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Ethical issues in naturalistic versus controlled trials

Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because th...

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Autor principal: Helmchen, Hanfried
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Les Laboratoires Servier 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3182002/
https://www.ncbi.nlm.nih.gov/pubmed/21842614
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author Helmchen, Hanfried
author_facet Helmchen, Hanfried
author_sort Helmchen, Hanfried
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description Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because the former are interventional in nature and may have unknown and perhaps severe somatic risks, whereas naturalistic studies seem not to intervene but only to observe, and therefore are assumed to have fewer or almost no risks. However, there are also ethical implications in naturalistic trials, although their weight is differently accentuated, more with potential, more with potential psychological burdens of the observational procedures and more with potential physical risks in interventional trials. This will be elaborated with examples of placebo-controlled trials and of incidental findings in screenings, of marketing influences on observational studies, and of psychological burdens by survey interviews. The ethical implications wilt be analyzed within a more general framework, Finally, recommendations will be offered.
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spelling pubmed-31820022011-10-27 Ethical issues in naturalistic versus controlled trials Helmchen, Hanfried Dialogues Clin Neurosci Clinical Research Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because the former are interventional in nature and may have unknown and perhaps severe somatic risks, whereas naturalistic studies seem not to intervene but only to observe, and therefore are assumed to have fewer or almost no risks. However, there are also ethical implications in naturalistic trials, although their weight is differently accentuated, more with potential, more with potential psychological burdens of the observational procedures and more with potential physical risks in interventional trials. This will be elaborated with examples of placebo-controlled trials and of incidental findings in screenings, of marketing influences on observational studies, and of psychological burdens by survey interviews. The ethical implications wilt be analyzed within a more general framework, Finally, recommendations will be offered. Les Laboratoires Servier 2011-06 /pmc/articles/PMC3182002/ /pubmed/21842614 Text en Copyright: © 2011 LLS http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Research
Helmchen, Hanfried
Ethical issues in naturalistic versus controlled trials
title Ethical issues in naturalistic versus controlled trials
title_full Ethical issues in naturalistic versus controlled trials
title_fullStr Ethical issues in naturalistic versus controlled trials
title_full_unstemmed Ethical issues in naturalistic versus controlled trials
title_short Ethical issues in naturalistic versus controlled trials
title_sort ethical issues in naturalistic versus controlled trials
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3182002/
https://www.ncbi.nlm.nih.gov/pubmed/21842614
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