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Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research

What happens to patients with cancer engaged in biomedical research when intellectual property regimes and ethical regimes intersect? This qualitative historical study addresses this question by situating the experiences, hopes, and reasons of patients to enter clinical trials within the historical...

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Autores principales: D’Abramo, Flavio, Bont, Annemieke, Nüßlein, Lisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238291/
https://www.ncbi.nlm.nih.gov/pubmed/35774510
http://dx.doi.org/10.3389/fgene.2022.872211
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author D’Abramo, Flavio
Bont, Annemieke
Nüßlein, Lisa
author_facet D’Abramo, Flavio
Bont, Annemieke
Nüßlein, Lisa
author_sort D’Abramo, Flavio
collection PubMed
description What happens to patients with cancer engaged in biomedical research when intellectual property regimes and ethical regimes intersect? This qualitative historical study addresses this question by situating the experiences, hopes, and reasons of patients to enter clinical trials within the historical trajectory of informed consent and monoclonal antibodies, the biotechnology underpinning many targeted drugs used in oncological clinical trials and biobank research. Based on fieldwork we undertook in a German university hospital where we interviewed patients and the medical personnel, a historical review, and an ethical analysis we inquire into the effects that financial, legal, and technological changes connected to the relevant pharmaceutical research and commerce have on cancer patients engaged in clinical trials and biobank research. We find that the controversial aspects of monoclonal antibodies, especially those related to the commercial interests at stake, enter the informed consent process mainly in the form of informative gaps. We highlight how a qualitative analysis of the clinic, especially when it is situated against the backdrop of the history of related technological advancements and patent regime, it can serve the purpose of giving voice to subjects who are silenced by regimes of an ethical, epistemic, and commercial kind while pointing to informed consent as an unhelpful device for addressing risks arising from the commercial purposes of biomedical products and infrastructure.
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spelling pubmed-92382912022-06-29 Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research D’Abramo, Flavio Bont, Annemieke Nüßlein, Lisa Front Genet Genetics What happens to patients with cancer engaged in biomedical research when intellectual property regimes and ethical regimes intersect? This qualitative historical study addresses this question by situating the experiences, hopes, and reasons of patients to enter clinical trials within the historical trajectory of informed consent and monoclonal antibodies, the biotechnology underpinning many targeted drugs used in oncological clinical trials and biobank research. Based on fieldwork we undertook in a German university hospital where we interviewed patients and the medical personnel, a historical review, and an ethical analysis we inquire into the effects that financial, legal, and technological changes connected to the relevant pharmaceutical research and commerce have on cancer patients engaged in clinical trials and biobank research. We find that the controversial aspects of monoclonal antibodies, especially those related to the commercial interests at stake, enter the informed consent process mainly in the form of informative gaps. We highlight how a qualitative analysis of the clinic, especially when it is situated against the backdrop of the history of related technological advancements and patent regime, it can serve the purpose of giving voice to subjects who are silenced by regimes of an ethical, epistemic, and commercial kind while pointing to informed consent as an unhelpful device for addressing risks arising from the commercial purposes of biomedical products and infrastructure. Frontiers Media S.A. 2022-06-13 /pmc/articles/PMC9238291/ /pubmed/35774510 http://dx.doi.org/10.3389/fgene.2022.872211 Text en Copyright © 2022 D’Abramo, Bont and Nüßlein. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Genetics
D’Abramo, Flavio
Bont, Annemieke
Nüßlein, Lisa
Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title_full Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title_fullStr Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title_full_unstemmed Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title_short Biomolecular Prospecting, Informative Gaps, and the Cancer Clinic: A Qualitative Fieldwork and an Epistemological, Historical and Ethical Analysis of Informed Consent for Clinical Trials for Monoclonal Antibodies and Biobank Research
title_sort biomolecular prospecting, informative gaps, and the cancer clinic: a qualitative fieldwork and an epistemological, historical and ethical analysis of informed consent for clinical trials for monoclonal antibodies and biobank research
topic Genetics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238291/
https://www.ncbi.nlm.nih.gov/pubmed/35774510
http://dx.doi.org/10.3389/fgene.2022.872211
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