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.^

A study to determine the association between medical decision-making and the performance of an institutional ethics committee

This study developed proxy measures to test the independent effects of medical specialty, institutional ethics committee (IEC) and the interaction between the two, upon a proxy for the dependent variable of the medical decision to withhold/withdraw care for the dying--the resuscitation index (R-index). Five clinical vignettes were constructed and validated to convey the realism and contextual factors implicit in the decision to withhold/withdraw care. A scale was developed to determine the range of contact by an IEC in terms of physician knowledge and use of IEC policy.^ This study was composed of a sample of 215 physicians in a teaching hospital in the Southwest where proxy measures were tested for two competing influences, medical specialty and IEC, which alternately oppose and support the decision to withhold/withdraw care for the dying. A sub-sample of surgeons supported the hypothesis that an IEC is influential in opposing the medical training imperative to prolong life.^ Those surgeons with a low IEC score were 326 percent more likely to continue care than were surgeons with a high IEC score when compared to all other specialties. IEC alone was also found to significantly predict the decision to withhold/withdraw care. Interaction of IEC with the specialty of surgery was found to be the best predictor for a decision to withhold/withdraw care for the dying. ^

Perceptions of institutional support of community -based participatory research within prevention research centers

The Institute of Medicine (IOM) report on the future of health care states that the focus on health needs to shift to the management and prevention of chronic illnesses and that academic health centers (AHCs) should play an active role in this process through community partnerships (IOM, 2002). Grant funding from the National Institutes of Health and the creation of the Centers for Disease Control and Prevention (CDC) Prevention Research Centers (PRC) across the county represent a transition toward more proactively seeking out community partnerships to better design and disseminate health promotion programs (Green, 2001). ^ The focus of the PRCs is to conduct rigorous, community-based, prevention research, to seek outcomes applicable to public health programs and policies. The PRCs work is to create and foster partnerships among public health and community organizations, to address health promotion and disease prevention issues (CDC, 2003). ^ The W.K. Kellogg Foundation defines CBPR as "a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community with the aim of combining knowledge and action for social change to improve community health." ^ In 1995, CDC asked the IOM to review the PRC program to examine the extent to which the program is providing the public health community with strategies to address public health problems in disease prevention and health promotion (IOM, 1997). No comprehensive evaluation n of the individual PRCs had ever been done (IOM, 1997). ^ The CDC was interested in understanding how it could better support the PRC program through improved management and oversight to influence the program's success. The CDC only represents one of the entities that influence the success of a PRC. Another key entity to consider is the support of and influence of the Schools of Public Health in which the PRCs reside. Using evaluation criteria similar to those that were developed by the IOM, this study examined how aspects of structural capacity of the Schools of Public Health in which the PRCs reside are perceived to influence PRC community-based research activities. ^

An Institutional Analysis of Environmental Pollution Disputes in Taiwan: Cases of 'Self-Relief'

During the late 1980s and early 1990s in Taiwan, people's protests against environmental pollution often took the form of "self-relief," meaning that they attempted to fight polluters using their own resources, without relying on legal or administrative procedures. Why did such an extreme form of disputes become so widespread? What institutional changes did these movements bring about? These questions are analyzed using the analytical framework of "law and economics." Our research shows that "self-relief" functioned to a certain extent as a means of realizing quick compensation for victims, and for reflecting the opinions of local people concerning development projects; in addition, it served to promote the formulation of law and administrative systems. However, as it was based on direct negotiations between the parties concerned, the outcome of each dispute only reflected the transient balance of forces, and the experience gained in negotiations was not accumulated as a social norm.

Institutional Development of Capital Markets in Nine Asian Economies

This paper is conducting a comparative analysis of the development of securities markets in nine Asian economies: Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand, Indonesia, the Philippines, and China. This study focuses on two aspects: the history and institutional development of securities market, such as legal systems, payment systems, etc. From the analyses, this paper reveals several common features of the development of securities markets in nine Asian economies. First, most economies had an informal capital market in the early period of their history. Second, the background of the foundation of their official markets was influenced by experiences of colonization. Third, most governments recognized the importance of the capital market for economic development and had a positive attitude in promoting the market. Fourth, statistics clearly showed that most economies experienced several booms in their capital market from the late 1980s.

The causal relationships in mean and variance between stock returns and foreign institutional investment in India

This paper examines the causalities in mean and variance between stock returns and Foreign Institutional Investment (FII) in India. The analysis in this paper applies the Cross Correlation Function approach from Cheung and Ng (1996), and uses daily data for the timeframe of January 1999 to March 2008 divided into two periods before and after May 2003. Empirical results showed that there are uni-directional causalities in mean and variance from stock returns to FII flows irrelevant of the sample periods, while the reverse causalities in mean and variance are only found in the period beginning with 2003. These results point to FII flows having exerted an impact on the movement of Indian stock prices during the more recent period.

Yangtze River Delta's system integration: institutional barriers and countermeasures

This paper addresses the issue of institutional barriers to the Yangtze River Delta integration and the resulting slow development. It analyzes the problems including the coordination of local interests and regional interests, market segmentation during the regional integration, competition for the local government‘s investment on the public goods, labor movement within the delta. The paper argues that to reduce the negative impacts of these barriers and to promote the further integration of the Yangtze Delta region, the central government should strengthen the coordination between local governments, regulate their disorderly competition and reform the official evaluation system.

Promoting institutional connectivity in the Asia Pacific region : a study of supply chain and trade in services

This paper analyzes "institutional connectivity", or the degree of seamless trade in services centering on the distribution sector. Foreign equity participation in mode 3 (commercial presence) of trade in services and business firms’ investment performance has been studied closely. Net economic benefits of transparent institutional connectivity in the wholesale sector have also been revealed statistically in the case of Japan’s bilateral FTAs with other APEC members. Given these results, APEC could work on establishing its own harmonized "service trade commitment table" with only the foreign capital participation as its simple policy restriction. This would surely enhance an APEC-wide, institutional supply chain connectivity.

Aiming at improving access to research output through the institutional repository

The paper is to introduce the institutional repository (IR) as a powerful tool to support the researchers of the institution to archive and disseminate their research findings freely to the scholarly community on the Internet. The IR can improve the access to an institution’s research output enormously. The operations of an IR also require various interactions with researchers, which enables the library to gain a solid understanding of research needs and expectations. Through such interaction, the relationship and mutual trust between researchers and the library are strengthened. The experiences of the Institute of Developing Economies (IDE) library can be useful to other special libraries.

The impact of institutional environment and cultural context in the four different approaches to social enterprise

This article analyzes the characteristics of four different social enterprise schools of though (social economy, earned-income school in developed countries, earned-income in emerging countries, and social innovation) and the influence of the contextual elements (cultural, political, economic and social) on their configuration. This article draws on the qualitative discussions of social enterprise in different regions of the world. This paper is intended to contribute to the field of social enterprise by broadening the understanding of the influence of environment and institutions on the emergence of social enterprise.