Bleiberg H, Decoster G, de Gramont A, Rougier P, Sobrero A, Benson A, 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
Institut Jules Bordet, Brussels, Belgium.
Freelance Auditor, Basel, Switzerland.
Ann Oncol. 2017 May 1;28(5):922-930. doi: 10.1093/annonc/mdx050.
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.
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.
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.
This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.
就自主原则和自决权而言，在将潜在参与者纳入研究之前获得其知情同意是一项基本的伦理义务。国家法律、法规和文化的差异导致参与临床试验的患者的知情同意文件复杂多样。目前，似乎只有少数伦理委员会愿意处理这些文件的复杂性和篇幅问题，并要求研究者和申办者对其进行修订，以使潜在参与者能够理解。这项工作的目的是关注药物研发临床试验知情同意文件中的书面信息，并建议：（i）区分必要信息和非必要信息；（ii）确定能使这些文件具有最佳易读性的最佳格式。
消化肿瘤辅助与研究（ARCAD）小组是一个由来自世界各地的肿瘤学家组成的国际科学委员会，该小组解决了这些问题，并为未来的临床研究制定并统一接受了一份简化的知情同意文件。
提供了一种简化的知情同意书形式，其主要部分为1200 - 1800字，包含满足伦理和监管要求所需的所有关键信息，以及2000 - 3000字的“相关支持性信息附录”。
本立场文件基于ARCAD小组专家的讨论，提出了我们的知情同意模型及其内容的基本原理。
