"These criteria can be assessed at the business enterprise and societal levels. They are based on various influences, including the history of occupational safety and health in the 20th century; the anticipatory work of various researchers and officials (Ashford 1976; Samuels 1986; Colvin 2002; Roco 2003; Aitken et al. 2004; Maynard and Kuempel 2005; Maynard 2006; Murashov and Howard 2008; Tomellini and Giordani 2008; Howard 2011; Roco et al. 2011; Murashov and Howard 2013); the ethical framework described by Schulte and Salamanca-Buentello (2007); and the practices of governmental agencies [e.g., the National Institute for Occupational Safety and Health (NIOSH)], corporations, and labor organizations worldwide conducting research or developing risk management guidance. The criteria also build on the 1983 and 2009 risk assessment paradigms by the U.S. National Research Council (NRC 1983) of the National Academies of Science; the Rio Conference of 1992 (UN 1992); the reports by the National Academy of Engineering (2004) and the Royal Society and Royal Academy of Engineering (2004); the principles of tiered toxicological screening (Oberdörster et al. 2005); and the Nano Risk Framework (2007). "
[Show abstract][Hide abstract] ABSTRACT: Organizations around the world have called for the responsible development of nanotechnology. The goals of this approach are to emphasize the importance of considering and controlling the potential adverse impacts of nanotechnology in order to develop its capabilities and benefits. A primary area of concern is the potential adverse impact on workers, since they are the first people in society who are exposed to the potential hazards of nanotechnology. Occupational safety and health criteria for defining what constitutes responsible development of nanotechnology are needed. This article presents five criterion actions that should be practiced by decision–makers at the business and societal levels—if nanotechnology is to be developed responsibly. These include (1) anticipate, identify, and track potentially hazardous nanomaterials in the workplace; (2) assess workers’ exposures to nanomaterials; (3) assess and communicate hazards and risks to workers; (4) manage occupational safety and health risks; and (5) foster the safe development of nanotechnology and realization of its societal and commercial benefits. All these criteria are necessary for responsible development to occur. Since it is early in the commercialization of nanotechnology, there are still many unknowns and concerns about nanomaterials. Therefore, it is prudent to treat them as potentially hazardous until sufficient toxicology, and exposure data are gathered for nanomaterial-specific hazard and risk assessments. In this emergent period, it is necessary to be clear about the extent of uncertainty and the need for prudent actions.
Journal of Nanoparticle Research 12/2013; 16(1). DOI:10.1007/s11051-013-2153-9 · 2.18 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Recent progress in synthetic biology (SynBio) has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials (FIH) will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including 'risk' minimization. These concerns are associated with any FIH trial, however, due to the novelty of the approach, they become more pronounced for medical applications of emerging technologies (emTech) like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using 'risk assessment' as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as 'risk' and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue.
Medicine Health Care and Philosophy 08/2015; DOI:10.1007/s11019-015-9660-7 · 0.91 Impact Factor
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