Stored Human Bodily Material: Use in Research in the United Kingdom

Abstract

Human bodily material can be removed from a living person and stored and used in research if the person has been informed about the storage and use of the material in research, and consented. If the person is a child (under 18), or not competent to consent, a parent or other lawfully authorised person may consent. Similarly, a lawfully authorised representative may consent for an adult who is not competent to consent. People, or their nominated representatives, may authorise the use of bodies or bodily material after death, for research. Bodily material removed for diagnostic or treatment procedures, or kept for audit or forensic testing, may be used in research without consent if a recognised research ethics committee has approved the research and the material is provided in unidentifiable form.

Key Concepts:

  • Human bodily material from a living person may be used in research if the person consents to its use in research.

  • A parent or legally authorised representative may be able to consent if the person is a child and not able to do consent; and a legally authorised representative may be able to consent for an adult who is not competent to consent.

  • Consent does not need to be in writing but the person should be provided with written or verbal information about the proposed research before consenting.

  • A person or the person's nominated representative may consent to the use of the person's body or bodily material in research after the person's death.

  • If the bodily material was initially removed for a purpose other than research, such as a diagnostic test, treatment, an audit or a forensic test, it can be used in research if consent can be obtained later; or in limited circumstances without consent, if it is unidentifiable; a recognised research ethics committee (REC) has approved the project; and, in England, Wales and Northern Ireland, but not Scotland, a licence has been obtained from the Human Tissue Authority.

  • People do not legally ‘own’ bodily material removed from their body. They have no legal right to have the material returned to them; used only in a particular way or destroyed. However, under ethical guidelines, bodily material should not be used in research if people are known to object.

Keywords: bodily material; research; storage; consent; property rights; commercialisation

References

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Further Reading

Australian Law Reform Commission Report No 96 (2003) Essentially Yours: The Protection of Human Genetic Information in Australia. http://www.austlii.edu.au/au/other/alrc/publications/reports/96/

Human Genetics Commission, UK (October–December 2000) Public Attitudes to Human Genetic Information. London: Human Genetics Commission. www.ipsos‐mori.com/Assets/Docs/Archive/Polls/hgcrep.pdf

Human Genome Organisation (HUGO) Ethics Committee (1998) S tatement on DNA Sampling: Control and Access. London, UK: HUGO. http://hugo‐international.org/img/dna_1998.pdf

Kennedy I and Grubb A (2000) Medical Law, 3rd edn. London, UK: Butterworths.

Laurie G (2002) Genetic Privacy. A Challenge to Medico‐legal Norms. Cambridge, UK: Cambridge University Press.

Magnusson RS (1998) Proprietary rights in human tissue. In: Palmer N and McKendrick E (eds) Interests in Goods, 2nd edn. London, UK: Lloyds of London Press.

MRC (2000) Public Perceptions of the Collection of Human Biological Samples. London, UK: Medical Research Council.

Nuffield Council on Bioethics (2010) Human Bodies: Donation for Medicine and Research. London, UK. http://www.nuffieldbioethics.org/sites/default/files/Donation_full_report.pdf

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How to Cite close
Skene, Loane(Sep 2014) Stored Human Bodily Material: Use in Research in the United Kingdom. In: eLS. John Wiley & Sons Ltd, Chichester. http://www.els.net [doi: 10.1002/9780470015902.a0005656.pub3]