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Research and Development Forum |
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Integrated Research Application System
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Research Governance Documentation and Information Guide 6. OTHER RESEARCH REGULATION Regulation protects both participants in research and researchers. It sets out clearly what is acceptable and what is not, and therefore provides a framework within which researchers work. This section provides links to important government acts and regulations as well as guidance and resources to help researchers in planning and undertaking research. Useful Websites: HREA: Human Fertilisation & Embryology Authority ARSAC: Administration of Radioactive Substances Advisory Committee GTAC: Gene Therapy Advisory Committee PIAG: Patient Information Advisory Group a) Government Acts and Regulations Human Fertilisation and Embryology Act (1990) Health and Social Care Act (2001) The Ionising Radiation (Medical Exposure) Regulations 2000 Ionising Radiation (Medical Exposure) (Amendment) Regulations 2006 NHS R&D Forum guidance: Approval for research involving ionising radiation (2006) Control of Substances Hazardous to Health Regulations (2002) UK Medicines for Human Use (Clinical Trials) Regulations (2004) b) CONSENT, CONFIDENTIALITY and DATA PROTECTION CONSENT AND MENTAL CAPACITYHealth and Social Care Act 2001 Section 60 - Control of Patient InformationSection 60 of the Health and Social Care Act 2001 was introduced to allow organisations to obtain patient identifiable information, for medical purposes, in circumstances where it was impracticable to obtain informed consent from the patients concerned.
Scrutiny of the use of these arrangements by the Patient Information Advisory Group (PIAG), as well as wider consultation and Parliamentary approval for controversial activities, were built into the legislation to prevent the use of these powers for trivial or inappropriate purposes.
Patient Information Advisory Group (PIAG) The Patient Information Advisory Group 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.
The website has a range of useful information
Applications for Section 60 supportGuidance and forms for application for section 60 support
MRC Ethics Guide 2007 - Medical research involving adults who cannot
consent Mental Capacity Act Code of Practice (2007) Explains how the act will operate on a day-to-day basis
Guide to the Mental Capacity Act 2005 in relation to research
NRES - Research involving adults unable to consent for themselves Links to a range of guidance on the Mental Capacity Act can be found on the NRES Guidance section
Consent: patients and doctors making decisions together GMC 2008 Guidance for doctors covering consent for t examination or investigation, providing treatment, or involving patients in teaching and research.
The GMC is currently seeking views to help it review guidance on obtaining consent for research
BMA Consent Tool Kit (second edition 2003) Provides information in the form of answers to some of the most frequently asked questions around consent. Card 10 covers questions related to consent for research
CONFIDENTIALITY Confidentiality: The NHS Code of Practice (2003) Published by the DH following a major public consultation.
Patient confidentiality & Caldicott Guardians frequently asked questions
Patient confidentiality and access to health records Further Department of Health information Useful links & publications about patient confidentiality covering areas of legislation, regulation and guidance.
DATA PROTECTION AND SECURITY Health Services Circular 2000/009 Data Protection Act 1998 Key points summary
Security of NHS patient data shared for research purposes (July 2008) NHS Information Governance guidance note on the protection of patient information
This document suggests practical changes for delivery that will reduce unnecessary bureaucracy associated with dealing with requests for information and clarify information sharing requirements within the health and adult social care sectors whist respecting the need to maintain patient confidentiality and information security
c) HUMAN TISSUE ACT The HTA regulates the removal, storage, use and disposal of human bodies, organs and tissue from the living and the deceased.
Codes of practices relating to the removal, storage, use and disposal of human tissue and organs.
Organisations in England, Wales and Northern Ireland that store relevant material may require a licence from the HTA. The HTA web pages on licensing help to clarify which activities are licenced.
HTA webpages on inspections provides information on the inspections process MRC Tips for Human Tissue Authority inspections
Brings together guidance to help organisations implement the requirements of the Human Tissue Act d) THE DATA & TISSUES TOOL KIT The Tool Kit brings together information and guidance on legislative and good practice requirements relating to the use of personal information and human tissue samples.
The Tool Kit was developed by MRC and uses the same 'route map' system as the Clinical Trials Tool Kit.
The Data and Tissues Tool Kit resource index
The resource index
provides links to a wide range of practical help with implementation of
the
Data Protection Act (1998), Section 60 of the Health & Social Care Act
(2001), the common law of confidentiality, the Human Tissue Act (2004) and
Human Tissue Authority codes of practice |
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| page last updated November 13, 2008 |
© NHS R&D Forum 2008 |