The Human Tissue Act 2004 (the Act) makes consent the fundamental principle underpinning the lawful removal, use and storage of human tissue. All relevant material collected and stored for scheduled purposes, before 1 September 2006, does not require consent. However, research ethics committees have the discretion to require consent before the archived tissue is used for research.
Consent for specific, ethically approved research projects
The National Research Ethics Service (NRES) consent form for your specific project should be used. It is good practice to gain consent for all types of tissue even if they are not licensable under the Act.
Please visit our seeking consent section for further guidance on the NRES consent process.
Samples used in specific, ethically approved research projects may be a valuable resource for future research projects. Once the research project is complete, surplus tissue from the project may be stored for future research but separate consent must be in place. The site of storage must be covered by an HTA Licence. The JRMO has a consent form available for this purpose -Consent to donation and storage of tissue samples for future medical research [PDF 21KB]. This form must be incorporated into the Research Ethics Committee application.
Consent for the use of surplus tissue for research
The National Consent Forms for Treatment or Investigation (Forms 1 and 2) have been amended within this Trust to comply with the Act..
The addition of a section on research ensures that the Trust is compliant with the Act and with the HTA's Code of Practice on Consent. The amended National Consent Forms for Treatment or Investigation (Forms 1, 2 and 3) are in triplicate and a copy of the form should be forwarded to the Human Tissue Resource Centre via Pathology for their records.
The Trust's consent form process flowchart [PDF 32KB] provides information on the process for the forms. Tissue Use Information Leaflets should be made available to patients in all pre-admission clinics and on all wards.
Withdrawal of consent
By signing the research section of the National Consent Form, patients who have given their permission for surplus diagnostic tissue to be used for research are fully entitled to withdraw this consent at any time. A 'withdrawal of consent letter' is available for this purpose and patients should contact the HTRC to discuss the process. A copy of the letter will then be sent out to the patient for completion and then the HTRC will ensure that the patient’s wishes are fully implemented.
Donated tissue that is stored will then be withdrawn from storage. However, any tissue that has been distributed and used for research cannot be withdrawn.
Consent for tissue samples which are additional to surplus tissue
The amended national consent form for treatment or investigation only covers tissue that is surplus to diagnosis and would normally be discarded. Separate consent is required if additional samples are to be taken, which would not be needed for diagnostic purposes. The 'consent to donation and storage of tissue samples for future medical research form' may be used for this purpose.
Please contact the Human Tissue Resource Centre for more information and to obtain a copy of this form.
Consent for post-mortems
The Trust’s current post-mortem consent form includes a section on research.