Consent and the Human Tissue Act
The Human Tissue Act makes informed consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display.
The Human Tissue Authority has produced a Code of Practice on Consent which is available as a resource on this page and should be referred to for detailed and specific guidance.
Training in Consent
Anyone who takes consent for the use of human tissue for research purposes must have received training in the fundamental principles of informed consent as detailed by the HTA Code of Practice 1: Consent; they must have full knowledge of the research including any sensitive and/or future use of the material; and they must know all risks associated with the collection and/or use of the material for the purposes of the research.
The Cardiff University HTA Standard Operating Procedure for Informed Consent details the consent requirements for clinical and non-clinical individuals. A training manual on informed consent has been produced that, when read in its entirety, will constitute consent training for the collection of human tissue from the living for research purposes. The training manual also provides guidance on the contents of information sheets and consent forms with regard to planned and future use of human tissue. Both documents can be found at the top right of this page.
Training in informed consent is also available to University and UHB staff through the Good Clinical Practice (GCP) course provided by UHB and Research, Innovation and Enterprise Services.
Certificates of all consent training must be retained along with documented evidence that the person taking consent has knowledge and an understanding of the research for which they will be obtaining consent, such evidence could be as a named investigator in the protocol, confirmed attendance at a study briefing/training session or a signed declaration confirming knowledge and understanding of the study. Evidence of consent training and study knowledge for those who take consent will form part of the internal audit process.
The Code of Practice outlines the statutory requirements for consent, including circumstances in which consent is not required.
- Consent is not required to use or store material from the living for the following scheduled purposes: clinical audit, education or training relating to human health, performance assessment, public health monitoring and quality assurance. However consent is required for the use of tissue from a deceased person for the above purposes.
- Consent is not required for existing holdings, i.e. tissue samples held before the HT Act came into force (1 September 2006).
- Tissue from the living may be stored and/or used for research purposes without consent provided that the project has appropriate ethics approval by a Research Ethic Committee recognised by the National Research Ethics Service (NRES) AND the tissue is anonymised such that the researcher is not in possession of information identifying the donor, nor is likely to come into possession of such information.
Note: If a project is exempt from consent it is not necessarily exempt from the HTA Licence.
Consent and use of DNA
Typically consent must be in place for DNA analysis, however the HTA has provided guidance on when DNA analysis may be used for obtaining scientific or medical information about the person whose body manufactured the DNA even if their consent has not been obtained. A link to this guidance can be found at the top right of this page.
Records of Consent
The researcher should ensure that valid and appropriate informed consent has been taken for the removal, storage and use of the human tissue. Ideally copies of consent forms should be available. However, if consent is taken elsewhere, a document will need to be produced from the supplier stating that consent is in place for all the tissue supplied.
Data Protection Act 1998
In addition to the HT Act requirements on consent, researchers are reminded of the potential need to seek explicit consent under the Data Protection Act 1998.
Further advice from Cardiff University on the Data Protection Act 1998 is available here.