The Human Tissue Bill: good for consent but is it good for patients?

Abstract

The Human Tissue Bill, which is currently being considered by Parliament, has been written in response to the Alder Hey scandal involving the widespread retention of post-mortem human organs without patient consent.1 Whilst this practice was begun during the era of patrician doctors, the normative values of society have changed, and with them the nature of the doctor^patient relationship. The Bill has been written with the philosophy of patient autonomy and, moreover, will change the law so that individuals will have control over their bodies even after death. Furthermore, the Bill regards all bodily materials to be ‘tissue’, including tears, blood, urine and stools.Whilst it is widely accepted that patients should be aware of the use made of their bodily parts, is the Bill in its current form a good thing for patients? The Bill is designed to prevent use of human tissue without patient consent. The major issue raised by professional bodies has been the lack of diierentiation between samples taken at post mortem from those samples taken during life and which are redundant after appropriate investigations have been performed.2 After all, the vast majority of tissue and £uid samples sent to all clinical laboratories are from living individuals. The Bill allows the use of human samples to be used without consent for four purposes: clinical audit, education and training that is ‘incidental to medical diagnosis or treatment’, public health monitoring and quality assurance.3 The key question lies in the de¢nition of quality assurance. Does it include comprehensive maintenance of assays which would include full method evaluation, sample collection and storage conditions, development of reference ranges, determination of interfering agents, regular assessment of patient means as well as internal and external quality assessment? Would it include only assays currently in service or potential additions to our menu of tests? Information on these issues is not currently available on reagents provided by the diagnostics industry to the full requirements of clinical need. Perhaps this information would become available if the diagnostics industry was required to provide similar levels of evidence as the pharmaceutical industry ^ but this would be ¢nancially sti£ing. A further issue regarding assay maintenance is in the training of future laboratory stai. If small-scale projects (e.g. method evaluations) are included as quality assurance, they will become incidental to the diagnostic process and therefore be an acceptable use of the sample. If they are de¢ned as research, then the combination of available resource and the demand for ethical approval and patient consent would end hands-on method evaluation and improvement within NHS laboratories; and severely impact on training. What is the way forward? The bill envisages the birth of a HumanTissueAuthority whose remit will be removal, storage, and ‘. . . the disposal of relevant material which has been removed . . . for the purposes of his (sic) medical treatment’. Its function of oversight will include the establishment of codes of conduct. These codes will need to take into consideration the full needs of laboratory scientists to deliver best practice. Should the Bill be interpreted literally there are fundamental risks to laboratory medicine, which will have serious rami¢cations for patient safety. In addition to the problems of maintaining a comprehensive menu of diagnostically useful laboratory investigations, there is the problem of training. The Royal College of Pathologists bulletin board shows the fears of histopathologists who have interpreted the Bill quite literally. They understand it to say that it is lawful to teach tissue microscopy whilst seeing a sample for diagnosis but the same activity the following dayafter the diagnosis has been madewould represent unconsented teaching and would therefore be a criminal oience. It is di⁄cult to understand how the technical skills required for analytical techniques involving the use of tissue can be taught in the light of this interpretation. The HumanTissue Bill was developedwith a speci¢c focus on post mortem examinations without apparent regard for the wider rami¢cations on laboratory medicine. Our profession needs to be ready to interact with the future Human Tissue Authority to ensure that the law is interpreted for the real bene¢t of patients.