2 February 2012
One of the best ways to research human disease is to use human tissue and cells. This can be either in living subjects or donated tissue, which might be given after removal during surgery, if surplus to requirements. In legal terms human tissue is defined as “material that has come from a human body and consists of, or includes, human cells”.
The LDF is funding Professor Geoff Pilkington at the University of Portsmouth for his brain tumour research. We recently asked Professor Pilkington about the difficulties he has faced in obtaining tissue for study.
Professor Pilkington has been researching brain tumours for over 35 years and in his view, in order to progress science and research at a sufficient pace to save lives, the system for tissue donation needs to change.
Firstly, there are strict regulations on the use of human tissue. The Human Tissue Authority (HTA) is an independent statutory regulator, sponsored by the Department of Health. The HTA licences organisations that store and use human tissue for research, teaching, post mortems or treating patients and approves the use of organs and bone marrow for transplants (ref 1).
The Human Tissue Act 2004 (HT Act), which covers England, Wales and Northern Ireland, is the regulation that governs the removal, use and storage of human tissue. Scotland is covered by the Human Tissue (Scotland) Act 2006.
The HT Act also makes it unlawful to have human tissue with the intention of analysing the DNA without the donor’s consent.
The red tape
The HTA code of practice relates directly and solely to research, and licences organisations that store human tissue for research.
There are different rules regarding tissue from the living and the deceased. Tissue taken from a patient for diagnosis, and then stored in a diagnostic archive can be valuable in research, but can only be released when the following conditions have been met:
The guidance also states that “Ethical approval can only be given by a recognised research ethics committee”. This being either an REC operating to standards issued by the UK Health department, or an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA) to review clinical trials of certain products.
If the researcher intending to use the tissue is a university researcher, the situation is slightly different in that “A university ethics committee is not, for the purpose of consent exception considered to be a recognised research ethics committee. Therefore consent is still required for tissue to be used in a research project approved by a university ethics committee, even if it uses tissue from the living and the researcher is not in possession, and is not likely to come into possession, of information identifying the participant” (ref 2).
Professor Pilkington comments that the system of applying for ethical clearance to use tissue is cumbersome and, rather than increasing the availability of tissue and thereby the amount of research that could be conducted with it, it actually hampers such research. This leads to frustration, not only to researchers but also to those who wish to donate tissue for research, and their clinicians.
Professor Pilkington explained to New Science the complexity of the on-line forms and the periodic reviews of ethical clearance which take up time. He is regularly contacted by patients who would like their tissue to be used in research to save lives, but he has to inform them that this is unlikely - he must have separate ethics clearance for each hospital from which he is to receive tissue. If that ethics clearance is not in place, even if the patient wishes to donate their tissue, Professor Pilkington would be unable to accept it.
In his words, this is leading to "around 99% of all brain tumour tissue, which could be used in research, being discarded". He also points out that "This system is not helping patients, clinicians or researchers, and it is ultimately wasting time and hampering our research". He would like to see "the system being replaced with an opt-out, where tissue, which is removed during surgery and will be discarded, would automatically go to researchers who could use it in their research. If patients were unhappy with this, they could opt out of the system".
Professor Pilkington would also like to see the anonymisation of samples removed, giving researchers access to patient information that may help with research. This would also allow patients to follow the progress of their tissue in the laboratory.
How to donate tissue
The HTA advise that “If you want your tissue to be used for any medical research, or you may want it to be used only for specific types of research, it is important that you make these wishes clear to the healthcare professional who seeks your consent, and that they are stated in writing on a consent form. However, you should be aware that some tissue establishments may not be able to use your tissue at all if you impose very specific requirements for its use” (ref 3).
Tissue and Brain Banks
The HTA also note that people who are on the NHS organ donor register have not consented to their tissue being used after their death for research, although it may be possible for someone to do both, should they wish to (ref 3).
1. http://www.hta.gov.uk/aboutus.cfm - accessed 12/11/10
2. HTA Code of Practice 9 – Research http://www.hta.gov.uk/
legislationpoliciesandcodesofpractice/codesofpractice/code9research.cfm - accessed 02/11/10
howtodonateyourtissueforresearch.cfm - accessed 11/11/10