O florir da violeta: um estudo de caso em avaliação terapêutica / The flowering of violet: a case study in therapeutic assessment / La flor de la violeta: un estudio de caso en evaluación terapéutica

A Avaliação Terapêutica (AT) é um processo avaliativo e interventivo proposto para ser semiestruturado e colaborativo com o objetivo de promover mudanças positivas no cliente, que é convidado a ter uma participação ativa durante o processo. Na AT, os resultados dos testes psicológicos padronizados ganham destaque como facilitadores do processo de autoconhecimento do cliente. Desse modo, usualmente, integram-se os achados de testes psicológicos de autorrelato com os métodos projetivos para gerar informações que possam ampliar a visão que o cliente tem de si. Neste artigo, buscou-se compreender o potencial de uso dos testes psicológicos e da relação colaborativa a partir de um caso atendido na perspectiva da AT. A participante, Violeta (nome fictício), foi atendida em 10 sessões com duração entre 60 e 115 minutos. Foram utilizados os testes psicológicos Escala de Bem-Estar Psicológico (Ebep), Escala de Vulnerabilidade e Estresse no Trabalho (Event), Bateria Fatorial de Personalidade (BFP), Método de Rorschach e Inventários de Habilidades Sociais 2 (IHS-2). Observou-se que, durante o processo, Violeta ampliou sua autopercepção, o que possibilitou mudanças no modo de agir em seus relacionamentos amorosos e na reflexão sobre como sua postura era vista por si e por seus colegas de trabalho. Acredita-se que a AT cumpriu com o objetivo de estabelecer uma experiência terapêutica que possibilitasse mudanças positivas para a cliente. Este estudo de caso contribuiu para ampliar a compreensão sobre a importância e o uso dos testes psicológicos neste modelo de avaliação psicológica.(AU)

The Therapeutic Assessment (TA) is an evaluative and interventional process proposed to be semi-structured and collaborative with the objective of promoting positive changes in the client, who is invited to have an active participation during the process. At the TA, the results of standardized psychological tests are highlighted as facilitators of the client's self-knowledge process. In this way, the findings of psychological self-report tests are usually integrated with projective methods to generate information that can broaden the client's view of themselves. In this article, understanding the potential use of psychological tests and of the collaborative relationship from a case treated from the TA perspective was sought. The participant, Violet (fictitious name), was assisted in 10 sessions lasting between 60 and 115 minutes. The psychological tests Psychological Well-Being Scale (EBEP), Vulnerability and Stress at Work Scale (EVENT), Personality Factorial Battery (BFP), Rorschach Method and Social Skills Inventories 2 (IHS-2) were used. It was observed that, during the process, Violet increased her self-perception, which allowed changes in her way of acting in her love life and in her reflection on how her posture was seen by herself and herco-workers. It is believed that TA fulfilled the objective of establishing a therapeutic experience that would enable positive changes for the client. This case study contributed to broaden the understanding about the importance and use of psychological testing in this psychological assessment model.(AU)

La Evaluación Terapéutica (ET) es un proceso de evaluación e intervención que se propone ser semiestructurado y colaborativo, con el objetivo de lograr cambios positivos en el cliente, quien es invitado a tener participación activa durante el proceso. En la ET se destacan los resultados de las pruebas psicológicas estandarizadas como facilitadoras del proceso de autoconocimiento del cliente. Los hallazgos de las pruebas psicológicas de autoinforme suelen integrarse con métodos proyectivos para generar información que pueda ampliar la visión que el cliente tiene de sí mismo. En este artículo se buscó comprender el uso potencial de las pruebas psicológicas y de la relación colaborativa a partir de un estudio de caso tratado desde la perspectiva de la ET. Atendieron a la participante Violeta (nombre ficticio), en 10 sesiones que duraron entre 60 y 115 minutos. Se utilizaron las pruebas psicológicas Escala de Bienestar Psicológico (EBEP), Escala de Vulnerabilidad y Estrés en el Trabajo (EVENT), Batería de Factorial de la Personalidad (BFP), Método de Rorschach e Inventario de Habilidades Sociales 2 (IHS-dos). Se observó que, durante el proceso, Violeta amplió su autopercepción, lo que permitió cambios en la forma de actuar en sus relaciones amorosas y en el reflejo de como ella y sus compañeros de trabajo veían su postura. Así, se cree que ET ha cumplido el objetivo de establecer una experiencia terapéutica que permitió cambios positivos a la cliente. Este estudio contribuyó a ampliar la comprensión sobre la importancia y el uso de las pruebas psicológicas en este modelo de evaluación psicológica.(AU)

Perfil e vozes dos participantes de pesquisas clínicas no Brasil / Profiles and voices of participants in clinical research in Brazil / Perfil y voces de los participantes de investigaciones clínicas en Brasil

Resumo Este estudo de caso buscou traçar o perfil socioeconômico de participantes de ensaios clínicos em centro de pesquisa brasileiro, analisando suas decisões, motivações e experiências, seu conhecimento sobre riscos, benefícios e cuidados dispensados e o processo de consentimento. Dados de 327 participantes foram coletados, realizando-se entrevistas semiestruturadas com 19 deles. Nas pesquisas executadas no centro estudado houve maior participação de homens, de pessoas com poucos anos de estudo formal e de baixa renda. A maioria é aposentada, não tem assistência privada à saúde e tende a não perceber os efeitos da investigação ou superestimar os benefícios médicos diretos. A busca pelo tratamento médico foi o principal fator que influenciou suas decisões/participação, e a assinatura do termo de consentimento livre e esclarecido não garantiu a expressão da autonomia. Conclui-se que o perfil e o conteúdo dos discursos dos participantes são sensíveis indicadores de vulnerabilidade e desigualdade social.

Abstract This case study aimed to trace the socioeconomic profile of participants in clinical research at a Brazilian research center, analyzing their decisions, motivations, experiences, knowledge of risks, benefits and health care provided, and the consent process. The data of 327 participants were collected, and semi-structured interviews conducted with 19 of them. In the research carried out at the center studied there was a greater participation of men and of people with few years of formal education and low income. Most are retired and have no private health plan, tend not to notice the effects of the investigation, or to overestimate its direct medical benefits. The search for medical treatment was the main factor influencing their decisions/participation, and signing the informed consent form did not guarantee the expression of autonomy. We concluded that the participants' profile and speeches content are sensitive indicators of vulnerability and social inequality.

Resumen Este estudio de caso trató de esbozar el perfil socioeconómico de participantes de ensayos clínicos en un centro de investigación brasileño, analizando sus decisiones, motivaciones y experiencias, su conocimiento sobre los riesgos, beneficios y cuidados prestados y el proceso de consentimiento. Se recopilaron datos de 327 participantes y se realizaron entrevistas semiestructuradas con 19 de ellos. En las investigaciones realizadas en el centro estudiado hubo una mayor participación de hombres, de personas con pocos años de educación formal y con bajos ingresos. La mayoría es jubilada y no tiene asistencia sanitaria privada, tiende a no percibir los efectos de la investigación o a sobrestimar los beneficios médicos directos. La búsqueda de tratamiento médico fue el factor principal que influyó en sus decisiones/participación, y la firma del término de consentimiento libre e informado no garantizó la expresión de la autonomía. Se concluye que el perfil y el contenido de los discursos de los participantes son sensibles indicadores de vulnerabilidad y desigualdad social.

Engagement of Urban, Pregnant Puerto Rican Women in Health Disparities Research.

Persistent challenges surround the recruitment of minority women from marginalized communities in health disparities research. These challenges include lack of the following: interest in research participation, trust, positive relationships between researchers and participants/community, and principal investigators from minority groups. The purpose of this article is to describe successful recruitment strategies used in health disparities research with pregnant Puerto Rican women and to suggest ways to ensure the future success of studies on health disparities. Suggested strategies include creating trust, facilitating active participation of stakeholders, and strengthening the research pipeline with undergraduate and graduate nursing students.

Involving patients and the public in medical and health care research studies: An exploratory survey on participant recruiting and representativeness from the perspective of study authors.

Research on patient and public involvement so far concentrates on defining involvement, describing its methods, and analyzing involvement practices in various individual research disciplines. There is little empirical data on the process of and aims for selecting (lay) PPI participants, and to what extend they can and should be representative of the population at large. To explore practices and perceptions on these issues and on future PPI conduct more generally, we sent an electronic survey to authors who published involvement activities as part of their studies in medical and social science journals. We identified such authors with a systematic search of five databases and applied descriptive statistics for analysis. Of those who returned the survey (n = 127 of 315; 40%), most had previously conducted involvement activities (73%). 45% reported more than one type of involvement, e.g. consultation and deliberation and participation (14%) and to have recruited more than one type of participant for their PPI activity (56%), e.g. 'lay publics' and 'expert publics' (33% of 71). Representativeness was often seen as a crucial objective when selecting PPI participants, while less than half found it very easy (9%) or rather easy (34%) to select participants. Many respondents considered achieving good representativeness difficult (52%) or very difficult (17%). They identified significant respective challenges and desired more guidance on various aspects of planning and conducting PPI (56%). 55% thought that the concept of "involvement" should be changed or improved. We conclude that recruiting lay people for PPI activities and deciding about and handling representativeness are controversial in current PPI practice, given the manifold challenges mentioned by the survey respondents. Our findings may inform further research particularly regarding-the potentially many cases of-unpublished PPI.

Research use of electronic health records: patients' perspectives on contact by researchers.

Objective: The use of electronic health records (EHRs) for research has the potential to improve the diagnosis and treatment of disease, yet contact with patients based on results of EHR phenotyping has received little attention. Researchers will almost certainly discover discrepancies in EHRs that call for resolution and, in some cases, raise the ethical dilemma of whether to contact patients about a potentially undiagnosed or untreated health concern. The objective of this study was to explore patients' attitudes and opinions about potential contact by researchers who have had access to their EHRs. Materials and methods: We conducted 15 focus groups in four diverse counties in the southeastern United States. We designed vignettes to describe different situations in which researchers conducting a hypothetical study might have reason to consider contact with patients. Results: Many patients believed it was important for researchers to take action if they discovered information suggesting a current serious health concern. Relaying the information through patients' physicians was considered the most appropriate course of action. Across vignettes, there were significant differences between urban and rural sites. Discussion and conclusions: Researchers may increasingly encounter situations involving contact with patients following EHR phenotyping. They should carefully consider the possibility of such contact when planning their studies, including the time and expertise needed to adjudicate potentially serious discrepancies. Our focus group results are one source of input for the development of ethical approaches to the research use of EHRs.

Afetividade e práxis transformadora na pesquisa qualitativa / Afetividad y práxis transformadora en la investigación cualitativa / Affectivity and transforming praxis in qualitative research

Resumo A partir da premissa de que a realização de pesquisas acadêmicas pode estar engajada com a transformação social, principalmente em territórios marcados pela desigualdade, pretendemos com este artigo dar visibilidade à intersubjetividade e ao compromisso ético-político como elementos balizadores da atividade de pesquisa. As pesquisas descritas, de caráter qualitativo, referenciadas pela etnografia e pesquisa participante foram realizadas em uma comunidade da Baixada Santista, no estado de São Paulo, Brasil. Os resultados indicaram que a riqueza da pesquisa está em seu processo de construção de vínculos afetivos e sociais, na medida em que cria espaços de troca de experiências e diálogo, os quais, por sua vez, geram novos aprendizados conjuntos, entre os atores sociais envolvidos. Além disso, estas pesquisas, engajadas com o fortalecimento comunitário, desencadearam outras atividades, destacando a extensão universitária no território.

Resumen A partir de la premisa de que la realización de la investigación académica se puede acoplar con la transformación social, especialmente en las zonas marcadas por la desigualdad, tenemos la intención de dar visibilidad a intersubjetividad y al compromiso ético-político como guías para los miembros de la actividad de investigación. La investigación descrita, cualitativa, la que hace referencia a la etnografía y la encuesta participante, se llevó a cabo en una comunidad de la Bajada Santista en el estado de São Paulo, Brasil. Los resultados indicaron que la riqueza de la investigación se encuentra en el proceso de construcción de lazos sociales y emocionales, ya que crea espacios de intercambio de experiencias y el diálogo, que, a su vez, son capaces de generar nuevos conjuntos de aprendizaje entre los actores sociales involucrados. Por otra parte, estas investigaciones, comprometidas con el fortalecimiento de la comunidad, originaron otras actividades, destacándose la extensión universitaria en el territorio.

Abstract Taking as a starting point the premise that conducting academic research can be engaged in social change, particularly in areas marked by social inequality, we intend with this article to give visibility to intersubjetivity and ethical-political commitment as a guide for members of the research activity. The research described, which has qualitative character, is referenced by ethnography and participant survey and was carried out in Baixada Santista's community in the state of São Paulo, Brazil. The results indicated that much of the good aspects of research are due to the process of building social and emotional bonds, to the extent that such bonds allow for experiences to be shared and stimulates dialogue, which, in turn, generate new learning sets among the social actors involved. Furthermore, this research engaged with the goal of community strengthening, which triggered other activities, the main one being university outreach programs in the territory.

What do young people with rheumatic disease believe to be important to research about their condition? A UK-wide study.

BACKGROUND: The involvement of people of all ages including young people in research is now widely advocated but prioritisation of research topics is still driven largely by professional agendas. Evidence from adult literature has reported a mismatch between a researcher and patient generated list of research topics. There have been no studies to date exploring the priorities of young people with long term conditions other than in SLE. The study aimed to explore the research priorities of young people across the UK with respect to rheumatic conditions. METHODS: Focus groups were undertaken with young people aged 11-24 years with rheumatic conditions recruited across the UK via members of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR and relevant national charities. Data was analysed using a Framework approach. Participants discussed their beliefs about what should be researched in: Basic Science; Clinical Medicine; Health Services, Psychosocial, and Public Health. They were then invited to prioritize these areas in terms of how much funding they should receive. RESULTS: Thirteen focus groups were held involving 63 participants (18 males: 45 females, mean age 16 years, range 10 to 24) in all four nations of the UK. Young people's research priorities were influenced by whether they felt research would achieve benefits for all or just some patients and long or short term goals. Another influence was whether participants felt that research areas were already well funded. Across all groups, Basic Science was a key priority and participants felt that psychosocial research should be prioritized more. Health Services Research was a lower priority, as the majority of participants were happy with their care. Clinical medicine was not a high priority as young people were happy with their medication or uncomfortable with trying new ones. Finally, for nearly all groups, Public Health was a low priority. Differences were also observed between the two age groups and across the geographically diverse focus groups. CONCLUSION: Understanding young people's research priorities is important to develop research that is in tune with their needs. The results highlight the importance of considering the whole age range of adolescence and young adulthood as well as geographical diversity. The findings from this work will inform the future research of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR in the UK.

Vulnerabilidade de adolescentes em pesquisa e prática clínica / Vulnerability of adolescents in clinical research and practice / La vulnerabilidad de los adolescentes en la investigación y en la práctica clínica

Resumo Os adolescentes são considerados grupo vulnerável e exposto a diferentes ameaças à saúde, tornando-se necessária a discussão sobre aspectos éticos relacionados a sua participação em pesquisa e prática clínica. Por meio de revisão integrativa de literatura foram selecionados estudos que abordaram aspectos bioéticos relacionados à vulnerabilidade de adolescentes nos últimos quinze anos. Nove artigos atenderam aos critérios pré-estabelecidos para o estudo e foram agrupados em três categorias: 1) trabalhos que pontuaram a compreensão psicológica e cognitiva do adolescente ao participar de pesquisa científica; 2) estudos que enfatizaram aspectos relacionados a decisões médicas; e 3) estudos que abordaram a temática da sexualidade na adolescência. Após análise dos estudos selecionados, verificou-se que não é possível chegar a consenso válido para todas as situações que envolvem adolescentes em pesquisa e prática clínica.

Abstract Adolescents are considered vulnerable and exposed to different threats to health group, making it necessary discussion about ethical aspects related to their participation in research and clinical practice. The employed methodology was an integrative literature review and it was selected studies that approached the subject "bioethical matters related to vulnerability of adolescents" within the last fifteen years. Nine articles included the pre-established criteria to the study, grouped into three categories: 1) works that mentioned the psychological-cognitive comprehension of adolescent to participate in scientific research; 2) works emphasizing aspects related to medical decisions; and 3) studies approaching the issue of sexuality in adolescence. The analysis of selected studies found out it is not possible to reach a valid consensus to all situations involving adolescents in research and clinical practice.

Resumen Los adolescentes son considerados como grupo vulnerable y expuesto a diferentes amenazas en el ámbito de la salud, por lo cual es necesario que exista un debate sobre los aspectos éticos relacionados con su participación en la investigación y en la práctica clínica. Por medio de una revisión integradora de la literatura, se seleccionaron estudios que abordaban aspectos bioéticos relacionados con la vulnerabilidad de los adolescentes en los últimos quince años. Nueve artículos contemplaban los criterios preestablecidos para el estudio y se agruparon en tres categorías: 1) trabajos que contemplaban la comprensión psicológica y cognitiva del adolescente al participar en la investigación científica; 2) estudios que enfatizaban los aspectos relacionados con las decisiones médicas; y 3) estudios que abordaban la sexualidad en la adolescencia. Después del análisis de los estudios seleccionados, se verificó que no es posible llegar a un consenso válido para todas las situaciones que involucran adolescentes en la investigación y en la práctica clínica.

A Personal Touch: The Most Important Strategy for Recruiting Latino Research Participants.

People from non-White racial groups and other underserved populations, including Latinos, are frequently reluctant to participate in research. Yet their participation into research is foundational to producing information that researchers and health care providers need to address health disparities. The purpose of this article is to describe challenges we have encountered along with culturally relevant strategies we used in five research studies to recruit Mexican American participants from community settings, some of whom were also of low socioeconomic status. We found that the most effective recruitment strategies reflect the common cultural values of personalismo, simpátia, confianza, respeto, and familismo.

Champions for social change: Photovoice ethics in practice and 'false hopes' for policy and social change.

Photovoice methodology is growing in popularity in the health, education and social sciences as a research tool based on the core values of community-based participatory research. Most photovoice projects state a claim to the third goal of photovoice: to reach policy-makers or effect policy change. This paper examines the concerns of raising false hopes or unrealistic expectations amongst the participants of photovoice projects as they are positioned to be the champions for social change in their communities. The impetus for social change seems to lie in the hands of those most affected by the issue. This drive behind collective social action forms, what could be termed, a micro-social movement or comparative interest group. Looking to the potential use of social movement theory and resource mobilisation concepts, this paper poses a series of unanswered questions about the ethics of photovoice projects. The ethical concern centres on the focus of policy change as a key initiative; yet, most projects remain vague about the implementation and outcomes of this focus.

Integrating relationship- and research-based approaches in Australian health promotion practice.

We examine the perspectives of health promotion practitioners on their approaches to determining health promotion practice, in particular on the role of research and relationships in this process. Using Grounded Theory methods, we analysed 58 semi-structured interviews with 54 health promotion practitioners in New South Wales, Australia. Practitioners differentiated between relationship-based and research-based approaches as two sources of knowledge to guide health promotion practice. We identify several tensions in seeking to combine these approaches in practice and describe the strategies that participants adopted to manage these tensions. The strategies included working in an evidence-informed rather than evidence-based way, creating new evidence about relationship-based processes and outcomes, adopting 'relationship-based' research and evaluation methods, making research and evaluation useful for communities, building research and evaluation skills and improving collaboration between research and evaluation and programme implementation staff. We conclude by highlighting three systemic factors which could further support the integration of research-based and relationship-based health promotion practices: (i) expanding conceptions of health promotion evidence, (ii) developing 'relationship-based' research methods that enable practitioners to measure complex social processes and outcomes and to facilitate community participation and benefit, and (iii) developing organizational capacity.

Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

BACKGROUND: Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. METHODS: A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. RESULTS: Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. CONCLUSIONS: Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial.

Estigma moral e sofrimento psi: problematizando a individualização do superendividamento do consumidor / Moral stigma and psychological suffering: problematizing theindividualization of consumer overindebtness

Em face da ausência de estudos no campo da Psicologia Social sobre o tema, desenvolvemos uma pesquisa exploratória que objetivou conhecer asimplicações subjetivas da situação de superendividamento do consumidor.Entrevistamos 24 consumidores que, estando nessa condição, aderiram aum projeto do judiciário gaúcho que propõe a conciliação paraprocessualcom os credores; realizamos a análise do material obtido nas entrevistas emconsonância com a metodologia da análise de discurso. Dois aspectosinterligados que se evidenciaram – a individualização e a dimensão moralizante do superendividamento, que acarretam considerável sofrimentopsíquico aos sujeitos – são discutidos e problematizados aqui a luz da perspectiva foucaultiana e das proposições de Nietzsche sobre a moral.Indicamos a necessidade de políticas públicas e estratégias de enfrentamento que considerem a complexidade da situação...

Given the lack of studies in the field of Social Psychology on this topic, wedeveloped an exploratory research aiming to know the subjectiveimplications of consumer’s overindebtedness. We interviewed 24 consumers who, being in this condition, joined a project developed by the southern Brazil Judiciary, which proposes legal paraprocedural conciliation with creditors. We analyzed the material obtained in interviews according to the methodology of discourse analysis. Two interrelated aspects that were revealed – individualization and the moralizing dimension of overindebtedness, which cause considerable psychological distress to the subjects – are discussed and problematized here in the light of Foucault’s perspective, and Nietzsche’s propositions about morality. We indicate the need for public policies and facing-up strategies that take into account thecomplexity of this situation...

Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process.

BACKGROUND: This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication. METHODS: This was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan. RESULTS: Only one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to. CONCLUSION: Participants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment.

Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships.

The most contentious, unresolved issue in biomedicine in the last twenty-five years has been how to best address compensated partnerships between academic researchers and the pharmaceutical industry. Law and policy deliberately promote these partnerships through intellectual property law, research funding programs, and drug and device approval pathways while simultaneously condemning them through conflict-of-interest (COI) regulations. These regulations have not been subjected to the close scrutiny that is typically utilized in administrative law to evaluate and improve regulatory systems. This Article suggests that the solution to this standoff in biomedical law and policy lies in an informed, empirical approach. Such an approach must both recognize such partnerships' legal and practical variations, as well as classify them based on their benefit to innovation and their harm to research biases. Ultimately, this approach must facilitate administrative reforms that would convert what is now an inherently arbitrary, yet widespread, regulatory regime into an epistemically rich mechanism for distinguishing between harmful and beneficial partnerships.

Beyond procedural ethics: foregrounding questions of justice in global health research ethics training for students.

Interest in global health is growing among students across many disciplines and fields of study. In response, an increasing number of academic programmes integrate and promote opportunities for international research, service or clinical placements. These activities raise a range of ethical issues and are associated with important training needs for those who participate. In this paper, we focus on research fieldwork conducted in lower income nations by students from more affluent countries and the ethics preparation they would benefit from receiving prior to embarking on these projects. Global health research is closely associated with questions of justice and equity that extend beyond concerns of procedural ethics. Research takes place in and is shaped by matrices of political, social and cultural contexts and concerns. These realities warrant analysis and discussion during research ethics training. Training activities present an opportunity to encourage students to link global health research to questions of global justice, account for issues of justice in planning their own research, and prepare for 'ethics-in-practice' issues when conducting research in contexts of widespread inequality. Sustained engagement with questions of justice and equity during research ethics training will help support students for involvement in global health research.

Challenging research on human subjects: justice and uncompensated harms.

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1-8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65-81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75-98, 2010) and "sham" surgery (Macklin in N Engl J Med 341:992-996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent.

Evolving friendships and shifting ethical dilemmas: fieldworkers' experiences in a short term community based study in Kenya.

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes.