Two major incidents were cited – retention of hearts at Bristol Royal Infirmary in 1996 and retention of >200 organs or tissue samples at Alder Hey Children’s Hospital in 1999. The investigation into the Alder Hey incident lead to the Redfern Report, which when presented to parliament prompted the development of this new regulation.
Consent is, therefore, a founding principle of the Human Tissue Act and this regulation provides the assurance that any human tissue donated for research is donated under fully informed consent. This regulation is governed by the Human Tissue Authority (HTA) who have prepared a set of guidance documents, including Codes of Practice published on HTA web site. https://www.hta.gov.uk/guidance-professionals/hta-legislation/human-tissue-act-2004
Any human tissue being stored for research purposes must be stored in HTA Licenced premises, unless the samples are anonymised, and the research study is covered by an approved Research Ethics Committee (REC) or an Institutional Review Board (IRB).
Samples collected as part of an ethically approved clinical trial do not fall within the HT Act, however they are regulated under the Medicines for Human Use (Clinical Trials) Regulations 2004 (2006/2008) which includes the provision of fully informed consent.
An HTA Licence allows samples to be stored for research purposes but does not approve the use of the samples. Approval for use comes through RECs or IRBs.
In the UK, ethics may be granted under a specific project or a generic approval under a Research Tissue Bank approval.
If you have any questions, feel free to drop Sonia Houghton a message through our contact form.
Douglas McKechnie M.D.