Search results

Under the Medical Devices Regulations 2002, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another commercial company in order to demonstrate the safety and performance of a non-CE marked medical device, or a CE-marked device that has been modified or is to be used for a new purpose.

If your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).

For the purposes of the content provided within this area we have adopted the definition of the term “regenerative medicine” that was used in the House of Lords Regenerative Medicine Report. "Regenerative medicine is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices."

The Mental Capacity Act 2005 (MCA) provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.

This section relates to the application of the Human Tissue Act 2004 to issues of consent, ethical review and licensing.

Legislation sets out when information about people can be processed for research and the safeguards that must be in place.

This operational guidance has been produced for researchers and study coordinators on the implications of the GDPR for the delivery of research in the UK.