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A research recruitment guide has been developed by the NIHR Primary Care Research Recruitment Methods Group (see www.nspcr.ac.uk), in conjunction with the NIHR Primary Care Research Network (PCRN). The guide is intended as a practical resource to help researchers in primary care with participant recruitment. It draws on information from a variety of experienced research-active professionals from a range of settings who shared information about how they and their organisations approach the task of recruiting to studies in primary care. Users are encouraged to give feedback and constructive criticism. Email: crncc.pcrn@nihr.ac.uk
The Medical Devices (Amendment) Regulations
The Medical Devices (Amendment) Regulations 2008 No 2936 which transpose Directive 2007/47/EC into UK law, were passed by Parliament in December 2008 and fully come into force 21 March 2010. Guidance on this is available on the MHRA website.
Life Sciences 2010: Delivering the Blueprint
The Office of Life Sciences has published a report describing the progress that has been made since Government created the Office for Life Sciences in January 2009 to strengthen research in the life sciences, and laying out plans for future work.
EMEA – FDA Good Clinical Practice Initiative
The European Medicines Agency has published a GCP initiative document outlining a process which focuses on enhanced and systematic Good Clinical Practice related information exchanges between the European Medicines Agency and the US Food and Drug Administration combined with collaboration in the conduct of Good Clinical Practice inspections of clinical trials.
Revised 'Defining Research' leaflet
NRES have released their updated leaflet for ‘Defining Research’ which now also aims to distinguish surveillance and usual practice from research, service evaluation and audit.
Preparing raw clinical data for publication: Guidance for journal editors, authors, and peer reviewers
New guidance published on the British Medical Journal (BMJ) website in late January sets out how personal information from clinical trials should be shared to help minimize risks to patient privacy. They advise researchers to seek informed consent about data sharing and list 28 items of personal and clinical information that can make patients identifiable in anonymised datasets.
Guidance on requesting amendments to health and social care records
The NIGB have launched the 'Guidance on requesting amendments to health and social care records' on the 14 January 2010.
Announcement of independent review of the regulation and governance of medical research
The government has asked the Academy of Medical Sciences to conduct a rapid independent review of the regulation and governance of medical research. This will be chaired by Sir Michael Rawlins in his capacity as a senior fellow. The review follows concerns that the process of medical research is being jeopardised by a complex legal and regulatory framework. The framework is affecting both:
Updated Research in the NHS
The Research in the NHS: HR Good Practice Resource Pack has been updated. The Resource Pack sets out guidance and good practice standards (including the Research Passport system) to streamline the issuing of honorary research contracts (HRCs) and letters of access (LoAs), and enable NHS organisations to be confident that substantive employers have undertaken the appropriate pre-engagement checks for researchers.
Guidance on the attribution of NHS Non-commercial Research costs, Support Costs and Treatment Costs (ReSeT Guidance)
The Department of Health has published this ReSeT Guidance to clarify the distinction between the three categories of costs associated with non-commercial research studies: Research Costs, NHS Support Costs and Treatment Costs. This supercedes the ARCO guidance ( Attributing Revenue Costs of non-commercial research in the NHS), and must be used to attribute the costs of non-commercial research studies taking place in the NHS where the outline or full grant funding application is submitted to funders on or after 1 September 2010.
Free ISRCTN registration for NIHR Clinical Research Network Portfolio studies
In line with its policy to promote public access to information about research and research findings affecting health and social care, the Department of Health in England will fund the registration of all non-commercial studies, with an interventional component included in the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Portfolio, on the International Standard Randomised Controlled Trial Number (ISRCTN) register. Further details are available on the NIHR CRN website.
Developing a publication on the impact of Patient and Public Involvement (PPI) on cancer research
The National Cancer Research Institute (NCRI) and the National Cancer Research Network (NCRN) are putting together material for a definitive publication on the impact of PPI on cancer research. You can help by completing a survey and telling us about your involvement in a PPI initiative. If you have been involved in any way with a PPI initiative and feel that the PPI has made a difference, we would like to know about it, no matter how large or small you feel the impact was.
CONSORT 2010 - updated guidance for RCT reporting
New updated CONSORT Statement, guidance for reporting randomised trials, was published by nine leading medical journals - BMJ, Annals of Internal Medicine, BMC Medicine, Journal of Clinical Epidemiology, The Lancet, Obstetrics and Gynaecology, Open Medicine, PLoS Medicine, and Trials.
Please see the updated CONSORT websites for more details
Research Support Service (RSS) Progress
The RSS Workstream are starting to publish the draft outputs from their work. These will be available for review as part of the stakeholder engagement phase of the project. The initial information includes slide packs providing background information.
Report - Managing Clinical Research in the UK (CTU use only)
This report presents the findings from a 2-year EPSRC-funded study which was undertaken to systematically explore the challenges of organising and managing different models of clinical research.
ReSet Cancelled
Following consultation with its research funding partners, the Department of Health has decided not to proceed with the implementation of ReSeT guidance. The Department will continue discussions with its partners to agree an approach that builds on the principles set out in HSG(97)32 and in the currently-used ARCO guidance.
MHRA - GCP Compliance Reports
NHS organisations and universities are reminded to submit their annual GCP Compliance Report to MHRA by 30 June 2010. Guidance, including revised FAQs, are available on the MHRA website.
Changes to REC Names
There have been a number of changes to Research Ethics Committees effective 1 April 2010. Contact details are available on the NRES website if any difficulties are encountered.
Industry Costing Programme launches new templates
Two new templates (Medical Technology & Primary Care) have been launched, alongside the Industry Costing Template, following a year of successful consultation and collaboration between Industry, the NHS and the NIHR Clinical Research Networks to deliver a costing framework for these important sectors of the health research system.
New GMC guidance
The General Medical Council (GMC) has published new guidance for doctors, Good Practice in Research and Consent to Research. These replace the guidance booklet, Research: The role and responsibilities of doctors (2002).
New Payment for Involvement Guide
INVOLVE have published a revision to Payment for Involvement: a guide to making payment to members of the public actively involved in NHS, public health and social care research.
EFGCP Report Update 2010
The 2010 update of the EFGCP report on ‘The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe is now freely available on the EFGCP Website.
Research Ethics Guidebook
Funded by the ESRC as part of the Researcher Development Initiative and developed by a team here at the Institute of Education, The Research Ethics Guidebook is a guide through ethics review and regulatory processes for social scientists. Aimed at early career researchers, the site is easily accessible and clearly written. It will be a useful resource for anyone doing or managing social science research.
Last updated: 09 June 2010
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