Human Tissue in Research
The Human Tissue Act
The Human Tissue Act 2004 (HT Act) and the Human Tissue (Scotland) Act (2006) has the broad purpose of regulating the storage and use of human tissue from the living, and the removal, storage and use of tissue from the deceased. The HT Act makes 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. This includes ‘residual’ tissue remaining following clinical and diagnostic procedures. It also covers the removal of such material from the deceased.
Human tissue can be defined as material which has come from the human body which consists of, or includes, human cells. Investigators should check the HTA guidance on relevant material to confirm whether or not the sample types they intend to use in their research are covered by the HT Act.
Cell lines are excluded, as is hair and nail from living people. Live gametes and embryos are excluded as they are already covered by the Human Fertilisation and Embryology Act (1990).
The Human Tissue Act (2004) deems the retrieval of human tissue or organs for the scheduled purpose of research, from a deceased person, as a licensable procedure.
Any research proposal that involves the retrieval of organs or tissues from a deceased organ donor for the purpose of research, within England, Wales or Northern Ireland, must ensure that this activity is performed on a premises covered by a HTA removal licence.
No HTA licence is required if the research proposal requires access to an organ retrieved for the purpose of transplantation that is subsequently found not suitable for transplant purpose.
The Human Tissue Act (2004) also established the Human Tissue Authority (HTA) (The HTA has no authority in Scotland but does carry out some activities on behalf of the Scottish Parliament) to:
- Advise on and ensure compliance with the Act
- Develop national operational procedures and guidelines
- Licence activities using human tissue
The HTA has issued good practice guidance in its Codes of Practice, including the recently released Code of Practice for Research, and answers to Frequently Asked Questions are available. The HTA also licences a number of activities under the HT Act, one of which is the storage of tissue for “scheduled purposes” which includes research.
The Research Manager – ODT can provide advice on licencing issues.
Local NHS Trusts and Universities may have local policies on the handling of human tissue for research. Applicants must ensure that research involving human tissue, whether undertaken by University or NHS Trust employees, is subject to common governance procedures in line with local policies and current legislation.
Consenting/ authorising to use human tissue in research
The HTA Code of Practice on consent provides detailed guidance on all aspects of consent for the use of human tissue for a scheduled purpose.
It is routine for the families of organ donors to be asked to provide consent/ authorisation for the use of non-transplantable tissue to be used in research. Please consult with the Research Manager – ODT over issues around generic consent or if you require specific research consent for your study.
Consent/ Authorisation Exceptions in Research
There are exceptions to the consent provisions of the HT Act for research and these are detailed in the HTA Code of Practice for Consent and on the HTA website. The most important exceptions to the consent provisions of the HT Act for research are:
Consent is not legally required to store and use tissue for research where:
- the tissue is an existing holding (it was held before 1 September 2006 when the HT Act was implemented)
- the tissue has been taken from a living person and the researcher is not able to identify the donor and the research is ethically approved by a Research Ethics Committee.
- imported tissue
HRA approval will need to be sought. Please refer to https://www.myresearchproject.org.uk/help/hlphraapproval.aspx#Which-projects-apply-for-HRA-Approval.
Human Tissue Authority
Department of Health - Tissue
Data and Tissue Tool Kit (MRC)
National Research Ethics Service
To ensure that researchers are aware of their responsibilities when seeking to access human organs or tissues for research from NHSBT the PI will be expected to sign an agreement with ODT. Next section: QUOD