Ethical concerns around use of artificial intelligence in health care research from the perspective of patients with meningioma, caregivers and health care providers: a qualitative study.

BACKGROUND: As artificial intelligence (AI) approaches in research increase and AI becomes more integrated into medicine, there is a need to understand perspectives from members of the Canadian public and medical community. The aim of this project was to investigate current perspectives on ethical issues surrounding AI in health care. METHODS: In this qualitative study, adult patients with meningioma and their caregivers were recruited consecutively (August 2018-February 2019) from a neurosurgical clinic in Toronto. Health care providers caring for these patients were recruited through snowball sampling. Based on a nonsystematic literature search, we constructed 3 vignettes that sought participants' views on hypothetical issues surrounding potential AI applications in health care. The vignettes were presented to participants in interviews, which lasted 15-45 minutes. Responses were transcribed and coded for concepts, frequency of response types and larger concepts emerging from the interview. RESULTS: We interviewed 30 participants: 18 patients, 7 caregivers and 5 health care providers. For each question, a variable number of responses were recorded. The majority of participants endorsed nonconsented use of health data but advocated for disclosure and transparency. Few patients and caregivers felt that allocation of health resources should be done via computerized output, and a majority stated that it was inappropriate to delegate such decisions to a computer. Almost all participants felt that selling health data should be prohibited, and a minority stated that less privacy is acceptable for the goal of improving health. Certain caveats were identified, including the desire for deidentification of data and use within trusted institutions. INTERPRETATION: In this preliminary study, patients and caregivers reported a mixture of hopefulness and concern around the use of AI in health care research, whereas providers were generally more skeptical. These findings provide a point of departure for institutions adopting health AI solutions to consider the ethical implications of this work by understanding stakeholders' perspectives.

Patient perspectives on compensation for biospecimen donation.

BACKGROUND: The purpose of this study was to determine whether biospecimen donors believe they should receive compensation. This is the first study to report biospecimen donors' views on compensation and can potentially improve informed consent and recruitment practices. METHODS: Researchers asked patients undergoing surgical removal of tissue to donate biological materials to a biobank; the request was made at their presurgical appointment or in the preoperative clinic of the Emory University Hospital. We interviewed 126 biospecimen donors within 30 days post surgery regarding their perspective on compensation for biospecimen donation. RESULTS: In response to the question "Should you be paid for your participation in the tissue bank?," 95 (95/126, 75%) participants answered "No." Of these, 55 (55/95, 58%) indicated that donating biological materials should be about altruism, not gaining a monetary reward. Only 11 (11/126, 9%) participants unequivocally believed they should receive compensation, while 14 (14/126, 11%) felt entitled to compensation only under specific circumstances. Eleven (11/14) "Depends" participants indicated that donors should only be compensated when researchers perform for-profit research. Responses varied by race and income level, with whites more likely to not feel entitled to compensation and higher income participants more likely to respond "Depends." CONCLUSIONS: The majority of biospecimen donors stated they should not be paid for tissue bank participation. However, a minority believe they should be paid for donating tissue if the tissue is used in revenue-generating projects. These results provide some support for the current biobanking practice of not providing compensation.

Embedded survey study harms colorectal cancer screening attendance: Experiences from Finland 2010 to 2015.

Objective We previously found that administering a pre-screening lifestyle questionnaire lowered the subsequent attendance proportion in the first-ever colorectal cancer screening. We sought to determine whether the effect continued in subsequent screening rounds. Methods The eligible survey cohort ( n = 10,375) received a follow-up questionnaire in 2012, and in 2013, they were invited for colorectal cancer screening for the second time. For the third screening round, in 2015, no questionnaires were sent in the previous year. Screening attendance in 2013 and in 2015 was examined in relation to survey mailings. Results The colorectal cancer screening attendance rate in 2013 was 58.4% in the survey population, and 63.9% in those not surveyed ( P < 0.001). In 2015, the screening attendance rate was 61.7% among those who had been sent the questionnaires in 2010 and in 2012, and 66.2% in those not surveyed ( P < 0.001). The reduction in screening attendance was greater at the second (2013) round than at the first (2011). Conclusion The effect of the initial survey seemed to continue even when no questionnaires were being sent. Attendance among those who had been sent questionnaires earlier did not reach the level of the group that was never surveyed.

Consideraciones éticas para la investigación en salud con pueblos indígenas de Colombia / Ethical considerations for health research regarding Colombian indigenous peoples

RESUMEN La investigación en salud puede producir conocimientos valiosos para orientar las intervenciones de este tipo ofrecidas a individuos y grupos humanos. No obstante, requiere de especificidades para preservar del daño a sujetos de especial protección ante la ley, tales como las poblaciones pertenecientes a etnias indígenas. Por parte de las autoridades internacionales encargadas de trazar normas éticas para proyectos de investigación, se han reconocido conductas científicas poco éticas en investigaciones que involucran a pueblos indígenas. Por esta razón, se han proclamado principios sobre bioética de aplicación internacional para estos grupos poblacionales. Este artículo presenta, analiza y discute posicionamientos del orden nacional e internacional al respecto. En suma, el respeto por la autonomía y la defensa del conocimiento propio son derechos que deben cumplirse y ser tenidos en cuenta al momento de realizar investigaciones científicas con pueblos indígenas. Además del consentimiento informado individual y comunitario, el uso del proceso de consulta previa y concertación permite obtener una adecuada contextualización respecto a las perspectivas, marcos y conceptos a partir de los cuales se realizará la investigación; así como las problemáticas, necesidades y beneficios de la investigación en estos grupos poblacionales.(AU)

ABSTRACT Health research can produce valuable insights to guide interventions offered to individuals and human groups. However, it requires specific precautions to protect potentially vulnerable subjects, such as indigenous populations. It has been recognized that there has been unethical conduct in research -from the international authorities responsible for outlining ethical standards for research projects- with regards to indigenous peoples. This article presents and discusses national and international guidelines to regulate research involving indigenous peoples. In summary, respect for the autonomy and for the own knowledge are rights that must be met to carry out scientific research with indigenous peoples. In addition to the informed consent, the process of consultation and agreement allows adequate contextualization in relation to the problems, needs, and benefits of research in these populations.(AU)

[Proposals for the study of the second victim phenomenon in Spanish Primary Care Centres and Hospitals]. / Propuestas para el estudio del fenómeno de las segundas víctimas en España en atención primaria y hospitales.

OBJECTIVE: To identify the Spanish studies conducted since 2014 on second victims. Its main objective was to identify a global response to the second victim problem, assessing the impact of adverse events (AE) on caregivers and developing of a set of tools to reduce their impact. METHOD: Descriptive studies in which a sample of managers and safety coordinators from Hospitals and Primary Care were surveyed to determine the activities being carried out as regards second victims, as well as a sample of health professionals to describe their experience as a second victims. Qualitative studies are included to design a guide of recommended actions following an AE, an online awareness program on this phenomenon, an application (app) with activities on safety that are the responsibility of the managers, and a web tool for the analysis of AEs. RESULTS: A total of 1,493 professionals (managers, safety coordinators and caregivers) from eight Spanish regions participated. The guide of recommendations, the online program, and the developed applications are accessible on the website: www.segundasvictimas.es, which has received more than 2,500 visits in one year. DISCUSSION: Study results represent a starting point in the study of the second victim phenomenon in Spain. The tools developed raise the awareness of the medical healthcare community about this problem, and provide professionals with basic skills to manage the impact of AEs.

[Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study]. / Die Rolle von Ethikkommissionen für die nationale Versorgungsforschung - eine Querschnittsstudie des Aufwandes zur Erlangung von Sekundärvoten anhand der DACAPO-Studie.

BACKGROUND: Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). METHODS: Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. RESULTS: The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). CONCLUSION: Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed.

7° Encuentro de la Red de Unidades de Investigación en Enfermería ENEO/UNAM, Instituciones e Institutos Nacionales de Salud / 7th Meeting of the Network of Nursing Research Units ENEO/UNAM, Institutions, and National Institutes of Healt

El término red tiene dos usos como un campo social constituido por relaciones entre personas. La palabra campo hace referencia a un concepto espacial que va asociado a cada punto o “integrante” como un valor determinado.

MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

BACKGROUND: There is little guidance on the particular ethical concerns that research raises with a palliative care population. AIM: To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. DESIGN: Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. SETTING/PARTICIPANTS: Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. RESULTS: The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. CONCLUSIONS: The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

Developing longitudinal qualitative designs: lessons learned and recommendations for health services research.

BACKGROUND: Longitudinal qualitative methods are becoming increasingly used in the health service research, but the method and challenges particular to health care settings are not well described in the literature.We reflect on the strategies used in a longitudinal qualitative study to explore the experience of symptoms in cancer patients and their carers, following participants from diagnosis for twelve months; we highlight ethical, practical, theoretical and methodological issues that need to be considered and addressed from the outset of a longitudinal qualitative study. RESULTS: Key considerations in undertaking longitudinal qualitative projects in health research, include the use of theory, utilizing multiple methods of analysis and giving consideration to the practical and ethical issues at an early stage. These can include issues of time and timing; data collection processes; changing the topic guide over time; recruitment considerations; retention of staff; issues around confidentiality; effects of project on staff and patients, and analyzing data within and across time. CONCLUSIONS: As longitudinal qualitative methods are becoming increasingly used in health services research, the methodological and practical challenges particular to health care settings need more robust approaches and conceptual improvement. We provide recommendations for the use of such designs. We have a particular focus on cancer patients, so this paper will have particular relevance for researchers interested in chronic and life limiting conditions.

Procedure versus process: ethical paradigms and the conduct of qualitative research.

BACKGROUND: Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. DISCUSSION: Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic 'procedural' resolution. This is not to say that qualitative studies are 'unethical' but that their ethical nature can only be safeguarded through the practice of 'micro-ethics' based on the judgement and integrity of researchers in the field. SUMMARY: This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of 'empirical ethics' as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.

Bereaved relatives' views about participating in cancer research.

BACKGROUND: Bereaved relatives are considered to be a vulnerable group and there is debate as to whether it is ethical to engage them in research at a time that can be difficult for them. AIM: We conducted a cross-sectional study using cognitive interviewing with the aim of exploring the acceptability of a mortality follow-back survey among bereaved relatives of recently deceased cancer patients to inform the development of a large-scale survey about end-of-life care. RESULTS: Thirty-three next-of-kin of recently deceased cancer patients were invited to participate in a face-to-face interview, or to complete a postal questionnaire. At the end, they were asked about their views of engaging in the study. Nine bereaved relatives participated in a face-to-face interview and 11 completed the postal questionnaire. Eleven relatives reported it was helpful to take part in the study; of these, six did not consider it distressing, and five stated whilst it had been distressing it had been helpful. Thoughts about bringing back memories, altruism and therapeutic value emerged. CONCLUSIONS: We have new evidence that although engaging in follow-back surveys can evoke distress, many participants report it to be a positive experience. We therefore believe that this approach is acceptable when conducted sensitively.

Community researchers conducting health disparities research: Ethical and other insights from fieldwork journaling.

Lay persons who are trained to conduct research in their own communities form an essential part of many research projects. However, the effects of conducting research in their own communities have not been adequately explored. This paper examines the experiences, perceptions, and challenges faced by a group of community researchers during their involvement in a research project that examined if, and how, the relationships between mothers and their adolescent daughters could be harnessed to develop a daughter-initiated cervical cancer intervention. Seven community researchers interviewed 157 mother-daughter pairs in Cape Town, South Africa. We examine the use of journaling as a tool to document the experiences of community researchers, and we consider how journaling may help the community-based researcher grapple with the research process, and, more broadly, what such journal content illustrates with respect to the nature and challenges of community-engaged health research. An analysis of the content of the journals provides a strong indication of how personal and intimate the research process can be for community researchers by virtue of the background that they bring into the process as well as the additional weight of the research process itself. The complexities of navigating dual and somewhat oppositional roles - the role of impartial scientist or researcher and the role of invested community person - has been both underestimated and insufficiently researched.

[Shared decision making (SDM): a systematic survey of terminology use and concepts]. / Partizipative Entscheidungsfindung (PEF): eine systematische Übersichtsarbeit zu Begriffsverwendung und Konzeptionen.

Shared decision making (SDM) has been investigated in numerous research projects. In 2001 the German Ministry of Health initiated a research program on patients as partners in medical decision making ("Der Patient als Partner im medizinischen Entscheidungsprozess"). In this context a large number of studies has been conducted on SDM. In this review the concept of SDM and the use of this term in scientific publications of German study groups is explored. A systematic literature review generated 147 publications on SDM by German researchers, which had been published between 2000 and 2009. The majority of publications identified in this study refer to clinical studies on patients with chronic diseases. Content analysis of the retrieved publications indicates that SDM as a term is used heterogeneously. There is only little research on the theoretical foundations and ethical implications of SDM. In addition to existent Anglo-Saxon definitions of SDM, new concepts of SDM such as involvement of relatives in the process of decision making were identified as part of this review of the German literature. There is only a limited number of empirical studies with a consistent approach towards a definition of SDM and the respective measurements. Against this background, the "SDM questionnaire", which had been developed as part of the German Ministry of Health's research programme, is an important contribution with respect to operationalising SDM and testing possible effects of SDM in clinical practice.

Atenção primária à saúde: diretrizes, desafios e recomendações. Revisão de bibliografia internacional / Primary health care: guidelines, challenges and recommendations. A review of international literature

Apresentamos uma revisão de bibliografia internacional que teve por objetivo identificar e analisar a diversidade de temas associados à Atenção Primária à Saúde, especialmente o cotidiano de trabalho de seus profissionais, suas diretrizes e seus desafios políticos e clínicos. Analisamos os resumos de 105 artigos publicados entre 1999 e 2009. Selecionamos, para análise, 34 artigos identificados de acordo com critérios específicos. Criamos categorias temáticas e comparamos os dados com certa literatura brasileira sobre o tema. Os artigos centram-se no profissional de medicina e enfatizam a noção de medicina baseada em evidências. Abordam principalmente a implementação de diretrizes na Atenção Primária e as relações entre profissionais e usuários. Admitem a complexidade da Atenção Primária e a importância de aproximação à realidade dos pacientes. Entretanto, não abordam a intersetorialidade, não questionam radicalmente o especialismo curativista e não mencionam a promoção de cidadania, autonomia e cogestão junto aos usuários. Falam da necessidade de abordar problemas "humanos" nos níveis de implementação de diretrizes, encontro clínico etc., mas se mostram distanciados das ciências humanas.

We present a review of international literature, aiming at identifying and analyzing the diversity of themes associated to Primary Health Care. We focused on the characteristics of the work of health care personnel, its guidelines and its political and clinical challenges. We analyzed the abstracts of 105 articles published between 1999 and 2009. Then, we integrally read and analyzed 34 articles, creating thematic categories. We compared data to Brazilian literature on the subject. The articles focus on physician's work and emphasize the notion of evidence-based medicine. They mainly approach the implementation of guidelines to primary health care and the professional-patient relations. They acknowledge the complexity of Primary Care and the importance of patient-centered care. However, they do not mention integrated actions with other public policies. The authors do not radically overthrow the cure-centered specialism and they do not write about fostering patients' participation, autonomy and empowerment. They acknowledge the need to approach "human" issues at the levels of guidelines implementation, clinical practices etc. Nevertheless, in general, these authors are far from the social sciences.

Transição tecnológica em uma operadora de plano de saúde: o olhar do usuário / Technological transition in a supplemental health care provider: the user's viewpoint

O setor de saúde suplementar no Brasil vem experimentando, nos últimos anos, novos modelos de atenção à saúde. O presente estudo teve como objetivo caracterizar como os usuários percebem e se posicionam em relação à implantação da Estratégia Saúde da Família (ESF) por uma operadora do tipo autogestão. Utilizando-se de grupos focais com usuários considerados "aderidos" e "não-aderidos" à ESF, a pesquisa revela que os usuários têm uma compreensão bastante clara do significado da estratégia, inclusive de seus fortes elementos racionalizadores, percebem as contradições e deficiências no seu processo de formulação e implantação e mantêm um elevado grau de autonomia na escolha dos serviços que lhe sejam mais adequados, muito influenciados pelo tipo de inserção que têm no estabelecimento bancário que mantém a operadora. O usuário percebe, ainda, o impasse da autogestão entre manter uma ampla rede credenciada de livre acesso ou conseguir avançar no sentido de fazer da ESF o eixo estruturante de sua rede assistencial.

The Brazilian supplemental health care sector has been experiencing new health care models in the last few years. This paper aims at featuring how users perceive and how they express themselves in relation to the deployment of a program known as Family Health Strategy (FHS) by a self-management health care provider. Through focal groups, the research reveals that users present a rather clear view on the meaning of strategy, including its remarkable rationalizing elements. In addition, they percept contradictions as well as deficiencies in the formulation and deployment process, and they keep a high level of autonomy in the choice for more adequate services, which are greatly influenced by the type of insertion that they exert in the bank institution that maintains the health care service provider. Users also perceive the predicament presented by self-management regarding the maintenance of a broad authorized free access network and the advance towards turning FHS into the structuring backbone of its assistance network.