Cargando…

A survey in Mexico about ethics dumping in clinical research

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 am...

Descripción completa

Detalles Bibliográficos
Autores principales: Germán, Novoa-Heckel, Rosemarie, Bernabe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547477/
https://www.ncbi.nlm.nih.gov/pubmed/31159787
http://dx.doi.org/10.1186/s12910-019-0378-6
_version_ 1783423685241077760
author Germán, Novoa-Heckel
Rosemarie, Bernabe
author_facet Germán, Novoa-Heckel
Rosemarie, Bernabe
author_sort Germán, Novoa-Heckel
collection PubMed
description 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.
format Online
Article
Text
id pubmed-6547477
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-65474772019-06-06 A survey in Mexico about ethics dumping in clinical research Germán, Novoa-Heckel Rosemarie, Bernabe BMC Med Ethics Research Article 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. BioMed Central 2019-06-03 /pmc/articles/PMC6547477/ /pubmed/31159787 http://dx.doi.org/10.1186/s12910-019-0378-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Germán, Novoa-Heckel
Rosemarie, Bernabe
A survey in Mexico about ethics dumping in clinical research
title A survey in Mexico about ethics dumping in clinical research
title_full A survey in Mexico about ethics dumping in clinical research
title_fullStr A survey in Mexico about ethics dumping in clinical research
title_full_unstemmed A survey in Mexico about ethics dumping in clinical research
title_short A survey in Mexico about ethics dumping in clinical research
title_sort survey in mexico about ethics dumping in clinical research
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547477/
https://www.ncbi.nlm.nih.gov/pubmed/31159787
http://dx.doi.org/10.1186/s12910-019-0378-6
work_keys_str_mv AT germannovoaheckel asurveyinmexicoaboutethicsdumpinginclinicalresearch
AT rosemariebernabe asurveyinmexicoaboutethicsdumpinginclinicalresearch
AT germannovoaheckel surveyinmexicoaboutethicsdumpinginclinicalresearch
AT rosemariebernabe surveyinmexicoaboutethicsdumpinginclinicalresearch