Science and engineering ethics
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The potential for dual use of research in the life sciences to be misused for harm raises a range of problems for the scientific community and policy makers. Various legal and ethical strategies are being implemented to reduce the threat of the misuse of research and knowledge in the life sciences by establishing a culture of responsible conduct.
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Growing powers to manipulate human bodies and minds, not merely to heal disease but to satisfy desires, control deviant behavior, and to change human nature, make urgent questions of whether and how to regulate their use, not merely to assure safety and efficacy but also to safeguard our humanity. Oversight in democratic societies rightly belongs to the polity, not merely to self-appointed experts, scientific or ethical. Yet the task of governing the uses of dangerous knowledge is daunting, and there is little evidence that we have the will or the wisdom to do it well.
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Despite a decade of federal regulation and debate over the appropriateness of financial ties in research and their management, little is known about the actual decision-making processes of university conflict of interest (COI) committees. This paper analyzes in detail the discussions and decisions of three COI committees at three public universities in California. University committee members struggle to understand complex financial relationships and reconcile institutional, state, and federal policies and at the same time work to protect the integrity of the scientific process, the autonomy and intellectual freedom of their faculty colleagues and students, and the financial interests of the university.
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Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. ⋯ All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.