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‣ Ethical considerations, confidentiality issues, rights of human subjects, and uses of monitoring data in research and regulation.

Schulte, P A; Sweeney, M H
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /04/1995 Português
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Biomarkers are potentially powerful tools for use in research and regulation. Their derivation from biologic specimens collected from human subjects does, however, present many ethical implications. Ethical issues are relevant in almost each facet of human biomarker research studies: design, identification and recruitment of subjects, handling and use of the data, and interpretation and communication of results. Researchers also face a number of dilemmas when considering the use of human biologic specimens and new biomarkers. The mere fact that such markers are the result of measurements in human specimens gives the appearance of being more accurate than traditional sources of information such as questionnaires or environmental monitoring; yet, this may not always be the case. The meaning of the results of biomarker studies may be unclear because the purpose of the study is usually for research rather than clinical purposes. There generally are no established normal ranges for biomarkers and the interpretation of findings are often difficult. Researchers may not communicate these results to subjects or consider followup action because the task may be too difficult or undefined, or the reaction of the subject cannot be anticipated. A wide range of practices in this regard exists among researchers. Many questions remain unanswered about the use of biologic specimens. These include questions of ownership and access to specimens. Related to this is the question of whether specimens collected for one research purpose can be used for an entirely different research purpose. This is still an open question.(ABSTRACT TRUNCATED AT 250 WORDS)

‣ How can health service users contribute to the NHS research and development programme?

Oliver, S. R.
Fonte: BMJ Group Publicador: BMJ Group
Tipo: Artigo de Revista Científica
Publicado em 20/05/1995 Português
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The National Childbirth Trust, along with other groups of health service users, is working with health professionals and researchers in planning clinical trials, setting priorities for research, systematically reviewing research reports, and getting research findings into practice. User groups may bridge the gap between the public and researchers by explaining research issues to a wide audience, presenting the needs and views of health service users to the research community, and suggesting how members of the public may be approached for their views directly. Service users recognise their need for training and support, and they call for development and evaluation of this work.

‣ Safety and efficacy of fertility-regulating methods: a decade of research.

Skegg, D. C.
Fonte: World Health Organization Publicador: World Health Organization
Tipo: Artigo de Revista Científica
Publicado em //1999 Português
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An international venture was launched in 1985 to fill a recognized gap in post-marketing surveillance of fertility-regulating methods. For this purpose a new task force was set up by the Special Programme of Research, Development, and Research Training in Human Reproduction, which is cosponsored by the United Nations Development Programme, the United Nations Population Fund, the World Bank, and WHO. Research priorities were chosen and epidemiological studies inaugurated, involving a total of 47 countries--mostly from the developing world. Important progress has been made, especially in helping to define the beneficial and possible adverse effects of oral contraceptives on the risk of neoplasia; in showing that the injectable contraceptive depot-medroxyprogesterone acetate protects against endometrial cancer and does not increase the overall risk of breast cancer, in clarifying which groups of women are susceptible to the rare cardiovascular complications of oral contraceptives (myocardial infarction, stroke, and venous thromboembolism); and in establishing the long-term effectiveness and safety of intrauterine devices. The research has already made a significant impact on family planning policies and practice. Critical appraisal of this venture...

‣ The participation of minorities in published pediatric research.

Kelly, Michael L.; Ackerman, Paul D.; Ross, Lainie Friedman
Fonte: National Medical Association Publicador: National Medical Association
Tipo: Artigo de Revista Científica
Publicado em /06/2005 Português
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OBJECTIVES: There is extensive documentation that minority adults are underrepresented in medical research, but there are scant data regarding minority children and their parents. DESIGN: All full-length articles published in three general pediatric journals between July 2002 through June 2003 were collected and reviewed. Articles were excluded if they did not include at least one U.S. researcher, all subjects enrolled at U.S. institutions, parents or children as subjects, some prospective data collection, or between eight and 10,000 subjects. Corresponding authors were surveyed to clarify race/ethnicity data, language barriers and how race/ethnicity data were collected. RESULTS: Two-hundred-twenty-eight articles qualified for further analysis. Black children and parents and Asian/Pacific Islander parents were overrepresented, and Hispanic children and parents were underrepresented compared to the Census data. Most researchers collected race/ethnicity data by having subjects self-report. Most studies did not have translation available, although most Hispanic and Asian/Pacific Islander subjects were enrolled in studies in which translation was available. CONCLUSION: Our data show that Hispanic and Asian/Pacific Islander research subjects are more likely to participate in pediatric research when translation is available. If the goal is to ensure access to pediatric research for all ethnic populations...

‣ Building capacity in health research in the developing world.

Lansang, Mary Ann; Dennis, Rodolfo
Fonte: World Health Organization Publicador: World Health Organization
Tipo: Artigo de Revista Científica
Publicado em /10/2004 Português
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Strong national health research systems are needed to improve health systems and attain better health. For developing countries to indigenize health research systems, it is essential to build research capacity. We review the positive features and weaknesses of various approaches to capacity building, emphasizing that complementary approaches to human resource development work best in the context of a systems and long-term perspective. As a key element of capacity building, countries must also address issues related to the enabling environment, in particular: leadership, career structure, critical mass, infrastructure, information access and interfaces between research producers and users. The success of efforts to build capacity in developing countries will ultimately depend on political will and credibility, adequate financing, and a responsive capacity-building plan that is based on a thorough situational analysis of the resources needed for health research and the inequities and gaps in health care. Greater national and international investment in capacity building in developing countries has the greatest potential for securing dynamic and agile knowledge systems that can deliver better health and equity, now and in the future.

‣ Evaluating Research and Impact: A Bibliometric Analysis of Research by the NIH/NIAID HIV/AIDS Clinical Trials Networks

Rosas, Scott R.; Kagan, Jonathan M.; Schouten, Jeffrey T.; Slack, Perry A.; Trochim, William M. K.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 04/03/2011 Português
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Evaluative bibliometrics uses advanced techniques to assess the impact of scholarly work in the context of other scientific work and usually compares the relative scientific contributions of research groups or institutions. Using publications from the National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS extramural clinical trials networks, we assessed the presence, performance, and impact of papers published in 2006–2008. Through this approach, we sought to expand traditional bibliometric analyses beyond citation counts to include normative comparisons across journals and fields, visualization of co-authorship across the networks, and assess the inclusion of publications in reviews and syntheses. Specifically, we examined the research output of the networks in terms of the a) presence of papers in the scientific journal hierarchy ranked on the basis of journal influence measures, b) performance of publications on traditional bibliometric measures, and c) impact of publications in comparisons with similar publications worldwide, adjusted for journals and fields. We also examined collaboration and interdisciplinarity across the initiative, through network analysis and modeling of co-authorship patterns. Finally, we explored the uptake of network produced publications in research reviews and syntheses. Overall...

‣ Ethical Issues in Pharmacologic Research in Women Undergoing Pregnancy Termination: A Systemic Review and Survey of Researchers

Gedeon, Christelle; Nava-Ocampo, Alejandro A.; Koren, Gideon
Fonte: Hindawi Publishing Corporation Publicador: Hindawi Publishing Corporation
Tipo: Artigo de Revista Científica
Português
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Objective. To evaluate the ethics of performing research in the field of maternal-fetal medicine involving women undergoing pregnancy termination. Methods. We identified published pharmacological studies performed during elective pregnancy termination. In addition, a questionnaire was administered to investigate whether this research would be acceptable to professionals performing research in the field of maternal-fetal pharmacology. Results. The majority of participants believe that this form of research is necessary to furthering our understanding of drug use in pregnancy. Twenty studies were identified in women undergoing a pregnancy termination where exogenous drug was administered and drug measurement conducted during an abortion. The majority of studies were completed by international groups and not in North America or Western Europe. Conclusions. While a majority of respondents to the survey felt that, although research in women undergoing a pregnancy termination is ethically acceptable, 40% stated that it is not likely to be approved by institutional review boards of most North American medical institutions.

‣ Disciplining Bioethics: Towards a Standard of Methodological Rigor in Bioethics Research

Adler, Daniel; Shaul, Randi Zlotnik
Fonte: Taylor & Francis Publicador: Taylor & Francis
Tipo: Artigo de Revista Científica
Português
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Contemporary bioethics research is often described as multi- or interdisciplinary. Disciplines are characterized, in part, by their methods. Thus, when bioethics research draws on a variety of methods, it crosses disciplinary boundaries. Yet each discipline has its own standard of rigor—so when multiple disciplinary perspectives are considered, what constitutes rigor? This question has received inadequate attention, as there is considerable disagreement regarding the disciplinary status of bioethics. This disagreement has presented five challenges to bioethics research. Addressing them requires consideration of the main types of cross-disciplinary research, and consideration of proposals aiming to ensure rigor in bioethics research.

‣ Occupational Injury Prevention Research in NIOSH

Hsiao, Hongwei; Stout, Nancy
Fonte: Occupational Safety and Health Research Institute Publicador: Occupational Safety and Health Research Institute
Tipo: Artigo de Revista Científica
Português
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This paper provided a brief summary of the current strategic goals, activities, and impacts of the NIOSH (National Institute for Occupational Safety and Health) occupational injury research program. Three primary drivers (injury database, stakeholder input, and staff capacity) were used to define NIOSH research focuses to maximize relevance and impact of the NIOSH injury-prevention-research program. Injury data, strategic goals, program activities, and research impacts were presented with a focus on prevention of four leading causes of workplace injury and death in the US: motor vehicle incidents, falls, workplace violence, and machine and industrial vehicle incidents. This paper showcased selected priority goals, activities, and impacts of the NIOSH injury prevention program. The NIOSH contribution to the overall decrease in fatalities and injuries is reinforced by decreases in specific goal areas. There were also many intermediate outcomes that are on a direct path to preventing injuries, such as new safety regulations and standards, safer technology and products, and improved worker safety training. The outcomes serve as an excellent foundation to stimulate further research and worldwide partnership to address global workplace injury problems.

‣ Attention to Local Health Burden and the Global Disparity of Health Research

Evans, James A.; Shim, Jae-Mahn; Ioannidis, John P. A.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 01/04/2014 Português
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Most studies on global health inequality consider unequal health care and socio-economic conditions but neglect inequality in the production of health knowledge relevant to addressing disease burden. We demonstrate this inequality and identify likely causes. Using disability-adjusted life years (DALYs) for 111 prominent medical conditions, assessed globally and nationally by the World Health Organization, we linked DALYs with MEDLINE articles for each condition to assess the influence of DALY-based global disease burden, compared to the global market for treatment, on the production of relevant MEDLINE articles, systematic reviews, clinical trials and research using animal models vs. humans. We then explored how DALYs, wealth, and the production of research within countries correlate with this global pattern. We show that global DALYs for each condition had a small, significant negative relationship with the production of each type of MEDLINE articles for that condition. Local processes of health research appear to be behind this. Clinical trials and animal studies but not systematic reviews produced within countries were strongly guided by local DALYs. More and less developed countries had very different disease profiles and rich countries publish much more than poor countries. Accordingly...

‣ The Trajectory of Dispersal Research in Conservation Biology. Systematic Review

Driscoll, Don A.; Banks, Sam C.; Barton, Philip S.; Ikin, Karen; Lentini, Pia; Lindenmayer, David B.; Smith, Annabel L.; Berry, Laurence E.; Burns, Emma L.; Edworthy, Amanda; Evans, Maldwyn J.; Gibson, Rebecca; Heinsohn, Rob; Howland, Brett; Kay, Geoff; M
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 17/04/2014 Português
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Dispersal knowledge is essential for conservation management, and demand is growing. But are we accumulating dispersal knowledge at a pace that can meet the demand? To answer this question we tested for changes in dispersal data collection and use over time. Our systematic review of 655 conservation-related publications compared five topics: climate change, habitat restoration, population viability analysis, land planning (systematic conservation planning) and invasive species. We analysed temporal changes in the: (i) questions asked by dispersal-related research; (ii) methods used to study dispersal; (iii) the quality of dispersal data; (iv) extent that dispersal knowledge is lacking, and; (v) likely consequences of limited dispersal knowledge. Research questions have changed little over time; the same problems examined in the 1990s are still being addressed. The most common methods used to study dispersal were occupancy data, expert opinion and modelling, which often provided indirect, low quality information about dispersal. Although use of genetics for estimating dispersal has increased, new ecological and genetic methods for measuring dispersal are not yet widely adopted. Almost half of the papers identified knowledge gaps related to dispersal. Limited dispersal knowledge often made it impossible to discover ecological processes or compromised conservation outcomes. The quality of dispersal data used in climate change research has increased since the 1990s. In comparison...

‣ ClinicalCodes: An Online Clinical Codes Repository to Improve the Validity and Reproducibility of Research Using Electronic Medical Records

Springate, David A.; Kontopantelis, Evangelos; Ashcroft, Darren M.; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 18/06/2014 Português
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Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

‣ The Validation of Peer Review through Research Impact Measures and the Implications for Funding Strategies

Gallo, Stephen A.; Carpenter, Afton S.; Irwin, David; McPartland, Caitlin D.; Travis, Joseph; Reynders, Sofie; Thompson, Lisa A.; Glisson, Scott R.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 03/09/2014 Português
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There is a paucity of data in the literature concerning the validation of the grant application peer review process, which is used to help direct billions of dollars in research funds. Ultimately, this validation will hinge upon empirical data relating the output of funded projects to the predictions implicit in the overall scientific merit scores from the peer review of submitted applications. In an effort to address this need, the American Institute of Biological Sciences (AIBS) conducted a retrospective analysis of peer review data of 2,063 applications submitted to a particular research program and the bibliometric output of the resultant 227 funded projects over an 8-year period. Peer review scores associated with applications were found to be moderately correlated with the total time-adjusted citation output of funded projects, although a high degree of variability existed in the data. Analysis over time revealed that as average annual scores of all applications (both funded and unfunded) submitted to this program improved with time, the average annual citation output per application increased. Citation impact did not correlate with the amount of funds awarded per application or with the total annual programmatic budget. However...

‣ “The One Who Chases You Away Does Not Tell You Go”: Silent Refusals and Complex Power Relations in Research Consent Processes in Coastal Kenya

Kamuya, Dorcas M.; Theobald, Sally J.; Marsh, Vicki; Parker, Michael; Geissler, Wenzel P.; Molyneux, Sassy C.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 15/05/2015 Português
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Consent processes have attracted significant research attention over the last decade, including in the global south. Although relevant studies suggest consent is a complex negotiated process involving multiple actors, most guidelines assume consent is a one-off encounter with a clear ‘yes’ or ‘no’ decision. In this paper we explore the concept of ‘silent refusals’, a situation where it is not clear whether potential participants want to join studies or those in studies want to withdraw from research, as they were not actively saying no. We draw on participant observation, in-depth interviews and group discussions conducted with a range of stakeholders in two large community based studies conducted by the KEMRI Wellcome Trust programme in coastal Kenya. We identified three broad inter-related rationales for silent refusals: 1) a strategy to avoid conflicts and safeguard relations within households, - for young women in particular—to appear to conform to the wishes of elders; 2) an approach to maintain friendly, appreciative and reciprocal relationships with fieldworkers, and the broader research programme; and 3) an effort to retain study benefits, either for individuals, whole households or wider communities. That refusals and underlying rationales were silent posed multiple dilemmas for fieldworkers...

‣ The evolution of withdrawal: negotiating research relationships in biobanking

Melham, Karen; Moraia, Linda Briceno; Mitchell, Colin; Morrison, Michael; Teare, Harriet; Kaye, Jane
Fonte: Springer Berlin Heidelberg Publicador: Springer Berlin Heidelberg
Tipo: Artigo de Revista Científica
Publicado em 05/10/2014 Português
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The right to withdraw from research, along with the necessity of adequately informed consent, is at the heart of the post-Nuremburg code of ethical safeguards in biomedical research on human participants. As biomedical research moves away from direct interventional studies towards research using networks of linked human tissue samples and data, however, questions arise about what withdrawal can and should mean in these new contexts. Some of the more expansive traditional understandings, such as the right to withdraw from a study ‘at any time’ are limited in practice by the nature of biobank- supported research, particularly where it makes possible widespread dissemination and ongoing reuse of data. It is time for a more nuanced, granular arrangement for withdrawal, appropriate to the ongoing relationships between participants and long-term biobanking enterprises.

‣ Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies

Hanrahan, Donna; Sexton, Patrina; Hui, Katrina; Teitcher, Jennifer; Sugarman, Jeremy; London, Alex John; Barnes, Mark; Purpura, James; Klitzman, Robert
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 30/07/2015 Português
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Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word...

‣ Understandings of Participation in Behavioural Research: A Qualitative Study of Gay and Bisexual Men in Scotland

Boydell, Nicola; Fergie, Gillian May; McDaid, Lisa Margaret; Hilton, Shona
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 07/08/2015 Português
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An array of empirical research has emerged related to public participation in health research. To date, few studies have explored the particular perspectives of gay and bisexual men taking part in behavioural surveillance research, which includes the donation of saliva swabs to investigate HIV prevalence and rates of undiagnosed HIV. Semi-structured interviews were conducted with twenty-nine gay and bisexual men in Scotland who had participated in a bar-based survey. Thematic analysis of men’s accounts of their motives for participation and their perceptions of not receiving individual feedback on HIV status suggested a shared understanding of participation in research as a means of contributing to ‘community’ efforts to prevent the spread of HIV. Most men expressed sophisticated understandings of the purpose of behavioural research and distinguished between this and individual diagnostic testing. Despite calls for feedback on HIV results broadly, for these men feedback on HIV status was not deemed crucial.

‣ Neonicotinoid Insecticides and Their Impacts on Bees: A Systematic Review of Research Approaches and Identification of Knowledge Gaps

Lundin, Ola; Rundlöf, Maj; Smith, Henrik G.; Fries, Ingemar; Bommarco, Riccardo
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 27/08/2015 Português
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It has been suggested that the widespread use of neonicotinoid insecticides threatens bees, but research on this topic has been surrounded by controversy. In order to synthesize which research approaches have been used to examine the effect of neonicotinoids on bees and to identify knowledge gaps, we systematically reviewed research on this subject that was available on the Web of Science and PubMed in June 2015. Most of the 216 primary research studies were conducted in Europe or North America (82%), involved the neonicotinoid imidacloprid (78%), and concerned the western honey bee Apis mellifera (75%). Thus, little seems to be known about neonicotinoids and bees in areas outside Europe and North America. Furthermore, because there is considerable variation in ecological traits among bee taxa, studies on honey bees are not likely to fully predict impacts of neonicotinoids on other species. Studies on crops were dominated by seed-treated maize, oilseed rape (canola) and sunflower, whereas less is known about potential side effects on bees from the use of other application methods on insect pollinated fruit and vegetable crops, or on lawns and ornamental plants. Laboratory approaches were most common, and we suggest that their capability to infer real-world consequences are improved when combined with information from field studies about realistic exposures to neonicotinoids. Studies using field approaches often examined only bee exposure to neonicotinoids and more field studies are needed that measure impacts of exposure. Most studies measured effects on individual bees. We suggest that effects on the individual bee should be linked to both mechanisms at the sub-individual level and also to the consequences for the colony and wider bee populations. As bees are increasingly facing multiple interacting pressures future research needs to clarify the role of neonicotinoids in relative to other drivers of bee declines.

‣ The outcomes of outcomes and effectiveness research: impacts and lessons from the first decade.

Stryer, D; Tunis, S; Hubbard, H; Clancy, C
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /12/2000 Português
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OBJECTIVE: To assess the outcomes of the Agency for Healthcare Research and Quality's (AHRQ; formerly the Agency for Health Care Policy and Research, AHCPR) first decade of focus on outcomes and effectiveness research (OER) and to identify needs and opportunities for the study of OER in the coming years. DATA SOURCE: Study findings were collected in response to an inquiry by the Center for Outcomes and Effectiveness Research at AHRQ in July 1997 to all principal investigators (PIs) funded between 1989 and 1997. The request was for investigators to identify their "most salient findings" and supply material for up to three slides. STUDY DESIGN: A taxonomy of 11 non-mutually exclusive categories was used to group the investigators' salient findings by characteristics of methodology or purpose. Two health services researchers assigned findings to up to three categories for each discrete study. PRINCIPAL FINDINGS: Responses were received from 61 (64 percent) of the 91 PIs, reporting on 115 studies. Of the 246 category assignments made, descriptive epidemiology was the most common (24 percent), followed by comparative effectiveness (17 percent) and economic assessments (12 percent). Most studies were retrospective analyses of administrative data. Viewed within a conceptual framework for assessing the impact of research...

‣ Pesticides--how research has succeeded and failed to translate science into policy: endocrinological effects on wildlife.

Colborn, T
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /09/1995 Português
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Toxicological research became institutionalized in the United States in response to society's concern about cancer and acute mortality. Driven by risk assessment, research focused on the need for data development and the standardization of testing for regulatory and management purposes in a reactive mode. Although the research community has provided evidence for over 40 years that a number of pesticides and industrial chemicals have disruptive effects on the endocrine system, little attention was given to the evidence when determining the health hazards of synthetic chemicals because of the fixation on cancer. However, recent findings concerning the effects of a number of widespread chemicals on the reproductive success and fertility of wildlife and humans has led to the call for a proactive approach using investigative research (forensic science). Suggestions are presented to modernize the research agenda of public health institutions to meet society's needs to address the problems of exposure to endocrine, nervous, and immune system disruptors.