 | | | 
 | 
Sponsored by the Wellcome Trust | |  |  |  |   | | | 
|  |  | | (This debate is closed and is a read-only archive.) | | The Human Tissue Bill is the UK government's response to the 'body parts scandal' at Alder Hey and Bristol Royal Infirmary. Will the tighter regulations on consent help restore public confidence and hold doctors to account? Or could it further corrode the trust we put in the medical profession? How do we safeguard patients' right to autonomy and privacy without undermining medical research and the health service's ability to act in the public interest? | Consent is the key
[25-May-2004]
| | 'The Human Tissue Bill is a critical first step in restoring public confidence.' |  | | | In recent decades the molecular revolution in medicine has immeasurably increased our understanding of disease pathways and our potential to intervene with novel preventative, diagnostic and therapeutic agents. Taking today's genomic and proteomic research from the laboratory to the clinic and the patient is dependent on access to human tissue samples. For example, the development of Herceptin, a revolutionary anti-cancer drug that results in increased survival of breast cancer patients, is a success story that could not have been realised without tissue samples. I believe that this research needs to be related to the priorities of the national health service (NHS), and must be made integral to the delivery of accessible, patient-centred services.
| It is my belief and experience that by working together and creating a forum for genuine dialogue, scientists, doctors and patients can integrate the voice of the public into the conduct of research, and the formulation of potential solutions to the moral and ethical issues that arise in the use of human tissue. Patients and their families can be empowered to maintain a vigilance that was a missing element in the scandals at Alder Hey and Bristol hospitals, which hit the UK's scientific and medical community in the 1990s. In one instance, hearts were removed post-mortem from children for unspecified research, without the consent of their parents. One can only imagine the horror this engendered in the parents; the resulting field day had by the tabloid press could only be described as lurid.
| I believe that the current Human Tissue Bill, which places patients' informed consent at the heart of clinical practice, provides a real opportunity to re-engage patients in the purpose of research. Consent in all aspects of tissue removal enables proper account to be taken of patients' and families' views, improving trust between patient and doctor for a more equitable relationship. The old maxim 'Trust me, I'm a doctor' is an anachronism. Doctors no longer command a god-like status - they must work hard to build the respect and trust of patients and others. I believe that the Human Tissue Bill is a critical first step in restoring public confidence in research, ensuring that never again can organs and tissue be taken and stored for unspecified or prospective research without consent.
| Since Alder Hey and Bristol, there has been an apparent lack of trust in and respect for medical science. Yet during this time, my sister and her colleagues have worked to remove cornea at post-mortem for transplantation and research, which allows some people who are blind the opportunity to see. My sister talks to relatives of the deceased donors in order to gain their consent, and has never ceased to be amazed and moved by the families' willingness to consent to use of their loved ones' tissue in this way. In the most terrible of circumstances, being involved in this dialogue brings a sense to the bereaved families that something positive may come by helping others - and this is true for the relatives of both the young and old.
| Since Alder Hey, the National Cancer Research Network (NCRN) has managed to achieve its target of doubling patient accrual rate for trials. The evidence from the NCRN does not back up the perception that there is a lack of trust in medicine (and was perhaps due in part to the setting up of an effective infrastructure to provide support and information to patients who are likely accrual candidates). The perception remains in part due to a lack of communication about what has happened in the light of Alder Hey, and what has been achieved (for example) in cancer research.
| I recognise among my own professions of science and medicine certain reactions to change. The conservative nature of our professions naturally means that some would prefer to maintain the status quo; however, I believe that if our professions are to mature in ways comparable with other countries, we need to grasp the opportunities presented in the Human Tissue Bill. We need to see the patients and their families as individuals and as real human beings, and work through dialogue to take proper account of their views in the use of human tissue for research.
| This problem was encapsulated in a comment by a former cancer patient, Derek Stewart: 'Over the past few months a number of individuals from research charities and scientific organisations have sought to inform me that their work will come to an end with the introduction of this (Human Tissue) Bill. They seemed less interested in my opinion and keener to tell me that they needed to take whatever tissue was required, without consent, especially from living patients. I felt that the paternalism referred to by the Kennedy Report was evident in their approach.'
| There have been cries from within the profession that this bill will mean the end of medical research in this country. I do not believe that the requirement for consent to use of tissue will stifle research. It builds on what is current good practice set out in General Medical Council guidance and required under general standards of practice through Research Ethics Committees.
| It is the duty of all healthcare professionals and researchers to ensure that patients and their families are given information about the potential research uses of their body parts, and to ensure that they have the opportunity to consent or object to such uses. Many NHS trusts and clinical trials are already using patient consent procedures for the use of tissue for research. It will, however, be critical to ensure that any new systems for taking and recording consent aren't onerous for frontline doctors and researchers. Rather, they should build on the principles of information and communication - including where there is the need for exceptions to be made, for example, where tonsils are screened for vCJD as part of an ongoing public health surveillance.
| Dr Kirstine Knox is deputy director of the National Translational Cancer Research Network (NTRAC) (email kirstine.knox@ntrac.org.uk).
|
|
| | |
|
|
|
