Last updated on 20 Apr 2021

Research FAQs

I plan to undertake some work using human tissue. The work is not diagnostic, but I’m not sure if I should classify it as research either. Can you help?

The HTA considers research to be a study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge. In addition, the HTA endorses the definition provided by the Department of Health and the Welsh Assembly Government, which is as follows: ‘‘Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.’’
However, human tissue might be stored and used for another scheduled purpose that might first be thought of as research, for example:

Performance assessment

This term is intended to encompass use of material in the evaluation and assessment of in-vitro diagnostic kits. This is to make it quite clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent.

Quality assurance

A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

This includes separate examination or testing of tissue in order to ensure a high quality service and effective clinical procedures and diagnostic tests. In practice, this term could cover a review of the whole diagnostic process, including checking how information relating to tissue is recorded. The review is not, for example, limited to checking the accuracy of apparatus.

Clinical audit

A process to review explicit criteria, and the implementation of change, to continuously improve patient care and outcomes.
This is a means of finding out whether what is being done is appropriate and is being done correctly. For example, are guidelines being followed? Is best practice being applied? Tissue stored in diagnostic archives may need to be reviewed as part of the clinical audit process.

Our role and the Human Tissue Act
Other guidance