Risk and research

A management system promotes safety and defines the route to it. But it is the culture of staff that determines whether or not the route is systematically taken. Methods of measuring an organisation s safety climate or safety culture, based on questionnaires that test the attitudes of members of the organisation, have been developed (e.g. Cooper and Phillips 1994, The Keil Centre 2001). It could be possible to reflect the results of such measurements as levels of risk, and research could be conducted into ways of doing so. This, however, is not within the objectives of this paper and will not be discussed further. 

New product development programs present another type of challenge to the researcher. Often the researcher has no guidelines for evaluating the new product and must formulate a unique plan for developiag enough iaformation to constmct a matrix that would show the risks and rewards of the project. Reference 6 presents 10 commandments for new-product development. 

Insurance is protec tion against risk. Commercial insurance companies minimize their own risks by covering a large number of individuals against a given risk and also by offering coverage on a wide variety of different types of risk. It is frequently quite difficult to assess the probability of success of a particular research and development project. It is much easier for an insurance company to assess its probabih-ties from its casualty tables. 

EPA must first make determinations about which contaminants to regulate. These determinations are based on health risks and the likelihood that the contaminant occurs in public water systems at levels of concern. The National Drinking Water Contaminant Candidate List (CCL), published March 2, 1998, lists contaminants that (1) are not already regulated under SDWA (2) may have adverse health effects (3) are known or anticipated to occur in public water systems and (4) may require regulations under SDWA. Contaminants on the CCL are divided into priorities for regulation, health research and occurrence data collection. 

Proponents of the laboratories counter that, despite these shortcomings, the laboratories seiwe a vital mission of undertaking the high risk and expensive investments that the private sector would never agree to invest in. Although natural gas research and development was minimal, DOE support accelerated technological advances on natural gas-fired turbines. Much of the research and development at the laboratories has provided a net social benefit to the nation and economy, work such as safe nuclear reactors and the development of sophisticated defense weapons. 

Potential Risks and Management Opportunities A Research Agenda. 90... 

In a tiny fraction of cases, a quick formula can be used. For most cases, the analysis uses an options tree, with one leaf per possible outcome. However, this falls prey to the curse of dimensionality —the number of leaves on the tree grows exponentially in the number of risk and decision dimensions considered. Thus only a limited, simple set of situations can be optimized in this way because one has to severely limit the decisions and risks that are considered. Tools available to help automate and simplify options analysis, widely used in pharmaceutical project evaluation, include Excel addons such as R1SK [11] and more graphically based solutions such as DPL [12]. Both of these support the creation and evaluation of decision trees and of influence diagrams Figure 11.2 shows a simple example of each of these. A primer in applied decision theory is Clemen s book Making Hard Decisions, other sources may be found in the website of James Vornov, Director of Clinical Research at Guildford Pharmaceuticals, a recent convert to decision theory for options analysis [13]. 

Figure 11.2 A decision tree, based on an associated inflnence diagram, can help organize and integrate information about risks and the way in which research work buys better information that allows choice of the options most likely to succeed. This example describes the relationship between in silico predictions and in vitro assay results for the same compound structures.

Finally, it is hoped that this book will facilitate the broadening of perspective in the domain of safety research, for example, to enable research of the correlations existing between quantitative expression of risk and recorded aocidents. 

Commercial software packages are available for conducting an LCA. A list of software packages, databases, and additional information on conducting an LCA are foimd at the U.S. EPA, Office of Research and Development, National Risk Management Research Laboratory Web site http // www.epa.gov / rumrl/lcaccess / resources.html Software. 

Spitzley, D. V., Keoleian, G. A., and McDaniel, J. S. (1997). Life Cycle Design of Milk and Juice Packaging. Project Summary. U.S. Environmental Protection Agency. National Risk Management Research Laboratory, EPA/600/SR-97/082. 

Communication with the potential volunteers prior to the study is essential. Prior to the initiation of the field phase of the study, a meeting should be held with the potential volunteers to explain the details of the procedures of the study, present the consent form, and inform the potential volunteers of the risks and benefits (including any monetary compensation to the worker) of participating in the study. At this meeting, consent in writing should be obtained from the worker. If there is any language barrier between the researcher and the potential volunteers, an interpreter should be present at the meeting. 

U.S. EPA, Introduction to Phytoremediation, EPA/600/R-99/107, National Risk Management Research Laboratory, Office of Research and Development, Cincinnati, OH, 1999. 

Speth, T.F. and Swanson, G.R., Demonstration of the HiPOx Advanced Oxidation Technology for the Treatment of MTBE-Contaminated Groundwater, EPA/600/R-02/098, U.S. EPA National Risk Management, Research Laboratory, United States Environmental Protection Agency, Cincinnati, OH. September 2002. 

Human risk assessment (HRA) was done applying guidelines from the Italian Institute for Environmental Protection and Research (ISPRA) and selecting water ingestion as route of exposure for human health assessment [20]. According to the... 

Italian Institute for Environmental Protection and Research (ISPRA) (2008) Method criteria for applying the absolute risk analysis to contaminated sites [Criteri metodologici per l applicazione dell analisi assoluta di rischio ai siti contaminati] draft 2, available at http // www.apat.gov.it/site/ files/Suolo Territorio/siti contaminati 02marzo08.pdf... 

A third path for research is to study associations between system change and improvement, on the one hand, and public and consumer responses, on the other. In particular, what are the conditions for the development and maintenance of trustworthiness and satisfaction through organisational and communicative procedures With better knowledge of consumer demands and improved quantification of risks and benefits to health, the future trend is likely to point towards increased differentiation, with different products targeting consumer groups with different priorities. Some consumers will demand more convenience, while others will invest in participatory community farm schemes that allow direct involvement in the production and preparation of their food. 

In the United States, as in most other countries, individual informed consent is generally required before research may be done with a living, identifiable human being. Informed consent for research generally has two different justifications. First, it allows the potential subject to weigh for himself or herself the balance of risks and benefits from his or her participation in the proposed research. Second, it embodies the individual s autonomy and control over interventions in or about his or her own body. 

---