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The Safe and Ethical Supply of Human Tissues for In Vitro Studies

Medical and scientific research workers in industry, academia and hospitals need human tissue samples for their research programmes. Many bioscientists have tried to achieve this by establishing a direct relationship with a surgeon or a pathologist at a local hospital. In many cases, the supply is unreliable and, consequently, the progress of good research has been frustrated.1 The recent controversy involving staff working at the Alder Hey and Bristol Hospitals has shown that the consent of the next of kin to use non-transplantable organs and tissues for medical research has not always been obtained. It is highly likely that this practice has occurred at other hospitals throughout the UK. Donations of cadaveric organs and tissues are accompanied by relevant medical information and results of virological testing. Even where donated human tissue is stated to be HIV1 or HIV2 negative and Hepatitis B and C negative, research workers receiving samples of this tissue are advised to treat all tissue as biohazardous. Tissue donated from living patients undergoing elective surgery cannot be tested for HIV1 or HIV2 without the patient’s prior informed consent. It is, therefore, the duty of staff operating a tissue banking service to ensure that ethically approved recipients of donated human tissue work according to government-recommended safety standards within properly equipped scientific laboratories. A computerised and manual tissue-management system of recording and auditing the collection, processing, storage and distribution of human tissue samples can ensure that the use and eventual disposal of all samples can be traced at any time. Providing these conditions are observed, I believe that it is now time to make it possible for ethically approved bioscientific institutions to have access to supplies of a wide range of human tissues that will enable research programmes to be planned and carried out more efficiently. The whole process of procurement, processing, storage and equitable distribution of non-transplantable human organs and tissues for research deserves the dignity of official government recognition. In the UK, the Human Tissue Act 19612 permits the procurement of non-transplantable human organs and tissues for medical research and education. The report of the Nuffield Council on Bioethics, published in April 1995,3 highlighted several important points concerning human tissue use in biomedical research. It recommended strict adherence to three important ethical principles.