The NHS R&D Forum


	Research and Development Forum

Research Governance Documentation and Information Guide

(October 2008)

Developed by Gill Sarre for Trent RDSU
Endorsed by the NHS R&D Forum Primary Care Working Group

The NHS R&D Forum and the Primary Care Working Group are delighted to recommend this guide on documentation relating to Research Governance, which has been developed by Gill Sarre with Trent RDSU. The guide provides a comprehensive summary of the current regulations, guidance and information relating to Research Governance, plus full reference details of how these documents can be accessed electronically, and will prove indispensable to all research managers within the NHS and to everyone planning to undertake health-related research.

The Forum's Primary Care Working Party will be working jointly with staff at Trent RDSU, to continue to update the relevant list of documentation relating to Research Governance. In addition, the Forum, through both its Primary Care and Research Governance working groups continues to provide R&D managers with practical advice on how to interpret and implement research governance procedures, through the development of the PCT RM&G Tool Kit and guidance notes, and this work is on-going.

We welcome any feedback on the Forum's activity in these areas.

You can access the guide online by clicking on the links below or download the guide as a Word document.

INDEX

1. Research Governance Framework
a) Department of Health research governance policy documents
b) Department of Health research governance guidance

2. Ethics
a) National Research Ethics Service (NRES)
b) Additional useful guidance

3. NHS R&D Approval

a) Data Capture using IRAS (Integrated Research Application System)
b) NIHR Coordinated System for gaining NHS Permission (CSP)

c) NHS Honorary Research Contracts and the Research Passport
d) Site-specific Assessment

4. Peer Review

5. The Clinical Trials Regulations
a) European Commission Directives and UK Directives
b) Medicines and Healthcare Products Regulatory Agency
c) The Clinical Trials Toolkit

6. Other Research Regulation

a) Government Acts & Regulations
b) Consent, Confidentiality and Data Protection

c) Human Tissue Act

d) The Data & Tissues Toolkit

7. Good Research Practice & GCP

8. Sponsorship

9. Commercial Research

10. Indemnity

11. Consumer Involvement
a) INVOLVE (formerly Consumers in NHS Research)
b) Other useful publications and resources

12. Intellectual Property

13. Monitoring & audit

14. Health Care Standards and Performance Management