ESTABLISHING REGULATORY APPROACHES TO ENABLE ALL SURPLUS TISSUE SAMPLES TO BE POTENTIAL RESEARCH SAMPLES

Abstract

Human tissue is routinely removed from patients in the course of diagnosis and treatment. Surgical procedures such as tumour excision or biopsies often involve removing relatively large amounts of tissue after which only a small amount is required for diagnostic purposes. The remainder is stored in a diagnostic archive in case further testing should be required. However, where all or some stored tissue is no longer required for diagnostic purposes it may have value for health research purposes, for which these diagnostic archives can be a rich source of tissue samples. Health research is generally considered to be something which is a ‘good’ and in the best interest of society, as the knowledge which is generated from research positively impacts on all members of society, whether directly or indirectly. Consent is the fundamental principle which underpins the lawful storage and use of tissue for research purposes. However, where tissue is removed during clinically directed procedures and is surplus to diagnostic requirements, the opportunity to request consent is often missed and obtaining consent retrospectively can be problematic. The Human Tissue Act 2004 does provide for the secondary research use of surplus tissue in the absence of consent where certain safeguarding mechanisms are in place. The research must be ethically approved and the research must be carried out in circumstances such that the person carrying it out is not in possession of information which could identify the person from whom it was removed. Whilst the Human Tissue Act 2004 is permissive of the secondary research use of surplus tissue in the absence of consent, there remain barriers to accessing such tissue samples for research purposes. My thesis aims to establish regulatory approaches which if implemented in practice, could be more enabling of the secondary research use of surplus tissue samples, whilst also safeguarding individual patient interests.

Date of Award	1 Aug 2022
Original language	English
Awarding Institution	The University of Manchester
Supervisor	Soren Holm (Supervisor) & Sarah Devaney (Supervisor)