Consent

The principle of Consent or Authorisation for use of human tissue underpins the current UK tissue legislation and is a strong component of the Human Tissue Authority's Codes of Conduct.

Consent is legally required for research if the tissue is:

  • From a living person and the samples are identifiable.
  • From a living person and the samples are anonymised with no NHS REC approval
  • From a deceased person and collected after September 1st 2006 (both anonymous and identifiable samples).

Consent for DNA analysis in Scotland should be explicit. It does not have to be in writing. However, if taken verbally this should be clearly documented. Consent is not legally required if the results of the DNA testing will not be used for the following research related purposes:

  • Medical screening or treatment.
  • The material is derived from a living person and will be used for clinical audit, education relating to human health, performance assessment, public health monitoring or quality assurance.
  • Tissue is from a living person, anonmyised (not irreversibly linked) and the research has/will be reviewed favourably by an NHS ethics committee.
  • The research involves adults with incapacity.

Who can give consent?

When consent is required it should be obtained from the individual themselves. However, some other ways of gaining appropriate consent are legally acceptable. For adults who lack the capacity to consent, it may be deemed to already be in place in certain circumstances e.g. for a clinical trial authorised and conducted under UK regulations.

If a person dies before consent is taken, the consent can be gained from a nominated representative i.e spouse, partner, child, brother, sister, grandparent, grandchild, niece, nephew, step parent, half sibling or friend of long standing. If the tissue originated from a living child, who cannot decide, or is not competent, consent can be gained by a person with parental responsibility. If the tissue originated from a deceased child consent can be gained by a person with parental responsibilities or a nominated representative.

Certain material is exempt and can be used legally for research without qualifying consent as described below:

  • Existing material procured prior to September 1st 2006
  • Material manufactured outside the body i.e. cell lines
  • Embryos outside the body. These are separately legislated for the Human Fertilisation and Embryology Act 1990.