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 Research Governance Documentation and Information Guide for Primary Care Trusts 2008

The Research Governance Documentation and Information Guide 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. The Guide, which was originally devised by Trent RDSU in 2004, has just been thoroughly reviewed and updated and Version 3 (October 2008) is available as a downloadable document. The Guide has been endorsed by the NHS R&D Forum and will provide links to essential information for all research managers within the NHS and to everyone planning to undertake health-related research. It will be available in interactive format on the Forum website shortly.


Research Governace in Social Care and Health

Research Governance Framework Resource Pack, produced by the Department of Health Research Governance in Social Care Advisory Group. Published April 2005.


The Clinical Trials Tool Kit

The Tool Kit brings together and disseminates the work of the MRC/DH Joint Project. The site has been developed to provide practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004 that implement the EU Clinical Trials Directive in the UK. The advice provided by the site is relevant for all publicly funded academic trials, whether funded by the MRC or by other sources. The site has been developed primarily for clinical trialists and R&D managers working in the academic sector, but will also be of use to other health professionals. Much of the advice in the routemaps is relevant to research other than clinical trials. The NHS R&D Forum has been actively involved in the Joint Project's working groups and in the creation of the Tool Kit.
  • Links to the NHS Research Governance Framework for Wales have been added to the Tool Kit, in the Planning a New Trial route map.
  • MHRA have released an algorithm to help determine if your trial falls with in the scope of the Directive.
The field of research governance is constantly changing. To ensure that your research bid meets current guidelines, we advise you strongly to visit the Department of Health's website for research and development.


Research Governance Responsibilities of Strategic Health Authorities

From 1 April 2004 Strategic Health Authorities are responsible for the management of standards of research governance in health and social care. The Briefing Note is aimed at supporting Strategic Health Authorities take on responsibility for the performance management of research governance.


Standard NHS REC Application form

The prototype new national application form is now available on the COREC website. It will initially be only jued by MRECs for a period of evaluation before the definitive version becomes abailable for use by all RECs. It is anticipated that all RECs will be using the form by October 2003.


Department of Health Research Governance Framework for Health and Social Care

Article by: Dr Elizabeth Clough, Deputy Director of R&D, DHSC Midlands and East of England, Department of Health, November 2002

Whether you are a University employee doing research in primary care, a member of a Research Ethics Committee, a manager of a PCT where research is going on, a principal investigator - or, indeed, if you are involved in health/social care research at all - you need to know about the Department of Health's Research Governance Framework

Research which puts people's safety at risk or disrespects the public's rights, for example the right to be properly informed before giving consent, damages the entire research community. It gives research a bad name and threatens scientific and clinical advancement. So, it is in everyone's interests for researchers to do the right things in the right way, and that, basically, is what governance is about.

The Research Governance Framework was published in March 2001, following extensive public consultation. It is not a new policy but brings together relevant standards and guidance on good practice in a single document. It has two main purposes - to protect the public and to improve the quality of research. In common with other governance systems, the framework describes:
  • standards for health and social care research
  • delivery mechanisms to ensure that standards are met
  • arrangements to monitor adherence to standards nationally
Standards are presented in the Annex to the framework as web addresses; they direct the reader to legislation and recognised guidelines on ethics, science, information, health, safety and employment and finance and intellectual property.

As well as setting standards, the framework has a lot to say about responsibilities. Research frequently involves many individuals and several organisations. This increases the possibility that responsibilities are unclear and defining responsibilities is one of the most important aspects of governance. The framework gives checklists of responsibilities for research participants, researchers, principal investigators, research funders, sponsors, Universities and other organisations employing researchers, organisations providing care, care professionals and research ethics committees. Clear agreements describing allocation of responsibilities must be reached and documented.

All NHS organisations were asked to complete a baseline assessment against the requirements of the framework. In September 2001 a national timetable was published and in July 2002 research active NHS organisations submitted their local research governance implementation plans which detail progress towards compliance, which should be complete by April 2004.

From January 2002, all NHS organisations undertaking research, in addition to meeting the legal requirements included in the Framework, must know about, and have approved, all research going on, must ensure that research ethics committee approval has been obtained and must have arrangements in place to ensure that properly informed consent procedures have been adhered to. Many organisations are ahead of the national timetable.

PCTs have been forging collaborations across organisations to exploit and integrate R&D management experience and expertise. In many parts of the country, one PCT in a city or county is taking lead responsibility for co-ordinating and managing the research activity in that area. The Department is building up a national picture of these collaborations and where the lead research management and governance organisations are located. It is also undertaking an investigation of several different models of R&D collaboration to determine what is involved in managing shared governance and the resources needed to do it.

PCT Chief Executives are accountable for governance of research undertaken in their organisation. Networks cut across PCTs and, not being NHS organisations, cannot be the accountable body for research governance.

It is heartening that the framework has been welcomed. It will take a little time for some smaller organisations to become fully compliant but there is a general recognition that this is something which the entire R&D community, including of course the Department itself, must do.


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