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Regulatory Compliance Section

Research Governance


In this section, you will find an explanation of what Research Governance is, an overview of how Research Governance has developed and summaries of key documents, regulations and other resources which are of relevance to healthcare research.


Subsections

What is Research Governance?

This page explains what research governance is and whether it applies to you.

How has Research Governance developed?

This page summarises how research governance has evolved.

Responsibilities

This section states the responsibilities of employees and College in health research.

Research Governance Framework

This page explains the Research Governance Framework for Health and Social Care.

Good Clinical Practice

This page explains what GCP is and links to the ICH GCP Guideline.

Data Protection

This section has information on the Act and also the NHS Caldicott Guardians.

Medicines for Human Use Regulations

This page describes the Medicines for Human Use (Clinical Trials) Regulations 2004.

EU Directives

This page outlines the EU Directives on Clinical Trials and Good Clinical Practice. 

Human Tissue Act

This page outlines the content of the Human Tissue Act.

Mental Capacity Act

This page briefly summarises the content of the Mental Capacity Act.

Declaration of Helsinki

This page describes the Declaration of Helsinki, with links to the full text version.

Nuremburg Code

This page gives a short description of the Nuremburg Code.