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Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center
The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which i...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5799953/ https://www.ncbi.nlm.nih.gov/pubmed/29430418 http://dx.doi.org/10.4103/picr.PICR_172_17 |
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author | Shetty, Parvan A Maurya, Mitesh R Figer, Brinal H Thatte, Urmila M Gogtay, Nithya J |
author_facet | Shetty, Parvan A Maurya, Mitesh R Figer, Brinal H Thatte, Urmila M Gogtay, Nithya J |
author_sort | Shetty, Parvan A |
collection | PubMed |
description | The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which is the ability to assimilate and understand the information presented in the consent form. In India, a unique aspect of the informed consent process is the need for audio-video [AV] recording of the process for vulnerable populations and new chemical entities. The present narrative summates authors' experiences as investigators with A-V recording of the informed consent process as also providing a brief narrative review of relevant literature. It also offers potential solutions for challenges faced during this process. |
format | Online Article Text |
id | pubmed-5799953 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-57999532018-02-09 Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center Shetty, Parvan A Maurya, Mitesh R Figer, Brinal H Thatte, Urmila M Gogtay, Nithya J Perspect Clin Res Investigator Insights The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which is the ability to assimilate and understand the information presented in the consent form. In India, a unique aspect of the informed consent process is the need for audio-video [AV] recording of the process for vulnerable populations and new chemical entities. The present narrative summates authors' experiences as investigators with A-V recording of the informed consent process as also providing a brief narrative review of relevant literature. It also offers potential solutions for challenges faced during this process. Medknow Publications & Media Pvt Ltd 2018 /pmc/articles/PMC5799953/ /pubmed/29430418 http://dx.doi.org/10.4103/picr.PICR_172_17 Text en Copyright: © 2018 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-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. |
spellingShingle | Investigator Insights Shetty, Parvan A Maurya, Mitesh R Figer, Brinal H Thatte, Urmila M Gogtay, Nithya J Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title | Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title_full | Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title_fullStr | Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title_full_unstemmed | Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title_short | Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center |
title_sort | audiovisual recording of the consenting process in clinical research: experiences from a tertiary referral center |
topic | Investigator Insights |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5799953/ https://www.ncbi.nlm.nih.gov/pubmed/29430418 http://dx.doi.org/10.4103/picr.PICR_172_17 |
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