Knowledge, Attitude and Practice of Research Ethics among Researchers in Nepal.

INTRODUCTION: The universal health research ethical principles must be adhered to ensure a balance between science and safeguarding participants' rights, safety and dignity. A cross-sectional study was conducted to assess the knowledge, attitude, and practice of research ethics among researchers in Nepal. METHODS: The study was carried out among 449 researchers who submitted proposals for ethical review and approval from the Ethical Review Board of the Nepal Health Research Council between January 2017 to August 2021. Simple random sampling was done ensuring a proportional representation of researchers from all areas of health research. A structured questionnaire was administered online for data collection. RESULTS: The participants aged between 23-80 years old consented to complete the survey questionnaire. The median age of the respondents was 35 (23-80) years. Among all the respondents, 52 (11.58%) were unaware about the National Ethical Guideline for Health Research. Similarly, 110 (24.50%) respondents strongly agreed that the ethical review process impairs research and makes it harder for researchers to conduct research; 372 (82.85%) respondents had pursued research activity only after obtaining ethical approval. CONCLUSIONS: Half of the respondents had knowledge on different aspects of research ethics.

Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

BACKGROUND: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials. METHODS: Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) 'roundtable' discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team. RESULTS: Over 40 experts contributed to the ACCESS project-patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The 'roundtable' discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk . CONCLUSION: Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population.

Randomised clinical trials compare one or more treatments to another to see which ones work best. Trials don't always include people or groups who might benefit from the results: those excluded are sometimes called 'under- served groups'. Recent work has shone a light on this and now researchers are being asked by the public, trial funders and others to design their research so that under-served groups are more able to take part.We worked on a project to find out how to make sure everyone can be part of clinical trials. We looked at published work and held five online meetings with researchers, doctors, and patients to see what was being done already, and to think of other things that could help under-served groups take part in trials. Three groups of people, including scientists, patients, doctors and other NHS workers then  used this information to redesign three older trials using some existing inclusivity frameworks to think through the barriers for under-served groups in these trials. The three groups then talked through these trials at a 2-hour meeting, suggesting changes to the original trial plan, and discussed whether the suggestions were practical and useful. From this we came up with recommendations for how to design trials so that they have fewer barriers for under-served groups.We interviewed people to find out the best way to put these things into practice and talk through any practical issues. Using all of this information: the recommendations and what came out of the interviews, the study team created some guidance ­ 'STEP UP (Strategies for Trialists to promote Equal Participation in clinical trials for Under-served Populations)' ­ for people working in trials.

Planejamento e Políticas de Saúde na Amazônia / Health Planning and Policies in the Amazon

Na Amazônia, a política de saúde se encontra com um território de vida específico, caracterizado por um tecido social diverso, dinâmico e imigrante, transitando pelas águas e florestas. Nesse cenário, a vida é pujante, que vibra e faz acontecer um sistema de saúde amazônico, plural étnica e socialmente, biodiverso e culturalmente específico. Assim, é imperativo construirmos referencial teórico da saúde coletiva regional, bem como refletirmos e contextualizarmos o SUS com "DNA amazônico". Compreendemos ser esta uma referência para colaborar com o campo das ciências gerenciais que compõe o campo da saúde coletiva no Brasil, sem dissociar do desafio de realizar a gestão e as práticas das políticas de saúde por pesquisadores gestores da Amazônia. O 'fator amazônico' aqui apresentado roteiriza os desafios de se fazer saúde nessas diversas amazônias. Cenários de experiências promissoras no campo das políticas e planejamento aqui expressos podem contribuir com a comunicação entre gestore(a)s, pesquisadore(a)s e membros do controle social a vislumbrarem métodos e oportunidades de mudanças sistêmicas nas práticas assistenciais e nos modos de gerir a saúde na Amazônia.

Bill targeting Chinese firms worries U.S. researchers.

Biosecure Act could hinder science collaborations, limit sequencer purchases.

Conducting mixed methods research with women in a forensic mental health setting: A reflexive account from a nurse as researcher.

AIMS: To describe a reflexive account of a mental health nurse as researcher undertaking a mixed methods study as part of a doctoral degree, with women in a secure forensic hospital. DESIGN: A discursive paper that draws upon the primary author's experience of dual roles as a mental health nurse and a novice researcher, and relevant literature pertaining to positionality and reflexivity in the context of conducting mixed methods research. METHODS: A mixed methods study was conducted within a secure forensic hospital in Australia, to identify factors associated with the frequency and duration of seclusion for women and, to explore their experiences of seclusion. Notes and a reflective diary were used to demonstrate the reflexive approach and strategies used throughout the study design and data collection stages of the research. RESULTS: Women in the secure forensic hospital setting often have complex histories and experiences and are considered a vulnerable group, which can add additional challenges when undertaking research with this population. As a doctoral student with clinical experience in mental health undertaking research in the forensic hospital setting with women, positionality and the connection with reflexivity requires exploration to understand self and the influence on research. This understanding along with identified strategies to enhance reflexivity, supports the management of the dual nurse as researcher roles to enhance all stages of the research process. CONCLUSION: Doctoral nursing candidates undertaking clinical research in their area of clinical practice and at the location of previous employment, may experience challenges in relation to identity and the dichotomy of roles. Further challenges can be posed when research involves complex populations and/or controversial practices. Support to balance role conflict and maintain reflexivity is critical to understanding the role of self in research and to enhance credibility. IMPLICATIONS FOR THE PROFESSION AND/OR CLINICAL PRACTICE: Women are a complex, yet minority population in forensic mental health settings, however the numbers of women being admitted to services is increasing. Future research may consider the use of the strategies explored here to enhance the reflexive process, and support future researchers in this field to conduct research that aims to support an often-misheard population to better support health outcomes. PATIENT OR PUBLIC INVOLVEMENT: There was no patient or public contribution to this paper, however the study in which this paper is based on, is grounded in the experience of patients (women).

Researchers' experience in data collection with families of femicide victims.

OBJECTIVES: to describe researchers' experience in collecting data from families of femicide victims. METHODS: this descriptive, qualitative study took the form of an experience report and was conducted in Manaus, Amazonas, Brazil. It involved documentary consultation, training researchers, scheduling and conducting interviews, and using a field diary to record the researchers' perceptions and experiences. RESULTS: the descriptions and photographs of the crime scene were both distressing and impactful for the researchers. The mementos of the victims (including clothing, objects, and childhood photos) shown by their families were deeply moving. Identifying with these experiences facilitated listening to the stories told by the relatives. It was essential to maintain a non-judgmental attitude, acknowledge the loss, provide support for the suffering, and demonstrate a willingness to help. FINAL CONSIDERATIONS: the experience encompassed both theoretical and methodological aspects that were planned and executed in data collection, fostering the development of skills and sensitivity towards the cases. Beyond knowledge and preparation, researchers are expected to exhibit ethical conduct and empathetic capacity.

A qualitative exploration of disseminating research findings among public health researchers in China.

BACKGROUND: Research dissemination is essential to accelerate the translating of evidence into practice. Little is known about dissemination among Chinese public health researchers. This study aimed to explore the understanding and practices of disseminating research findings and to identify barriers and facilitators that influence dissemination activities to non-research audiences. METHODS: This study deployed an exploratory qualitative design with purposive and snowball sampling. One focus group with 5 participants and 12 in-depth interviews were conducted with participants working in diverse fields from universities (n = 10), the National Chinese Center for Disease Control and Prevention (n = 4), the Chinese National Cancer Center (n = 1), the Chinese National Center for Cardiovascular Disease (n = 1), and China office of a global research institute (n = 1) from May to December 2021 to reach saturation. Data were initially analyzed using inductive thematic analysis. The designing for dissemination (D4D) logic model was then used to organize themes and subthemes. Two coders independently coded all transcripts and discussed disparities to reach a consensus. RESULTS: Out of 17 participants, 12 misunderstood the concept of dissemination; 14 had disseminated to non-research audiences: 10 to the public, 10 to practitioners, and 9 to policymakers. We identified multiple barriers to dissemination to non-research audiences across four phases of the D4D logic model, including low priority of dissemination, limited application of D4D strategies, insufficient support from the research organizations, practice settings, and health systems, and overemphasis on academic publications. CONCLUSIONS: There was a lack of understanding and experience of dissemination, indicating a lack of emphasis on active dissemination in China. We provide implications for raising awareness, building capacity, facilitating multidisciplinary collaboration, providing incentives and infrastructure, changing climate and culture, establishing communication and executive networks, and accelerating systematic shifts in impact focus.

Challenges and opportunities of translating animal research into human trials in Ethiopia.

BACKGROUND AND OBJECTIVES: Although the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented in different countries. Therefore, the aim of this study was to investigate the challenges and opportunities of translating animal research into human trials in Ethiopia. METHODS: A descriptive qualitative study, using in-depth interviews, was conducted in which preclinical and clinical trial researchers who have been involved in animal research or clinical trials as principal investigator were involved. Data were analyzed using inductive thematic process. RESULTS: Six themes were emerged for challenges: lack of financial and human capacity, inadequate infrastructure, operational obstacles and poor research governance, lack of collaboration, lack of reproducibility of results and prolonged ethical and regulatory approval processes. Furthermore, three themes were synthesized for opportunities: growing infrastructure and resources, improved human capacity and better administrative processes and initiatives for collaboration. CONCLUSION AND RECOMMENDATIONS: The study found that the identified characteristics/features are of high importance either to hurdle or enable the practice of translating animal research into human trials. The study suggests that there should be adequate infrastructure and finance, human capacity building, good research governance, improved ethical and regulatory approval process, multidisciplinary collaboration, and incentives and recognition for researchers to overcome the identified challenges and allow translating of animal research into human trials to proceed more efficiently.