Regulatory-directed studies

The nature of regulatory-directed studies is also such that, compared to basic research, they are frequently held in low esteem by administrators and discipline peers alike. As unjust as this may sound, it is a fact of academic life and those of us who are engaged in these areas must live and work with it — some of it is justified. There is a certain repetitiveness to these studies that obscures their scientific merit and the original research that may have preceded these phases. Unfortunately, it is this mundane aspect that is remembered when space and resource allocations are made. Any mandates that reinforce this image of hackneyed data production will only hurt the position of practical and/or regulatory programs. 

In the late 1980s attempts were made in California to shift fuel use to methanol in order to capture the air quaHty benefits of the reduced photochemical reactivity of the emissions from methanol-fueled vehicles. Proposed legislation would mandate that some fraction of the sales of each vehicle manufacturer be capable of using methanol, and that fuel suppHers ensure that methanol was used in these vehicles. The legislation became a study of the California Advisory Board on Air QuaHty and Fuels. The report of the study recommended a broader approach to fuel quaHty and fuel choice that would define environmental objectives and allow the marketplace to determine which vehicle and fuel technologies were adequate to meet environmental objectives at lowest cost and maximum value to consumers. The report directed the California ARB to develop a regulatory approach that would preserve environmental objectives by using emissions standards that reflected the best potential of the cleanest fuels. 

It is accepted that oxidation of LDL is a key event in endothelial injury and dysfunction. Oxidised LDL (oxLDL) may directly injure the endothelium and trigger the expression of migration and adhesion molecules. Monocytes and lymphocytes interact with oxLDL and the phagocytosis which follows leads to the formation of foam cells, which in turn are associated with the alteration of the expression pattern of growth regulatory molecules, cytokines and pro-inflammatory signals. The proposed role of oxLDL in atherogenesis, based on studies in vitro, is shown in Fig. 2.1. 

Analysis of the study reports shows that the MEB in the Netherlands and the dmg regulatory authorities of Uganda and Zimbabwe are organized in a board format. The MEB, which is the main DRA in the Netherlands, is organized as a board whose members are appointed directly by the Crown. This appointment procedure makes it relatively free from the influence of other Government bodies. The MCAZ and the Ugandan NDA are also established as statutory authorities, with executive committees plus some specialized advisory committees. Although board members are appointed by the Minister of Health, their independence is established by statute. 

Many and varied field techniques involved in the planning, execution, and direction of the field portion of worker exposure and re-entry studies have been considered. Suffice it to say that there are many ways to perform such studies, and the important thing to remember is that good scientific thought and planning will produce an excellent study. The scientific validity of such studies should rest on the basic principles of science. There are various guidelines and protocols which may be followed for regulatory... 

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