The Use of Human Tissue in Biomedical Science Flashcards
Burke & Hare
1828 - Insufficient cadavers available to meet high demand for medical research
William Burke and William Hare, murdered and sold the corpses of 16 victims to Doctor Robert Knox in Edinburgh for his well attended anatomy lectures
Lead to The Anatomy Act in 1832
Tuskegee
Macon County Alabama, 1932-1972
Natural history study of syphilis in African American men run by US Public Health Service
Treatment available but never given even to late stage cases, no consent obtained, no ethical review.
Results published in journals
Henrietta Lacks - HeLa cells
Was treated in Johns Hopkins (Baltimore, USA) for cervical cancer in 1951, and died shortly afterwards.
Henrietta was not asked to consent to her cells being used for research.
George Otto Gey worked in the tissue lab at Johns Hopkins and managed to coax ‘HeLa’ cells into dividing. Divisions are still going on today.
HeLa cells were used to develop therapies.
John Moore
Received a splenectomy in 1976 in Los Angeles.
John was not asked to consent for his cells to be used in research.
Mo cells were developed by Dr David Golde and used in a wide range of research.
Human Tissue Act 2004
Created Human Tissue Authority (HTA) as body within Department of Health to regulate the Act.
Covers six regulated “Sectors” for “Scheduled Purposes” – Human Application, Anatomy, Post Mortem, Public Display, Research, Organ Donation and Transplantation.
Fully informed consent as a central principle
Storage and use of human tissue and cells now requires a licence from the HTA
Licensed establishments must have a Designated Individual who is in charge of licensed activities
Regulates the removal, storage and use of human tissue.
Human tissue (Relevant Material) is defined as material that has come from a human body and consists of, or includes, human cells.
The Human Tissue Act 2004 makes it lawful to take minimum steps to preserve the organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased, or, in the absence of their known wishes, obtaining consent from someone in a qualifying relationship.’
New regulations covering DNA analysis
What materials are not included in the Human Tissue Act (HTA)?
- Gametes
- Embryos outside the human body & ESC
- Hair & nail from the body of a living person
- Plasma & serum
- Cell lines & dividing cells
European Union Tissue and Cells Directives
Transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007: focus on human application (patient treatment).
All tissues must be traceable from donor to recipient.
The remit of the HTA was widened to the regulation of procurement, testing, processing, storage, distribution and import/export of tissues for human application.
Offences of the Human Tissue Act 2004
Removing, storing or using human tissue for Scheduled Purposes without appropriate consent.’
Storing or using human tissue donated for a Scheduled Purpose for another purpose.
Trafficking in human tissue for transplantation purposes.
Carrying out licensable activities without holding a licence from the HTA (with lower penalties for related lesser offences such as failing to produce records or obstructing the HTA in carrying out its power or responsibilities).
Having human tissue, including hair, nail, and gametes (i.e. cells connected with sexual reproduction), with the intention of its DNA being analysed without the consent of the person from whom the tissue came or of those close to them if they have died. (Medical diagnosis and treatment, criminal investigations, etc., are excluded).’
Are cell lines covered by the HTA?
An HTA licence is required for the storage of primary tissues (i.e. tissues directly derived from the human body).
No licence is required for obtaining samples if tissue is obtained under REC approval specifically for cell line production.
No licence is required for cell lines developed from these as they have been created outside the human body
UK Stem Cell Bank
In 2003, the UK Stem Cell Bank was established at the National Institute for Biological Standards and Control (NIBSC) to curate standardised human stem cell lines on a single site.
The Bank is overseen by an independent Steering Committee, which also oversees all UK research involving established human embryonic stem cell lines.
Human Fertilisation and Embryology Act 2008
Use of human embryos was regulated by the HFE Act 2008
The HFEA demands that those who receive a licence for projects involving the derivation of human embryonic stem cell lines deposit a sample of each cell line created in the UK Stem Cell Bank, and they are not permitted to carry out secondary research projects on ES cells or to transfer ES cell lines to third parties without the approval of the Steering Committee.
