Understanding the use of human tissue in research – an introduction to the legal framework

Clemency Pleming, associate in the commercial and intellectual property teams, has provided a clear and practical overview of the legal framework governing the use of human tissue in research.

She explains what constitutes human tissue, when the Human Tissue Act 2004 applies, and the key responsibilities organisations have when collecting, storing or using human samples. The session covers licensing requirements, consent considerations for both living and deceased donors, the role of regulators and the interaction between tissue-handling obligations and data protection law.

In addition to clarifying the regulatory landscape, the presentation highlights common practical challenges faced by organisations navigating this area, from interpreting overlapping regulatory regimes to managing donor consent in evolving research contexts. Clemency offers pragmatic insights to help organisations anticipate risk, embed good governance and ensure that research involving human tissue is conducted to the highest ethical and compliance standards.

Whether conducting research directly or working with third party tissue banks and service providers, this presentation outlines the essential safeguards, approvals and compliance steps needed to handle human tissue responsibly and lawfully.