Functional aspects of driver impairment - a guide for state medical advisory boards.

Mode of access: Internet.

Medical advisory boards.

National Highway Traffic Safety Administration, Washington, D.C.

The role of medical advisory boards in driver licensing.

Mode of access: Internet.

The role of citizen advisory boards in the federal government's resolution of the S&L crisis.

Mode of access: Internet.

Establishing community advisory boards for clinical trial research in Malawi: engendering ethical conduct in research

In this article I deal with extending the ethical principles of research to include communities through the establishment of Community Advisory Boards (CABs). The aim of the project on which this article is based demonstrates the need for protecting communities that participate in research in order to stimulate ethical conduct in research in Malawi. In the article, I provide an overview on the role and functions of CABs. I discuss the establishment of CABs in Malawi and present descriptions of the processes and challenges involved. I conclude by sharing experiences of some of the key lessons learnt from the establishment of CABs.

The last taboo: Patenting human beings

This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): ’Human beings and the biological processes for their generation are not patentable inventions.' It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed.

The succession process at social enterprises in Brazil

This research was based on a study of social enterprises in Brazil, to find out if and how these organizations plan and manage the succession process for their senior positions. The study investigated the subset of the associations dedicated to collectively producing goods and services, because they are formally set up and aimed at speeding up the dynamism of local development. The empirical research consisted of two stages. The first was a survey covering a sample of 378 organizations, to find out which of those had already undergone or were undergoing a succession process. The second interviewed the main manager of 32 organizations, to obtain a description of their succession experience. In this stage, the research aimed to analyze how the Individual, Organization and Environment dimensions interact to configure the succession process, identifying which factors of each of these dimensions can facilitate or limit this process. The following guiding elements were taken as the analytical basis: Individual dimension - leadership roles, skill and styles; Organization dimension - structure, planning, advisory boards, communication (transparency), control and evaluation; and Environment dimension - influence of the stakeholders (community, suppliers, clients, and business partners) on the succession process. The results indicated that succession in the researched associations is in the construction stage: it adapts to the requirements of current circumstances but is evidently in need of improvement in order for more effective planning and shared management of the process to be achieved.

Benefits and challenges in practice-oriented psychotherapy research in Germany: The TK and the QS-PSY-BAY projects of quality assurance in outpatient psychotherapy

Objective: Two patient-focused long-term research projects performed in the German outpatient psychotherapy system are focused on in this article. The TK (Techniker Krankenkasse) project is the first study to evaluate a quality assurance and feedback system with regard to its practical feasibility in German routine care. The other study (“Quality Assurance in Outpatient Psychotherapy in Bavaria”; QS-PSY-BAY) was designed to test a new approach for quality assurance in outpatient psychotherapy using electronic documentation of patient characteristics and outcome parameters. In addition this project provides the opportunity to analyze data on health-related costs for the patients undergoing outpatient psychotherapy. Method: Both projects and their results indicating high effect sizes are briefly described. Results: From the perspectives of the research teams, advisory boards and other stakeholders, the experiences with these projects are discussed focusing on obstacles, challenges, difficulties, and benefits in developing and implementing the studies. The triangle collaboration of therapists, researchers, and health insurance companies/health service institutions turned out to be fruitful in both studies. Conclusions: Despite some controversies between the partners the experiences indicate the importance of practiced-research collaborations to provide relevant information about the delivery of outpatient psychotherapy in the health system

Table 1 of experts and representatives interviewed

In a modern society it is generally accepted that the major cause for environmental problems is the current consumption pattern in industrialized countries, thus it is crucial to understand underlying processes and search for solutions in order to consciously progress towards sustainable consumption. In this paper the exclusive role of municipalities in promoting sustainable consumption is recognized. By analyzing the example of the situation of municipalities in Latvia, the reason for focusing on local level when dealing with sustainable consumption issues, as well as main obstacles and possibilities for municipalities' progress towards sustainability are revealed. Promotion of sustainable consumption cannot be based solely on eco-efficiency. Sufficiency strategy plays a crucial role. Since positive social environment for sufficiency dimension is vitally important, local level holds exclusively crucial role for its implementation - the potential of municipalities here is unbounded. Although local authorities already have many tools available, they are insufficiently discovered. Insufficiently exploited tools are property tax relief as support mechanism, establishment of advisory boards, green procurement, promotion of social entrepreneurship and collaborative consumption, as well as delegation of municipalities' functions to NGOs, thus encouraging nonmaterial wellbeing by strengthening social ties and community activities.

Diretrizes regulatórias aplicáveis à cadeia dos produtos para saúde

A ciência e a tecnologia cada vez mais vêm proporcionando avanços em produtos inovadores. Particularmente na área da saúde nota-se eminente sinergismo entre os materiais utilizados, suas propriedades de biocompatibilidade, biofuncionalidade, processabilidade, esterilidade e a área de aplicabilidade no organismo humano. O setor farmacêutico por apresentar grande complexidade exige conhecimentos multidisciplinares, atualizados e em conformidade às tendências internacionais. A Agência Nacional de Vigilância Sanitária (ANVISA) tem sob sua responsabilidade extensa diversidade de bens, serviços e produtos, dentre eles estão os correlatos, que também compreende os produtos para saúde. Os produtos para saúde são classificados conforme o seu risco, no Brasil podendo apresentar até quatro classes, sendo as classes III e IV as que caracterizam maior risco. Para alguns produtos, devido seu risco sanitário, é compulsório a Certificação de Conformidade pelo Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) previamente a concessão de seu registro sanitário pela ANVISA. Dentre as normas técnicas aplicáveis pelo INMETRO estão as normas da Associação Brasileira de Normas Técnicas (ABNT) e na sua ausência, as normas da International Organization for Standardization (ISO). Outros requisitos técnicos e regulatórios devem ser contemplados com o propósito de comprovação da segurança e eficácia dos produtos. Entretanto, as regulamentações sanitárias inerentes a essa categoria de produtos ainda se encontram incipientes no país. A desenvoltura do setor produtivo nesse segmento pode ser evidenciada pelo aumento de novas solicitações na ANVISA e de seu crescimento na balança comercial. No entanto, observa-se pouco estudo e entendimento do setor regulado e regulador referente à relação mútua entre ANVISA, INMETRO e ABNT e quanto à regulação sanitária aplicável para obtenção da anuência do produto ao consumo. Na conjuntura das demandas apontadas o objetivo deste estudo foi avaliar o processo regulatório aplicável à cadeia produtiva dos produtos para saúde com a finalidade de compreender a relação entre ANVISA, INMETRO e ABNT na garantia da qualidade, segurança e eficácia dos produtos. A metodologia aplicada neste trabalho foi à pesquisa qualitativa. Com o auxílio da pesquisa documental constatou-se que o processo regulatório brasileiro é complexo, específico e robusto e apresenta estrutura e exigências semelhantes dos Estados Unidos e União Europeia. A fiscalização pós-uso é uma tendência internacional e a ANVISA vem adotando com frequência com intuito de acompanhar a qualidade dos produtos comercializados. As três instituições apresentam competências definidas e regulamentadas, bem como mecanismos de inter-relação por meio de conselhos consultivos. O estudo de caso caracterizou que o perfil dos profissionais do setor regulado apresenta em grande percentual formação na área da saúde e nível de pós-graduação, porém o nível de conhecimento dos principais conceitos relativos aos produtos para saúde é parcial, reforçando a necessidade de incentivos de capacitação de recursos humanos em regulação em saúde.

Driver licensing laws affecting handicapped drivers.

National Highway Traffic Safety Administration, Washington, D.C.

Comparative data and analysis in state motor vehicle administration. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

State and provincial licensing systems: comparative data.

Mode of access: Internet.

Management summary of the Idaho ASAP demonstration project, July 1972-June 1975. Final report.

National Highway Traffic Safety Administration, Washington, D.C.

Idaho Alcohol Safety Action Project. Volume I: final report summary.

National Highway Traffic Safety Administration, Washington, D.C.