A Trust-Based Pact in Research Biobanks. From Theory to Practice.

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.

Puppets as a strategy for communication with Brazilian children with cancer.

Children are considered competent social actors. Although they are able to express their opinions, they may have some difficulties in answering direct verbal questions, requiring researchers and health professionals to enter their world by using auxiliary resources for communication. This study presents the experience of using finger puppets as a playful strategy for improving interaction and communication with hospitalized children with cancer, aged seven to 12. It describes the strategy of making and using puppets as an auxiliary tool to communicate with children with cancer and presents the results and limitations of using puppets in clinical practice. The use of the puppets, creatively and in accordance with the children's motor, cognitive, and emotional development, showed benefits, such as allowing the children to freely express themselves; respecting their autonomy; and minimizing the hierarchical adult-child relationship. The use of puppets is an appropriate strategy to communicate with hospitalized children. This tool can also enrich clinical practice, as it encourages children with cancer to report their experience of being ill and also helps the health team during evaluation and intervention.

A técnica de autoapresentação do psicodrama no auxílio de diagnóstico de depressão em idosos / The technique of self-presentation of psychodrama in the diagnosis of depression in the elderly

Há evidências de que há um aumento dos casos depressão e suas consequências em idosos. A depressão vai se instalando no indivíduo sem que por ele seja percebida. É o resultado de alterações bioquímicas (serotonina, noradrenalina e dopamina) que trazem mudanças físicas e psicológicas significativas no dia a dia das pessoas. A depressão pode aparecer em qualquer fase do desenvolvimento humano, com apresentação clínica e cursos diferentes, mas com um grupo de sintomas básicos (inibição psíquica, estreitamento do campo vivencial, dos interesses e sofrimento moral) dependendo da personalidade da pessoa os sintomas se repetem, sendo de vários tipos, como episódios de humor, transtornos depressivos, transtornos bipolares. Nos idosos, os sintomas depressivos muitas vezes têm relação com a idade, tais como cansaço físico, falta de iniciativa, poucas interações sociais. Por isso, torna-se necessário desenvolver estudos mais aprofundados com essa população. Assim, o objetivo desta tese foi avaliar e descrever o uso da técnica de autoapresentação do Psicodrama, como auxílio no diagnóstico de depressão em idosos. Para alcançar esse objetivo, o trabalho buscou se apropriar do arcabouço teórico e da técnica de autoapresentação do Psicodrama, enfatizando a criação do vínculo terapêutico pesquisadora-participantes com desdobramento em várias categorias. Este estudo apresenta o delineamento de caso-controle, com 232 idosos freqüentadores da Universidade Aberta à Terceira Idade (UNATI), da Pontifícia Universidade Católica de Goiás, de ambos os sexos e idade entre 55 e 85 anos. Do grupo de casos, participaram indivíduos com pontuações altas no instrumento de Hamilton, com sintomas de humor depressivo, e no grupo- controle, a amostra pareada à do primeiro grupo, com indivíduos cujos índices foram baixos e, portanto, não compatíveis com o humor depressivo. Os resultados apontaram que a técnica de autoapresentação é uma aliada dos profissionais psicoterapeutas-psicodramatistas, apresentando auxílio preciso ao diagnóstico, por se tratar de uma técnica que leva o indivíduo a perceber sua psicodinâmica e reavaliar seus papéis sociais adoecidos.(AU)

There is evidence that there is an increase in cases depression and its consequences in the elderly. Depression will be installing on individual without that for it to be perceived. It is the result of biochemical alte-rations (serotonin, norepinephrine and dopamine) that bring significant physical and psychological changes from day to day lives. Depression can occur at any stage of human development, with clinical presentation and different courses, but with a group of core symptoms (psychological inhibition, narrowing the experiential field, interests and moral suffering) depending on the personality of the person the symptoms recur, It is of various types, such as mood episodes, depressive disorders, bipolar disorders. In the elderly, depressive symptoms often are related to age, such as physical fatigue, lack of initiative, poor social interactions. Therefore, it becomes necessary to develop further studies with this population. The objective of this thesis was to assess and describe the use of self-presentation technique of psychodrama as an aid in the diagnosis of depression in the elderly. To achieve this goal, the study sought to appropriate the theoretical ark-bouço and self-presentation technique of psychodrama, emphasizing the creation of therapeutic vin-century researcher - participants split into several categories. This paper presents the design of case-control with 232 elderly members of the Univer-sity Open for Elderly (UNATI), the Catholic University of Goiás, of both sexes and aged between 55 and 85 years. The group of cases, participated individuals with high scores on the Hamilton instrument, with symptoms of depressed mood, and in the control group, the sample matched to the first group, with individuals whose rates were low and therefore not compatible with humor depressant. The results showed that the selfpresentation technique is an ally of psychotherapists - psychodramatists professionals, with assistance necessary to the diagnosis, because it is a technique that takes the individual to realize his psychodynamic and reassess their diseased social roles.(AU)

'I still believe...' Reconstructing spirituality, culture and mental health across cultural divides.

Whilst striving to create a balanced and healthy life, individuals experience challenges across their life span. Spirituality can contribute to mental health and well-being, as can cultural constructs. In South Africa, apartheid categories are still vivid, which affect spiritual, cultural and racial mental constructs and impact on the mental health of individuals across cultural groups. This article focuses on the long-term development of spiritual and cultural concepts within a selected individual in Cape Town, South Africa, during 11 years of field work. It also explores the impact of spirituality and culture on the researcher-researched relationship. A mixed-method approach was used, including various qualitative methods of data collection as well as content analysis to analyse the data and intersubjective validation to interpret them. Findings show a strong intrapersonal interlinkage of spirituality, culture and mental health and the researcher-researched relationship having a strong impact on spiritual, cultural and mental health constructions. We are not human beings having a spiritual experience. We are spiritual beings having a human experience. (Pierre Teilhard de Chardin, 1976).

Qualitative studies using in-depth interviews with older people from multiple language groups: methodological systematic review.

AIM: This paper is a report of a methodological review of language appropriate practice in qualitative research, when language groups were not determined prior to participant recruitment. BACKGROUND: When older people from multiple language groups participate in research using in-depth interviews, additional challenges are posed for the trustworthiness of findings. This raises the question of how such challenges are addressed. DATA SOURCES: The Cumulative Index to Nursing and Allied Health Literature, Scopus, Embase, Web of Science, Ageline, PsycINFO, Sociological abstracts, Google Scholar and Allied and Complementary Medicine databases were systematically searched for the period 1840 to September 2009. The combined search terms of 'ethnic', 'cultural', 'aged', 'health' and 'qualitative' were used. REVIEW METHODS: In this methodological review, studies were independently appraised by two authors using a quality appraisal tool developed for the review, based on a protocol from the McMaster University Occupational Therapy Evidence-Based Practice Research Group. RESULTS: Nine studies were included. Consideration of language diversity within research process was poor for all studies. The role of language assistants was largely absent from study methods. Only one study reported using participants' preferred languages for informed consent. CONCLUSION: More examples are needed of how to conduct rigorous in-depth interviews with older people from multiple language groups, when languages are not determined before recruitment. This will require both researchers and funding bodies to recognize the importance to contemporary healthcare of including linguistically diverse people in participant samples.

Forging convictions: the effects of active participation in a clinical trial.

This qualitative study explored non-specific influences on participation in, and outcomes of, a randomised controlled trial. It was nested within a single-blind clinical trial of western acupuncture which compared real acupuncture with two types of placebo control administered to National Health Service (NHS) patients awaiting hip and knee replacement surgery in England. Data collection (2004-2008) was based on narrative-style interviews and participant observation. The results indicate that trial recruitment and retention depend on a set of convictions forged largely as a result of contextual factors peripheral to the intervention, including the friendliness and helpfulness of research centre staff and status of the administering practitioner. These convictions also influence the reporting of the study outcomes, particularly if participants experience uncertainties when choosing an appropriate response. The findings suggest that participants in clinical trials are actively involved in shaping the research process, rather than passive recipients of treatment. Thus the outcomes of trials, notably those involving contact interventions, should be regarded not as matters of fact, but as products of complex environmental, social, interpretive and biological processes. In this paper, we develop and present a 'theory of active research participation' which offers a framework for understanding the impact of non-specific processes in clinical trials.

Research with Aboriginal peoples: authentic relationships as a precursor to ethical research.

Recent ethics guidelines and policies are changing the way health research is understood, governed, and practiced among Aboriginal communities in Canada. This provides a unique opportunity to examine the meanings and uses of such guidelines by Aboriginal communities themselves. This qualitative study, conducted in Labrador, Canada, with the Innu, Inuit, and Inuit-Metis, examined how communities and researchers collaborate in a co-learning environment whereby mutual interests and agendas are discussed and enacted throughout the entire research process-a process referred to an authentic research relationship. The purpose of this study was to answer the following questions: (1) Why are authentic research relationships important? (2) What is authenticity in research? (3) How do we achieve authenticity in research with Aboriginal peoples? This shift to more wholistic methodologies can be used in various contexts in Canada and internationally. This is the first study by an Aboriginal person to examine the perspectives of Aboriginal people, in an Aboriginal context, using Aboriginal methodologies.

Conceptual, holistic, and pragmatic considerations for interviewing research participants.

Interviews are commonly used as data collection method in many types of studies. Interviewers and researchers may be challenged to take a holistic view of the interviewing process and to acknowledge participants' perspectives and experiences, understand the implications of dialogue between interviewers and participants, guide data collection to address research questions and aims of a study, and ensure that high-quality data is collected for analysis. This article addresses the need to integrate a holistic perspective into data collection and reviews general and specific interviewing considerations, including assessment and conceptualization of potential research vulnerability of participants, factors that may influence the quality of data collected through interviews, interviewing strategies, interview facilitation, and specific strategies to acknowledge a specialized population in terms of vulnerability, dialogue, power, and study rigor. Data and exemplars from a grounded theory study of mothers of medically fragile infants are used to illustrate some of the challenges inherent in the use of interviews for data collection.

The role of patient advocacy organisations in neuromuscular disease R&D--The case of the Dutch neuromuscular disease association VSN.

This article investigates to what extent patient advocacy organisations play a role in influencing R&D and policymaking for rare neuromuscular diseases. The Dutch neuromuscular disease organisation VSN is studied in depth. A brief history of the VSN is sketched along with the international embedding of the organisation. Then, a more general perspective is provided on the reasons and extent of the involvement of patient organisations (and especially the VSN) in innovation processes. Lastly, internal mechanisms are presented that can best be applied by these organisations. The VSN adheres to a rare, long-term vision on drug innovation that requires long-term planning and policy and vision creation and steering the direction of science and technology. At the same time, other actors like scientific organisations and science policymakers and managers can benefit from these lessons to learn how to deal with patients and patient organisations in the future.

Committees for Ethics in Research involving human subjects.

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.

Using puppetry to elicit children's talk for research.

Although puppets have been employed by various disciplines in clinical and community (e.g. homes and schools) environments, little has been written about their use as a communication tool in research. In this article, a critical review of the literature is undertaken integrating the use of puppets in a qualitative research study exploring children's perspectives on and responses to a camp for children with cancer. Methodological considerations and ethical issues of using puppets as a data collection technique are discussed. Although some limitations exist, using puppets in interviews with children appear to help them to identify, clarify and verbalize their feelings.

Communication and laboratory performance in parapsychology experiments: demand characteristics and the social organization of interaction.

This paper reports findings from a conversation analytic study of experimenter-participant interaction in parapsychology experiments. It shows how properties of communication through which the routine business of the experiment is conducted may have an impact on the research participant's subsequent performance. In this, the study explores social psychological features of the psychology laboratory. In particular, it examines aspects of Orne's (1962) account of what he called the demand characteristics of the psychological experiment. The data come from a corpus of audio recordings of experimenter-participant interaction during experiments on extra-sensory perception. These kinds of experiments, and the phenomena they purport to study, are undoubtedly controversial; however, the paper argues that there are grounds for social psychologists to consider parapsychology experiments as a class (albeit distinctive) of psychology experiments, and, therefore, as sites in which general social psychological and communicative phenomena can be studied. The empirical sections of the paper examine interaction during part of the experimental procedure when the experimenter verbally reviews a record of the participant's imagery reported during an earlier part of the experiment. The analysis shows that the way in which the experimenter acknowledges the research participants' utterances may be significant for the trajectory of the experiment and explores how the participants' subsequent performance in the experiment may be influenced by interactionally generated contingencies.

Clinical nurse specialist influence in the conduct of research in a clinical agency.

Clinical nurse specialists (CNSs) have a unique view and understanding of patients in their environment and are a valuable resource that has not been adequately engaged in research, even when CNSs assist researchers in the conduct of research. The purpose of this article is to outline activities for supporting the conduct of research that capitalize on the clinical strengths of the CNS from an ecological framework. To illustrate the contributions of CNSs in the conduct of research, 3 clinical research studies are described. Discussion of these studies within the context of an ecological framework offers a systematic approach to describing the potential involvement of the CNS in the implementation of nursing research.

Learning from the grandmothers: incorporating indigenous principles into qualitative research.

In this article, the author describes the process she undertook to incorporate Indigenous principles into her doctoral research about the midlife health experiences of elder Aboriginal women in Nova Scotia, Canada. By employing qualitative methods within the context of an Indigenous worldview, she gained knowledge of and developed competence in Aboriginal health research. The emergent partnership among Aboriginal community research facilitators, participating Mi'kmaq women, and the researcher provided many opportunities for the researcher to incorporate the paradigmatic and methodological traditions of Western science and Indigenous cultures. The application of these principles to this study might provide a useful example for other health researchers who are attempting to incorporate diverse methodological principles.

Research as spiritual covenant.

Conducting research with Native American communities poses special challenges from misunderstandings that may arise from the interface of differing cultural worldviews held by the scientific and the Native communities. Although the community-based participatory research approach shows promise for conducting research that can maximize benefits and minimize the risks of harm to Native American people, there is little information related to the practical implementation of culturally appropriate research practices when working with Native American communities. Drawing on the authors' research with three Native American communities in the Northwest, this article describes culturally appropriate processes for engaging Native American communities. The first section identifies and describes the principles that provide the foundation for the authors' research activity as a spiritual covenant and guides the authors' research with the three communities. The second section describes the project phase matrix that was used to organize the approaches employed in this work.

Medical students' perceptions of medical education research and their roles as participants.

PURPOSE: To better understand whether medical students perceive medical education research as important to their medical training and whether published opinions about why medical students participate in research are accurate. METHOD: In 2003-04, 896 first- through fourth-year medical students at Kansas City University of Medicine and Biosciences College of Osteopathic Medicine were asked to complete an online eight-item questionnaire by responding Yes or No to each question. Responses were tallied by year of medical training and converted into numbers and percentages. Chi-square analysis was used to compare response rates among first- through fourth-year students and responses between preclinical and clinical students. RESULTS: A total of 524 students (58.5%) completed the questionnaire. A total of 488 (93%) medical students believed medical education research should be conducted to improve their medical training, 477 (91%) did not feel coerced to participate in studies because of faculty members' positions of authority, and 398 (76%) did not believe they would receive better grades, recommendations, and/or other favors. Four hundred sixty-eight (89%) students were not concerned with their confidentiality as study participants, while 326 (62%) wanted special protections. Response rates by year of medical school were not significantly different (p > .05). Responses of preclinical and clinical students for six of the eight questions were significantly different (p < .05). CONCLUSIONS: Medical school decisionmakers should recognize that students value medical education research. Published opinions about why medical students participate in studies are incongruent with medical students' views. Full review of medical education studies by Institutional Review Boards may be unnecessary and inappropriate.

Reflections on the researcher-participant relationship and the ethics of dialogue.

Research concerned with human beings is always an interference of some kind, thus posing ethical dilemmas that need justification of procedures and methodologies. It is especially true in social work when facing mostly sensitive populations and sensitive issues. In the process of conducting a research on the emotional life histories of Israeli men who batter their partners, some serious ethical questions were evoked such as (a) Did the participants really give their consent? (b) What are the limits of the researcher-participants relationship and who decides them? (c) For whom is the study beneficial? and (d) To what degree did the methodology fit with the participants? In this article, I discuss the Socratic idea of truth revealed through dialogue and the idea of reciprocity that was developed in Buber's (1949) ethics of dialogue and Habermas' (1990) communicative ethics. The 3 essential conclusions drawn from the ethical questions raised and the discussion of the thinkers that are mentioned previously are (a) dialogical methodology is ethically justified; (b) dynamic interactions give a more holistic perspective of the human nature, thus enriching the field; and (c) through dialogical methodology both researcher and participant profit from growth of knowledge, which is a key for empowerment and change.

The problem of privacy in transcultural research: reflections on an ethnographic study in Sri Lanka.

Western laws and codes of ethics frequently require that private health information be treated confidentially. However, cross-cultural research shows that it is not always easy to determine what members of a culture consider to be private or how they wish private information to be handled. This article begins by presenting an ethnographic study of patient-healer relationships in Sri Lanka; researchers were surprised to find that participants' views of health and privacy differed greatly from typical Western views, and that the privacy protections they had put in place caused discomfort among participants. Building on this ethics case study, the article explores two main questions. First, can a single definition of privacy possibly do justice to the cultural variations that exist, or does a conceptual definition inevitably run the risk of ethnocentrism? Second, to what extent is strict compliance with research regulations or ethics codes ethically justifiable when following the rules will obviously cause unease in international participants?