Training needs of health researchers in research ethics in Cameroon: a cross-sectional study.

BACKGROUND: Researchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon. METHODS: It was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants' exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants. RESULTS: Of 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants' protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31-7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant's protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles. CONCLUSION: The coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Evaluation of artificial intelligence clinical applications: Detailed case analyses show value of healthcare ethics approach in identifying patient care issues.

This paper is one of the first to analyse the ethical implications of specific healthcare artificial intelligence (AI) applications, and the first to provide a detailed analysis of AI-based systems for clinical decision support. AI is increasingly being deployed across multiple domains. In response, a plethora of ethical guidelines and principles for general AI use have been published, with some convergence about which ethical concepts are relevant to this new technology. However, few of these frameworks are healthcare-specific, and there has been limited examination of actual AI applications in healthcare. Our ethical evaluation identifies context- and case-specific healthcare ethical issues for two applications, and investigates the extent to which the general ethical principles for AI-assisted healthcare expressed in existing frameworks capture what is most ethically relevant from the perspective of healthcare ethics. We provide a detailed description and analysis of two AI-based systems for clinical decision support (Painchek® and IDx-DR). Our results identify ethical challenges associated with potentially deceptive promissory claims, lack of patient and public involvement in healthcare AI development and deployment, and lack of attention to the impact of AIs on healthcare relationships. Our analysis also highlights the close connection between evaluation and technical development and reporting. Critical appraisal frameworks for healthcare AIs should include explicit ethical evaluation with benchmarks. However, each application will require scrutiny across the AI life-cycle to identify ethical issues specific to healthcare. This level of analysis requires more attention to detail than is suggested by current ethical guidance or frameworks.

Testing an active intervention to deter researchers' use of questionable research practices.

INTRODUCTION: In this study, we tested a simple, active "ethical consistency" intervention aimed at reducing researchers' endorsement of questionable research practices (QRPs). METHODS: We developed a simple, active ethical consistency intervention and tested it against a control using an established QRP survey instrument. Before responding to a survey that asked about attitudes towards each of fifteen QRPs, participants were randomly assigned to either a consistency or control 3-5-min writing task. A total of 201 participants completed the survey: 121 participants were recruited from a database of currently funded NSF/NIH scientists, and 80 participants were recruited from a pool of active researchers at a large university medical center in the southeastern US. Narrative responses to the writing prompts were coded and analyzed to assist post hoc interpretation of the quantitative data. RESULTS: We hypothesized that participants in the consistency condition would find ethically ambiguous QRPs less defensible and would indicate less willingness to engage in them than participants in the control condition. The results showed that the consistency intervention had no significant effect on respondents' reactions regarding the defensibility of the QRPs or their willingness to engage in them. Exploratory analyses considering the narrative themes of participants' responses indicated that participants in the control condition expressed lower perceptions of QRP defensibility and willingness. CONCLUSION: The results did not support the main hypothesis, and the consistency intervention may have had the unwanted effect of inducing increased rationalization. These results may partially explain why RCR courses often seem to have little positive effect.

Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA).

BACKGROUND: Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders. METHODS: The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity. DISCUSSION: The study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.

Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

ETHICAL CONSIDERATIONS ON CASE REPORTS AND ANALYSIS OF QUALITY OF LIFE IN PATIENTS WITH COSMETIC RHINOPLASTY / CONSIDERACIONES ÉTICAS SOBRE INFORMES DE CASOS Y ANÁLISIS DE LA CALIDAD DE VIDA EN PACIENTES CON RINOPLASTIA COSMÉTICA / CONSIDERAÇÕES ÉTICAS SOBRE RELATÓRIOS DE CASOS E ANÁLISES DA QUALIDADE DE VIDA EM PACIENTES COM RINOPLASTIA COSMÉTICA

The paper discusses an ethical analysis of three common cases involving the most popular requests in rhinoplasty. As the nose plays a fundamental role in the aesthetics and physiognomy of the human face, the request for rhinoplasty may be an expression of both subjective discomfort and objective dysfunction. The paper aims, therefore, to fill the gap between qualitative-subjective impressions related to bodily self-perception and its quantitative-objective assessment. Ethical evaluation should start with consideration of the formal object and circumstances of the act, by posing the following question: Is this a real clinical case? Only after an undoubtedly positive answer to this question, should we consider specific case-related aspects; i.e., the best scientific evidence, available nosography and informed consent, before conducting an ethical evaluation of the case.

En el artículo se describe un análisis ético de tres casos comunes relacionados con las peticiones más habituales de la rinoplastia. Como la nariz juega un papel fundamental en la estética y la fisonomía del rostro humano, la solicitud de la rinoplastia puede ser una expresión subjetiva de incomodidad y objetiva de la disfunción. El documento tiene por objeto, por lo tanto, llenar el vacío entre las impresiones cualitativas-subjetivas relacionadas con la autopercepción corporal y su evaluación cuantitativa-objetiva. La evaluación ética debe comenzar con el examen del objeto y las circunstancias del acto formal, planteando la siguiente pregunta: ¿Es este un caso clínico real? Solo después de una respuesta, sin duda positiva a esta pregunta, debemos considerar los aspectos específicos relacionados con el caso; es decir, la mejor evidencia científica, la nosografía disponible y el consentimiento informado, antes de realizar una evaluación ética del caso.

Este artigo apresenta uma análise ética de três casos comuns relacionados com a maioria das petições habituais de rinoplastia. Como o nariz desempenha um papel fundamental na estética e na fisionomia do rosto humano, essa solicitação pode ser uma expressão subjetiva de desconforto e uma expressão objetiva da disfunção. Portanto, este texto tem como objetivo preencher o vazio entre as impressões qualitativas-subjetivas relacionadas com a autopercepção corporal e sua avaliação quantitativa-objetiva. A avaliação ética deve começar com o exame do objeto e as circunstâncias do ato formal, apresentando a seguinte pergunta: este é um caso clínico real? Somente após uma resposta, sem dúvida positiva a essa pergunta, devemos considerar os aspectos específicos relacionados com o caso, isto é, a melhor evidência científica, a nosografía disponível e o consentimento informado antes de realizar uma avaliação ética do caso.

”FOCUS ON PRACTICE”: CLINICAL ETHICS CONSULTATION ON AN ORTHOTOPIC LIVER TRANSPLANT CASE / "CENTRARSE EN LA PRÁCTICA": ÉTICA CLÍNICA DE CONSULTA EN UN CASO DE TRASPLANTE HEPÁTICO ORTOTÓPICO / "CENTRALIZAR-SE NA PRÁTICA": ETICA CLÍNICA DE CONSULTA NUM CASO DE TRANSPLANTE HEPÁTICO ORTOTÓPICO

The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the "Agostino Gemelli" School of Medicine of the Università Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient's prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.

El artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad "Agostino Gemelli" de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.

Este artigo apresenta um caso clínico dirigido em 2011 pela equipe de serviço de consulta ética clínica do Instituto de Bioética e Humanidades Médicas da Faculdade de Medicina Agostino Gemelli, da Università Cattolica del Sacro Cuore (Roma, Itália). O caso clínico se refere aos dilemas éticos sobre as perspectivas da paciente para receber um transplante hepático ortotópico porque não era residente do país, carecia de um cuidador para assisti-la durante o período de observação e de um lugar para ficar depois da respectiva cirurgia.

AN ETHICAL DILEMMA IN THE FIELD OF GYNECOLOGY / UN DILEMA ÉTICO EN EL CAMPO DE LA GINECOLOGÍA / UM DILEMA ÉTICO NO CAMPO DA GINECOLOGIA

The aim of this paper is to assess a case report in the field of gynecology, starting from an ethical paradigm that relates primarily to the so-called "sources of morality" (objective structure, circumstances, aim). In order to do so, we first will present four ethical paradigms for the evaluation of clinical cases (preference utilitarianism, principlism, ontologically-grounded personalism and Aristotelian/Thomist objective ethics). After introducing the main aspects of these paradigms and pointing out that what matters in an ethical evaluation is not so much the final judgement, but rather the argument that leads to it, we will assess the case report in light of the chosen paradigm. Lastly, we will outline a possible solution to the problem, starting from the previous ethical evaluation.

El objetivo de este texto es evaluar el informe de un caso clínico en el campo de la ginecología, a partir de un paradigma ético que se refiere principalmente a las denominadas "fuentes de la moral" (la estructura objetiva, las circunstancias, el objetivo). Primero se presentan cuatro paradigmas éticos para la evaluación de casos clínicos (utilitarismo de preferencia, principialismo, personalismo fundado ontológicamente y ética objetiva aristotélica/tomista). Después de la introducción de los aspectos principales de estos paradigmas y al señalar que lo que importa en una evaluación ética no es tanto el juicio final, sino más bien el argumento que conduce a ella, se evalúa el informe del caso a la luz del paradigma elegido. Por último, se esboza una posible solución al problema, a partir de la evaluación ética anterior.

O objetivo deste trabalho é avaliar o relatório de um caso clínico no campo da ginecologia a partir de um paradigma ético que se refere principalmente às denominadas "fontes da moral" (a estrutura objetiva, as circunstâncias, o objetivo). Nesse sentido, primeiramente apresentamos quatro paradigmas éticos para a avaliação de casos clínicos (utilitarismo de preferência, principialismo, personalismo fundado ontologicamente e ética objetiva aristotélica/tomista). Após introduzir os aspectos principais desses paradigmas e indicar que o importante numa avaliação ética não é tanto o julgamento final, mas sim o argumento de que conduz a ela, avaliamos o relatório do caso à luz do paradigma escolhido. Por último, esboçamos uma possível solução ao problema a partir da avaliação ética anterior.

AN ETHICAL EVALUATION METHODOLOGY FOR CLINICAL CASES / UNA METODOLOGÍA DE EVALUACIÓN ÉTICA PARA CASOS CLÍNICOS / UMA METODOLOGIA DE AVALIAÇÃO ÉTICA PARA CASOS CLÍNICOS

In the present article, we introduce an ethical evaluation methodology for clinical cases. Although rejecting proceduralism as a system, we develop a procedure that eventually could be formalized as a flow chart to help carry out an ethical evaluation for clinical cases. We clarify the elements that constitute an ethical evaluation: aim (patient's health), integration (action interconnections), and how the action is performed. We leave aside the aspect of intentions, focusing on the object of a medical action, arguing that the internal aim of a clinical action carries a moral value per se. Our evaluation system takes into account only objects and circumstances and their intrinsic morality, since we are dealing with the evaluation of a clinical case, and not with a personal and complete clinical action.

En el presente artículo se introduce una metodología de evaluación ética de los casos clínicos. Aunque se rechaza el procedimentalismo como sistema, se ha desarrollado un procedimiento que podría llegar a ser formalizado como un diagrama de flujo para ayudar a llevar a cabo una evaluación ética de los casos clínicos. Se aclaran los elementos que constituyen una evaluación ética: el objetivo (la salud del paciente), la integración de interconexiones (acción) y cómo se realiza la acción. Se dejan a un lado las intenciones para centrarse en el objeto de una acción médica; se argumenta que el objetivo interno de una acción clínica tiene un valor moral en sí. El sistema de evaluación tiene en cuenta solamente los objetos y las circunstancias y su moral intrínseca, ya que se trata de la evaluación de un caso clínico, y no de una acción clínica personal y completa.

No presente artigo, introduz-se uma metodologia de avaliação ética dos casos clínicos. Embora rejeitemos o procedimentalismo como sistema, desenvolvemos um procedimento que poderia chegar a ser formalizado como um diagrama de fluxo para ajudar a realizar uma avaliação ética dos casos clínicos. Esclarecemos os elementos que constituem uma avaliação ética: o objetivo (a saúde do paciente), a integração de interconexões (ação) e como se realiza a ação. Deixamos de lado o aspecto das intenções e centralizamo-nos no objeto de uma ação médica, argumentando que o objetivo interno de uma ação clínica tem um valor moral em si. Nosso sistema de avaliação considera somente os objetos e as circunstâncias e sua moral intrínseca, visto que se trata da avaliação de um caso clínico, e não de uma ação clínica pessoal e completa.