Obtaining informed consent is a critical part of any research project involving human volunteers, or their organs, tissue or data.
Royal Brompton & Harefield NHS Foundation Trust’s policy for consent to examination and treatment applies when seeking consent for participation in any research.
Good clinical practice requirements set out what must be discussed as part of the process of obtaining informed consent for a research project.
Where the research project involves the removal, storage and use of human tissue, additional consent in accordance with the Human Tissue Act 2004 must be obtained before any tissue can be used in research.
Any person who is responsible for obtaining consent must be appropriately trained to do so by:
- undertaking face-to-face training in obtaining consent
- being familiar with, and following the relevant consent policies and procedures
Please contact the tissue governance manager for details of upcoming consent training courses.
It is the principal investigator’s responsibility to ensure that appropriate procedures are in place prior to obtaining consent. Key points are:
GCP principles – general
- consent must be a positive act; absence of refusal is not sufficient
- project-specific consent forms and procedures must be approved by an appropriate research ethics committee
- the consent process must be accompanied by information in a format that the person giving consent can understand
- any person seeking consent must be appropriately trained in obtaining informed consent
- the person seeking consent must have a thorough understanding of the procedure involved and the research to be able to answer any questions that may arise during the consenting process to ensure the person giving consent is fully informed
- it is the responsibility of the person removing the material from the body for research purposes or releasing surplus material or receiving material from another establishment to be satisfied that appropriate consent is in place
- it is the responsibility of the person using or storing the material for research purposes to ensure that there is appropriate consent and that the consent is recorded accurately
Human Tissue Act principles – material from the living
- informed consent is required under common law to remove tissue from the living,
- under the Human Tissue Act, appropriate consent is required to store and use tissue from the living for the following scheduled purposes:
- anatomical examination
- obtaining scientific or medical information about that person which may be relevant to any other person
- public display
- research
- transplantation
- tissue taken from the living can be used without consent for research providing it is used for a specific research project approved by a recognised research ethics committee and the material is, and remains, fully anonymised to the researcher
- generic consent is required to store tissue for future, unspecified research once the specific project it was donated for has ended. It is preferable that generic consent is sought at the same time as project-specific consent
Human Tissue Act principles – material from the deceased
- appropriate consent is required to remove, retain or use organs, tissue or cells from the deceased for all scheduled purposes
- consent is not required to remove or retain organs, tissue or cells under the authority of a coroner or for a criminal investigation, although appropriate consent must be sought for any retention or use of the material beyond the coroner’s authority
- if material is to be removed for the primary purpose of research during a post-mortem examination, then consent for this removal must be obtained separately to consent for the examination
- Trust bereavement service staff are trained in sensitively seeking consent for post-mortem examinations and retention of tissue from bereaved family members. If you wish to seek consent for the removal of tissue from a deceased patient, this should be referred to the bereavement service
The documents at the bottom of this page give more information and guidance on the requirements of obtaining consent in accordance with the Human Tissue Act.