Sources of Guidance

Sources of Guidance

The National Research Ethics Service (NRES) website Applicants section is a good source of guidance for researchers including how to apply for ethics review and researcher responsibilities after ethical review.

http://www.mhra.gov.uk - The MHRA (Medicines and Healthcare products Regulatory Agency) regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering.

http://www.hta.gov.uk - The HTA (Human Tissue Authority) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act).

The NHS R&D Forum website has a useful Guidance section for researchers and the Contacts section provides a list and the contact details for all NHS organisations in the UK.

For general advice on research, training and funding see www.rdinfo.org.uk.

Through the Clinical Research Network (CRN), researchers have access to a wide range of support at the planning, set-up and delivery phases of a study. Go to their website at http://www.crncc.nihr.ac.uk/researchers. This section of their website gives an overview of that support, and provides links to other pages where more detail can be found.

Tool Kits

Two web-based resources have been developed by the Medical Research Council (MRC) and collaborative partners specifically to guide researchers through the legislative, regulatory and good practice requirements in three specific types of research – medicinal products, use of data and tissue. To help researchers navigate through the guidance, the information is organised within Route Maps.

Clinical Trials Tool Kit. On this site researchers will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations implement the EU Clinical Trials Directive in the UK. Even if a research project falls outside the Regulations, researchers could still find the tool kit useful.   Much of the advice it contains is relevant to clinical trials and research more generally.

Data and Tissues Tool Kit. On this site researchers will find practical help with the legislative and good practice requirements relating to the use of personal information and human tissue samples in healthcare research in the UK, eg, Data Protection Act (1998), Human Tissue Act (2004) and focuses on the planning and approvals stage of setting up a research project.

External Links

The Research Governance Framework for Health & Social Care: second edition, DH (Department of Health) April 2005, outlines principles of good governance that apply to all research within the remit of the Secretary of State for Health and defines roles and responsibilities for organisations and individuals.

The UK Clinical Trial Regulations: indexed and consolidated

EudraLex - Volume 10 Clinical trials guidelines -  The rules governing medicinal products in the European Union contains guidance documents applying to clinical trials.

http://www.dh.gov.uk - The DH (Department of Health) is a government department and provides health and social care policy, guidance and publications for NHS and social care professionals.

http://www.nigb.nhs.uk/ The NIGB (The National Information Governance Board for Health and Social Care) provides leadership and promotes consistent standards for information governance across health and social care. It considers ethical issues; the interpretation and application of the law and policies;  and provides advice on information governance matters at a national level.  From January 2009 the NIGB functions included administration of applications under 'section 251' of the NHS Act 2006 which allows the common law duty of confidentiality to be set aside in specific circumstances.  This function was formerly carried out by the Patient Information Advisory Group (PIAG) which was abolished on 31 December 2008. From 04 March 2013 information on the 'section 251' approval process has been transferred to the HRA website and the NIGB website is no longer updated. All current information on the application process and approved applications is now sited on the Health Research Authority website http://www.hra.nhs.uk/hra-confidentiality-advisory-group/. Applicants should bookmark this link and use this to locate up to date information.

NHS Litigation Authority
The Data Protection Act 1998
Confidentiality: NHS Code of Practice
Mental Capacity Act 2005
Mental Capacity Act training materials & code of practice

http://www.mrc.ac.uk/index.htm - The MRC (Medical Research Council) is a publicly-funded organisation dedicated to improving human health. The MRC support research across the entire spectrum of medical sciences, in universities and hospitals, in their own units and institutes in the UK, and in their units in Africa.

INVOLVE
English Consent Law FAQ
NHS Litigation Authority
NHS Indemnity – HSG (96)48: NHS indemnity

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