Below there are a suite of documents that outline best practice, make reference to legislation and regulations, to help meet the requirements of conducting research with human participants, their tissues or data.

Best Practice Documents

UK Regulations - 

England, Wales and Northern Ireland

Mental Capacity Act 2005

Scotland

Adults with Incapacity (Scotland) Act 2000

Legislation (The Act)

Guidance -

MRC Ethics Guide 2007: Medical research involving adults who cannot consent

NHS R&D Forum: A simple guide to the Mental Capacity Act 2005 in relation to research

Archiving / Record Retention

Guidance -

MRC: Personal Information in Medical Research

Research involving the NHS: retention of records

Children

Guidance -

ICH Topic E 11: Clinical Investigation of Medicinal Products in the Paediatric Population, EMEA

MRC: Medical Research involving Children (2004)

Children’s Assent to Clinical Trial Participation

Consent

Guidance -

MRC: Personal Information in Medical Research

A Guide to Understanding Informed Consent 

Clinical Trial Agreement

Guidance -

Commercial Sponsored Studies

Model Clinical Trial Agreement (mCTA) for Commercial Sponsored Studies

Tripartite Agreement

Contract Research Organisation model Clinical Trial Agreement (CRO mCTA)

Clinical Trial Applications (CTA)

Guidance -

What is a Medicinal Product?

A Guide to What is a Medicinal Product, revised June 2007, Guidance Note 8, MHRA

The European Clinical Trials Database

Detailed guidance on the European clinical trials database (EUDRACT Database), April 2003, EC

Authorisation of a Clinical Trial on a Medicinal Product for Human Use

Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments and Declaration of the End of the Trial, October 2005, EC

Example of the Contents of an Investigator's Brochure

Contents of an Investigator’s Brochure (IB), Appendix 2

Clinical Trials of Investigational Medicinal Products (CTIMPs)

EU Legislation -

EU Clinical Trials Directive (2001/20/EC)

GCP Directive (2005/28/EC)

UK Regulations -

The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI No. 1031)

The Medicines for Human Use (Clinical Trials) Amendment (No. 1) Regulations 2006 (SI No. 1928)

The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (SI No. 2984)

Guidance -

Good Clinical Practice (GCP)

Guidelines for Clinical Trials

Eudralex – Volume 10

Sponsorship

EUCTD: Sponsorship Responsibilities in Publicly Funded Trials, April 2004, DH

Serious Breaches of GCP or the Trial Protocol

Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol, MHRA

GCP Inspection by the MHRA

How to prepare for an inspection for Good Clinical Practice by the MHRA: A Guide for NHS organisations that Sponsor or host clinical trials of medicinal products

Medicinal Products

Best Practice Guidance on the labelling and packaging of medicines, June 2003, Guidance Note 25

A Guide to Defective Medicinal Products (2004), 1 Jan 2004

Data Protection / Confidentiality / Access to Data

UK Regulations -

Data Protection Act 1998

Health and Social Care Act 2001

Guidance -

Caldicott Guardian Manual

The Caldicott Guardian Manual 2006

Maintaining Confidentiality

Patient Confidentiality and Access to Health Records

NHS Code of Confidentiality

MRC: Personal Information in Medical Research

NHS Information Governance: Guidance note on Security of NHS patient data shared for research purposes

National Information Governance Board (NIGB) (formerly PIAG)

National Information Governance Board

Developing Societies and Research

Guidance -

MRC: Research involving Human Participants in Developing Societies

Ethics, REC Applications and related issues

Guidance -

Declaration of Helsinki (2008)

World Medical Association: Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

National Research Ethics Service

National Research Ethics Service (NRES)

NRES Standard Operation Procedures for NHS RECs

National Research Ethics Service (NRES) Glossary

 

Good Laboratory Practice (GLP)

UK Regulations -

The Good Laboratory Practice Regulations 1999 (SI No. 3106)

The Good Laboratory Practice (Codification Amendments Etc.) regulations 2004 (SI No. 994)

Guidance -

UK GLP Regulations

Guide to UK GLP Regulations 1999 – 1 Feb 2000

Good Practice in Research

Guidance -

MRC: Good Research Practice (2000)

MRC: Guidelines for Good Clinical Practice in Clinical Trials

Gene Therapy

Guidance -

Gene Therapy Advisory Committee (GTAC)

Human Fertilisation and Embryology

Guidance -

Human Tissue

UK Regulations -

England, Wales and Northern Ireland

Human Tissue Act 2004

Scotland

Human Tissue (Scotland) Act 2006

Guidance -

HTA guidance on relevant material

MRC Research and Human Tissue Legislation Series:

Summary of consent requirements, applicable for England, Wales and Northern Ireland

Summary of HTA licensing requirements, applicable for England, Wales and Northern Ireland

Summary of disposal requirements, applicable for England, Wales and Northern Ireland

Summary of import/export requirements, applicable for England, Wales and Northern Ireland

Summary of requirements in Scotland

Summary of consent requirements for research involving DNA analysis

Human Tissue Authority Codes of Practice:

Consent

Import and export of human bodies, body parts and tissue

The removal, storage and disposal of human organs and tissue

MRC Guidance:

Human Tissue and Biological Samples for use in Research - Operational and Ethical guidelines (2001)

Insurance / Indemnity

Guidance -

NHS Indemnity Arrangements

NHS Indemnity (arrangements for clinical negligence claims in the NHS)

Research in the NHS: Indemnity Arrangements

NHS Litigation Authority Schemes

Is it Research?

Guidance -

Defining and Categorising Research

NHS R&D Forum: Guidance on managing and categorising research and related projects

NRES: Defining Research

Research / Audit / Service Evaluation

NRES Ethics Consultation Group: Differentiating Audit, Service Evaluation and Research

NRES: Research or Audit?

Medical Devices

UK Regulations -

The Medical Devices Regulations 2002 (SI No. 618)

The Medical Devices (Amendment) Regulations 2003 (SI No. 1697)

Guidance -

Information for Clinical Investigators

Information for Clinical Investigators, updated December 2006, Guidance Note 3

Pharmacovigilance

Guidance -

Collection, Verification and Presentation of Adverse Research Reports

Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports arising from Clinical Trials on Medicinal Products for Human Use, April 2006, Revision 2, EC

The European Database of Suspected Unexpected Serious Adverse Reactions

Detailed Guidance on the European Database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module), April 2004, Revision 1, EC

Clinical Trials Tool Kit Material

Pharmacovigilance Document: MRC/DH Joint Project Workstream 6

Primary Care Research

Guidance -

Information Tool Kit

Information Tool kit for RM&G PCTs

What PCTs need to consider before giving permission for research

Research Governance in Health and Social Care: NHS permission for R&D involving NHS patients (2nd edition, Nov08)

Radiation in Research

Guidance -

Approval Process (updated sept 2008)

Approval flowchart for research involving ionising radiation

NRES Ionising Radiation - Approval Process

Research Governance

Frameworks (RGF) -

England

Research Governance Framework for Health and Social Care, 2nd Edition, April 2005

Wales

Research Governance Framework for Health and Social Care in Wales

Northern Ireland

Research Governance Framework for Health and Social Care in Northern Ireland

Scotland

Research Governance Framework for Health and Community Care,
2nd edition, 2006

Guidance -

Sponsorship

Responsibilities of the Sponsor, Research Governance Framework (Health and Social Care), 2nd Edition, April 2005

R&D Management

Guidance -

NHS R&D Offices Contacts List

NHS R&D Forum: Contacts List for NHS R&D Offices

Honorary Contracts

National Institute for Health Research: Human Resources (HR) Good Practice Resource pack

Research Passports

National Institute for Health Research: Human Resources (HR) Good Practice Resource pack

UKCRC: The Research Passport:- A Streamlined Approach to Issuing NHS Honorary Research Contracts

Research Permission

Clinical Trials Tool Kit

Data and Tissues Tool Kit

Experimental Medicine Tool Kit