Causality assessment: A casualty of compensation?

Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of cau...

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Detalles Bibliográficos
Autores principales: Kulkarni, Anuradha, Bhatt, Arun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2013
Materias:
Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3835961/
https://www.ncbi.nlm.nih.gov/pubmed/24312885
http://dx.doi.org/10.4103/2229-3485.120166
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author Kulkarni, Anuradha
Bhatt, Arun
author_facet Kulkarni, Anuradha
Bhatt, Arun
author_sort Kulkarni, Anuradha
collection PubMed
description Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment.
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spelling pubmed-38359612013-12-05 Causality assessment: A casualty of compensation? Kulkarni, Anuradha Bhatt, Arun Perspect Clin Res Opinion Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment. Medknow Publications & Media Pvt Ltd 2013 /pmc/articles/PMC3835961/ /pubmed/24312885 http://dx.doi.org/10.4103/2229-3485.120166 Text en Copyright: © Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Opinion
Kulkarni, Anuradha
Bhatt, Arun
Causality assessment: A casualty of compensation?
title Causality assessment: A casualty of compensation?
title_full Causality assessment: A casualty of compensation?
title_fullStr Causality assessment: A casualty of compensation?
title_full_unstemmed Causality assessment: A casualty of compensation?
title_short Causality assessment: A casualty of compensation?
title_sort causality assessment: a casualty of compensation?
topic Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3835961/
https://www.ncbi.nlm.nih.gov/pubmed/24312885
http://dx.doi.org/10.4103/2229-3485.120166
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