Legislation and Guidance

The Department of Health Research Governance Framework for Health & Social Care 2005 sets out the broad principles of good research management for health and social care.

The Declaration of Helsinki sets out the ethical principles for medical research involving human subjects, including research on identifiable material and data.

The Medicines for Human Use (Clinical Trials) Regulations 2004 regulate trials of medicines on people.

The EU Clinical Trials Directive was introduced to establish standardisation of research activity in clinical trials throughout the European Community.

The Mental Capacity Act 2005 covers who can provide consent or be consulted and what type of research is appropriate to be conducted with people who lack capacity.

Guidance on Nominating a Consultee for Research Involving Adults who Lack Capacity to Consent

The nature of research means that there is a large amount of paper and electronic data held about research subjects. Research staff have a responsibility to their research subjects and their employer regarding data protection and must adhere to the Data Protection Act.

Governance Arrangements for Research Ethics Committees - A Harmonised Edition