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Informed Consent for Phase I Oncology Trials: Form, Substance and Signature

BACKGROUND: Federal regulations state consent information should be understandable to participants; concerns have been voiced about the quality of informed consent forms (ICFs) in oncology trials. METHODS: The content of ICFs for phase I studies that were conducted at a tertiary care cancer center o...

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Autores principales: Malik, Laeeq, Mejia, Alex
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elmer Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985563/
https://www.ncbi.nlm.nih.gov/pubmed/24734147
http://dx.doi.org/10.14740/jocmr1803w
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author Malik, Laeeq
Mejia, Alex
author_facet Malik, Laeeq
Mejia, Alex
author_sort Malik, Laeeq
collection PubMed
description BACKGROUND: Federal regulations state consent information should be understandable to participants; concerns have been voiced about the quality of informed consent forms (ICFs) in oncology trials. METHODS: The content of ICFs for phase I studies that were conducted at a tertiary care cancer center over 3 years’ period was reviewed. Information pertaining to the length of the ICF, description of study purpose, research regimen/methods, treatment agent, potential risks, benefits and alternatives to the research was extracted. RESULTS: In total, 54 ICFs for phase I trials approved by the local Institutional Review Board were reviewed. Median length of ICF was 20 pages. Nearly one half of the forms (57.4%) were of first-in-human phase I studies. The main goal of research was explicitly stated as safety testing in 59.2% forms, while 37.1% studies described primary objective as dose finding. All of the forms identified serious risks, unexpected risks, possibility of death and risks to pregnant and or lactating women. A detailed estimation of the frequency or intensity of risks (range 3-8 pages) was provided qualitatively or quantitatively if known. Information regarding mechanism of action of investigational agent, study schema, dose escalation, loss of time/energy and possibility of receiving sub-therapeutic dose was missing in significant number of forms. CONCLUSION: We found that these ICFs were compliant with approved guidelines and provided a thorough description of risks or potential benefits. However, there still remains room for improvement, so patients can make better informed decisions.
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spelling pubmed-39855632014-04-14 Informed Consent for Phase I Oncology Trials: Form, Substance and Signature Malik, Laeeq Mejia, Alex J Clin Med Res Short Communication BACKGROUND: Federal regulations state consent information should be understandable to participants; concerns have been voiced about the quality of informed consent forms (ICFs) in oncology trials. METHODS: The content of ICFs for phase I studies that were conducted at a tertiary care cancer center over 3 years’ period was reviewed. Information pertaining to the length of the ICF, description of study purpose, research regimen/methods, treatment agent, potential risks, benefits and alternatives to the research was extracted. RESULTS: In total, 54 ICFs for phase I trials approved by the local Institutional Review Board were reviewed. Median length of ICF was 20 pages. Nearly one half of the forms (57.4%) were of first-in-human phase I studies. The main goal of research was explicitly stated as safety testing in 59.2% forms, while 37.1% studies described primary objective as dose finding. All of the forms identified serious risks, unexpected risks, possibility of death and risks to pregnant and or lactating women. A detailed estimation of the frequency or intensity of risks (range 3-8 pages) was provided qualitatively or quantitatively if known. Information regarding mechanism of action of investigational agent, study schema, dose escalation, loss of time/energy and possibility of receiving sub-therapeutic dose was missing in significant number of forms. CONCLUSION: We found that these ICFs were compliant with approved guidelines and provided a thorough description of risks or potential benefits. However, there still remains room for improvement, so patients can make better informed decisions. Elmer Press 2014-06 2014-03-31 /pmc/articles/PMC3985563/ /pubmed/24734147 http://dx.doi.org/10.14740/jocmr1803w Text en Copyright 2014, Malik et al. http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Short Communication
Malik, Laeeq
Mejia, Alex
Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title_full Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title_fullStr Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title_full_unstemmed Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title_short Informed Consent for Phase I Oncology Trials: Form, Substance and Signature
title_sort informed consent for phase i oncology trials: form, substance and signature
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985563/
https://www.ncbi.nlm.nih.gov/pubmed/24734147
http://dx.doi.org/10.14740/jocmr1803w
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