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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

HTA - Human Tissue Authority

Data & Tissues Tool Kit

a) Government Acts and Regulations

Human Fertilisation and Embryology Act (1990)

Health and Social Care Act (2001)

Human Rights Act 1998

Data Protection Act 1998

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)

Human Tissue Act 2004

UK Medicines for Human Use (Clinical Trials) Regulations (2004)

Mental Capacity Act 2005

b) CONSENT, CONFIDENTIALITY and DATA PROTECTION

CONSENT AND MENTAL CAPACITY

Health and Social Care Act 2001 Section 60 - Control of Patient Information

Section 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 support

Guidance and forms for application for section 60 support

MRC  Ethics Guide 2007 - Medical research involving adults who cannot consent
Guidance for researchers that sets out the general principles for assessing whether adult individuals have the capacity to consent to participation in research.

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
NHS R&D Forum simple guide for researchers and research organisations

 

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.

 

Accessing Health Records

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

 

Making a Difference: Safe and Secure Data Sharing between Health and Adult Social Care Staff (March 2006)

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

Human Tissue Authority (HTA)

The HTA regulates the removal, storage, use and disposal of human bodies, organs and tissue from the living and the deceased.

 

HTA Codes of Practice

Codes of practices relating to the removal, storage, use and disposal of human tissue and organs.

 

HTA Licensing

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 Inspections

HTA webpages on inspections provides information on the inspections process

MRC Tips for Human Tissue Authority inspections

 

NHS R&D Forum - HTA Guidance

Brings together guidance to help organisations implement the requirements of the Human Tissue Act

d) THE DATA & TISSUES TOOL KIT

The Data and 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

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