‘OH PICK ME, PICK ME’—SELECTING PARTICIPANTS FOR XENOTRANSPLANT CLINICAL TRIALS
Abstract
‘OH PICK ME, PICK ME’—SELECTING PARTICIPANTS FOR XENOTRANSPLANT CLINICAL TRIALS Sara Fovargue * I. INTRODUCTION the great problem for medical research … is the chasm between the society's general interest in medical progress and the individual interest of the patient involved. Resolving these two conflicting interests is the task of the law. 1 Research involving humans raises many ethical and legal issues, and its regulation essentially involves balancing the interests of the health professional/researcher conducting the trial, with those of medical science and progress generally, and the welfare of the humans who participate in it. While much has been written about the regulation of research, in this article I explore an under-considered aspect of the area—the selection of participants. The importance of clinical trials, participant selection and ‘informed consent’ was dramatically highlighted by the Phase 1 clinical trials of TGN1412, held in London in March 2006. 2 TGN1412 is a monoclonal antibody, a genetically engineered protein that is part mouse and part human, designed to suppress an immune system reaction. It was developed to treat immunological diseases, including multiple sclerosis, some cancers and rheumatoid arthritis, and had previously been tested on non-human animals. On the first day of the Medicines and Healthcare products Regulatory Agency (MHRA)-approved clinical trial, six healthy volunteers required intensive care following allegedly hitherto unexpected side effects, including breathing difficulties and extreme inflammation in their tissues and organs. Despite extensive media coverage of the trial and outrage at the side effects thereby experienced, inquiries from people wanting to be involved in other clinical trials have apparently increased. 3 Thus, far from deterring potential participants, the risks of side effects appear to be outweighed by the ability to help others and the financial benefit, £2,000 in the TGN1412 trial, which can accrue from involvement in trials. The selection of trial participants thus remains a relevant and important area of study. In exploring this … Full Text of this Article