The Human Tissue Act, passed in 2004, covers tissue from both living and deceased donors and sets out stringent requirements for obtaining consent. We carried out a detailed analysis of the Bill and followed its progress through the parliamentary process, working with several other organisations to suggest amendments.
Since the Human Tissue Act passed into law, we have responded to consultations on its implementation and have published a critical commentary on the Act in a leading legal journal. We have also delivered presentations and training workshops to a variety of different groups who need an understanding of the Act in order to carry out their work.
Documents
A Hall, A Lucassen, G Norbury, H Skirton and A Kent (a working party of the Joint Committee on Medical Genetics) The Human Tissue Act 2004: an assessment of the Act and its implications for the specialties of clinical and laboratory genetics
We have participated in several projects that consider the ethical and regulatory issues raised by the use of medical information and aim to contribute to the development of a balanced approach that protects patients’ interests and avoids harm, while placing as few barriers as possible in the path of research that is in the public interest.
We have been closely involved in a working group set up by the Academy of Medical Sciences to look at the use of patient data in research. Ron Zimmern served on the group and our policy team provided legal expertise and working papers that informed the group’s work.
Documents
Iverson, Liddell et al. Consent, Confidentiality, and the Data Protection Act (2006) British Medical Journal 332:165-169Academy of Medical Sciences Personal data for public good: using health information in medical research (2006)
Contacts: Alison Hall, Ron Zimmern
Stem cell research, in particular research involving embryonic stem cells, raises ethical, legal and social questions. A complex set of regulatory issues also arises from the potential use of stem cells in a therapeutic setting. We have prepared a briefing paper that outlines these ethical and regulatory issues and summarises the current UK policy position.
Documents
Liddell, K and Wallace, S. 2005. Emerging Regulatory Issues for Human Stem Cell Medicine. Genomics, Society and Policy 1(1), 54-73. http://www.gspjournal.com
Corrigan, O, Liddell, K, MacMillan, J, Stewart, A and Wallace, S (2005) Ethical, legal and social issues in stem cell research and therapy. A briefing paper from Cambridge Genetics Knowledge Park Edition 1 - summary version
Corrigan, O, Liddell, K, MacMillan, J, Stewart, A and Wallace, S (2006) Ethical, legal and social issues in stem cell research and therapy. A briefing paper from Cambridge Genetics Knowledge Park Edition 2 - full version, March 2006
http://www.cgkp.org.uk/resources/pdf/stem_cell_paper2.pdf
The Wellcome Trust is funding a project to explore how governments, regulatory and healthcare systems are reacting to ensure that good clinical evaluative information is available in practice. The project brings together a team from PHGU, the University of Cambridge, the University of Exeter and Anglia Ruskin University, with expertise in health policy, public health, health technology assessment and the policy implications of genetics.
We are trying to identify what experts in the field see as the information needed to make reasonably informed decisions about genetic tests. We are:
In the first phase of the project we have interviewed approximately 70 experts in the field, drawn from a wide range of groups with a stake in the evaluation of genetic tests for complex conditions. This programme of individual interviews and focus groups includes experts both in Europe and the USA. A final report will aim to outline consensus-based policy options.
Documents
Hogarth, S, Melzer, D and Zimmern, R (2005) The regulation of commercial genetic testing services in the UK. A briefing paper for the Human Genetics CommissionContacts: Ron Zimmern, Simon Sanderson