Generalisable Overview of Study Risk for Lead Investigators Needing Guidance (GOSLING): A data governance risk tool.

INTRODUCTION: Digitisation of patient records, coupled with a moral imperative to use routinely collected data for research, necessitate effective data governance that both facilitates evidence-based research and minimises associated risks. The Generalisable Overview of Study Risk for Lead Investigators Needing Guidance (GOSLING) provides the first quantitative risk-measure for assessing the data-related risks of clinical research projects. METHODS: GOSLING employs a self-assessment designed to standardise risk assessment, considering various domains, including data type, security measures, and public co-production. The tool categorises projects into low, medium, and high-risk tiers based on a scoring system developed with the input of patient and public members. It was validated using both real and synthesised project proposals to ensure its effectiveness at triaging the risk of requests for health data. RESULTS: The tool effectively distinguished between fifteen low, medium, and high-risk projects in testing, aligning with subjective expert assessments. An interactive interface and an open-access policy for the tool encourage researchers to self-evaluate and mitigate risks prior to submission for data governance review. Initial testing demonstrated its potential to streamline the review process by identifying projects that may require less scrutiny or those that pose significant risks. DISCUSSION: GOSLING represents the first quantitative approach to measuring study risk, answering calls for standardised risk assessments in using health data for research. Its implementation could contribute to advancing ethical data use, enhancing research transparency, and promoting public trust. Future work will focus on expanding its applicability and exploring its impact on research efficiency and data governance practices.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region.

BACKGROUND: Research cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations. METHODS: Virtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes. RESULTS: Two sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers' competence in both applied research ethics and research methodology as revealed by their applications. CONCLUSIONS: Narratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

Coercion Authorship: Ubiquitous and Preventable.

Coercion authorship (CA), typically enforced by principal investigators, has detrimental effects on graduate students, young researchers, and the entire scientific endeavor. Although CA is ubiquitous, its occurrence and major determinants have been mainly explored among graduate students and junior scientists in Sweden, Norway, and Denmark where the ratio of CA ranged from 13 to 40%. In addition to lacking comparable figures, developing countries usually lack institutional plans for promoting integrity and effective deterrents against CA and other malpractices. Hence, universities and research centers therein must publish their authorship policies and implement specific strategies to instruct graduate students, junior scientists, and experienced researchers on integrity, publishing ethics, and responsible authorship. Finally, I remark that the primary responsibility of principal researchers to promote fair authorship practices and discourage unfair ones is even greater when it comes to CA due to the asymmetrical power relationship between senior authors and novice scientists.

Ethical clearance paper as a bottleneck.

The significance of the ethical review process in human-based research undertakings cannot be overemphasized as it is necessary to uphold ethical standards and protect participants. However, the review process per se can act as a bottleneck, potentially hindering research progress and leading to academic dishonesty. The present work explores the benefits and challenges of ethical review, emphasizing issues like intellectual theft, forced authorship, and the stifling of independent researchers. Proposed solutions include leveraging previously approved designs, empowering experienced professors for clearance, establishing panels of researchers, creating voluntary ethical approval offices, utilizing private consultancy offices, and establishing a transnational ethical clearance authority. In conclusion, this work stresses the importance of finding mechanisms to streamline the ethical review process while maintaining ethical standards to foster integrity in research and combat academic dishonesty.

Responsibility for the Environmental Impact of Data-Intensive Research: An Exploration of UK Health Researchers.

Concerns about research's environmental impacts have been articulated in the research arena, but questions remain about what types of role responsibilities are appropriate to place on researchers, if any. The research question of this paper is: what are the views of UK health researchers who use data-intensive methods on their responsibilities to consider the environmental impacts of their research? Twenty-six interviews were conducted with UK health researchers using data-intensive methods. Participants expressed a desire to take responsibility for the environmental impacts of their research, however, they were unable to consolidate this because there were often obstacles that prevented them from taking such role responsibilities. They suggested strategies to address this, predominantly related to the need for regulation to monitor their own behaviour. This paper discusses the implications of adopting such a regulatory approach as a mechanism to promote researchers' role responsibilities using a neo-liberal critique.

Research Ethics of Involving Adolescents in Health Research Studies: Perspectives From Australia.

PURPOSE: Adolescent participation in health research studies is critical yet complex given the lack of clarity around issues such as consent. This study aimed to understand how those conducting research in Australia navigate research ethics in health research involving adolescents, through qualitative interviews. METHODS: Purposive sampling was used to recruit 23 researchers involved in adolescent health research using semi-structured in-depth interviews. Interviews were conducted via Zoom and audio-recorded after obtaining informed consent. Thematic analysis was used to construct themes and data were organised using NVivo. RESULTS: Two contrasting positions emerged from the data: (1) framing of adolescents as inherently vulnerable, their participation in research understood in terms of risk and protection and (2) adolescent engagement in research is understood in terms of empowerment, emphasising their capacity to make decisions about research participation. We traced these positions through three key themes, particularly in relation to the role of ethics committees: (1) competing positions as a result of inferior or superior knowledge about adolescent lives, (2) competing positions resulting in a risk averse or an empowerment approach, and (3) reflections on processes of obtaining consent which involves gatekeeping and tokenism. DISCUSSION: Our study highlights the contentious topic of navigating ethics committee requirements for the needs of adolescents. Majority of participants felt the current research ethics establishment is not favourable for researchers or adolescents themselves. While it is imperative that perceptions of ethics committees also be studied in the future, our study provides preliminary understanding of how experiences and perceptions shape how researchers interact with the research ethics establishment.

Perspectives of researchers, science policy makers and research ethics committee members on the feedback of individual genetic research findings in African genomics research.

BACKGROUND: Genetic research can yield information that is unrelated to the study's objectives but may be of clinical or personal interest to study participants. There is an emerging but controversial responsibility to return some genetic research results, however there is little evidence available about the views of genomic researchers and others on the African continent. METHODS: We conducted a continental survey to solicit perspectives of researchers, science policy makers and research ethics committee members on the feedback of individual genetic research findings in African genomics research. RESULTS: A total of 110 persons participated in the survey with 51 complete and 59 incomplete surveys received. Data was summarised using descriptive analysis. Overall, our respondents believed that individual genetic research results that are clinically actionable should be returned to study participants apparently because participants have a right to know things about their health, and it might also be a means for research participation to be recognized. Nonetheless, there is a need for development of precise guidance on how to return individual genetic research findings in African genomics research. DISCUSSION: Participants should receive information that could promote a healthier lifestyle; only clinically actionable findings should be returned, and participants should receive all important information that is directly relevant to their health. Nevertheless, detailed guidelines should inform what ought to be returned. H3Africa guidelines stipulate that it is generally considered good practice for researchers to feedback general study results, but there is no consensus about whether individual genomic study results should also be fed back. The decision on what individual results to feedback, if any, is very challenging and the specific context is important to make an appropriate determination.

Rationale and Study Checklist for Ethical Rejection of Participants on Crowdsourcing Research Platforms.

Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs.

Prioritization of ethical concerns regarding HIV molecular epidemiology by public health practitioners and researchers.

BACKGROUND: HIV molecular epidemiology (HIV ME) can support the early detection of emerging clusters of new HIV infections by combining HIV sequence data routinely obtained during the clinical treatment of people living with HIV with behavioral, geographic, and sociodemographic information. While information about emerging clusters promises to facilitate HIV prevention and treatment efforts, the use of this data also raises several ethical concerns. We sought to assess how those working on the frontlines of HIV ME, specifically public health practitioners (PHPs) and researchers, prioritized these issues. METHODS: Ethical issues were identified through literature review, qualitative in-depth interviews, and stakeholder engagement. PHPs and researchers using HIV ME prioritized the issues using best-worst scaling (BWS). A balanced incomplete block design was used to generate 11 choice tasks each consisting of a sub-set of 5 ethical concerns. In each task, respondents were asked to assess the most and least concerning issue. Data were analyzed using conditional logit, with a Swait-Louviere test of poolability. Latent class analysis was then used to explore preference heterogeneity. RESULTS: In total, 57 respondents completed the BWS experiment May-June 2023 with the Swait-Louviere test indicating that researchers and PHPs could be pooled (p = 0.512). Latent class analysis identified two classes, those highlighting "Harms" (n = 29) (prioritizing concerns about potential risk of legal prosecution, individual harm, and group stigma) and those highlighting "Utility" (n = 28) (prioritizing concerns about limited evidence, resource allocation, non-disclosure of data use for HIV ME, and the potential to infer the directionality of HIV transmission). There were no differences in the characteristics of members across classes. CONCLUSIONS: The ethical issues of HIV ME vary in importance among stakeholders, reflecting different perspectives on the potential impact and usefulness of the data. Knowing these differences exist can directly inform the focus of future deliberations about the policies and practices of HIV ME in the United States.

[Opportunities and Challenges Of The Ethics Review Of Qualitative Health Services Research: A Survey Of Qualitative Researchers]. / Chancen und Herausforderungen der Ethikbegutachtung qualitativer Versorgungsforschung ­ eine Befragung qualitativ Forschender.

Ethics committees ensure compliance with ethical principles in medical research. They are oriented towards clinical studies, but also review e. g., qualitative research. Using a semi-structured online survey, we collected data on experiences of qualitative researchers with the review by ethics committees and analysed them via content analysis. In July 2019, 73 researchers took part in the survey. Five main topics were derived from their statements regarding the ethics review of qualitative research: 1. relevance of qualitative research expertise; 2. cooperation between researchers and ethics committees; 3. transparency of review criteria; 4. dealing with formal review requirements; 5. evaluation of the review's significance for qualitative research. The results show the potential of ethics review for reflection on ethical questions in qualitative research. Prerequisites for this are the fit with the characteristics and quality criteria of qualitative research, the presence of qualitative research expertise in ethics committees, the transparency of the ethics review process as well as openness to different professional cultures and a constructive communication culture.

Ethical preparedness in genomic medicine: how NHS clinical scientists navigate ethical issues.

Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face navigating ethical problems in their work, but how they should be best supported to do this is underexplored. This lack of attention is also reflected in the ethics tools available to clinical laboratory scientists such as guidance and deliberative ethics forums, developed primarily to manage issues arising within the clinic.We explore what ethical issues are being experienced by clinical scientists, how they think such issues could be best analysed and managed, and whether their practice might be enhanced by more situated approaches to ethics deliberation and practice such as ethical preparedness. From thematic analysis of cases presented by clinical scientists at a specially convened meeting of the UK Genethics Forum, we derived three main ethical themes: (1) the redistribution of labour and responsibilities resulting from the practice of genomic medicine; (2) the interpretation and certainty of results and (3) the proposal that better standardisation and consistency of ethical approaches (for example, more guidelines and policy) could resolve some of the challenges arising.We argue that although standardisation is important for promoting shared understandings of good (including ethical) practice, supplementary approaches to enhance and sustain ethical preparedness will be important to help clinical scientists and others in the recently expanded genetic/genomic medicine environment foster quality ethical thinking.

Desafios atuais da prática em pesquisa qualitativa: reflexões e posicionamento do pesquisador / Desafíos actuales de la práctica de la investigación cualitativa: reflexiones y posicionamiento del investigador / Challenges on current practice of qualitative research: reflections and researcher positioning

Este artigo parte do discurso provocativo feito pelo pesquisador Svend Brinkmann na 17ª Conferência sobre Pesquisa Qualitativa em Saúde para refletir criticamente sobre três desafios enfrentados na prática atual da pesquisa qualitativa e sobre o papel do pesquisador nesse contexto. São abordadas questões éticas, de reconhecimento e validade da pesquisa e relacionadas ao rigor metodológico que destacam o papel do posicionamento do pesquisador para o reconhecimento e a valorização da pesquisa qualitativa, em especial na área de pesquisa em saúde. (AU)

Este artículo se basa en el provocador discurso pronunciado por el investigador Svend Brinkmann en la 17ª Conferencia de Investigación Cualitativa en Salud para reflexionar críticamente sobre tres desafíos enfrentados en la práctica actual de la investigación cualitativa y el papel del investigador en ese contexto. Se abordan cuestiones éticas, de reconocimiento y vigencia de la investigación y relacionadas con el rigor metodológico, destacando el papel del puesto de investigador para el reconocimiento y valorización de la investigación cualitativa, especialmente en el área de la investigación en salud. (AU)

Building on the provocative speech given by researcher Svend Brinkmann at the 17th Qualitative Health Research Conference, this paperwork aims to critically think over three challenges faced during the current practice of qualitative research, and also the role of the researcher in this context. We have taken into consideration ethical issues and issues of recognition and validation of the research, as well as issues related to methodological rigor, which highlight the role of the researcher in the recognition and valuation of qualitative research, particularly in the health research field. (AU)

Navegando em águas raras: notas de uma pesquisa com famílias de crianças e adolescentes vivendo com doenças raras / Navigating in rare oceans: notes from a family survey of children and adolescents living with rare diseases

Resumo No presente artigo, procura-se evidenciar a construção da navegação social em um hospital. O enfoque dado privilegiou os bastidores da aplicação de um questionário quantitativo sobre os custos da família com os cuidados/tratamento de seu(sua) filho(a) com doença rara. Permeando a descrição desses processos estão os marcadores de gênero, raça e geração de um dos autores deste artigo. A interação entre pesquisador e sujeitos da pesquisa em campo é socialmente construída, conforme as circunstâncias específicas que demarcam o convite para participar da pesquisa, bem como a coleta de dados, por isso o lugar que ocupa e a postura ética precisam estar bem definidos e claros para o pesquisador. O exercício metodológico e ético de construção desta navegação social com a instituição hospitalar e os sujeitos pesquisados foi permeada por dificuldade e incertezas, mas também por surpresas e aprendizados. Foi possível observar características marcantes da instituição, de seus funcionários e das famílias entrevistadas e, avaliar as estratégias metodológicas utilizadas.

Abstract This article seeks to highlight the construction of social navigation in a hospital. Our focus is to reflect on scenes of application of a questionnaire on family costs of care/treatment of children with rare diseases. These processes are linked to the markers of gender, race, and generation of one of the authors. The interaction between researcher and subjects of field research is socially constructed according to the specific circumstances that demarcate the invitation to participate in the research, as well as data collection. It implies that his position as a researcher and the ethical perspective need to be well defined. The approach and ethics build this social navigation with the hospital and the subjects are permeated by difficulty and uncertainty, but also by surprises and learning. It was possible to observe remarkable characteristics of the institution, of their employees and the families, to evaluate the used methodological strategies.