Background The exportation of unethical practices to low- and middle-income countries (“Ethics Dumping”) has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. Method We designed an exploratory survey based on a five-point Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. Results Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. Conclusion From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives. Electronic supplementary material The online version of this article (10.1186/s12910-019-0378-6) contains supplementary material, which is available to authorized users.

Resumen: El sistema internacional de farmacovigilancia recopila información sobre eventos adversos por medicamentos a partir de informes emitidos por los médicos en la práctica clínica. Los reportes de reacciones adversas a medicamentos (RAM) son escasos. Diseñamos un cuestionario basado en una escala de Likert de cinco puntos. El cuestionario, de 24 preguntas, se administró a una muestra de médicos. Las respuestas de los cuestionarios indican que es importante contar con sistemas de farmacovigilancia. A pesar de ello, casi tres cuartos de los encuestados no sabían cómo informar de una reacción adversa y dos quintos no deseaban hacerlo. Tres cuartas partes de los encuestados expresaron que la instrucción sobre la elaboración de informes debería comenzar durante la carrera de Medicina. Los resultados sugieren que la elaboración de informes de RAM debe incluirse en la educación médica. Es necesario establecer protocolos que aseguren que los lineamientos para informar RAM sean fáciles de seguir. Es recomendable que los programas de capacitación y educación médica continua generen una conciencia de responsabilidad frente al reporte de RAM.Palabras clave: farmacovigilancia, sistemas de reporte de reacciones adversas a medicamentos, encuesta, cuestionario, responsabilidad Professional responsibility applied to drug surveillance: a study case in México Abstract: The international pharmacovigilance system collects adverse drug events reported by physicians in their clinical practice. Adverse drug reactions (ADR) reported are scarce. We designed a questionnaire based on a 5-point Likert scale. The questionnaire (24 questions) was administered to a sample of physicians in Mexico City. Questionnaire responses indicated that having pharmacovigilance systems is important. Despite this, nearly three quarters of respondents did not know how to report an adverse drug reaction, and two-fifths were not willing to do so. Three quarters believed that education regarding reporting and its methods should be initiated during medical school. The results from our questionnaire suggest that medical school training in ADR report writing should be implemented. Good protocols have to be in place to ensure that ADR report forms have easy-to-follow guidelines and are easy to complete. It is recommended that the programs of training and medical education generate conscience of responsability towards the report of ADRs.Key words: pharmacovigilance, adverse drug reaction reporting systems, survey, questionnaire, responsibilityResponsabilidade profissional aplicada à farmacovigilância: um estudo de caso no México Resumo: O sistema internacional de farmacovigilância recopila informação sobre eventos adversos por medicamentos a partir de informes emitidos pelos médicos na prática clínica. Os informes de reações adversas a medicamentos (RAM) são escassos. Idealizamos um questionário baseado numa escala de Likert de cinco pontos. O questionário, de 24 perguntas, foi administrado a uma mostra de médicos. As respostas dos questionários indicam que é im...

Introduction: The pharmacovigilance system collects adverse events registered by physicians in their clinical practice. However, there is a low index of reports in this regard. There are various publications at international level oriented to determine causes for this low notification. In this respect, it would be valuable to count with an instrument that would diagnose the situation prevailing for México. The objective was to develop and validate a questionnaire reliable and sensible for measuring causes of low reports. Material and Methods: Experts validated the questionnaire and the final instrument was applied to 124 physician subjects that responded to the 30 final questions, and their answers were tabulated and categorized for measuring confidence and internal congruence. Alfa of Cronbach and "t" student tests were applied for the validation and test-posttest application. Results: The internal consistency value was 1.097. The different answers and scores were calculated, where the final global average in points for responses for the pilot group studied was 100.72, that translated to percentage resulted in 67% (S.D. 8). The final Cronbach alpha value obtained was 0.7. Conclusions: The validated questionnaire meets the objectives for which it was designed, and proved to be useful, reflecting the state of knowledge, abilities and attitudes.