Jacquier Elise, Laurent-Puig Pierre, Badoual Cécile, Burgun Anita, Mamzer Marie-France
Centre de Recherche Des Cordeliers (UMRS 1138), INSERM, Sorbonne Université, Université de Paris, Team ETREs, 75006, Paris, France.
Centre de Recherche Des Cordeliers (UMRS 1138), Team Personalized Medicine, INSERM, Sorbonne Université, Université de Paris, Pharmacogenomics and Therapeutic Optimization, 75006, Paris, France.
BMC Med Ethics. 2021 Mar 2;22(1):21. doi: 10.1186/s12910-021-00592-9.
In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM's translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants' rights.
Informed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program "Flesch Score".
29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs.
Our review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. "Old fashion written ICFs" should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested.
在转化研究的背景下，研究人员在基础研究阶段越来越多地使用生物样本和数据。为了探索知情同意的实践情况，我们对用于CARPEM转化研究项目的知情同意文件进行了一项回顾性研究。本综述着重详细阐述这些文件的形式、信息内容，以及这些文件与国际伦理原则和参与者权利的契合度。
从CARPEM的研究人员处收集知情同意书（ICF）。内容分析聚焦于与生物样本和数据处理相关的信息（采样和收集背景、目的、再利用、同意更新），包括同意的类型。使用IT程序“弗莱什阅读易读性评分”对ICF的可读性进行自动评估。
在应用选择标准后，对49项研究中25项的29份ICF进行了分析。确定了三种同意类型：11份广义同意、6份特定同意和2份退出同意。弗莱什阅读易读性评分显示，大多数文件过于复杂，大多数潜在研究参与者无法完全理解。大多数生物样本是在医疗常规过程中收集的，但ICF之间关于生物样本二次使用的信息内容各不相同。所有文件都提到了个人数据处理，但ICF中关于其再利用的信息并不规范。
我们对CARPEM当前知情同意程序的综述表明，考虑到新的转化研究方法，实践可以得到改进。“老式书面ICF”应适应转化研究方法，以更好地尊重个人权利和国际研究伦理原则。在这种情况下，理论上，一个允许通过电子互动平台实现参与者动态信息和同意的数字工具可能是促进更积极参与研究的好方法。然而，其在生物样本和数据研究复杂环境中的可行性仍有待证明。也可以测试先采用广义同意再结合动态信息的方式。
