Personal monitors institutions

Universities and research institutions also vary in their practices for wearing personal monitors. In typical situations, each individued is issued a single personal monitor and instructed orally to wear it at a location between the shoulders and the waist. These instructions are usually given in the initial employee training and are not found in laboratory procedures. 

The use of multiple personal monitors is not common at universities and research institutions and, if necessary, would be implemented on an ad hoc basis. 

OSHA requires employers of workers who are occupationally exposed to 2-butoxyethanol to institute engineering controls and work practices to reduce employee exposure and maintain it at or below pennissible exposure limits (PEL). The PEL for 2-butoxyethanol is 50 ppm (OSHA 1974). Workers exposed to 2-butoxyethanol should wear personal protective equipment such as gloves, coveralls, and goggles to protect exposure to tire skin (OSHA 1974). NIOSH recommends that industrial hygiene surveys be completed at work places where airborne exposure to 2-butoxyethanol or 2-butoxyethanol acetate may occur (NIOSH 1990). If exposure levels are at or above one-half the recommended exposure limit (REL = 5 ppm), NIOSH recommends that a program of personal monitoring be instituted so that tlie exposure of each worker can be estimated. If exposure levels are at or greater than the REL, or if there is a potential for skin contact, NIOSH recommends that 2-butoxyacetic acid be measured in the urine of the workers. 

Name and address of Sponsor and Monitor Name of authorized person Name of Sponsor s medical expert Name of Investigator responsible for the trial Name of physician responsible for trial-related medical decisions Name of clinical laboratory and other institutions involved in the trial... 

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

Based on the research of Dr. E. D. Palmes (1) at New York University s Institute of Environmental Medicine and on additional study supported by a contract from the United States Bureau of Mines, a unique personal sampler has been designed to passively collect N0X. This is accomplished by way of molecular diffusion and subsequent trapping of the molecules onto a matrix coated with triethanolamine (TEA) at the closed end of the sampler. Constructed of polypropylene, the tubular sampler shown in Figure 1 is small, lightweight, unbreakable and can be easily worn in the breathing zone of the employee whose exposure is to be monitored. No pumping mechanism is required. The components of N0X diffuse at constant, known rates towards the sealed end of... 

PTXs have been found in shellfish from most regions of the world, reflecting the world-wide distribution of Dinophysis spp. There is relatively little information on concentrations of PTXs in shellfish due to the previous scarcity of analytical standards and because monitoring for PTXs by instrumental methods has until recently not been widespread, but the bulk of the published information is summarized in Table 9.3. A certified reference material (CRM) for PTX-2 became available from the Certified Reference Materials Program (CRMP) of the National Research Council of Canada (Institute for Marine Biosciences, Halifax http //imb-ibm.mc-cmc.gc.ca/cimp/shellfisli/index e.php) in 2003 (Quilliam 2004), and a CRM for PTX-11 is expected in 2006 (M.A. Quilliam, personal communication). The availability of such standards should result in an increasing amount of reliable information on the type and concentration of PTXs present in natmal samples. 

An investigator formally submits a research protocol to the RDRC with detailed description of the study, but prior to submission, the protocol must be approved by the Institutional Review Board. The RDRC meets at least quarterly if active research is pursued, with at least 50% membership present. Members with conflict of interest in a protocol must excuse themselves from voting on the protocol. Based on the critical review of the protocol, the study may be or may not be approved by the RDRC. If approved, the study will be regularly monitored on the progress. Any adverse effects encountered during the study must be immediately reported to the FDA. The Chairman of the RDRC is the primary contact person with FDA and must submit an annual report on all projects. Also any change in the membership must be reported to and approved by the FDA. 

I am convinced that the leader must set the tone by understanding personal and team gaps. The leader and team must develop action plans to address organizational shortcomings and institute processes for monitoring improvement. 

Monitoring the working environment is a complex task and advice is available in the U.K. from the HSE, and in the U.S.A. from occupational health authorities, the Occupational Health and Safety Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH). The primary objectives of monitoring are to estimate personal exposure and the effectiveness of engineering and process control measures. 

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