Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.

Construção e aplicabilidade de um termo de assentimento em pesquisa em nutrição com crianças hospitalizadas em tratamento oncológico / Construction and applicability of a term of consent in nutrition research with children hospitalized for oncological treatment

Objetivo: relatar a experiência na construção e aplicabilidade de um termo de assentimento livre esclarecido em uma pesquisa com crianças pré-escolares e escolares hospitalizadas para tratamento oncológico. Material e método: trata-se de um relato de experiência sobre a construção e aplicabilidade de um Termo de Assentimento Livre e Esclarecido lúdico para realização de um estudo sobre perfil nutricional e educação alimentar e nutricional de crianças em tratamento oncológico de um hospital público infantil em Santa Catarina-Brasil. Resultados: a construção e aplicabilidade do Termo de Assentimento Livre Esclarecido permitiu melhor compreensão da criança anterior à realização da pesquisa referente às etapas e fases da coleta dos dados do estudo, assim como os riscos e benefícios do mesmo. Foi possível à criança esclarecer suas dúvidas e participar ativamente do estudo. Foram convidadas para participar do estudo 13 crianças de ambos os sexos entre 5 ­ 12 anos de idade que estavam internadas no ambulatório de oncologia. Considerações Finais: adoção do Termo de Assentimento Livre Esclarecido Lúdico construído mostrou-se efetivo ao alcance do objetivo de sua utilização no contexto ético em pesquisa e avançou no sentido de despertar sobre potencialidade para além da pesquisa e, também, como recurso fundamental para o assentimento das crianças em situações específicas no processo de adoecimento e internação, possibilitando o exercício de direito e compreensão do que está sendo realizado durante seu tratamento.

Objective: report the experience in the construction and applicability of an informed term of consent in a survey of children hospitalized for cancer treatment. Material and method: experience report on the construction and applicability of a free and informed term of consent for conducting a study on the nutritional profile and food and nutrition education of children and adolescents undergoing cancer treatment at a public hospital in Santa Catarina, Brazil. Results: the construction and applicability of the informed term of consent allowed a better understanding of the child prior to conducting the research regarding the steps and phases of data collection, as well as its risks and benefits. It was possible for the child to clarify their doubts and actively participate in the study. Thirteen children of both sexes, aged between 5 - 12 years, hospitalized and in the oncology outpatient clinic, were invited to participate. Final considerations: adoption of the playful free and informed term of consent proved to be effective in reaching the objective of its use in the ethical research context and it has advanced in the sense of raising awareness of the potentiality beyond research, and also as a fundamental resource for the consent of children in specific situations in the illness and hospitalization process, enabling them to exercise their rights and understand what is happening during their treatment.

Operationalising a real-time research ethics approach: supporting ethical mindfulness in agriculture-nutrition-health research in Malawi.

BACKGROUND: There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of 'ethics in practice' by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel 'real-time research ethics approach' (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the 'Addressing Hidden Hunger with Agronomy'. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation. RESULTS: The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants' 'lived research experience'. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants' (TPs) perspectives and experiences. CONCLUSIONS: The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers 'ethical mindfulness' which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.

Tratamento homeopático e prevenção da Covid-19: protocolo de pesquisa clínica para avaliar a eficácia e a segurança do medicamento do gênio epidêmico / Homeopathic treatment and prevention of Covid-19: clinical research protocol to evaluate the effectiveness and safety of the epidemic genius medicine

Além da reconhecida aplicação nas doenças crônicas, a homeopatia individualizada também pode atuar de forma resolutiva ou complementar nos casos agudos, incluindo as doenças epidêmicas. No entanto, para atingir esse intento, apresenta uma metodologia semiológica e terapêutica específica que deve ser seguida e respeitada, com o risco de não apresentar a eficácia e a segurança desejada. No caso das doenças epidêmicas, que pela virulência dos seus agentes provoca um quadro sintomatológico comum na maioria dos indivíduos suscetíveis, o medicamento homeopático individualizado (medicamento homeopático do gênio epidêmico) deve apresentar semelhança com o conjunto de sinais e sintomas característicos dos pacientes acometidos nos diferentes estágios de cada surto epidêmico. Estudos evidenciam a eficácia e a segurança desta prática terapêutica e/ou profilática em diversas epidemias do passado. Assim sendo, após o levantamento dos possíveis medicamentos homeopáticos individualizados do gênio epidêmico de cada epidemia, sua aplicação terapêutica e/ou profilática em larga escala deve ser sustentada por ensaios clínicos prévios que demonstrem sua eficácia e segurança, em consonância com os aspectos éticos e bioéticos da pesquisa envolvendo seres humanos. Cumprindo essas premissas da boa prática clínica, elaboramos, em março de 2020, esse protocolo de pesquisa para investigar, em ensaio clínico randomizado, duplo-cego e placebo-controlado, a eficácia e a segurança de possíveis medicamentos homeopáticos individualizados do gênio epidêmico da COVID-19. Caso a eficácia e a segurança se confirmem, e tão somente nessa condição, o medicamento poderá ser utilizado de forma generalizada e coletiva no tratamento e na prevenção da atual epidemia. Com esse intuito, encaminhamos este projeto a médicos, pesquisadores e gestores de diversos hospitais públicos e privados, solicitando uma oportunidade para aplicar essa proposta em pacientes internados em enfermarias e/ou centros de terapia intensiva destinadas ao tratamento da COVID-19.

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this therapeutic and/or prophylactic practice in several epidemics of the past. Therefore, after the survey of possible individualized homeopathic medicine from the epidemic genius of each epidemic, its therapeutic and/or large-scale prophylactic application should be supported by previous clinical trials that demonstrate its effectiveness and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed, in March 2020, this research protocol to investigate, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic medicines of epidemic genius of COVID-19. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. To this end, we refer this project to physicians, researchers and managers of several public and private hospitals, requesting an opportunity to apply this proposal to patients hospitalized in wards and/or intensive care units for the treatment of COVID-19.

Using the Emanuel Framework to Explore the Ethical Issues Raised in a Participatory Visual Research Project in Rural South Africa.

Participatory visual research can offer critical insight into the experiences of those most affected by health issues. As these methods are increasingly used to research sensitive topics, there is a need for a clear ethical framework to guide best practice on the part of researchers and research ethics committees. Here we reflect on a project where we used digital storytelling as a participatory visual methodology to explore HIV treatment adherence in rural South Africa, with a focus on the ethical issues we encountered during the lifetime of the project. To ground our reflections, we use the framework for ethical research developed by Emanuel et al., and the adaptation of this framework for social science proposed by Wassenaar and Mamotte. We suggest that fellow PVM practitioners and REC members draw on this holistic framework to support the optimal application of PVM in health research.

Principles guiding ethical research in a collaboration to strengthen Indigenous primary healthcare in Australia: learning from experience.

INTRODUCTION: Indigenous communities worldwide are leading calls for all research involving Indigenous people to be underpinned by values and principles articulated by them. Many researchers are explicitly adopting these principles to guide what, where, how and when research is undertaken with Indigenous people. With critical reflection to support the implementation of such principles largely absent from published literature, this paper explores both the implementation of, and the outcomes from a set of guiding principles used in a large-scale Australian research collaboration to improve Indigenous health. METHODS: In this inductive qualitative study, we adopted a principles-focused evaluation approach. Based on interviews with 35 actors in the collaboration and a review of project documents, we generated themes that were then iteratively discussed, refined and categorised into (1) 'strategies'-activities by which implementation of our guiding principles were recognised; (2) 'outcomes'-results seen from implementing the principles and (3) 'conditions'-aspects of the context that facilitated and constrained implementation of the principles. RESULTS: Respondents found it difficult to articulate how the guiding principles were actually implemented, and frequently referred to them as part of the fabric of the collaboration. They viewed the set of principles as mutually reinforcing, and as providing a rudder for navigating complexity and conflict. Implementation of the principles occurred through five strategies-honouring the principles; being dynamic and adaptable; sharing and dispersing leadership; collaborating purposefully and adopting a culture of mutual learning. Outcomes included increased Indigenous leadership and participation; the ability to attract principled and values-driven researchers and stakeholders, and the development of trusting and respectful relationships. The conditions that facilitated the implementation of the principles were collaborating over time; an increasing number of Indigenous researchers and taking an 'innovation platform' approach. CONCLUSION: Our findings show that principles guiding collaborations are valuable in providing a focus, direction and a way of working together when they are collaboratively developed, hold genuine meaning for all members and are implemented within a culture of continuous critical reflection, learning and adaptation, with ongoing reinterpretation of the principles over time.

Methodological and ethical challenges while conducting qualitative research on spirituality and end of life in a Muslim context: a guide to novice researchers.

Abstract Spirituality could be understood as a personal belief, a relation with sacred, divine experience, a sense of purpose and meaning towards life, authenticity and connectedness. It is a continually evolving, highly complex, contextual, subjective, and sensitive construct. A continuous development is seen around understanding about spirituality and spiritual concepts, such as spiritual experiences, spiritual pain and spiritual distress, especially among patients and families at the end of life. The concepts, values, attitudes, and beliefs around spirituality, spiritual needs and expressions vary among different individuals, cultures, and religions. There is a dearth of literature around spirituality, especially among Muslim patients and families at the end of life. The complexities around the concept of spirituality in the literature raise several ethical and methodological concerns for a novice researcher while planning and conducting a study on spirituality during end-of-life care in a hospice setting, especially among a Muslim population. This paper aims to share some of the methodological and ethical challenges that can be faced by qualitative researchers while conducting research around spirituality and end-of-life care in an Islamic/Muslim context. Major challenges include defining the term spirituality, spirituality and culture, communication, power relations, language and translation, recruitment and selection of the participants, emotional distress, and reflexivity and reciprocity. Having an in-depth understanding of these challenges can guide researchers to address these issues adequately in their spirituality research in a Muslim context.

Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy.

A central tension in pediatric research ethics arises from our desire to protect children from harm while also allowing progress toward discoveries that could improve child health. A prime example of this tension is research on a controversial yet increasingly common practice: the use of cannabis by women to treat nausea and vomiting of pregnancy. Studies of cannabis use in pregnancy face a combination of ethical hurdles because of the inclusion of pregnant women and involvement of a schedule I controlled substance. Given the growing need for research on the safety and efficacy of cannabis for nausea and vomiting of pregnancy, we reflect on the multiple historical contexts that have contributed to the challenge of studying cannabis use during pregnancy and make a case for the ethical rationale for such research.

At a Moment's Notice: Community Advisory Board Perspectives on Biobank Communication to Supplement Broad Consent.

INTRODUCTION: To address ethical concerns about the of future research authorization, biobanks employing a broad model of consent can design ongoing communication with contributors. Notifying contributors at the time of sample distribution provides one form of communication to supplement broad consent. However, little is known about how community-informed governance might anticipate contributor responses and inform communication efforts. OBJECTIVE: We explored the attitudes of members of a three-site Community Advisory Board (CAB) network. CAB members responded to a hypothetical proposal for notifying biobank contributors at the time of sample distribution to researchers utilizing the biobank. METHODS: We used regularly scheduled CAB meetings to facilitate 3 large-group and 6 small-group discussions. Discussions were audio-recorded, transcribed, and analyzed for thematic content using descriptive thematic analysis. RESULTS: The results challenged our expectation of general support for the proposed communications. While CAB members identified some advantages, they were concerned about several potential harms to biobank contributors and the biobank. The CABs understood biobank communication in terms of an ongoing relationship with the biobank and a personal contribution to research. CONCLUSION: Our findings contribute to the emerging literature on community engagement in biobanking. Additional communication with biobank contributors can serve a variety of value-based objectives to supplement broad consent. Design of communication efforts by biobanks can be improved by CAB members' anticipation of the unintended consequences of additional contact with contributors. CAB members' holistic interpretation of communication efforts suggests that biobank leadership considers all communication options as part of a more comprehensive communications strategy.

Protocolo de pesquisa clínica para avaliar a eficácia e a segurança de medicamento homeopático individualizado no tratamento e na prevenção da epidemia de COVID-19 / Clinical research protocol to evaluate the efficacy and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic

Além da reconhecida aplicação nas doenças crônicas, a homeopatia individualizada também pode atuar de forma resolutiva ou complementar nos casos agudos, incluindo as doenças epidêmicas. No entanto, para atingir esse intento, apresenta uma metodologia semiológica e terapêutica específica que deve ser seguida e respeitada, com o risco de não apresentar a eficácia e a segurança desejada. No caso das doenças epidêmicas, que pela virulência dos seus agentes provoca um quadro sintomatológico comum na maioria dos indivíduos suscetíveis, o medicamento homeopático individualizado (medicamento homeopático do gênio epidêmico) deve apresentar semelhança com o conjunto de sinais e sintomas característicos dos pacientes acometidos nos diferentes estágios de cada surto epidêmico. Estudos evidenciam a eficácia e a segurança desta prática profilática e/ou terapêutica em diversas epidemias do passado. Assim sendo, após o levantamento dos possíveis medicamentos homeopáticos individualizados do gênio epidêmico de cada epidemia, sua aplicação profilática e/ou terapêutica em larga escala deve ser sustentada por ensaios clínicos prévios que demonstrem sua eficácia e segurança, em consonância com os aspectos éticos e bioéticos da pesquisa envolvendo seres humanos. Cumprindo essas premissas da boa prática clínica, elaboramos o atual protocolo com o objetivo de investigar, em ensaio clínico randomizado, duplo-cego e placebo-controlado, a eficácia e a segurança de possíveis medicamentos homeopáticos individualizados do gênio epidêmico da COVID-19, em tratamento adjuvante e complementar de pacientes acometidos pela doença. Caso a a eficácia e a segurança se confirme, e tão somente, o(s) medicamento(s) poderão ser utilizado de forma generalizada e coletiva no tratamento e na prevenção da atual epidemia. (AU)

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiological and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the efficacy and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If efficacy and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)

Clinical research protocol to evaluate the effectiveness and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)

A Qualitative Investigation of Provers' Experiences of Participation in Homeopathic Pathogenetic Trials.

BACKGROUND: Information on homeopathic medicines is derived from "provings" or homeopathic pathogenetic trials (HPTs), in which people (often homeopaths and homeopathy students) are invited to take an unnamed and often untested highly diluted and serially succussed substance, and record in detail their experiences and perceived effects. HPTs are assumed to have an "excellent safety record", but there has been no academic research to date into provers' experiences of participating in an HPT. AIMS: This qualitative study aimed to explore the lived experience of participation in an HPT. It is hoped that the results from this study will inform the future conduct of HPTs. METHODS: Semi-structured interviews were conducted in person, by phone or via Skype, according to the interviewees' preferences. Thematic analysis was used for the generation of themes. RESULTS: Eight former provers were interviewed from across the European Union (EU) and Australia. Of these, seven were practicing homeopaths and one was not a practitioner. Overarching themes were identified as: (1) the ethical conduct of HPTs, and (2) the impact of participation in HPTs. CONCLUSION: Former provers who participated in this study reported enthusiasm for, and trust in, the proving process. However, some also reported adverse events, which varied in intensity and duration. The process of gaining fully informed consent for participation in an HPT is complex and there were examples of both failure and inadequacy in terms of informed consent and support mechanisms. RECOMMENDATIONS: The researchers recommend that HPTs are subject to ethical approval processes and that consent is fully informed and ongoing. It is also recommended that appropriate and robust support mechanisms be developed.

Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent.

Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like-for-like, designative translations which often involve the 'indigenization' of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re-examination of how researchers develop and present protocols to institutional ethics review boards.

Research and Responsibility in Global Health: An Analysis of the Joining Forces Study in Ghana.

We explore conceptions of responsibility and integrity in global health research and practice as it is being carried out in the academic setting. Our specific motivation derives from the recent publication of a study by a clinical research team involving the delivery of mental health care services in a Ghanaian prayer camp. The study was controversial on account of the prayer camp's history of human rights abuses and therefore was met with several high-profile critiques. We offer a more charitable evaluation of the Joining Forces study. Our analysis has three primary goals. First, we respond to criticism suggesting that the Joining Forces research team needed to maintain some form of morally "clean hands" in relation to the human rights abuses at Mount Horeb prayer camp. We argue that, for academic global health practitioners working under severe resource constraints, what is reasonable and responsible to pursue is a complex proposition without a one-size-fits-all ethical answer. Second, we offer an explanation for why the Joining Forces study team designed the project as they did in spite of their obvious vulnerability to ethical concern. We argue that the Joining Forces study was a morally risky, but ethically earnest effort to reach a neglected patient population and promote behavior change in prayer camp staff. Third, we identify an open ethical question born of the researchers' commitment to pragmatism that, to our knowledge, has not been previously addressed in published discussion of the Joining Forces project. Namely, was the incomplete disclosure of information to prayer camp staff defensible? We close with a broader reflection on the notion of moral integrity in the pursuit of the salutary aims of global health.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas.

Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.

La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.