Os sujeitos da pesquisa, em razão de seu estado de vulnerabilidade, reclamam por cuidados éticos e jurídicos. Esta tutela deve anteceder ao status em que o sujeito da pesquisa ainda não está caracterizado como tal, ou seja, quando, como paciente, participa de seleções para integrar experimentos, no caso, promovidos por Instituições de Ensino Superior públicas (IES). No aspecto jurídico, pacientes, sujeitos da pesquisa e comunidade científica foram colocados sob a égide do Código de Defesa do Consumidor a fim de se apurar a tutela desse diploma legal sobre referidas figuras. Em face dessa abordagem ética e jurídica, este estudo teve como objetivo, por meio de uma revista da literatura, desenvolver uma análise crítica sobre a formatação atual utilizada pelas IES pública para recrutamento de sujeitos da pesquisa, através de seus pacientes pré-concebidos; mensurar a importância da formalização de edital pela IES pública nesse contexto de recrutamento. Analisar, ainda, a dicotomia jurídica desenvolvida em torno do Código de Defesa do Consumidor pertinente ao paciente atendido pela IES Pública, por intermédio do SUS e o paciente atendido pela IES privada não submetido ao SUS. Por fim, conferir sob a ótica do Código de Defesa do Consumidor a responsabilidade civil da comunidade científica em decorrência de danos causados ao sujeito da pesquisa. Trata-se de um estudo exploratório e descritivo, com abordagem qualitativa desenvolvida a partir de pesquisas em material existente na literatura nacional e internacional, pertinente à pesquisa envolvendo seres humanos, a sua forma de recrutamento e a responsabilidade civil suscitada em face dos sistemas de saúde público e privado e, não menos, sobre a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. Especificamente, a fundamentação teórica se deu sobre a doutrina da bioética, do biodireito e da ordem jurisdicional, com fomento da legislação brasileira. Foram utilizadas as bases de dados Pubmed, Scielo, Lilacs, Google Acadêmico, Google e Tribunais de Justiça, com a combinação dos seguintes descritores: seleção de pacientes, sujeitos da pesquisa, defesa do consumidor, ética em pesquisa e academia e institutos. Considera-se, ao final, que na IES pública o recrutamento de sujeitos da pesquisa não deve configurar coerção tácita, sendo superlativa a valoração de conceitos éticos intrínsecos à dignidade humana, restando-lhe, ainda a observância de princípios constitucionais referente à administração pública. Nesse âmbito público, a necessidade de edital é requisito formalístico, imperioso para recrutamento de sujeito da pesquisa. Tanto o sistema público de saúde, promovido pela IES pública, como o sistema privado de saúde, promovido pela IES privada, estão sob a tutela do Código de Defesa do Consumidor; ainda devendo ficar sob o pálio deste diploma legal a relação jurídica desenvolvida entre sujeito da pesquisa e comunidade científica. / Human research subjects, due to their vulnerability status, claim to ethical and legal care. This protection must precede the status in which the research subject is not characterized as such, that is when, as a patient, attends selections to integrate experiments in the case, promoted by Public Higher Education Institutions (HEI). In the legal aspect, patients, research subjects and scientific community were placed under the aegis of the Consumer Protection Code in order to establish the tutelage of this statute on those figures. Faced with this ethical and legal approach, this study aimed, through a literature review, develop a critical analysis of the current format used by public HEIs to the recruitment of research subjects, through their predesigned patients; measure the importance of the announcement of the formal public HEIs in this recruitment context. Also, analyze the legal dichotomy developed around the Consumer Protection Code relevant to patients attended by public HEIs, through the Brazilian Public System of Health (BSH) and the patient treated by the private institution not subjected to the BSH. Finally, check, from the perspective of the Consumer Protection Code, the liability of the scientific community due to damages caused to the research subject. This is an exploratory and descriptive study with qualitative approach, developed from research into existing material in national and international literature, relevant to researches involving human beings, their form of recruitment and liability raised in the face of public and private system of health and, not least, on the legal relationship developed between the research subject and the scientific community. Specifically, the theoretical foundation took over the doctrine of bioethics, the bio law and court order, fostering by the Brazilian law. Databases used were Pubmed, Scielo, Lilacs, Google Scholar, Google and Courts of Justice, with the combination of the following descriptors: Patient Selection, Research Subjects, Consumer Advocacy, Ethics, Research and Academies and Institutes. In the end, is considered that in the public HEI, the research subject recruitment should not configure tacit coercion, being superlative the valuation of intrinsic ethical concepts of human dignity, leaving him, yet compliance with constitutional principles relating to public administration. In this public sphere, the need for notice is formalistic requirement imperative for the recruitment of research subjects. Both systems of health, as public promoted by public HEIs, as the private promoted by the private HEIs are under the authority of the Consumer Protection Code; should still be under the canopy of this instrument the legal status developed between the research subject and the scientific community.

INTRODUÇÃO: A recuperação motora é o principal foco dos estudos sobre reabilitação de indivíduos com acidente vascular cerebral (AVC), já que a hemiparesia ocorre em 75% dos casos. No intuito de diminuir o impacto da paresia do membro superior na funcionalidade, diversas modalidades de tratamento têm sido estudadas. O interesse pelo uso de técnicas de neuroestimulação não invasivas, como a estimulação magnética transcraniana repetitiva (EMTr), cresceu de forma acelerada nas últimas décadas. Apesar de cerca de dois terços dos AVCs ocorrerem em países de baixa ou média renda e em desenvolvimento, a maior parte dos estudos sobre o emprego da EMTr na reabilitação após AVC tem sido realizada em países desenvolvidos. Dificuldades de recrutamento são comuns em ensaios clínicos ou estudos de comprovação de conceitos ligados a reabilitação em geral, ou ao uso da EMTr em pacientes com AVC em particular, mesmo em países desenvolvidos. Este trabalho teve como objetivo descrever as barreiras para a inclusão de participantes em um protocolo de reabilitação do membro superior utilizando EMTr em pacientes com AVC, realizado em nosso meio. CASUÍSTICA E MÉTODO: Este estudo foi realizado como parte de um ensaio clínico aleatorizado, controlado e duplo-cego conduzido no Hospital das Clínicas da Universidade de São Paulo. Foi realizada uma avaliação prospectiva da frequência dos motivos de não inclusão de pacientes para um protocolo de tratamento com EMTr de baixa frequência do hemisfério não afetado, em pacientes com paresia da mão após AVC. RESULTADOS: A mediana da idade dos indivíduos triados foi de 63 anos (intervalo, 14-102 anos). Houve leve predomínio do sexo masculino (57%), e 78% dos indivíduos foram considerados brancos. Dos 673 indivíduos triados, foram coletadas informações completas de 571 pacientes. Destes, apenas 32 (5,6%) foram incluídos. O critério de não inclusão mais frequente foi lesão afetando mais que 50% do território da artéria carótida interna (53,4%). As principais razões para exclusão foram AVC recorrente (45,4%), condições clínicas não controladas (17,2%) e presença de contraindicações para a EMT (11,7%). CONCLUSÕES: Considerando que 85% dos AVCs ocorrem nos países em desenvolvimento ou subdesenvolvidos onde a taxa de recorrência é alta, protocolos de reabilitação com critérios de exclusão menos restritivos são necessários para torná-los mais adequados para a população estudada / INTRODUCTION: Considering that hemiparesis occurs in 75% of patients with stroke, motor recovery is the main goal of rehabilitation research protocols. Different modalities of treatment have been developed to minimize the burden of upper limb paresis. The number of studies concerning the use of transcranial magnetic stimulation (TMS) as a potential tool for stroke rehabilitation has grown in the last decades. In spite of the fact that two-thirds of the strokes worldwide occur in low- or middle-income countries, most of TMS stroke rehabilitation studies have been performed in high-income countries. Recruitment barriers are a common issue in clinical trials or proof-of-principle studies related to rehabilitation in patients with stroke, even in developed countries. The main goal of this study was to describe the barriers to participant inclusion in an upper limb rehabilitation protocol with TMS in patients with stroke in Brazil. METHODS: This study was developed as part of a randomized clinical trial conducted at Hospital das Clínicas of the University of São Paulo, Brazil. We analyzed the frequency of reasons for participant non-inclusion in a proof-of-principle rehabilitation trial that applied low-frequency TMS to the non-affected hemisphere of patients that presented hand paresis after stroke. RESULTS: The median age of patients screened for the protocol was 63 years (interval, 14-102 years). Seventy-eight percent of them were White and 57% were male. From the 673 screened patients, complete data were collected from 571 participants but only 32 (5.6%) of them were included. The inclusion criterion that was fulfilled less frequently was a lesion affecting more than 50% of the internal carotid artery territory (53.4%). The three most frequent exclusion criteria were multiple strokes (45.4%), uncontrolled clinical conditions (17.2%) and contraindications to TMS (11.7%). CONCLUSION: Considering that 85% of strokes occur in low- and middle-income countries, where the incidence of recurrent stroke is high, rehabilitation protocols with less stringent exclusion criteria are suggested, in order to make them applicable to more patients

Ontology-mediated query answering is a popular paradigm for enriching answers to user queries with background knowledge. For querying the absence of information, however, there exist only few ontology-based approaches. Moreover, these proposals conflate the closed-domain and closed-world assumption, and therefore are not suited to deal with the anonymous objects that are common in ontological reasoning. Many real-world applications, like processing electronic health records (EHRs), also contain a temporal dimension, and require efficient reasoning algorithms. Moreover, since medical data is not recorded on a regular basis, reasoners must deal with sparse data with potentially large temporal gaps. Our contribution consists of three main parts: Firstly, we introduce a new closed-world semantics for answering conjunctive queries with negation over ontologies formulated in the description logic ELH⊥, which is based on the minimal universal model. We propose a rewriting strategy for dealing with negated query atoms, which shows that query answering is possible in polynomial time in data complexity. Secondly, we introduce a new temporal variant of ELH⊥ that features a convexity operator. We extend this minimal-world semantics for answering metric temporal conjunctive queries with negation over the logic and obtain similar rewritability and complexity results. Thirdly, apart from the theoretical results, we evaluate minimal-world semantics in practice by selecting patients, based their EHRs, that match given criteria.

Selecting patients for clinical trials is very labor-intensive. Our goal is to develop an automated system that can support doctors in this task. This paper describes a major step towards such a system: the automatic translation of clinical trial eligibility criteria from natural language into formal, logic-based queries. First, we develop a semantic annotation process that can capture many types of clinical trial criteria. Then, we map the annotated criteria to the formal query language. We have built a prototype system based on state-of-the-art NLP tools such as Word2Vec, Stanford NLP tools, and the MetaMap Tagger, and have evaluated the quality of the produced queries on a number of criteria from clinicaltrials.gov. Finally, we discuss some criteria that were hard to translate, and give suggestions for how to formulate eligibility criteria to make them easier to translate automatically.

Yes / Bradford, one of the most deprived cities in the United Kingdom, has a wide range of public health problems associated with socioeconomic deprivation, including an infant mortality rate almost double that for England and Wales. Infant mortality is highest for babies of Pakistani origin, who comprise almost half the babies born in Bradford. The Born in Bradford cohort study aims to examine environmental, psychological and genetic factors that impact on health and development perinatally, during childhood and subsequent adult life, and those that influence their parents' health and wellbeing. This protocol outlines methods for the recruitment phase of the study. METHODS: Most Bradford women attend for antenatal care and give birth at the Bradford Royal Infirmary, which has approximately 5,800 births per year. Women are eligible for recruitment if they plan to give birth here. Babies born from March 2007 are eligible to participate, recruitment is planned to continue until 2010. Fathers of babies recruited are invited to participate. Women are usually recruited when they attend for a routine oral glucose tolerance test at 26-28 weeks gestation. Recruitment of babies is at birth. Fathers are recruited whenever possible during the antenatal period, or soon after the birth. The aim is to recruit 10,000 women, their babies, and the babies' fathers. At recruitment women have blood samples taken, are interviewed to complete a semi-structured questionnaire, weighed, and have height, arm circumference and triceps skinfold measured. Umbilical cord blood is collected at birth. Within two weeks of birth babies have their head, arm and abdominal circumference measured, along with subscapular and triceps skinfold thickness. Fathers self-complete a questionnaire at recruitment, have height and weight measured, and provide a saliva sample. Participants are allocated a unique study number. NHS numbers will be used to facilitate record linkage and access to routine data. A wide range of hospital and community sources is being accessed to provide data for the women and children. Data are checked for accuracy and consistency. CONCLUSION: Born in Bradford will increase understanding of the factors that contribute to health and wellbeing, and identify factors that influence differences in them between people of Pakistani and European origin.

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