Legislation

Key legislation for all research studies

All research and its associated activities, must be compliant with the:

The RGF sets out the guiding principles and standards for conducting research in a health or social care setting.

Provides for the legal obligation of public authorities to disclose information through an approved publication scheme and in response to requests.

The Declaration is a statement of ethical principles for research involving human subjects, including research on identifiable human material and data.

Regulates the processing of information relating to individuals, including the obtaining, holding, use or disclosure of such information.

A key requirement for anyone involved in the conduct of clinical research is Good Clinical Practice (GCP) training. GCP is the standard and guidelines to which all research is conducted. It is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human participants. The NIHR offers a range of online GCP training modules:

Other relevant legislation

Other legislation may also be applicable to study, depending upon the research topic, such as the:

Regulates the conduct of Clinical Trials of Investigational Medicinal Products (CTIMPs)

Regulates activities concerning the removal, storage, use and disposal of human tissue

Provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions

Provides a framework to ensure the protection of children and vulnerable adults.

Contact us

Please contact us if you need any further information about the potential impact of these acts upon your research.

Anthony Davis, Research and Knowledge Manager
anthony.davis@nhs.net

01322 625700 (Mon-Tues)
0203 260 5117 (Wed-Thurs)