A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

H. Bleiberg, G. Decoster, A. de Gramont, P. Rougier, A. Sobrero, Al B Benson III, B. Chibaudel, J. Y. Douillard, C. Eng, C. Fuchs, M. Fujii, R. Labianca, A. K. Larsen, E. Mitchell, H. J. Schmoll, D. Sprumont, J. Zalcberg

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents.

Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research.

Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided.

Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

Original languageEnglish (US)
Pages (from-to)922-930
Number of pages9
JournalAnnals of oncology : official journal of the European Society for Medical Oncology
Volume28
Issue number5
DOIs
StatePublished - May 1 2017

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Consent Forms
Informed Consent
Clinical Trials
Documentation
Neoplasms
Ethics Committees
Personal Autonomy
Research Personnel
Research
Pharmaceutical Preparations

Keywords

  • Institution Review Board
  • clinical trial
  • ethics
  • good clinical practice
  • inform consent
  • oncology

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Bleiberg, H. ; Decoster, G. ; de Gramont, A. ; Rougier, P. ; Sobrero, A. ; Benson III, Al B ; Chibaudel, B. ; Douillard, J. Y. ; Eng, C. ; Fuchs, C. ; Fujii, M. ; Labianca, R. ; Larsen, A. K. ; Mitchell, E. ; Schmoll, H. J. ; Sprumont, D. ; Zalcberg, J. / A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group. In: Annals of oncology : official journal of the European Society for Medical Oncology. 2017 ; Vol. 28, No. 5. pp. 922-930.
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abstract = "Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents.Methods: The Aide et Recherche en Canc{\'e}rologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research.Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided.Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.",
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author = "H. Bleiberg and G. Decoster and {de Gramont}, A. and P. Rougier and A. Sobrero and {Benson III}, {Al B} and B. Chibaudel and Douillard, {J. Y.} and C. Eng and C. Fuchs and M. Fujii and R. Labianca and Larsen, {A. K.} and E. Mitchell and Schmoll, {H. J.} and D. Sprumont and J. Zalcberg",
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Bleiberg, H, Decoster, G, de Gramont, A, Rougier, P, Sobrero, A, Benson III, AB, Chibaudel, B, Douillard, JY, Eng, C, Fuchs, C, Fujii, M, Labianca, R, Larsen, AK, Mitchell, E, Schmoll, HJ, Sprumont, D & Zalcberg, J 2017, 'A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group', Annals of oncology : official journal of the European Society for Medical Oncology, vol. 28, no. 5, pp. 922-930. https://doi.org/10.1093/annonc/mdx050

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group. / Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson III, Al B; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.

In: Annals of oncology : official journal of the European Society for Medical Oncology, Vol. 28, No. 5, 01.05.2017, p. 922-930.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

AU - Bleiberg, H.

AU - Decoster, G.

AU - de Gramont, A.

AU - Rougier, P.

AU - Sobrero, A.

AU - Benson III, Al B

AU - Chibaudel, B.

AU - Douillard, J. Y.

AU - Eng, C.

AU - Fuchs, C.

AU - Fujii, M.

AU - Labianca, R.

AU - Larsen, A. K.

AU - Mitchell, E.

AU - Schmoll, H. J.

AU - Sprumont, D.

AU - Zalcberg, J.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents.Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research.Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided.Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

AB - Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents.Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research.Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided.Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

KW - Institution Review Board

KW - clinical trial

KW - ethics

KW - good clinical practice

KW - inform consent

KW - oncology

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DO - 10.1093/annonc/mdx050

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