News and information relating to Research Governance will be published here.
Research and Development Forum (http://www.rdforum.nhs.uk/home.htm)
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.
16 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
8 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.
Clinical Research Collaboration Cymru - No new news items
Clinical Trials ToolKit - No new news items.
MHRA -No new news items.
UK Clinical Research Collaboration - No new news items.