research.
In light of amendments to the UK Medicines for Human Use (Clinical Trials) Regulations 2004 in 2006, CTT are currently working to update their website. This will be finalised following publication of the specific modality for non-commercial trials.
The Human Tissue Act section of the website has been updated. This section of the website brings together guidance to assist organisations in implementing the requirements of the Human Tissue Act 2004 (HT Act). How to prepare for an inspection for GCP by MHRA: a guide for NHS organisations that sponsor or host clinical trials of medicinal products. The NHS R&D Forum has published an updated and revised guide for non-commercial organisations on preparing for GCP inspections by the MHRA. The revised document takes account of the implementation of the Clinical Trials Amendment Regulations and up to date information from experience of MHRA inspections.
The COREC Business Plan has been updated following publication of Building on Improvement: Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operations of NHS Research Ethics Committees. You can also access a series of Appendices including:
The RfPB Programme Director, Professor Celia Davies, has provided feedback on the first competition of the new responsive funding scheme. It covers the most frequently cited reasons that applications were rejected. The closing date for the second competition submissions is 16th February 2007. Further details from the NIHR Central Commissioning Facility website
A letter (dated 11th December) from UKCRN should now have reached Chief Executives of NHS organisations outlining how R&D management will be supported across the NHS within the new CRNs which are due to be established in April 2007. There is a 2 page letter and 2 appendices: Appendix 1 - Description of the CRN, Appendix 2 map showing distribution of Local CRNs (CLRN) and a list of SHA areas and NHS organisations within each proposed CLRN An initial response is expected from trusts by 31st December indicating:
The second joint bulletin from COREC and the NHS R&D Forum has been published with full details of the New Integrated Site-specific Information Form. To download a copy visit the website (planned date for release is the end of December).
On 31 March 2006, the Chancellor of the Exchequer, Gordon Brown, appointed Sir David Cooksey to lead a review to build agreement on the best institutional arrangements for the new single fund for health research announced in the Budget. The Review undertook a call for evidence between 4 May and 28 July 2006. Over 280 responses were received, copies of all but a few confidential responses are now available on the website The review concludes that, although good progress has been made in some areas further work is needed to ensure that publicly funded health research is carried out in the most effective and efficient way, and to facilitate rapid translation of research findings into health and economic benefits. The report recommends specific actions which Government can take to achieve this. In his PreBudget Report on 6 December, The Chancellor announced that he and the Secretaries of States of Health and DTI accepted the recommendations.
The R&D Forum have produced the following document - How to prepare for an inspection for GCP by MHRA: a guide for NHS organisations that sponsor or host clinical trials of medicinal products. Visit the website
The Association of the British Pharmaceutical Industry has launched a new campaign to increase the uptake of new medicines in the UK. The manifesto describes the industry's plans to work towards fairness in prescribing, ending the'postcode lottery' in medicines and helping the NHS budget go further. It includes a section on research. See the website
A blank reference copy of the latest version of the REC application form is now available on the COREC website. This is a useful reference tool for R&D offices.
An amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 and Adults with Incapacity (Scotland) Act 2000 will come into force on 12 December to to facilitate clinical research in emergency settings. The regulations make it possible to enter an incapacitated person into a clinical trial involving emergency medicine without prior consent. For details see the website.
The section on the R&D Forum website about the Human Tissue Act has been updated. Information about the requirement for licences for removal of tissue from the deceased has been distributed by email to R&D offices.
The Royal College of Nursing R&D Coordinating Centre conducts a biannual survey of academic institutes to identify what research is currently being done in academic departments around the UK. The purpose of this is to facilitate networking and the identification of potential research partners. This is primarily nursing and midwifery research but also includes allied health professions. Further details of those that responded in the last round can be found on the website, RCN electronic Bulletins can be accessed through the R&D Coordinating Centre Notice Board.
The SDO website has a range of really useful 6 page summaries of research undertaken through the Service Development and Organisation R&D Programme.
New publication from the Service Development and Organisation R&D Programme website: Involving service users in nursing, midwifery and health visiting research October 2006 Available as a 6 page briefing paper or full report.
The Mental Capacity Act 2005 becomes law on 1st April 2007. The Department of Health is making resources available to enable Councils with Social Services Responsibilities (CSSRs) to: a) train staff across their Implementation Network to understand the implications of the Act and to act accordingly; b) commission an Independent Mental Capacity Advocate (IMCA) service to be in place by 1st April 2007, and c) increase the staff time needed for assessments of capacity and best interests decisions.
The NHS R&D Forum has published an updated and revised guide for non-commercial organisations on preparing for GCP inspections by the MHRA. The revised document takes account of the implementation of the Clinical Trials Amendment Regulations and up to date information from experience of MHRA inspections.
COREC & NHS R&D Forum have released a bulletin looking at developing an integrated approval process for research in the NHS. The bulletin provides detail of the changes to the ethics form (version 5.2 released 30 October 2006) with reasons & comments regarding the changes. It also discusses the development of new systems to support the transfer of responsibility for providing advice on the suitability of NHS research sites (Site Specific Assessments) from local RECs to NHS R&D through the development of a new form. This will combine the existing Part C for SSA approvals and the NHS R&D application form and will be issued for use and consultation in late November /early December.
COREC has published a Memorandum of understanding between the Medicines and Healthcare products Regulatory Agency (MHRA), COREC and the Gene Therapy Advisory Committee (GTAC). The purpose of the memorandum is to fulfil the requirements of the EU Directive on Good Clinical Practice relating to communication between ethics committees and the competent authority (in the UK this is MHRA). It provides a useful summary of roles and responsibilities, monitoring, inspections & reporting if you can pick your way through the language & acronyms of ''Directive-Speak''
UKCRC has published a Progress Report 2004 - 2006. Full report or executive summary versions are available on the website. The UKCRC has now been in existence for two years. It was formed to bring together the major organisations that conduct, sponsor, and regulate clinical research in the UK as a 'forum for leadership' in taking forward issues identified in the report of the Research for Patient Benefit Working Party. It is the driver behind much of the work now being implemented through the NHS R&D Strategy.
The UKCRC was established by the Chancellor of the Exchequer in his 2004 Budget and the UKCRC Partners have now been working together for two years. This report documents progress made and highlights key elements of the emerging clinical research environment. Electronic version of the full report and an executive summary can be downloaded from the UKCRC website.
There is increasing interest in the use of e-learning to support the training and education of the health and social care workforce. As part of this interest the NHS UK Alliance for e-Learning in Healthcare have devised a national e-learning database as part of activity to support the national implementation of e-learning. The purpose of the database is to capture and share details of e-learning programs that have been developed and are available for use within the health and care sector.
This is the fifth Quarterly Report from Health Services Research Network. Topics covered:
The Department of Health has published the report on the consultation on the Mental Capacity Act research regulations. For further information visit the website.
COREC, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Gene Therapy Advisory Committee (GTAC) have published a Memorandum of Understanding relating to communication of information on medicinal trials. For more information visit the website.
The NHS R&D Forum is heavily involved in running the pilots of the Research Passport system. Over 100 organisations, NHS and University, have so far indicated that they will take part in the pilots and local R&D leads are working with HR colleagues to implement the system. All other NHS organisations not involved in the pilots are reminded that new guidance on honorary research contracts is now available on the R&D Forum website.
A progress report from the Information Systems team is available. Janet Messer has been involved in a number of conversations and meetings with the IS team to ensure NHS R&D input into the developments, and to provide a link with the developments on the REC and R&D forms.
The revised model Clinical Trial Agreement has been published. The mCTA should be used routinely without modification by all pharmaceutical and biopharmaceutical sponsors of contract clinical trials and the NHS hospitals in which patients are recruited. Versions have been also prepared that reflect the special governance and legal arrangements of Scotland, Northern Ireland and Wales. The NHS R&D Forum recommends the use of the revised mCTA. For further information visit the website
We have produced a joint bulletin to communicate information about changes to the REC and R&D application forms. The first bulletin is available on the R&D Forum website and further editions will be published to share information as progress is made.
The aim of the scheme is to assist new researchers and academics at the start of their careers gain experience of managing and leading research projects. The scheme is open to all staff of Higher Education Institutions and recognised Research Organisations, who have not previously been Principal Investigators on Research Council awards, and who are within six years of the completion of their PhD or equivalent professional standing. For more information visit the website. Closing date 11 January.
Version 5.2 of the NHS REC application form will be released on the weekend of 28/29 October. The main change to the application form will be the provision of a distinct form for applicants requesting ethical review of licensed research tissue banks (RTBs). There is no statutory requirement for ethical review of RTBs. Applications will be made on a voluntary basis. The review process will complement rather than duplicate the licensing scheme operated by the Human Tissue Authority. In particular it aims to facilitate research sourcing tissue from licensed RTBs by allowing for generic ethical approval. Some other changes are being made which should be of benefit to NHS R&D offices. A revised version of the REC SOPs will also be issued. A new guidance document on approval of research involving ionising radiation, which has been developed collaboratively with the NHS R&D Forum and others, will be published. See the website for full details.
UKCRN has now published information about the local Leads who are supporting UKCRN in implementing and developing the Comprehensive NHS Research Network. The two leads for the Trent RDSU patch are:
The Faculty Implementation Plan has been revised.
Notes on developing procedures within NHS organisations for appropriate authorisation and management of research and related projects. The Forum have produced a revised version of the guidance on categorising and managing research and other projects. This has been discussed with COREC and the Department of Health.
This is an in-depth report from the SMi (Pharmaceuticals) conference in London, 27-28 March 2006 written by Dr Richard Wyse. The report provides analysis of issues raised in presentations at this event, discussing proven strategies to maximise patient recruitment, tools to assist the process, investigator-site selection and public perceptions of clinical trials. This was a conference for pharmaceutical company reps but the principles and issues raised may also apply to non-commercial trials. The report is free following registration on the website.
INVOLVE has a range of new publications downloadable from its website: Guidelines for researchers, commissioners and members of the public about public involvement in research commissioning. New series of seven guidelines. Guide to reimbursing and paying members of the public actively involved in research - this guide was originally published in 2002 and has now been revised. It is primarily intended for researchers and may also be useful for research commissioners. What User Controlled Research means, and what can it do. An easy read summary of a report about user controlled research by Michael Turner and Peter Beresford. National Institute for Health Research: Payment rates for public involvement. Guidance that has been agreed with the Department of Health on payment rates to members of the public for attendance at Committee meetings and carrying out peer review. This is an update to a paper published in 2003 ' Payments to the public for peer review - National NHS R&D Programmes' Why people get involved in health and social care research: a working paper (Maryrose Tarpey INVOLVE Support Unit) The paper looks at why people choose to get involved in research, and, in turn identify barriers that may prevent others getting involved. The paper discusses: * What motivates people to get involved in research; * Who gets involved and ways of involvement; * What are the factors influencing motivation and * How to support motivation
There have been changes to
COREC has launched its implementation plan: "Building on improvement: Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees". Through its Central Office for Research Ethics Committees (COREC) the National Patient Safety Agency has launched its plan to implement the recommendations of the Department of Health's Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees. The report contains summaries for each of the 9 recommendations, the implementation plan, plus a summary of consultation responses. Implementation will be phased over at least 18 months.
The Government is proposing to amend the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004, for consent in emergency situations. For updated information please see the cover note from Professor Sally Davies and the Minister's letter page 1 and page 2.
The EU Commission consulted on the specific modalities for non-commercial trials, see the joint response to this consultation and additional comments on monitoring.
The MHRA support a risk-based approach to management and monitoring in clinical trials. The Joint Project produced guidance on conducting risk-based management and monitorin, and for ease of access, these four documents have been moved to the top of the GCP ( Management and Monitoring) station resource list
SCIE is looking for examples of evaluations or research projects which measure the impact of service user and carer participation in order to develop new good practice guidance. The research - which SCIE has commissioned to Sheffield Hallam University (SHU) - aims to fill the gap in knowledge SCIE identified in the position paper Has service user participation made a difference to social care services? SCIE found that service user and carer participation is not routinely evaluated so the difference it makes to the services people use is therefore unknown. The research team at SHU which is led by Professor Mark Doel, includes service users, carers and academics. If you have working examples of measuring effective service user and carer participation contact Mark Doel or 0114 225 5854. Further details and a copy of the SCIE position paper visit the website.
This framework document sets out the Government's plans for the future of patient and public involvement in health and social care. These plans include the establishment of Local Involvement Networks (LINks) which will replace patient forums. LINks will work with existing voluntary and community sector groups, as well as interested individuals to promote public and community influence in health and social care. The package of plans is designed to promote the importance of user and public involvement at all levels of the health and social care system, and to create a system which enables more people to become involved and have their voices heard.
The report from the second national survey of research governance compliance in local Councils with Social Services Responsibilities is now available from the DH social care website. The report reveals that the majority have established basic systems for the governance of social care research.
The UK Trial Management Network has published a revised edition of 'A Guide to Efficient Trial Management'. The guide covers the whole process of conducting clinical trials in health care. It is aimed at Trials managers but should also be a really useful guide for R&D managers on the set up and conduct of clinical trials in the UK.
The Implementation Plans for the National Institute of Health Research (NIHR) work streams have been revised. There is also a new implementation plan 5.1a for the Comprehensive NHS Research Network. The network will cover England and is for all diseases and areas of need not addressed by the networks already established for specific conditions. The network will also support local researchers and play an important role in R&D management. There are changes to the implementation of Bureaucracy Busting 4.1. The wording now indicates that the Comprehensive NHS Research Network will provide 'nationally networked NHS R&D management' across its constituent organisations rather than 'networked expert centres' as outlined in Version 1. The emphasis is on standard procedures and systems. The UKCRN is also currently overseeing a national survey of NHS R&D Managers to gather information about current arrangements for research governance and management. This includes staffing, reciprocal arrangements with other organisations, procedures and good practice. The results of this will be used to inform the implementation of streamlined research governance systems and the Comprehensive Research Network.
A new voluntary form for applicants requesting ethical review of licensed research tissue banks (RTBs) is due to be launched soon by COREC. The review process aims to facilitate research sourcing tissue from licensed RTBs by allowing for generic ethical approval. RTBs will be able to seek generic ethical approval to conduct research using stored tissue or to release anonymised samples to researchers, subject to certain conditions, without a requirement for further applications for ethical review on a project-specific basis. This type of generic ethical approval will satisfy the requirement of the Human Tissue Act for the researcher to have ethical approval where storing and using tissue without a licence.
The integrated UK Regulatory and Governance Advice Service pilots have started. The advice centre is coordinated by MRC and UKCRN. The Advice Service provides a coordinated way of supporting and assisting front-line advisers (such as NHS R&D offices) by providing integrated access to regulatory and governance organisations. The NHS R&D Forum is one of the organisations providing advice through the service. The national roll-out is planned for April.
The Research Passport is an application system for researchers who require Honorary Research Contracts to conduct research in or through the NHS. The Research Passport System is part of the research strategy "Best Research for Best Health". The system is being piloted in a number of areas across the UK from September 2006 to March 2007. The pilot is led by UKCRC with support from the NHS R&D Forum, the Council of Heads of Medical Schools and NHS Employers. Implementation of the pilot will be led by leads in each of the areas, who will receive support, advice and training from the Passport Project Team. The pilot is being evaluated through surveys and interviews with researchers, employers and NHS organisations. The evaluation will provide information to assist in the national roll-out of the system which is planned to start in April 2007. Information on the pilot of the Research Passport System is available on a mini-site on the R&D Forum website.
Ten secondment posts with UKCRN have been appointed to provide local support in the establishment of the Comprehensive Research Network. Each SHA area in England has one person who will spend 2-3 days per week working on the development of network arrangements. The two leads for th eTrent RDSU patch are: Nichola Seare, UKCRN Lead for East Midlands and Jonathan Gower, UKCRN Lead for Yorkshire and Humber.
The NHS R&D Forum has published new guidance on the use of Honorary Research Contracts in the NHS. The guidance forms the basis of the Research Passport System. The guidance on the use of Honorary Research Contracts is for use across the NHS now. It has been reviewed by NHS Employers and their legal advisers.
The Mental Capacity Act 2005 is due to come into effect in April 2007. A Best Practice self-assessment tool has been developed by the Department of Health for the NHS and other organisations to assist them to successfully implement the Act. The tool refers to the elements of the Act which relate to research. NHS R&D offices may wish to liaise with relevant staff in their organisations. The Mental Capacity Act will apply to research involving people without capacity, whether temporarily or permanently, and whether the incapacity is due to being unconscious, illness or learning disability.
The COREC Implementation Plan "Building on improvement: implementing the recommendations of the ad hoc advisory group on the operation of NHS research ethics committees" has been agreed by the Department of Health and has now been published. For more information see the COREC website.
The integrated Regulatory and Governance Advice Service is now being piloted - initially in Nottingham and Manchester and shortly in Edinburgh and Southampton. The Advice Service provides a coordinated way of supporting and assisting front-line advisers (such as NHS R&D offices) by providing integrated access to regulatory and governance organisations. The NHS R&D Forum is one of the organisations providing advice through the service. The national roll-out is planned for April.
The NHS R&D Forum has published a revised version of its document on categorising and managing research and related projects. This version takes into account feedback received and has been discussed with the Central Office for Research Ethics Committees and the Department of Health. A revision to Governance Arrangements for Research Ethics Committees is planned by the Department of Health and this may include changes to the remit of NHS Research Ethics Committees. The document will be reviewed again subsequently if necessary. The Forum continues to welcome feedback and comment on the document. COREC has more recently issued a revised version of its summary table distinguishing research, audit and service evaluation following discussion with the Forum, the Department of Health and REC members.
Funding has been awarded to develop and strengthen Clinical Research Facilities around the UK including Belfast, Birmingham, Cambridge, Edinburgh, The Institute of Cancer Research, Imperial College London, King's College London, Manchester, Newcastle, Oxford and University College London. In addition, another facility jointly funded by the Wellcome Trust and the Health Research Board of Ireland will be established in Dublin. The funding from a consortium of research funders led by the Wellcome Trust for experimental medicine will develop and strenghten Clinical Research Facilities, which bring together laboratory and clinical patient-based research. See the UKCRC website.
Many of the implementation plans for Best Research for Best Health have been updated. In addition the plan for the Comprehensive Research Network has been published. For details visit the DH website.
The Social Care Institute for Excellence is consulting on ways of strengthening social care research with the aim of developing resources and structures for research that will help to improve social care services, policies and practices. The consultation will run from July - September 2006 website.
The presentations from this conference, held on 13 June 2006 are now available on the Forum website.
An implementation plan for the Comprehensive NHS Research Network is now available. Revised versions of Implementation Plan 4.1 Bureaucracy busting: Governance, advice and ethics systems and Implementation Plan 4.2 Bureaucracy busting: Research information systems have also been published. See the DH website.
Asma Sandler, the Coordinator for the Leicester Centre for Ethnic Health Research is putting together a database of bilingual researchers and would very much appreciate hearing from experienced researchers of any grade who would be willing and interested in being included. Please find attached a letter of invitation and a questionnaire. For further details contact Asma on 0116 2954140 or email: Asma Sader.
Full details of all the new PCTs are available on the DH website.
The Resource Centre will promote the value of involving people and will work with NHS organisations, staff and patients to build on the foundations of involvement that are already in place in many parts of the country
The European Commission has published an update of the Pharmacovigilance guideline and the Algorithm "What is a clinical trial?". The pharmacovigilance guideline adds some clarity for non-commercial trials. The Commission version of the algorithm differs slightly from the algorithm available on the MHRA website. Where the classification of a trial is not clear as a result of these different versions, the MHRA should be consulted for further advice.
UKCRC has published an analysis of the UK health research portfolios of the largest government and charity funders of health research in the UK. The analysis provides a snapshot of research taking place in the UK between 1st April 2004 and 31st March 2005. It focuses exclusively on the directly funded peer reviewed research awards of the participating organisations. The report can be downloaded from the UKCRC website.
The report covers national and international networks as well as covering research methodologies and clinical focus'/fields of research.
UK Clinical Research Collaboration report - One of the goals of the UKCRC is to develop a coherent approach to funding health related research. A key step in this process is to ma the current UK-wide research portfolio and create an evidence base that can be used to inform individual and joint planning and to facilitate coordination between funders. This report presents the results of this mapping exercise - an analysis of the directly funded UK research. Collectively the portfolios of the participating organisations represent the overwhelming majority of non-commercial health research in the UK. It is the first time a national analysis of the distribution of research funding across all types of research activity and in all areas of health and disease has been carried out on this scale anywhere in the world.
In Budget 2006, the Chancellor of the Exchequer announced a single budget for health research for the Medical Research Council and the NHS R&D Programme, jointly-held by the Secretaries of State for Health and Trade and Industry and worth at least £1 billion per annum. Sir David Cooksey is leading the review of the best institutional arrangements for the new single fund which will report to the Secretaries of State for Health and Trade and Industry ahead of the pre-budget report in October 2006. Details of the press release and terms of reference for the review, details of the review process which closes on 28th July 2006.
The new Director of the School for Primary Care Research is Professor Martin Roland who is Director of the National Primary Care Research & Development Centre at the University of Manchester. The School currently comprises academic departments of primary care from Universities at Oxford, Cambridge, Birmingham and Manchester. The first task for the school will be to produce a business plan. Further details in Implementation Plan 5.4 are on the website.
The MHRA has released its interim report into the adverse incidents which occurred on 13 March during the clinical trials of TGN1412. For further details see the MHRA website. The government has set up an expert group set up to learn from the incident. The group will look at the science surrounding monoclonal antibody treatment, and how trials involving these types of drugs need to be managed in the future. More information is on the DH website.
The HTA commenced licensing the storage of tissue for human application from 7 April 2006. Licensing of the other activities, including research, involving tissue, organs or cells from the living or deceased will commence from 1 September 2006. More information about the licensing requirements of the HT Act and guidance for Designated Individuals is provided in the regulation section of the HTA website. The Human Tissue Act 2004 does not apply to Scotland.
The new UK Panel for Research Integrity in Health and Biomedical Sciences has been launched. It will be funded for three years by universities, the NHS, the ABPI and research councils to raise awareness of research misconduct and promote best practice in health and bioscience in the NHS, universities and industry. It will develop a code of practice for staff working in the NHS, universities and the health industry, offer support to whistleblowers, and provide experts to boost the quality of future research. However, it will remain the responsibility of employers or sponsors to investigate individual allegations of fraud or unethical working.
The National Institute for Health Research website has been launched.
Updated versions (April21st) of most of the Implementation Plans are now on available on the DH website. The Bureaucracy Busting (Research Governance) plans have not been updated.
The DH has published a new updated guide to the standards of practice required in the management of NHS records, based on current legal requirements and professional best practice. The guidance applies to all NHS records and contains details of the minimum retention period for each record type. The document is in two parts Part 1, Part 2 contains the Records Retention Schedule. The Code of Practice replaces: HSC 1999/053 - For the record HSC 1998/217 - Preservation, retention and destruction of GP general medical services records relating to patients (replacement for FHSL (94)(30)) HSC 1998/153 - Using electronic patient records in hospitals: Legal requirements and good practice
The new SHA configurations were announced in April. The new organisations will be established from 1 July 2006. Further information including a map visit the website. The Chair and Chief Executive of the new East Midlands SHA (merged Trent and LNR) has just been announced by the DH. The Chief Executive of the new East Midlands Strategic Health Authority is to be Barbara Hakin and the Chairman is to be Admiral Sir John Brigstocke. Barbara is currently combining work as the Department of Health's Acting Director of Commissioning with her post as Chief Executive of Bradford South and West PCT. Sir John has recently been Chief Executive of St Andrew's Hospital in Northampton, which is a charitable trust. Networks NHS website also provides useful updates on Commissioning a Patient-led NHS including proposed PCT reconfigurations.
Let me in - I'm a researcher! This DH report is about how to involve people with learning difficulties in research. It is for anyone and everyone who does research, takes part in research or pays for research. It is for people in universities, people in government, people in policy organisations, those who give grants for research and, of course, people with learning difficulties. This report was produced by a team of researchers with learning disabilities.
This is a new magazine covering clinical R&D. The first issue covers topics such as the Research Passport for Honorary Contracts, Good Clinical Practice Standards for Clinicla Trials of Medicinal Products and the challenges facing NHS Trust R&D departments. The magazine is offering a year's free subscription. The website also has a news section.
Modernising Adult Social Care Research Initiative newsletter.
UK Biobank will be a unique resource for ethical research into genetic and environmental factors that impact on human health and disease, to improve the health of future generations. There is a summary on the Networks NHS website. Further information on the UK Biobank website.
From 7 April 2006, anyone storing tissue or cells for human application must be in possession of a licence from the Human Tissue Authority (HTA). The Human Tissue Act regulates the removal, storage and use of human tissue, defined as material that has come from a human body and consists of, or includes, human cells (which includes blood for transfusion), and is referred to as 'relevant material'. The Act identifies who can give 'appropriate consent' before any of the listed 'scheduled purposes' on 'relevant material' can take place. The HTA has produced some guidance on completing the compliance report and information on licensing for Designated Individuals and Licence Holders, to help tissue establishments with their application. Further details from the Human Tissue Authority.
A new School for Primary Care Research within the National Institute for Health Research (NIHR) was announced in Best Research for Best Health. The aim of the NIHR School for Primary Care Research, which will be the first research school to be established within the NIHR, is to increase the evidence-base for primary care practice. This call is aimed at University Departments of primary care that were rated as 5 or 5* in the last RAE (in the first instance this includes Oxford, Cambridge, Birmingham and Manchester). For more information visit the website
This Command Paper sets out the Government's response to the Health Select Committee's second report of session 2005-06, Changes to Primary Care Trusts. It includes discussion on issues surrounding the reconfiguration of Primary Care Trusts and sets out in more detail the background to these changes and the benefits that will follow for patients. An interesting read!
The Science and innovation investment framework sets out the Government's ambition for UK science and innovation over the next decade, in particular their contribution to economic growth and public services, and the attributes and funding arrangements of a research system capable of delivering this. This consultation paper sets out a range of new proposals designed to create a more effective science and innovation system in the UK and maximise the impact of public investment in research on the economy. Of particular interest to health research is section 5: supporting world-class health research. Consultation runs until 16th June 2006.
The Department of Health has issued a report publishing plans for clarifying the policies and guidance around security, confidentiality and sharing of patient identifiable information. The plans include issuing a single set of guidance in September 2006 on the secondary uses of personal information for medical research, population health and management. This will take account of the recommendations of the Academy of Medical Sciences and of the Council for Science and Technology, the views of frontline staff and of appropriate patient and service user groups. This guidance will promote consistent interpretation of the legislation on the use of patient information for research purposes, and will provide clarity for frontline staff, patients and service users. It will also explore solutions based on anonymisation of personal data. View the report.
New arrangements for ethical review of medical devices applications: With effect from 3 April 2006, all applicants for medical devices research are asked to book their applications through the COREC Central Allocation System (CAS). A panel of 11 NHS Research Ethics Committees has been identified with relevant experience in reviewing this type of research. These arrangements apply to clinical investigations of devices, performance evaluation of in vitro diagnostic devices and all other research into medical devices. New guidance on ethical review of indemnity for GP researchers: In consultation with the NHS R&D Forum for England, guidance has been given on arrangements for indemnity cover in research conducted by GPs and other independent practitioners. This guidance refers to the Forum's position paper on indemnity arrangements in primary care. New guidance on suspension or termination of ethical opinion: In consultation with the Medicines and Health care products Regulatory Agency (MHRA), it has been clarified that an ethics committee may not suspend or terminate its ethical opinion on a clinical trial of an investigational medicinal product (CTIMP). There is no provision under the Medicines for Human Use (Clinical Trials) Regulations 2004 for the committee to take this action. However, the committee may raise with the sponsor or the MHRA any new ethical concerns that emerge during the trial. The committee continues to have a statutory duty to give an opinion on substantial amendments notified by the sponsor. It may give a favourable or unfavourable opinion on such amendments. Visit the website for the detailed guidance.
The Steering Committee of the RCN Research Society are especially keen to encourage those who conduct or are involved in research to disseminate the fruits of their labours. This list is an attempt to help you locate potentially suitable journals/publishers for the research you are trying to publish.
The Academy of Medical Sciences has published a report of a study examining the use of personal data in medical research.
The Medicindes and Healthcare Products Regulatory Agency has produced a questionnaire requesting information on clinical trials by non-commercial organisations. The questionnaire covers trials that are hosted and/or sponsored by non-commercial organisations. The MHRA will use the information to increase their understanding of the inspection requirements for non-commercial organisations.
This note summarises the current position on NHS indemnity for HNS bodies involved in research. It is a guide to managing the risks associated with research that involves NHS staff and/or NHS patients, including their organs, tissues or data.
The Association of Directors of Social Services (ADSS) website has the outline results from the second baseline assessment of Research Governance in Social Care, which was undertaken Summer 2005.
This paper replaces the draft version (dated February 2005). It aims to clarify the distinction between Research Costs, NHS Support Costs and Treatment Costs in relation to activity specified in a research application/protocol and to help attribution between the NHS and the external funder of: (1) patient-related activity; (2) clinical staffing; and (3) placebos and medicines. Although research in primary and community care settings may have specific features, these notes are intended for all NHS research covered by the 'Research governance framework for health and social care'. They should be read in conjunction with 'HSG (97)32: Responsibilities for meeting patient care costs associated with research and development in the NHS'. Both documents can be accessed through the website
COREC plan to release Version 5.1 of the REC application form during the weekend of 10-11 March 2006. This is a minor update of the form, which will include enhancements based on the feedback they have received following the major changes made to the form last year. For details of the changes see the COREC website.
The Human Tissue Authority has announced that its revised codes of practice guidelines will be laid before Parliament for 40 days before being published in April. Centres storing human tissue for research purposes will be licensed under the Human Tissue Act from 1 September 2006.
The strategy states that DH plans to use the National Costings Framework to develop a costings tool for studies undertaken through the research networks. The National Costings Framework was developed by the NHS R&D Forum with the Institute of Clinical Research and the ABPI. It provides guidance on setting up and costing commercial clinical trials conducted within the NHS. All NHS organisations and pharmaceutical companies should be aware of this guidance already. The Research Passport system will be rolled out as part of the new strategy in 2006. It aims to clarify when Honorary Research Contracts (HRCs) with NHS organisations are required and to streamline the process for obtaining HRCs. The system will provide clear, practical, national guidance to the NHS on the situations in which HRCs are required. It will also provide a process for NHS organisations to share information about pre-employment checks on potential honorary employees. This will avoid duplication of activities when a researcher requires an HRC with a number of NHS organisations. The guidance document has been drafted by the NHS R&D Forum and Greater Manchester SHA. NHS Employers, the body that provides advice to NHS Human Resources departments, is currently involved in finalising the guidance. Implementation of the system is being taken forward by a working group of representatives from universities and the NHS under the leadership of the UK Clinical Research Collaboration.
This is a very lengthy report but a summary is also available.
The new R&D Strategy has now been launched following the recent consultation exercise and is available from the Department of Health website This site has links to the full report and a brief 5 page summary document Best Research for Best Health has a range of related objectives which require different approaches. The implementation plans for sixteen of the major components for the new National Institute of Health Research (NIHR) have been developed. Each implementation Plan sets out the aim of the proposal, who will be involved, how it will be funded, and the timetable for implementation. These plans will be regularly updated. Implementation plans for: The National Institute for Health Research (NIHR), Funding Transition for NHS Providers, Research Systems & Governance, NHS Research Infrastructure, NIHR Projects, Programmes, Units and Centres.
COREC has now published the implementation plan for the recommendations of the Ad Hoc review of the Operation of NHS Research Ethics Committees for consultation. The plan contains details of 9 recommendations for change some of which will have a direct impact on NHS R&D procedures so it is important that NHS host organisations take the opportunity to respond. The NHS R&D Forum will also be sending a response on behalf of members. If you would like your feedback to be taken into account in the Forum's response please send comments to Janet Messer by 10th April. The consultation period ends on Friday 21st April 2006.
To encourage non-medical professionals to attend teh 35th Annucal Scientific Meeting of the SAPC they are offering a reduced price memberbishp fee (until 12 July 06) which will enable participants to register at the reduced members’ rate, apply for bursaries to attend and to be considered for the Keele Prize. For more informaiton visit the website.
Details of the annual reports submitted to the Department of Health by all organisations receiving NHS R&D support funding are now available on the National Research website.
The report of the DH and MRC Primary Care Research Infrastructure Working Party entitled, "A Primary Care Clinical Research Network for England (PCRN-E)" is available to download from the UKCRN website.
UKCRC have published "Report on Clinical Research in the UK: Towards a single system that reliably delivers distinctive quality and rapid access at reasonable cost". It can be accessed from the UKCRC website. |
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