Any relevant material collected and stored for scheduled purposes, before 1 September 2006, does not require consent to be in place.
However, research ethics committees have the discretion to require consent before 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 Human Tissue Act.
Visit our seeking consent section for further guidance on the NRES consent process.
Consent for specific, ethically approved research projects and for future research
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 a Human Tissue Authority 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.
A copy of this form will need to be recorded and held with the licensed research tissue bank once the specimens have been transferred.
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 Human Tissue Act 2004.
The addition of a section on research ensures that the Trust is compliant with the Act and with the Human Tissue Authority’s Code of Practice on Consent. The section will allow patients to agree to, or to refuse, the use of their surplus tissue for research. This is tissue which is taken for diagnostic purposes and any surplus would normally be discarded. Such consent should apply to tissue banks only for unspecified research. Research groups must complete an Application Request for Human Tissue if they would like access to stored surplus tissue for research.
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 new forms.
The amended forms must be used in conjunction with the Tissue Use Information Leaflet. This leaflet 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, 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 (020 3465 5376) for more information and to obtain a copy of this form.
Consent for post-mortems
The Trust’s current post-mortem consent form has a section on research included.
Which consent form do I use?