By Bryony Close, R. Coomber, Anthony Hubbard, John Illingworth
This article discusses using volunteers, both fit or present process therapy, within the examine and trying out of medicinal and non-medicinal items. the level to which the enhanced use of such volunteers may well decrease the necessity for animal exams is
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Extra info for Volunteers in Research and Testing
Example text
Despite all guidelines perpetuating the Helsinki Declaration requirement for ethical review, there is no legal underpinning of this function. The only reference in English Law appears in a statutory instrument made under the Medicines Act 1968 (SI 1981 No. 164 on Clinical Trial exemption from licensing)—where the fact that ethical approval is refused or withdrawn must be notified to the authorities who have issued a clinical trial exemption certificate for research. Anecdotal reports indicate that there is Clinical research 39 still research proceeding in the absence of any review.
Most people do not have any idea of what being involved in medical research means. There is an enormous gap between what the public and researcher know and value. Take, for example, ideas about what constitutes a good outcome. Some researchers still seem to find merit in the old maxim, ‘The operation was a success but the patient died’. The quantity and quality of side effects can be seriously underrated. One woman who had suffered extensive damage to her arm and shoulder after undergoing radiotherapy for breast cancer asked, ‘What is success?
Most people are not governed by altruistic motives and if we wait for people to volunteer out of willingness to help medical science, many of the studies would never be done. If there is to be a reward, at the moment it is paid as expenses. It is said only to be a reasonable amount related to the nature and degree of inconvenience, but there is no doubt that the majority of people who are involved are either unemployed or students who are getting an increasingly diminishing grant from the government to support them.