The Human Tissue Act: researcher responsibilities
This article aims to introduce researchers into the regulatory requirements for research with human tissue.
The Human Tissue Act (2004)
The Human Tissue Act aims to provide a consistent legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissue.
It makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons. Relevant material is defined as material that has come from a human body and consists of, or includes, human cells. It is worth noting that the act is only applicable in England, Wales and Northern Ireland as Scotland has its own legislation.
The Human Tissue Authority (HTA) was established in April 2005 to regulate various activities involving the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes such as research, transplantation, and education and training. HTA licenses premises for tissue storage and for regenerative medicine where the use of human tissue or cells is used for advanced therapy medicinal products (ATMPs).
The Human Tissue Act has significant implications for the conduct of clinical research. Human tissue can be taken, stored and used for specific research, providing the project has Research Ethics Committee (REC) approval. The Human Tissue Act incorporates the European Union Tissue and Cells Directives (EUTCD).
Researchers involved in studies using human tissue should refer to their Research Department Human Tissue Lead or the HTA for advice on the use of tissue in research.
Prior to study approval
All human tissue studies should be registered with your Research Department at the earliest opportunity. Appropriate ethical approval should be sought and the study Sponsor will need to review and approve the study documentation and ethical application. The Health Research Authority (HRA) reviews the ethical aspects of all human tissue research including clinical trials involving stem cells and other regenerative medicines. The Human Fertilisation and Embryology Authority (HFEA) regulate the use of embryos in stem cell research. Licensed research can only take place on embryos created in vitro following appropriate parental consent.
All studies will require a Protocol outlining the study background, study design and outcome measures. For prospective tissue collections appropriate participant information sheets (PIS) and consent forms (ICF) should be included in the submission. For retrospective anonymised sample requests there is no need for consent but ethics will need to review and agree to waive consent.
For research tissue bank (RTB) applications the ethical approval is valid for five years and it will require ethical renewal prior to the expiry date. Currently there is a requirement to gain Institution Research approval after ethical review but this is due to change with the implementation of the HRA approvals process from April 2016; Institutions will be assessing, arranging and confirming capacity and capability for studies going forward.
Table 1. List of documents required for human tissue studies.
Required for Ethical review
Required for Research Department review
Ethics application form
Participant Information Sheets
Withdrawal of consent form
Confirmation of destroyed samples
Study management arrangements
Ethical approved documents
Tissue sample tracking form
Tissue sample record form
Material Transfer Agreement
Research team training log
Study specific Standard Operating Procedures (SOPs)
Tissue sample transfer request form
Tissue sample coding document
When preparing the documents required for ethical review a few useful points to remember are:
- To include details in the PIS and ICF regarding long term tissue storage, DNA testing and animal testing.
- All investigators should be encouraged to consider long term tissue storage but this is not always feasible due to lack of funding.
- A lot of funders will not fund long term tissue storage. Tissue without valid ethics should only be stored in HTA Licenced premises. Access to stored tissue is via a new ethics application or adoption into an existing RTB.
- When tissue is to be transferred to an external lab or institution there should be a documented formal tissue transfer Agreement usually known as a Material Transfer Agreement (MTA) signed by authorised personnel.
During the study
The Research Ethics Committee approved protocol should be followed and signed consent forms must be kept in both the investigator site file and in the medical notes of the patient. The only exceptions to obtaining consent are if:
- the tissue was collected before 1 September 2006
- 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
For tissue storage, all samples should be appropriately labelled and a record should be kept in order that the origin, storage location, use and final destination of tissue samples can be traced. Tissue must be stored as described in the approved ethics application or in a HTA licensed tissue bank.
Annual progress reports will need to be submitted annually to the Ethics Committee. Any changes to the study documentation will need to be submitted to the Sponsor for classification. All substantial amendments will require ethical review.
The study Sponsor and the HTA may audit or inspect research tissue banks and storage facilities.
Following the end of the study
Submit the End of Study Report to the REC and the Research Department. Any remaining tissue samples should be destroyed according to local policies or transferred into a HTA licensed tissue bank. Following the study end, study documents should be archived appropriately and for long term tissue storage, consent forms should be available and accessible prior to any tissue release.
- Human Fertilisation and Embryology Authority http://www.hfea.gov.uk/
- Human Tissue Authority https://www.hta.gov.uk
- Human Tissue Act http://www.legislation.gov.uk/ukpga/2004/30/contents
- Health Research Authority http://www.hra.nhs.uk/
- Medical research Council Ethics series https://www.mrc.ac.uk/publications/browse/human-tissue-and-biological-samples-for-use-in-research/
- Research Tissue Bank applications https://www.myresearchproject.org.uk/Help/Help%20Documents/PdfDocuments/researchtissuebank.pdf
- Regenerative Medicine regulations summary https://www.hta.gov.uk/sites/default/files/Role_of_regulators_in_regenerative_medicine.pdf