Consent

Existing holdings of tissue and consent

Any relevant material collected and stored for scheduled purposes, before the 1st 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 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. For guidance on the NRES consent process please visit Seeking consent

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 an HTA License. The Joint R&D Office has a consent form available for this purpose - Consent to Donation and Storage of Tissue Samples for Future Medical Research. This form must be incorporated into the Research Ethics Committee application. A copy of this form will need to be recorded / held with the licensed research tissue bank once the specimens have been transferred.

Download Consent for donation and storage for future medical research form.

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 in order 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. For information on the process for the new forms please see the flowchart below.

Download The Trust consent form process flowchart.

The amended forms must be used in conjunction with the Tissue Use Information Leaflet (ref: BLT/PTINFO/064, download below). This leaflet should be made available to patients in all Pre-Admission Clinics and on all wards.

Download Tissue use information leaflet.

Withdrawal of consent

Patients who have given their permission for surplus diagnostic tissue to be used for research, by signing the research section of the National Consent Form, are fully entitled to withdraw this consent at any time. Note: Donated tissue that is stored will be withdrawn from storage. However, tissue that has been distributed and used for research cannot be withdrawn. A Withdrawal of Consent letter is available for this purpose and patients should contact the Human Tissue Resource Centre (020 7601 7521) 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.

Patients wishing to withdraw from specific research projects should continue to contact the study team for that project.

Consent for tissue samples which are additional to surplus tissue

The amended National Consent Forms for Treatment or Investigation only cover tissue which is surplus to diagnosis which would normally be discarded. Separate consent is required if additional samples are to be taken, which would not be needed for diagnostic purposes, for example:

An extra vial of blood
A biopsy of normal and abnormal tissue
A buccal swab
An extra pot of urine

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 7601 7521/ 15-7521) 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?

Download Which consent form flowchart.