However, further advances are under threat in the UK from inflexible laws, cumbersome licence requirements and fear of liability. Here we report a sequence of events that led to a UK clinical scientist withdrawing from participation in an international transplant research study in receipt of research ethics approval. We highlight the difficulties encountered and discuss possible solutions which, we believe, would promote legitimate research in the interest of the common good. We also contend that the current human tissue legislation should be replaced by a legal framework more responsive to the importance of scientific innovation for clinical service development in this field.
At least 83 Guatemalans are thought to have died after being deliberately infected with syphilis and gonorrhoea in the 1940s, a presidential commission in the United States has heard. US government scientists infected hundreds of Guatemalan prisoners, psychiatric patients and orphans to study the effects of penicillin. None of those infected consented. The head of the commission, Amy Gutmann, called the research a "shameful piece of medical history". The Presidential Commission for the study of Bioethical Issues is due to publish its report in September. President Obama set up the commission when the research came to light last year.
'A new pathway for the regulation and governance of health research' was published in January 2011. The report was prepared by a working group, chaired by Professor Sir Michael Rawlins FMedSci, convened in response to an invitation from Government to review the regulation and governance of UK health research involving human participants, their tissue or their data. The report proposes four key principles that should underpin the regulation and governance framework around health research in the UK, and makes recommendations to: * Create a new Health Research Agency (HRA) to rationalise the regulation and governance of all health research. * Include within the HRA a new National Research Governance Service to facilitate timely approval of research studies by NHS Trusts. * Improve the UK environment for clinical trials. * Provide access to patient data that protects individual interests and allows approved research to proceed effectively. * Embed a culture that value
Tony, 47, and Barrie Drewitt-Barlow, 42, of Chandlers Quay, Maldon, who were Britain's first gay surrogate parents, denied one charge of providing false information to an ethics panel. The pair, who ran Euroderm Research, also deny two counts of not conforming to protocol when conducting a trial. The pair appeared before Southwark Crown Court on Wednesday. They also deny two charges of conducting a clinical trial otherwise than in accordance of good clinical practice.
In the second part of a special report, Nina Lakhani exposes how survivors of the 1984 Bhopal gas disaster became unwitting guinea pigs in studies funded by Western drug companies. Secret reports seen by The Independent reveal that drug trials funded by western pharmaceutical firms at the Indian hospital set up for survivors of the Bhopal disaster violated international ethical standards and could have put patients at risk.
Biobanks are increasingly seen as new tools for medical research. Their main purpose is to collect, store, and distribute human body materials. These activities are regulated by legal instruments which are heterogeneous in source (national and international), and in form (binding and non-binding). We analyse these to underline the need for a new model of governance for modern biobanks. The protection initially ensured by respect for fundamental rights will need to focus on more interactions with society in order to ensure biobanks' sustainability. International regulation is more oriented on ethical principles and traces the limits of the uses of genetics, while European regulation is more concerned with the protection of fundamental rights and the elaboration of standards for biobanks' quality assurance. But is this protection adequate and sufficient? Do we need to move from the biomedical research analogy to new forms of legal protection, and governance systems which involve citizen
Jackson provides a meticulously argued, extensively researched and utterly compelling critique of the current regulation of phar- maceuticals. Her account of a medicine’s journey through the regulatory system in the UK paints a frightening picture of the widespread, predatory activities of profit-seeking pharmaceutical companies and the systematic failure of law and regulation effectively to hold them to account. The UK, with its well developed and well financed pharmaceutical industry and equally well entrenched tradition of state-run health care, provides a particularly fine case study for the exploration of the tension between the ideals of medicine and the pursuit of profit and, as such, it is to be hoped that this book will gain a wide, international audience.