Next door to Bradford College, on the top floor of a secure building on the University of Bradford campus, is a unique service: Ethical Tissue.
It responds to requests from researchers for human tissue, and it stores tissue for biomedical research. Ethical Tissue is unique in providing a primary source of tissue solely for research purposes.
There are important ethical issues in human tissue donation and use, so I went to talk to Dr Susan Boyce about the work of her team. Although they deal with many requests for tissue in a year and have thousands of samples serving multiple uses, the space is surprisingly compact: a small office, and a laboratory where the samples are stored and prepared, and just three members of staff delivering the service: Susan (Head of Ethical Tissue), Senior Scientist Wayne Burrill, and Khadeja Suleman, Research Nurse.
First, Susan provided a definition of tissue: “Tissue is anything that contains human cells – that might be substantial body parts, small slithers of flesh, or blood, urine and so on.”
Susan then explained what makes Ethical Tissue special: “Being a primary source of tissue means we are involved in finding potential donors, meeting them, explaining what is needed, and getting their consent.”
“Nearly everyone has something to give,” Susan says. “Sometimes we need donors with particular conditions, or from particular ethnic groups. Sometimes we need normal tissue. We usually get a very good response. Nearly everyone we ask says yes they want to help researchers. We are always very grateful when people do decide to donate.”
The legal requirements are covered by the Human Tissue Act and regulated by the Human Tissue Authority :
Relevance: The tissue has to be collected for relevant research. In most cases, the research is providing new insight into medical conditions, or helping with the development of treatment.
Donor consent: Samples must be provided with the informed consent of the donor. “You own your body tissue,” Susan says, “and you have the right to say what happens to your tissue during life and after death.”
Securing consent means accepting without pressure someone’s decision not to donate. Most people are very keen to help: we are hardly ever turned down. None of the major faiths have an objection to tissue donation. Sometimes people are facing complex and serious operations and they do not want to consider donation. This is of course acceptable, we always respect the wishes of the individual.“
Informed consent: Another important ethical aspect of consent is that the donor understands the purpose of the donation, and can ask for further information if they want. Not everyone is capable of informed consent: “We do not take consent from vulnerable adults ” Susan says. “We take samples from children if the parents consent, and if the child actively assents. The next of kin can consent following the death of a patient – this does not delay the funeral arrangements.”
Generalised consent: “When people donate tissue to a tissue bank, they cannot specify what they want the samples used for,” Susan says. “They cannot request or rule out a particular kind of research. But sometimes we are able to tell them if there is a specific research project involved, and they can read the findings if they want when those are made public.”
Not for profit: “We make it very clear that there is no financial element for the donor. This is an altruistic gift,” Susan says. In addition, the service only seeks to recover costs from the researchers that it helps. “This applies whether our client is a public sector or charity researcher or a large pharmaceutical company developing a drug. We are heavily funded by the University, and this enables us to provide the service at a cost which enable research to go ahead.”
Anonymity, confidentiality and security: Every tissue donation is unique and is assigned a number, so the database is anonymous. The donor names are never stored on a computer. The samples and all records are in a highly secure, restricted access building and office, with any sensitive information kept in locked filing cabinets.
Timeliness and optimisation: If somebody gives tissue it will often be with the researcher very soon after, or it may be optimised – this means that the tissue can be used in several ways, to minimise waste and increase utility.
Deciding which research requests to respond to: “We don’t decide who gets what tissue,” Susan says. “We have independent scientific advisers (ISACs), all reputable and appropriate experts, and they decide which research requests we should respond to. We never meet the ISACs. This means we don’t send tissue to projects run by our friends, and we can’t favour investigations into health issues we are particularly concerned about.”
Validity of the research requests: “The research must be relevant and reasonable, the standing of the researcher must be acceptable, and they must have sufficient funding to complete,” Susan explains. It is the role of the ISACs to determine whether this is the case.
Susan Boyce is a clinical scientist with a PhD in neuroscience. She began her career working in a burns unit in the NHS. She then moved on to set up a skin bank for therapeutic transplantation at the University of Sheffield, before coming to lead Ethical Tissue at Bradford.
“This is the ultimate in re-cycling,” Susan says. “It is very ethical. It gives you relevant results that are for the benefit of all.”