Federally regulated institutional review boards: The aspects of a "model" IRB---Is the current system in need of a tune up or complete overhaul?

Institutional Review Boards (IRBs) are the primary gatekeepers for the protection of ethical standards of federally regulated research on human subjects in this country. This paper focuses on what general, broad measures that may be instituted or enhanced to exemplify a "model IRB". This is done by examining the current regulatory standards of federally regulated IRBs, not private or commercial boards, and how many of those standards have been found either inadequate or not generally understood or followed. The analysis includes suggestions on how to bring about changes in order to make the IRB process more efficient, less subject to litigation, and create standardized educational protocols for members. The paper also considers how to include better oversight for multi-center research, increased centralization of IRBs, utilization of Data Safety Monitoring Boards when necessary, payment for research protocol review, voluntary accreditation, and the institution of evaluation/quality assurance programs. ^ This is a policy study utilizing secondary analysis of publicly available data. Therefore, the research for this paper focuses on scholarly medical/legal journals, web information from the Department of Health and Human Services, Federal Drug Administration, and the Office of the Inspector General, Accreditation Programs, law review articles, and current regulations applicable to the relevant portions of the paper. ^ Two issues are found to be consistently cited by the literature as major concerns. One is a need for basic, standardized educational requirements across all IRBs and its members, and secondly, much stricter and more informed management of continuing research. There is no federally regulated formal education system currently in place for IRB members, except for certain NIH-based trials. Also, IRBs are not keeping up with research once a study has begun, and although regulated to do so, it does not appear to be a great priority. This is the area most in danger of increased litigation. Other issues such as voluntary accreditation and outcomes evaluation are slowing gaining steam as the processes are becoming more available and more sought after, such as JCAHO accrediting of hospitals. ^ Adopting the principles discussed in this paper should promote better use of a local IRBs time, money, and expertise for protecting the vulnerable population in their care. Without further improvements to the system, there is concern that private and commercial IRBs will attempt to create a monopoly on much of the clinical research in the future as they are not as heavily regulated and can therefore offer companies quicker and more convenient reviews. IRBs need to consider the advantages of charging for their unique and important services as a cost of doing business. More importantly, there must be a minimum standard of education for all IRB members in the area of the ethical standards of human research and a greater emphasis placed on the follow-up of ongoing research as this is the most critical time for study participants and may soon lead to the largest area for litigation. Additionally, there should be a centralized IRB for multi-site trials or a study website with important information affecting the trial in real time. There needs to be development of standards and metrics to assess the performance of the IRBs for quality assurance and outcome evaluations. The boards should not be content to run the business of human subjects' research without determining how well that function is actually being carried out. It is important that federally regulated IRBs provide excellence in human research and promote those values most important to the public at large.^

Occupational respiratory disease in the services industry

Objective. To describe the spectrum and occurrence of occupational exposures of relevance to the respiratory system and their subsequent adverse effects within the service industries and occupations, as outlined by the U.S. Department of Labor Bureau of Labor Statistics Occupational Outlook Handbook, 2007. ^ Design. Systematic review of the literature from an Ovid search including years 1950 to 2008. Initially, occupational respiratory disease categories were searched, and then combined with each of the different occupations for a comprehensive review of the literature. ^ Results. Ten groups within the U.S. Department of Labor Bureau of Labor Statistics Occupational Outlook Handbook, 2007 were identified as having exposures leading to occupational respiratory disease. These include janitors/cleaners, dental personnel, cosmetology professionals, traffic police, veterinary personnel, firefighters, healthcare workers, bakers, and bar/restaurant workers. The most common respiratory disorder affecting this population was occupational asthma caused by many different exposures in each occupation. The biggest limitation was the absence of a uniform reporting method for occupational respiratory diseases. ^ Conclusion. There is evidence that there are risks for occupational respiratory disease in the services industry. ^ Key Words: occupational and respiratory disease and service industries ^

Efforts of hospital system wound care teams to reduce hospital acquired pressure ulcers

New reimbursement policies developed by the Centers for Medicare and Medicaid Services (CMS) are revolutionizing the health care landscape in America. The policies focus on clinical quality and patient outcomes. As part of the new policies, certain hospital acquired conditions have been identified by Medicare as "reasonably preventable". Beginning October 1, 2008, Medicare will no longer reimburse hospitals for these conditions developed after admission, pressure ulcers are among the most common of these conditions.^ In this practice-based culminating experience the objective was to provide a practical account of the process of program development, implementation and evaluation in a public health setting. In order to decrease the incidence of pressure ulcers, the program development team of the hospital system developed a comprehensive pressure ulcer prevention program using a "bundled" approach. The pressure ulcer prevention bundle was based on research supported by the Institute for Healthcare Improvement, and addressed key areas of clinical vulnerability for pressure ulcer development. The bundle consisted of clinical processes, policies, forms, and resources designed to proactively identify patients at risk for pressure ulcer development. Each element of the bundle was evaluated to ensure ease of integration into the workflow of nurses and clinical ancillary staff. Continued monitoring of pressure ulcer incidence rates will provide statistical validation of the impact of the prevention bundle. ^

A costing exercise of provision of prevention of HIV transmission from mother to child services in Vietnam

Objectives. This dissertation focuses on estimating the cost of providing a minimum package of prevention of mother-to-child HIV transmission (PMTCT) in Vietnam from a societal perspective and discussing the issues of scaling-up the minimum package nationwide. ^ Methods. Through collection of cost-related data of PMTCT services at 22 PMTCT sites in 5 provinces (Hanoi, Quang Ninh, Thai Nguyen, Hochiminh City, and An Giang) in Vietnam, the research investigates the item cost of each service in minimum PMTCT packages and the actual cost per PMTCT site at different organizational levels including central, provincial, and district. Next, the actual cost per site at each organizational level is standardized by adjusting for HIV prevalence rate to arrive at standardized costs per site. This study then uses the standardized costs per site to project, by different scenarios, the total cost to scale-up the PMTCT program in Vietnam. ^ Results. The cost for HIV tests, infant formula, and salary of health workers are consistently found to be the biggest expenditures in the PMTCT minimum package program across all organizational levels. Annual cost for drugs for prophylaxis treatment, operating and capital, and training costs are not substantial (less than 5% of total costs at all levels). The actual annual estimated cost for a PMTCT site at the central level is nearly VND 1.9 billion or US$ 107,650 (exchange rate US$ 1 = VND 17,500) while the annual cost for a provincial site is VND 375 million or US$ 21,400. The annual cost for a district site is VND 139 million (∼US$ 8,000). ^ The estimated total annual cost to roll out the PMTCT minimum package to the 5 studied provinces is approximately US$ 1.1 million. If the PMTCT program is to be scaled-up to 14 provinces until 2008 and up to 40 provinces through the end of 2010 as planned by the Ministry of Health, it would cost the health system an approximate annual amount of US$ 2.1 million and US$ 5.04 million, respectively. The annual cost for scaling-up the PMTCT minimum package nationwide is around US$ 7.6 million. Meanwhile, the total annual cost to implement PMTCT minimum packages to achieve PMTCT national targets in 2010 (providing counseling service to 90% of all pregnant women; 60% of them will receive HIV tests and 100% of HIV (+) mother and their newborn will receive prophylaxis treatment) would be US$ 6.1 million. ^ Recommendations. This study recommends: (1) the Ministry of Health of Vietnam should adjust its short-term national targets to a more feasible and achievable level given the current level of available resources; (2) a detailed budget for scaling-up the PMTCT program should be developed together with the national PMTCT action plan; (3) the PMTCT scaling-up plan developed by the Ministry of Health should focus on coverage of high prevalence population and quality of services provided rather than number of physical provinces reached; (4) exclusive breastfeeding strategy should be promoted as part of the PMTCT program; and (5) for a smooth and effective rolling out of PMTCT services nationwide, development of a national training plan and execution of this plan must precede any other initiations of the PMTCT scaling-up plan. ^

Validation of an instrument for assessing the medicolegal death investigation system: A public health approach

Background. This study validated the content of an instrument designed to assess the performance of the medicolegal death investigation system. The instrument was modified from Version 2.0 of the Local Public Health System Performance Assessment Instrument (CDC) and is based on the 10 Essential Public Health Services. ^ Aims. The aims were to employ a cognitive testing process to interview a randomized sample of medicolegal death investigation office leaders, qualitatively describe the results, and revise the instrument accordingly. ^ Methods. A cognitive testing process was used to validate the survey instrument's content in terms of the how well participants could respond to and interpret the questions. Twelve randomly selected medicolegal death investigation chiefs (or equivalent) that represented the seven types of medicolegal death investigation systems and six different state mandates were interviewed by telephone. The respondents also were representative of the educational diversity within medicolegal death investigation leadership. Based on respondent comments, themes were identified that permitted improvement of the instrument toward collecting valid and reliable information when ultimately used in a field survey format. ^ Results. Responses were coded and classified, which permitted the identification of themes related to Comprehension/Interpretation, Retrieval, Estimate/Judgment, and Response. The majority of respondent comments related to Comprehension/Interpretation of the questions. Respondents identified 67 questions and 6 section explanations that merited rephrasing, adding, or deleting examples or words. In addition, five questions were added based on respondent comments. ^ Conclusion. The content of the instrument was validated by cognitive testing method design. The respondents agreed that the instrument would be a useful and relevant tool for assessing system performance. ^

Occupational respiratory disease in the services industry

Objective. To describe the spectrum and occurrence of occupational exposures of relevance to the respiratory system and their subsequent adverse effects within the service industries and occupations, as outlined by the U.S. Department of Labor Bureau of Labor Statistics Occupational Outlook Handbook, 2007. ^ Design. Systematic review of the literature from an Ovid search including years 1950 to 2008. Initially, occupational respiratory disease categories were searched, and then combined with each of the different occupations for a comprehensive review of the literature. ^ Results. Ten groups within the U.S. Department of Labor Bureau of Labor Statistics Occupational Outlook Handbook, 2007 were identified as having exposures leading to occupational respiratory disease. These include janitors/cleaners, dental personnel, cosmetology professionals, traffic police, veterinary personnel, firefighters, healthcare workers, bakers, and bar/restaurant workers. The most common respiratory disorder affecting this population was occupational asthma caused by many different exposures in each occupation. The biggest limitation was the absence of a uniform reporting method for occupational respiratory diseases. ^ Conclusion. There is evidence that there are risks for occupational respiratory disease in the services industry. ^ Key Words. occupational and respiratory disease and service industries ^

Has implementation of integrated mental health services in primary care programs positively impacted health outcomes among the mentally ill in developing countries?

Objective. The World Health Organization (WHO) estimates that nearly 450 million people suffer from a mental disorder in the world. Developing countries do not have the health system structure in place to support the demand of mental health services. This study will conduct a review of mental health integration in primary care research that is carried out in low-income countries identified as such from the World Bank economic analysis. The research follows the standard of care that WHO has labeled appropriate in treatment of mental health populations. Methods. This study will use the WHO 10 principles of mental health integration into primary care as the global health standard of care for mental health. Low-income countries that used these principles in their national programs will be analyzed for effectiveness of mental health integration in primary care. Results. This study showed that mental health service integration in primary care did have an effect on health outcomes of low-income countries. However, information did not lead to significant quantitative results that determined how positive the effect was. Conclusion. More ethnographic research is needed in low-income countries to truly assess how effective the program is in integrating with the health system currently in place.^ ^

Are Intensive Family Preservation Services Useful?: A Study in the United Kingdom

This evaluation of the first year of an Intensive Family Preservation Service in England is based on the analysis of eighty-six families: fifty-seven families who received the service and a comparison group of twenty-nine families who did not. The study considered whether the program was fulfilling its objectives of reducing the number of children and young people in the public care system; offering a safe, supportive service for children who need protection; integrating the program into family support services as a whole, and improving family functioning. The findings were complex to interpret. Child protection was improved but there was not a reduction in the number of children needing out of home care (indeed there was an increase) meaning that short term savings in costs could not be made. Nor were there lasting improvements in the children’s behavior. There were instead a number of more subtle, arguably more sensitive outcomes: parents’ capacity to tolerate their child’s behavior was greater and overall family functioning was better for most families who received the service. Also families were, on the whole, able to make better use of follow up services.

Elaboración de vinos : defectos en el proceso que originan costos de no calidad

Los costos de calidad se asocian a su planificación, control, evaluación de la conformidad y a los costos ocasionados por no cumplir con los requisitos de satisfacción de la fábrica o del cliente (productos o servicios con defectos). Los objetivos del trabajo son identificar las causas que provocan la ausencia o pérdida de calidad (no calidad), proponer acciones correctivas en el proceso de elaboración de vinos, midiendo la frecuencia de aparición y clasificando los costos de no calidad. Conocer la frecuencia de aparición de las causas de no calidad en las etapas del proceso de elaboración de vinos permitirá optimizar la gestión y reducir los costos al disminuir sus correcciones. El estudio identifica los factores que alteran la calidad de los vinos. La mayor frecuencia de defectos es de origen prefermentativo, que junto con los de crianza, conservación y originados en el viñedo explican el 79% de los mismos. Los defectos encontrados constituyen costos de prevención y evaluación pero serán falla interna si la bodega está integrada y se atribuirán a falla externa en el caso de productor no integrado. Los establecimientos en los que se pudo identificar y establecer frecuencia de aparición de los defectos que influyen en la calidad del vino son aquellos que tienen algún sistema de gestión de la calidad, ya que han normalizado los registros que actuarán como herramienta de gestión. Los encargados de gerenciar las bodegas deberían conocer los puntos críticos del proceso para realizar la gestión preventiva de los posibles defectos. Los costos que inciden en la calidad del producto a comercializar se deben registrar y controlar, y trazarlos hacia adelante para conocer la incidencia de los mismos en los precios finales, y hacia atrás para que en la planificación de la próxima elaboración se contemple la prevención correspondiente.

A framework for demonstrating the value of human services

Tanto profesionales como quienes tienen a su cargo diferentes servicios están de acuerdo en que la evaluación es importante. Sin embargo, los orientadores rara vez evalúan su trabajo de manera de hallar una relación causal entre los servicios que los usuarios reciben y los cambios a los que acceden. Se ha desarrollado un marco teórico para evaluar los cambios en los conocimientos, habilidades, actitudes y creencias del usuario y examinar el impacto que dichos cambios han hecho en su vida y en la sociedad en la que se desenvuelve. El marco incluye también un sistema de seguimiento de las intervenciones realizadas y de los recursos necesarios para poder implementar exitosamente estas acciones. Ha sido empleado en diversas situaciones orientadoras, establecimientos educativos y acciones de orientación vocacional, con el objeto de proporcionar evidencia de que el servicio brindado realmente produce un impacto sobre la vida del usuario.

A framework for demonstrating the value of human services

Tanto profesionales como quienes tienen a su cargo diferentes servicios están de acuerdo en que la evaluación es importante. Sin embargo, los orientadores rara vez evalúan su trabajo de manera de hallar una relación causal entre los servicios que los usuarios reciben y los cambios a los que acceden. Se ha desarrollado un marco teórico para evaluar los cambios en los conocimientos, habilidades, actitudes y creencias del usuario y examinar el impacto que dichos cambios han hecho en su vida y en la sociedad en la que se desenvuelve. El marco incluye también un sistema de seguimiento de las intervenciones realizadas y de los recursos necesarios para poder implementar exitosamente estas acciones. Ha sido empleado en diversas situaciones orientadoras, establecimientos educativos y acciones de orientación vocacional, con el objeto de proporcionar evidencia de que el servicio brindado realmente produce un impacto sobre la vida del usuario.

A framework for demonstrating the value of human services

Tanto profesionales como quienes tienen a su cargo diferentes servicios están de acuerdo en que la evaluación es importante. Sin embargo, los orientadores rara vez evalúan su trabajo de manera de hallar una relación causal entre los servicios que los usuarios reciben y los cambios a los que acceden. Se ha desarrollado un marco teórico para evaluar los cambios en los conocimientos, habilidades, actitudes y creencias del usuario y examinar el impacto que dichos cambios han hecho en su vida y en la sociedad en la que se desenvuelve. El marco incluye también un sistema de seguimiento de las intervenciones realizadas y de los recursos necesarios para poder implementar exitosamente estas acciones. Ha sido empleado en diversas situaciones orientadoras, establecimientos educativos y acciones de orientación vocacional, con el objeto de proporcionar evidencia de que el servicio brindado realmente produce un impacto sobre la vida del usuario.

To fuse or not to fuse? Assessing the case for convergent disciplines on goods and services trade

Think piece by Pierre Sauvé for the E15 Initiative on Strengthening the Global Trade System In his latest essay for the ICTSD-World Economic Forum E15 initiative on Strengthening the Global Trade and Investment System for Sustainable Development, WTI Director of External Programmes and Academic Partnerships and faculty member Pierre Sauvé explores the case for fusing the law of goods with that of services in a world of global value chains. The paper does so by directing attention to the questions of whether the current architectures of multilateral and preferential trade governance are compatible with a world of trade in tasks; whether the existing rules offer globally active firms a coherent structure for doing business in a predictable environment; whether it is feasible to redesign the structure and content of existing trade rules to align them to the reality of production fragmentation; and what steps can be envisaged to better align policy and realities in the marketplace if the prospects for restructuring appear unfavourable. The paper argues that fusing trade disciplines for goods and services is neither needed nor feasible and may actually deflect attention from a number of worthwhile policy initiatives where more realistic (if never easily secured) prospects of generic rule-making may well exist.

TALISMAN+: Intelligent System for Follow-Up and Promotion of Personal Autonomy

The TALISMAN+ project, financed by the Spanish Ministry of Science and Innovation, aims to research and demonstrate innovative solutions transferable to society which offer services and products based on information and communication technologies in order to promote personal autonomy in prevention and monitoring scenarios. It will solve critical interoperability problems among systems and emerging technologies in a context where heterogeneity brings about accessibility barriers not yet overcome and demanded by the scientific, technological or social-health settings.

A New Multidisciplinary Home Care Telemedicine System to Monitor Stable Chronic Human Immunodeficiency Virus-Infected Patients: A Randomized Study

BACKGROUND: Antiretroviral therapy has changed the natural history of human immunodeficiency virus (HIV) infection in developed countries, where it has become a chronic disease. This clinical scenario requires a new approach to simplify follow-up appointments and facilitate access to healthcare professionals. METHODOLOGY: We developed a new internet-based home care model covering the entire management of chronic HIV-infected patients. This was called Virtual Hospital. We report the results of a prospective randomised study performed over two years, comparing standard care received by HIV-infected patients with Virtual Hospital care. HIV-infected patients with access to a computer and broadband were randomised to be monitored either through Virtual Hospital (Arm I) or through standard care at the day hospital (Arm II). After one year of follow up, patients switched their care to the other arm. Virtual Hospital offered four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and clinical evaluation of Virtual Hospital was carried out. FINDINGS: Of the 83 randomised patients, 42 were monitored during the first year through Virtual Hospital (Arm I) and 41 through standard care (Arm II). Baseline characteristics of patients were similar in the two arms. The level of technical satisfaction with the virtual system was high: 85% of patients considered that Virtual Hospital improved their access to clinical data and they felt comfortable with the videoconference system. Neither clinical parameters [level of CD4+ T lymphocytes, proportion of patients with an undetectable level of viral load (p = 0.21) and compliance levels >90% (p = 0.58)] nor the evaluation of quality of life or psychological questionnaires changed significantly between the two types of care. CONCLUSIONS: Virtual Hospital is a feasible and safe tool for the multidisciplinary home care of chronic HIV patients. Telemedicine should be considered as an appropriate support service for the management of chronic HIV infection. TRIAL REGISTRATION: Clinical-Trials.gov: NCT01117675.