Research ethical committees in Scotland.

A questionnaire was sent to 41 ethical committees in Scotland requesting information about their constitution and supervision of clinical research. Thirty-four (83%) replies were received. Committees varied in size from one to 73 members, most of whom were medical. Ten had no nurse members and only three had lay members without direct NHS connections. Sixteen saw their role as advisory rather than supervisory. Thirteen had not met in the past year whereas two had held 10 or more meetings. Limited use (12) was made of standard protocols, and only six had formal procedures for monitoring research in progress. Only seven of 370 proposals were rejected outright. Risk/benefit dilemmas and difficulties relating to informed consent were the commonest problems encountered. The committees provide only limited safeguards for patients and research workers, and more effective, standardised procedures are indicated.     

CAPACITY BUILDING OF ETHICS REVIEW COMMITTEES ACROSS AFRICA BASED ON THE RESULTS OF A COMPREHENSIVE NEEDS ASSESSMENT SURVEY

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31).
In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems.
Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.     

The new system of review by multicentre research ethics committees: prospective study

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested.ConclusionsThe new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.     

Reviewers’ Ratings and Bibliometric Indicators: Hand in Hand When Assessing Over Research Proposals?

Background

The peer review system has been traditionally challenged due to its many limitations especially for allocating funding. Bibliometric indicators may well present themselves as a complement.

Objective

We analyze the relationship between peers’ ratings and bibliometric indicators for Spanish researchers in the 2007 National R&D Plan for 23 research fields.

Methods and Materials

We analyze peers’ ratings for 2333 applications. We also gathered principal investigators’ research output and impact and studied the differences between accepted and rejected applications. We used the Web of Science database and focused on the 2002-2006 period. First, we analyzed the distribution of granted and rejected proposals considering a given set of bibliometric indicators to test if there are significant differences. Then, we applied a multiple logistic regression analysis to determine if bibliometric indicators can explain by themselves the concession of grant proposals.

Results

63.4% of the applications were funded. Bibliometric indicators for accepted proposals showed a better previous performance than for those rejected; however the correlation between peer review and bibliometric indicators is very heterogeneous among most areas. The logistic regression analysis showed that the main bibliometric indicators that explain the granting of research proposals in most cases are the output (number of published articles) and the number of papers published in journals that belong to the first quartile ranking of the Journal Citations Report.

Discussion

Bibliometric indicators predict the concession of grant proposals at least as well as peer ratings. Social Sciences and Education are the only areas where no relation was found, although this may be due to the limitations of the Web of Science’s coverage. These findings encourage the use of bibliometric indicators as a complement to peer review in most of the analyzed areas.     

NHS locally organised research scheme: regional research committees and the way they work.

Regional research committees vary so widely in size, composition, and their methods of judging proposals that the standards of adjudication may also vary. Once the research has started it tends to be poorly monitored, and comparatively little attempt is made to discover whether the inexperienced researcher''s ability has been promoted. Fostering the research spirit entails more than the provision of funds, and some regional health authorities may need to establish more formal ways of supervising and evaluating the research they support.     

Role of the embryology laboratory in the human embryonic stem cell line derivation process

With the introduction of regenerative medicine and cell therapy programmes by means of human embryonic stem cells (hESC), several research centres have begun projects of derivation of hESC lines. In some stem cell banks, such as the Andalusian Stem Cell Bank, the law also permits the creation of these cell lines. Therefore, the recovery of cryopreserved embryos, their culture and the subsequent derivation to hESC lines requires a suitable embryology laboratory and specialized and highly qualified staff. Moreover, new techniques, from therapeutic nuclear transfer, need this type of laboratory and staff, too. Several International Associations have drawn up some guidelines for laboratories where embryos are manipulated and they reflect the physical space, the staff and the equipment needed in these kinds of laboratories. Nevertheless, we can see that these guidelines do not distinguish between IVF laboratories and other laboratories that obtain hESC lines, so it would be convenient to make a distinction. Following these guidelines, we have tried to draw up concurrent aspects applicable to areas of embryology within stem cell banks. So, the design and the specific implementation programmes for these areas and other research centres with this area but which do not use IVF techniques is vital to develop embryonic cell lines in optimum conditions for future therapeutic applications, although maybe it is rather premature to standardize this type of research.     

Local technicians in long-term research projects: evaluation of 25 years experience in an active tropical research station

Most field ecology is conceived and financed by scientists from urban areas but is actually carried out in rural areas. Field staff can either be imported from urban areas or recruited from local residents. We evaluated the advantages and disadvantages of involving rural residents as local technicians over a 25- year period at active field research site in Costa Rica. We defined "local technicians" as local residents with no university education who acquired significant experience in field data collection, data management and/or laboratory work. We analyzed the experiences of incorporating these technicians into field research in developing countries from the points of view of scientist and of the local technicians themselves. Primary data were written responses from to a standardized survey of 19 senior scientists and Ph.D. students,and results from standardized personal interviews with 22 local technicians. Researchers highlighted the advantages of highly-skilled technicians with minimal staff turnover, as well as the technicians' knowledge of local ecological conditions. Local technicians considered the primary advantages of their jobs to be opportunities for continuing education training in science as well as cultural enrichment through interactions with people of different cultures. The main challenges identified by researchers were the lack of long-term funding for projects and extended training required for local technicians. Local technicians can be of great benefit to research projects by providing high-quality data collection at reasonable costs with low staff turnover. Over the last 25 years the research model at the field station we studied has evolved to the point that most long-term projects now depend heavily on local technicians. This model of involving local technicians in long-term research has multiple benefits for the researchers, the technicians and the local community, and could be adapted to a variety of settings in rural areas of developing countries.     

Diversity in the practice of district ethics committees.

A survey of ethics committees in district health authorities was carried out to find out the size and make up of committees and what information and guidance they offered to scientists who apply to do research. A sample (n = 28) of committees in England (n = 190), half from teaching districts and half from non-teaching districts, was contacted by post requesting this information. A high degree of diversity was found, not only in the methods that committees used but also in the ethical criteria each considered to be pertinent for research. It was also shown that published guidelines have made little impact. It is suggested that issuing more guidelines will be of limited use. Rather, the following are needed: information about why guidelines have been widely ignored, better communication between committees, some form of education for committee members, and a formal register of committees compiled.     

Harmonizing regulations for biomedical research: a critical analysis of the US and Venezuelan systems

This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze - as an example - the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries.     

The roles and functions of hospital-based ethics committees.

Ethics committees ar becoming much more visible on the Canadian health care scene. They range from research-ethics committees that decide whether research projects are ethically sound to case-oriented committees that look at particular issues and give advice. Eike-Henner Kluge says that ethics committees are useful tools, but only when they are appropriately constituted and function in a professional manner. Otherwise, he warns, they become either useless or a liability.     

国家自然科学基金动物学科资助昆虫生理学项目综述

昆虫生理学是昆虫学分支学科中发展最快的学科之一。本文对国家自然科学基金委员会生命科学部动物学科成立20多年以来昆虫生理学项目的资助情况进行了分析, 截止2009年, 昆虫生理学面上项目共资助92项, 占总资助项目1 208项的7.62%; 青年基金共资助16项, 占总资助项目132项的12.12%; 资助重点项目10项。目前, 我国昆虫生理学基础研究的发展已经从组织、 细胞水平深入到分子和基因水平。昆虫的基因组学, 昆虫发育的功能基因及激素调控, 寄主植物、 昆虫、 天敌三者之间的协同进化, 昆虫免疫及其机制等将是昆虫生理学的发展趋势。未来我国昆虫生理学研究应在研究方向、 人才队伍建设、 国际合作以及发挥基金的引领作用等几个方面有所加强。     

中美生物医学合作研究计划及其前景

中美生物医学合作研究计划实施3年来,收到了来自中美双方科学家共657项申请.这些申请在研究内容上涉及肿瘤、感染性疾病(包括HIV感染和艾滋病相关研究)、过敏性疾病、医学免疫学、精神健康及神经性疾病(中风和帕金森病).经过国家自然科学基金委员会和美国国立卫生研究院的联合评审程序,有109项申请项目获得了资助.联合评审的机制和获资助的109个研究项目的合作研究为今后中美双方的进一步合作奠定了基础.     

Incorporating ecological connectivity into ecological functional zoning: A case study in the middle reaches of Yangtze River urban agglomeration

Ecological functional zoning is critical for multiobjective sustainable management of social-ecological systems. However, the framework of ecological functional zoning needs to be further improved. In terms of the index system, the existing “element-structure–function” index system mainly considers the structural characteristics that have a negative impact on ecological processes, e.g., disturbances, while ignoring positive impacts, e.g., connectivity, which may weaken the role of key nodes in the ecosystem and is not conducive to regional ecological protection. In terms of research methodology, the widely used self-organizing feature mapping neural network (SOFM) produces a number of clusters that easily exceed expectations, thus increasing management difficulties. Therefore, there is an urgent need to explore new combining methods. Here, an improved index system combining ecological connectivity and ecological functions and a traditional index system including only ecological functions were constructed, and a zoning method combining a self-organizing feature mapping neural network and fuzzy mean clustering (SOFM-FCM) was used for functional zoning of the middle reaches of the Yangtze River urban agglomeration. The advantages of functional zoning incorporating ecological connectivity were verified by comparing the results of both zoning procedures before and after improvement. The results indicate that the study area could be divided into ecological conservation areas, biodiversity conservation areas, urban development areas, and grain production areas. The zoning schemes before and after the improved framework were reliable compared with the national planning scheme, but there was 20.6% inconsistency in the results after the improved framework. This was mainly manifested by the shift from biodiversity conservation areas to ecological conservation areas and from urban development areas to food production areas. This shift was more conducive to improving spatial continuity and landscape multifunctionality, thus maximizing ecological conservation, pushing back smart urban growth, and achieving food security. This study expands the research perspective concerned with ecological functional zoning, and these results can provide an important reference for regional ecological protection and related research.     

Conducting clinical research in the new NHS: the model of cancer. United Kingdom Coordinating Committee on Cancer Research.

The United Kingdom Coordinating Committee on Cancer Research represents the major organizations funding cancer research in the United Kingdom. The deliberations of a working party convened by the committee to evaluate recently expressed concerns that the changes in the NHS threaten research, especially clinical trials to evaluate new treatments, are reported. A survey of contributors to trials coordinated by the committee showed that half are now experiencing difficulties in continuing to participate in clinical trials. The two major problems identified were lack of time and of staff, especially for NHS staff in non-teaching hospitals. Recent changes in junior doctors'' hours and proposed reductions in the length of time for training will exacerbate this. It is possible to identify the direct and indirect excess costs of conducting research in the NHS, but currently the mechanism does not exist to designate funds specifically for this purpose. Consultation with the regional directors of research and development confirmed that the service increment for teaching and research is not the solution for this. Proposals are made to secure future clinical research in the NHS, including finance, indemnity, the licensing of new drugs, the greater use of nurse counsellors, and the value of cancer registries.     

The refining influence of ethics committees on animal experimentation in Sweden

Mandatory scrutiny of projects by animal ethics committees was introduced in Sweden in 1979. The present study investigated the minutes of meetings held between 1989 and 2000 at which consideration of applications for experimental work in animals resulted in requests for modification (n = 3607). 18.1% of the applications received were approved only after modifications. The majority of the changes requested may be classified as 'Refinement'. The most common requests were for improvement of project design, euthanasia method and housing and husbandry. There was a relative increase in modifications requested by the committees related to anaesthesia, choice of licensed supervisor and the need for licenses or informed consent from animal owners during the period investigated. There was a relative decrease in modifications related to euthanasia, housing and husbandry, and general endpoint assertions. The results suggest that the work of the committees may be perceived as an ongoing process, since several of the applications for which modification was requested were projects that had been approved on a previous occasion but were now up for renewal. In order to have maximal influence on the refinement of scientific protocols it is important that the scientists in the committees are continuously updated on developments in laboratory animal science.     

The community-based malaria control programme in Tigray, northern Ethiopia. A review of programme set-up, activities, outcomes and impact.

Tigray, the northernmost state of Ethiopia, has a population of 3.5 million, 86% rural, and 56% living in malarious areas. In 1992 a Community-Based Malaria Control Programme was established to provide region-wide and sustained access to early diagnosis and treatment of malaria at the village level. 735 volunteer community health workers (CHWs) serve 2,327 villages with a population of 1.74 million, treating an average of 489,378 patients yearly from 1994 to 1997. Recognition of clinical malaria is similar for CHWs and health staff at clinics where there is no access to microscopy. In 1996 a pilot community-financing scheme of insecticide-treated bednets was well accepted, but re-impregnation rates fell in 1998 because of war-related social upheaval. Indicators from health institutions show a progressive increase in malaria morbidity from 1994 to 1998. Repeated mortality surveys show a 40% reduction in death rates in under-5 children from 1994 to 1996 and a 10% increase from 1996 to 1998. These trends may be related to increased malaria transmission with water resources development, increased seasonal labour migration to malarious lowlands, prolongation of the transmission season with climate changes, and increasing chloroquine resistance throughout Ethiopia. Progressive extension of CHW services to ensure better coverage of women, children, migrant workers and communities near water development projects, change to first-line treatment with sulfadoxine-pyrimethamine, extension of the impregnated bednet initiative, and development of a regional warning system for epidemics should result in a greater impact on morbidity and mortality.     

Industrial Symbiosis in the Australian Minerals Industry: The Cases of Kwinana and Gladstone

The realization of regional synergies in industrial areas with intensive minerals processing provides a significant avenue toward sustainable resource processing. This article provides an overview of past and current synergy developments in two of Australia's major heavy industrial regions, Kwinana (Western Australia) and Gladstone (Queensland), and includes a comparative review and assessment of the drivers, barriers, and trigger events for regional synergies initiatives in both areas. Kwinana and Gladstone compare favorably with well‐known international examples in terms of the current level and maturity of industry involvement and collaboration and the commitment to further explore regional resource synergies. Kwinana stands out with regard to the number, diversity, complexity, and maturity of existing synergies. Gladstone is remarkable with regard to unusually large geographic boundaries and high dominance of one industry sector. Many diverse regional synergy opportunities still appear to exist in both industrial regions (particularly in Kwinana), mostly in three broad areas: water, energy, and inorganic by‐product reuse. To enhance the further development of new regional synergies, the Centre for Sustainable Resource Processing (CSRP), a joint initiative of Australian minerals processing companies, research providers, and government agencies, has undertaken several collaborative projects. These include research to facilitate the process of identifying and evaluating potential synergy opportunities and assistance for the industries with feasibility studies and implementation of selected synergy projects in both regions. The article also reports on the progress to date from this CSRP research.     

Does zoo herpetology have a future?

Fifty-two North American zoo reptile and amphibian departments were surveyed to determine their contributions to recognized American Zoo and Aquarium Association (AZA)-sponsored programs and formalized research projects over the past 10 years. Surveys also requested information concerning the allocation of resources for conservation and research programs, staff educational background, and entry level salaries. Twenty-two institutions responded to the survey, collectively indicating a total of 164 technical papers, 16 field studies, and 101 non-technical articles completed between 1987 and 1997. Of the 164 technical papers published, 130 (79%) were contributed by three institutions. Of the 16 field studies, seven were outside the United States, whereas nine focused on native species and ecosystems. Six of the reported field studies involved only financial or logistical support. Of the 101 non-technical articles, 42 (42%) were contributed by a single institution. Twenty-one formalized in-house research projects were reported. However, only four appeared to have a clearly defined objective. Survey respondents also reported nine species of reptiles and one amphibian taxon are managed by Species Survival Plans (SSPs). There are currently 12 Taxon Advisory Group (TAG) coordinators, with four of the current coordinators having served on multiple TAG committees. There are 41 AZA-approved studbooks for reptiles and two for amphibians, with 29 having actually been published to date. The average starting salary reported in our survey for entry level keeper positions was $19,500 (range, $13,500–30,000). The average level of education reported was high school graduate. There was no correlation between productivity and higher wages, or level of education. Only one institution received funding specifically for research. We conclude that zoo herpetology departments are not realizing their potential for formalized research and conservation projects and propose recommendations for future involvement. Zoo Biol 17:453–462, 1998. © 1998 Wiley-Liss, Inc.