772 resultados para Research Ethics Committee
Resumo:
PROGNOSTIC FACTORS PREDICTING FUNCTIONAL OUTCOME AT FOUR MONTHS FOLLOWING ACUTE ANKLE SPRAINBleakley C.M.1, O'Connor S.R.1, Tully M.A.2, Rocke L.G.3, MacAuley D.C.1, Bradbury I.4, Keegan S.4, McDonough S.M.11University of Ulster, Health & Rehabilitation Sciences Research Institute, Newtownabbey, United Kingdom, 2Queen's University, UKCRC Centre of Excellence for Public Health (NI), Belfast, United Kingdom, 3Royal Victoria Hospital, Department of Emergency Medicine, Belfast, United Kingdom, 4Frontier Science (Scotland), Kincraig, Inverness-shire, United KingdomPurpose: To identify clinically relevant factors assessed following acute ankle sprain that predict functional recovery at four months post-injury.Relevance: Ankle sprains are one of the most common musculoskeletal injuries with an estimated 5000 new cases occurring each day in the United Kingdom. In the acute phase, ankle sprains may be associated with pain and loss of function. In the longer-term there is a risk of residual problems including chronic pain or reinjury. Few studies have sought to examine factors associated with a poor long-term prognosis.Participants: 101 patients (Age: Mean (SD) 25.9 (7.9) years; Body Mass Index (BMI): 25.3 (3.5) kg/m2) with an acute grade 1 or 2 ankle sprain attending an accident and emergency department or sports injury clinic. Exclusion criteria included complete (grade 3) rupture of the ankle ligament complex, bony ankle injury or multiple injuries.Methods: Participants were allocated as part of a randomised controlled trial to an accelerated intervention incorporating intermittent ice and early therapeutic exercise or a standard protection, rest, ice, compression, and elevation intervention for one week. Treatment was then standardised in both groups and consisted of ankle rehabilitation exercises focusing on muscle strengthening, neuromuscular training, and sports specific functional exercises for a period of approximately four to six weeks. On initial assessment age, gender, mechanism of injury, presence of an audible pop or snap and the presence of contact during the injury were recorded. The following factors were also recorded at baseline and at one and four weeks post-injury: weight-bearing dorsi-flexion test, lateral hop test, presence of medial pain on palpation and a positive impingement sign. Functional status was assessed using the Karlsson score at baseline, at week four and at four months. Reinjury rates were recorded throughout the intervention phase and at four months.Analysis: A mixed between-within subjects analysis of variance (ANOVA) was used to determine the effect of each factor on functional status at week four and at four months. Significance was set at a Bonferroni adjusted level of 0.0125 (0.05/4).Results: Eighty-five participants (84%) were available at final follow-up assessment. Pain on weight-bearing dorsi-flexion and lateral hop tests at week four were both associated with a lower functional score at four months post-injury (P = 0.011 and P = 0.001). No other significant interactions were observed at any other timepoint (baseline or week one). There were only two reinjuries within the four month follow-up period with a further two reported at approximately six months post-injury. We were therefore unable to determine whether any factors were associated with an increased risk of reinjury.Conclusions: Potential prognostic factors on initial or early examination after acute ankle sprain did not help predict functional recovery at four months post-injury. However, pain on weight-bearing dorsi-flexion and lateral hop tests observed at four weeks were associated with a slower rate of recovery.Implications: Some clinical tests may help identify patients at risk of poor functional recovery after acute ankle sprain. However, further work is required to examine factors which may be predictive on initial assessment.Key-words: 1. Prognostic factors 2. Recovery 3. Ankle sprainFunding acknowledgements: Physiotherapy Research Foundation, Chartered Society of Physiotherapy, Strategic Priority Fund; Department of Employment and Learning, Northern Ireland.Ethics approval: Office for Research Ethics Committee (UK).
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Analisar sobre o processo de cuidar da equipe de enfermagem na visão dos usuários intoxicados por tentativa de suicídio. Metodologia: estudo descritivo exploratório, de abordagem qualitativa, realizada em um centro de assistência ao intoxicado da Paraíba/Brasil, com nove usuários. Como critérios de inclusão, participaram as pessoas que tentaram o suicídio por intoxicação, nos meses de abril e maio de 2010, período de coleta de dados do estudo, e que tivessem condições de responder as questões formuladas. A coleta de dados foi realizada por meio de entrevista semiestruturada com uso de formulário, cujos dados foram tratados pela Análise Temática. A pesquisa foi aprovada conforme avaliação do Comitê de Ética em Pesquisa da UEPB e mediante CAAE nº 0003.0.349.133-10. Resultados: os participantes concentraram-se na faixa etária de 14 a 26 anos, predominando o gênero feminino e o consumo de agrotóxicos na tentativa de suicídio. A análise dos discursos permitiu identificar que todos os integrantes demonstraram-se satisfeitos com a assistência de enfermagem, entretanto, apontaram ausência de comunicação com os profissionais cuidadores e atraso para a realização dos procedimentos. Conclusão: a ética na assistência de enfermagem supõe o estabelecimento da valorização do humano durante as atribuições profissionais, proporcionando o bem-estar daqueles que não enxergam a dádiva maior, que é nesse plano, a vida
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Ethics on scientific research is approached and often discussed in several areas of knowledge connected to health. In the Administration area there are very few studies which approach the topic of ethics on research. The present paper tried to fill in this gap in the production of knowledge about the topic, investigating how the ethical principles found in the literature and in the codes of conduct are noticed and taken into account in Administration research activities developed by acting researchers in Administration Post Graduation Programs. Theoretically speaking, the study was based mainly on the approaches by Creswell (2007) and Bell and Bryman (2007), which discuss the research ethical principles. Methodologically speaking it was all about an exploratory kind of study, with qualitative research approach. Upon data collection, personal interviews were made aiming at its depth and focus groups were formed. The first stage had interviews with four experienced researchers who took part on a teaching and researching event and on the second stage we used the focus group technique. The focus groups were done in four college institutions along with the post graduation programs in Administration in the states of Rio Grande do Norte, Paraíba and Pernambuco, in Brazil. The results suggest the existence of general principles and parameters for the scientific research recommended in the literature and on official resolution. However, in the Administration area, there are only a few recommendations of good practices when it comes to submitting articles for scientific publications but we found no guidance with ethical principles and parameters which cover all the activities in the scientific research and which specifically meet the research particularities in Administration. The main ethical dilemma pointed by the researchers refers to ethical questions which arise at the time of data collection and on disclosing the results. Most researchers do not know the guidelines and the ethical norms on ethics about research that we have in our country neither do they send in their projects to the research ethics committee. When dilemma arises, they decide the ethical question based on their values and common sense. These elements confirm the thesis that the researcher s procedure in the research activities in Administration is predominantly signed by personal values or by common sense and less by ethical principles, whether by not knowing the normative instruments related to ethics or by disagreeing with any disciplining rules on ethical behavior in the research
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No setor hospitalar, o marketing compõe um grupo interdependente de serviços e tem como objetivo principal aproximar clientes - externos, internos e corpo gestor -, através de estratégias específicas que promovem satisfação e qualidade. Esta organização possui uma larga diversidade de profissionais da saúde e o marketing, neste sentido, auxilia no processamento de seus serviços de forma a lapidá-los sob a ótica do cliente, buscando efetividade e produtividade. Neste cenário encontra-se o enfermeiro, cujo trabalho é composto pelas dimensões cuidar, gerenciar, educar/pesquisar, que se entrelaçam e caracterizam o serviço deste profissional. No entanto, costumeiramente, a enfermagem não declara o marketing como uma ferramenta estratégica ao seu processo de trabalho – fato verificável na exploração de publicações científicas -, e, paralelamente, depara-se com empecilhos na execução de seu trabalho que podem comprometer a sua excelência. Assim, este estudo busca analisar a relação do marketing com o trabalho do enfermeiro nas dimensões cuidar, gerenciar, ensinar/pesquisar. Para sua efetivação, optou-se pelo referencial metodológico Estudo de Caso, onde o fenômeno é verificado como ocorre em seu cenário real. Assim, a coleta, caracterizada por pesquisador e unidade únicos, ocorreu em um hospital universitário, geral e público no sul do país que declara publica e virtualmente o marketing institucional. Como fontes de evidência, foram utilizadas: entrevista focada com quatro sujeitos de áreas estratégicas para esta pesquisa; análise de documentação criada pela assessoria de marketing e observação direta. O tratamento e a análise dos dados ocorreram por meio da Análise Temática, que possibilitou a exposição dos resultados através de dois artigos: “A relação do marketing com o processo de trabalho do enfermeiro na dimensão cuidar” e “A relação do marketing com o processo de trabalho do enfermeiro nas dimensões gerenciar e educar/pesquisar”. Os resultados evidenciaram que o marketing no cuidar - auxilia a efetividade do cuidado através de novas estratégias de comunicação com o usuário, produz materiais elucidativos, lúdicos para sua continuação e manutenção e o divulga no meio intra e extra-hospitalar; no gerenciar - auxilia a o enfermeiro a ter um método mais inovador e criativo, a focar no cliente e no bom relacionamento interpessoal com a equipe; no educar/pesquisar - cria canais de comunicação interna e campanhas únicas que, além de auxiliar na realização da educação permanente e na atualização de enfermeiros, propicia meios para transmitir novos achados científicos à prática da enfermagem hospitalar. Através deste estudo, percebeu-se que ações de marketing podem contribuir para a efetividade do trabalho do enfermeiro em suas facetas dimensionais, aproximando este agente de saúde do usuário ao qual seu serviço é destinado e da gestão da organização, propiciando a este profissional maior visibilidade e valorização no espaço hospitalar e social.
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Introduction and background: Survival following critical illness is associated with a significant burden of physical, emotional and psychosocial morbidity. Recovery can be protracted and incomplete, with important and sustained effects upon everyday life, including family life, social participation and return to work. In stark contrast with other critically ill patient groups (eg, those following cardiothoracic surgery), there are comparatively few interventional studies of rehabilitation among the general intensive care unit patient population. This paper outlines the protocol for a sub study of the RECOVER study: a randomised controlled trial evaluating a complex intervention of enhanced ward-based rehabilitation for patients following discharge from intensive care. Methods and analysis: The RELINQUISH study is a nested longitudinal, qualitative study of family support and perceived healthcare needs among RECOVER participants at key stages of the recovery process and at up to 1 year following hospital discharge. Its central premise is that recovery is a dynamic process wherein patients’ needs evolve over time. RELINQUISH is novel in that we will incorporate two parallel strategies into our data analysis: (1) a pragmatic health services-oriented approach, using an a priori analytical construct, the ‘Timing it Right’ framework and (2) a constructivist grounded theory approach which allows the emergence of new themes and theoretical understandings from the data. We will subsequently use Qualitative Health Needs Assessment methodology to inform the development of timely and responsive healthcare interventions throughout the recovery process. Ethics and dissemination: The protocol has been approved by the Lothian Research Ethics Committee (protocol number HSRU011). The study has been added to the UK Clinical Research Network Database (study ID. 9986). The authors will disseminate the findings in peer reviewed publications and to relevant critical care stakeholder groups.
Resumo:
Analisar sobre o processo de cuidar da equipe de enfermagem na visão dos usuários intoxicados por tentativa de suicídio. Metodologia: estudo descritivo exploratório, de abordagem qualitativa, realizada em um centro de assistência ao intoxicado da Paraíba/Brasil, com nove usuários. Como critérios de inclusão, participaram as pessoas que tentaram o suicídio por intoxicação, nos meses de abril e maio de 2010, período de coleta de dados do estudo, e que tivessem condições de responder as questões formuladas. A coleta de dados foi realizada por meio de entrevista semiestruturada com uso de formulário, cujos dados foram tratados pela Análise Temática. A pesquisa foi aprovada conforme avaliação do Comitê de Ética em Pesquisa da UEPB e mediante CAAE nº 0003.0.349.133-10. Resultados: os participantes concentraram-se na faixa etária de 14 a 26 anos, predominando o gênero feminino e o consumo de agrotóxicos na tentativa de suicídio. A análise dos discursos permitiu identificar que todos os integrantes demonstraram-se satisfeitos com a assistência de enfermagem, entretanto, apontaram ausência de comunicação com os profissionais cuidadores e atraso para a realização dos procedimentos. Conclusão: a ética na assistência de enfermagem supõe o estabelecimento da valorização do humano durante as atribuições profissionais, proporcionando o bem-estar daqueles que não enxergam a dádiva maior, que é nesse plano, a vida
Resumo:
Ethics on scientific research is approached and often discussed in several areas of knowledge connected to health. In the Administration area there are very few studies which approach the topic of ethics on research. The present paper tried to fill in this gap in the production of knowledge about the topic, investigating how the ethical principles found in the literature and in the codes of conduct are noticed and taken into account in Administration research activities developed by acting researchers in Administration Post Graduation Programs. Theoretically speaking, the study was based mainly on the approaches by Creswell (2007) and Bell and Bryman (2007), which discuss the research ethical principles. Methodologically speaking it was all about an exploratory kind of study, with qualitative research approach. Upon data collection, personal interviews were made aiming at its depth and focus groups were formed. The first stage had interviews with four experienced researchers who took part on a teaching and researching event and on the second stage we used the focus group technique. The focus groups were done in four college institutions along with the post graduation programs in Administration in the states of Rio Grande do Norte, Paraíba and Pernambuco, in Brazil. The results suggest the existence of general principles and parameters for the scientific research recommended in the literature and on official resolution. However, in the Administration area, there are only a few recommendations of good practices when it comes to submitting articles for scientific publications but we found no guidance with ethical principles and parameters which cover all the activities in the scientific research and which specifically meet the research particularities in Administration. The main ethical dilemma pointed by the researchers refers to ethical questions which arise at the time of data collection and on disclosing the results. Most researchers do not know the guidelines and the ethical norms on ethics about research that we have in our country neither do they send in their projects to the research ethics committee. When dilemma arises, they decide the ethical question based on their values and common sense. These elements confirm the thesis that the researcher s procedure in the research activities in Administration is predominantly signed by personal values or by common sense and less by ethical principles, whether by not knowing the normative instruments related to ethics or by disagreeing with any disciplining rules on ethical behavior in the research
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A prepayment scheme for health through the National Health Insurance Scheme (NHIS) was commenced in Nigeria about ten years ago. Nigeria operates a federal system of government. Sub- national levels possess a high degree of autonomy in a number of sectors including health. It is important to assess the level of coverage of the scheme among the formal sector workers in Nigeria as a proxy to gauge the extent of coverage of the scheme and derive suitable lessons that could be used in its expansion. This is a cross-sectional, descriptive survey carried out among formal sector workers in Ilorin Kwara State, Nigeria. A stratified sampling technique was used to select study participants. A self-administered questionnaire was used to collect data from respondents. Data was analysed with the SPSS. Ethical approval to conduct the study was obtained from the Bowen University Teaching Hospital Research Ethics Committee. A total of 370 people participated in the study. Majority, (78.9%) of the respondents were aware of the NHIS, however only 13.5 % paid for health care services through the NHIS. Logistic regression analysis shows that respondents with post-secondary education (OR = 9.032, CI = 2.562 – 31.847, p = 0.001) and in federal civil service (OR = 2.679, CI = 1.036 – 6.929, p = 0.042) were over nine and three times more likely to be aware of the scheme than others. Coverage of the scheme among the respondents was unimpressive. A lot still need to be done to fast-track the expansion of the scheme among this sector of the population.
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In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.
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The processes used in Australian universities for reviewing the ethics of research projects are based on the traditions of research and practice from the medical and health sciences. The national guidelines for ethical conduct in research are heavily based on presumptions that the researcher–participant relationship is similar to a doctor–patient relationship. The National Health and Medical Research Council, Australian Research Council and Australian Vice-Chancellors’ Committee have made a laudable effort to fix this problem by releasing the National Statement on Ethical Conduct in Human Research in 2007, to replace the 1999 National Statement on Ethical Conduct in Research Involving Humans. The new statement better encompasses the needs of the humanities, social sciences and creative industries. However, this paper argues that the revised National Statement and ethical review processes within universities still do not fully encompass the definitions of ‘research’ and the requirements, traditions, codes of practice and standards of the humanities, social sciences and creative industries. The paper argues that scholars within these disciplines often lack the language to articulate their modes of practice and risk management strategies to university-level ethics committees. As a consequence, scholars from these disciplines may find their research is delayed or stymied. The paper focuses on creative industries researchers, and explores the issues that they face in managing the ethical review process, particularly when engaging in practice-based research. Although the focus is on the creative industries, the issues are relevant to most fields in the humanities and social sciences.
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Widespread scholarly interest in ethics in research with children, as an extant field of inquiry and practice, is a relatively new phenomenon. The discipline of ethics can be traced back to the Hippocratic school, but its contemporary applications in the everyday worlds of children and those around them are gaining greater attention from theorists, practitioners, and those involved in policy. Heightened international awareness of the United Nations Convention on the Rights of the Child (1979) gave significant impetus to increasing international awareness of children’s rights to provision, protection, and participation in everyday contexts, including those in which research occurs. Understandings of research ethics and of children’s involvement in research relate to broader understandings of children and childhood drawn from developmental science, sociology, human geography, health sciences, and children’s human rights to participation and protection. Key understandings pertain to children’s competence to participate in research, to operate as reliable informants with respect to their own lives, to provide voluntary informed consent and dissent in research, and to make meaningful decisions about the nature and extent of their participation. The field is international and interdisciplinary, although bounded by legislative, policy, and jurisdictional requirements governing research—its conduct and dissemination. So, too, the burgeoning work of ethics committees, whether in relation to health research or social research, is evidence of a sharpened focus on governance of child research. Oxford Bibliographies offers a suite of perspectives, resources, and strategies to guide the researcher, practitioner, and policymaker and serves to challenge readers to interrogate conceptual understandings, methodologies, and dissemination of research with and about children. Exploration of the suite opens up new possibilities for considering children’s rights to participation in matters that affect their lives and for children to be seen and heard in research.
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Indigenous commentators have long critiqued the way in which government agencies and member of academic institutions carry out research in their social context. Recently, these commentators have turned their critical gaze upon activities of Research Ethics Boards(REBs). Informed by the reflections on research processes and by Indigenous Canadian and New Zealand research participants, as well as the extant literature, this paper critiques the processes employed by New Zealand REBs to assess Indigenous‐focused or Indigenous‐led research in the criminological realm.
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Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.
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This article outlines the case for peace and conflict researchers to formulate a research covenant to better shape their ethical obligations and responsibilities. This is an urgent necessity given that ethical debates have in some proponents become emotive and are not conducted in an ethical manner. In coming to this assessment, the article reviews trends in the research ethics literature and draws out some of the generic issues addressed in a review of the personal reflexivity that an assortment of individual peace and conflict researchers have engaged in when recounting their fieldwork experiences. These generic issues are reformulated in an attempt to codify appropriate ethical practice in peace and conflict research, and they go towards determining the contents of the research covenant. It is suggested that the research covenant is a more ethical way to debate the ethics of peace and conflict research.
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Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.