Establishments that conduct human tissue research under recognised research ethics committee approvals are exempt from being licensed for the storage of relevant material for research under the HT Act 2004. In our experience, it is common for establishments that hold a storage licence under the HT Act 2004 to also store human tissue for projects with ethical approval from recognised research ethics committees.
During HTA inspections of research establishments, the inspection teams will focus on human tissue that is stored under the licence but will also seek to understand how systems are used to manage human tissue that is stored under ethical approval. This is important as research that is ethically approved will have an end date and, unless human tissue pertaining to that study is used or disposed of in the lifespan of the research project, it either has to be stored under a new ethical approval or stored under the licence when the approval expires. Where issues arise during the inspection that are relevant to human tissues being stored for projects with ethical approval from recognised research ethics committees, the inspection team may decide to take a note of relevant information. Examples of this include the ethical approval reference number, study title, study start/end dates, as well as the human tissue/s stored. This information can be shared and discussed with our colleagues at the Health Research Authority (HRA) Research Ethics Service. The HTA and HRA have a long-standing Memorandum of Understanding, part of which permits the sharing of information relevant to the related work of both bodies. By working together in this way, we aim to provide a coordinated regulatory approach for the benefit of researchers and public protection.