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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elmer Press
2014
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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. |
format | Online Article Text |
id | pubmed-3985563 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Elmer Press |
record_format | MEDLINE/PubMed |
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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