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A Tufts University study released in mid-2003 indicates that increasing numbers of clinical trials for U.S.-produced pharmaceutical are being conducted outside the United States, mainly by contract research organizations. This process speeds up clinical trials, but raises ethical issues of the possible coercion or exploitation of more vulnerable and naive patient populations.
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The realisation of the full potential of products based on stem cells in a clinical setting demands robust scientific evidence, underpinned by legitimate regulatory requirements to ensure their safety and efficacy. This review examines the legal aspects of the use of stem cells in the laboratory and in the development of new therapies and pharmaceutical products. UK and European legal and regulatory documents and directives are used as the framework for discussion of the current status and future prospects.
Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.
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This presentation covers the essentials of recent Good Laboratory Practice (GLP) inspections conducted in Japan, after applications have been made for new ethical drugs to be authorized by the Ministry of Health and Welfare (MHW) or for agricultural chemicals by the Ministry of Agriculture, Forestry, and Fishery. Recently, the functions of MHW/GLP inspections were, for the most part, transferred from MHW to "The Organization for Drug ADR Relief, R&D Promotion and Product Review" ("Drug Organization," in short). This organization is now responsible for the audit and facility inspections for GLP compliance, both for new drug applications and for animal safety tests conducted at contract laboratories. The methods of inspection are expected to be the same as those used by MHW. A recent inspection audited by the Ministry of Agriculture, Forestry, and Fisheries is also reviewed here, for comparison.
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Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable.
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