Sources of Guidance

The National Research Ethics Service (NRES) website is a good source of guidance for researchers when applying for ethics approval and what is required of researchers after ethical review. 

The NHS R&D Forum website has a useful Researchers section and includes guidance on applying to R&D offices for permission to conduct research. This section includes a link to a list of NHS R&D Contacts.. 

For general advice on research, training and funding go to www.rdinfo.org.uk. RDInfo can also direct you to appropriate local sources of advice and expertise.

Tool Kits

Two web-based resources have been developed by the 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 although the non-regulatory information provided is applicable for all types of research. To help you navigate through the guidance, the information is organised within Route Maps.  

Clinical Trials Tool Kit. On this site you will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trial) Regulations 2004. Even if your research falls outside these Regulations, you will 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 you 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 and focuses on the planning and approvals stage of setting up a research project that involves data and/or human tissue.

UKCRC Regulatory and Governance Advice Service

The UKCRC have established a Regulatory and Governance Advice Service to provide practical help with the legislative and good practice requirements that govern clinical research in the UK. The Service supports local advice providers, such as NHS R&D and university R&D offices, to provide consistent and authoritative advice to their research communities, and so the first port of call for any researcher with a query should be these local offices. The Advice Service is supported by the NHS R&D Forum in partnership with a number of other regulatory and governance bodies. Further information on the UKCRC R&G Advice Service can be obtained from the website http://www.ukcrc.org/regulationgovernance/rgadviceservice/

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.

http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm - The Medicines for Human Use (Clinical Trial) Regulations 2004.  Statutory Instrument 2004 No. 1031.

http://www.legislation.gov.uk/uksi/2005/2754/contents/made - The Medicines (Advisory Bodies) (No. 2) Regulations 2005.  Statutory Instrument 2005 No. 2754.

http://www.legislation.gov.uk/uksi/2005/2759/contents/made - The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005.  Statutory Instrument 2005 No. 2759

http://www.legislation.gov.uk/uksi/2006/1928/contents/made - The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006.  Statutory Instrument 2006 No. 1926

http://www.legislation.gov.uk/uksi/2006/2984/contents/made - The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006.  Statutory Instrument 2006 No. 2984

http://www.legislation.gov.uk/uksi/2008/941/contents/made - The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008.  Statutory Instrument 2008 No.941

http://www.legislation.gov.uk/uksi/2009/1164/contents/made - The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009.  Statutory Instrument 2009 No. 1164

http://www.legislation.gov.uk/uksi/2010/1882/contents/made - The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010.  Statutory Instrument 2010 No. 1882

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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.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).

http://www.nigb.nhs.uk/  - NIGB (National Information Governance Board) was established to provide advice on issues of national significance involving the use of patient information and to oversee arrangements created under Section 60 of the Health and Social Care Act 2001. Its membership is drawn from patient groups, healthcare professionals and regulatory bodies.

http://www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1 - The Data Protection Act 1998

http://www.dh.gov.uk - Confidentiality: NHS Code of Practice

http://www.legislation.gov.uk/ukpga/2005/9/contents  - Mental Capacity Act 2005

http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/MentalCapacity/MentalCapacityAct2005/DH_078789  - Mental Capacity Act 2005 and research

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.

MRC Good Research Practice, updated version September 2005 – an MRC (Medical Research Council) Publication

http://www.invo.org.uk/ - INVOLVE

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4125281 - Research in the NHS:  Indemnity arrangements, Department of Health guidance.

http://www.dh.gov.uk - English Consent Law FAQ

http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/ Consent guidance, National Research Ethics Service (NRES)

Internal Links

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