Landi Annalisa, Mimouni Yanis, Giannuzzi Viviana, Schaefer Franz, Altavilla Annagrazia, Gibson Spencer, Julkowska Daria
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy.
European Joint Programme on Rare Diseases Coordination, INSERM, Paris, France.
Front Med (Lausanne). 2024 Apr 17;11:1384026. doi: 10.3389/fmed.2024.1384026. eCollection 2024.
The lack of harmonization of evaluation criteria by Ethics Committees in the European Union (EU) has led to inconsistent ethics reviews received by research sites participating in multicenter non-interventional studies. The European General Data Protection Regulation (GDPR) appears to be implemented at national level with a substantial degree of variance in interpretation. The European Reference Networks (ERNs) were struggling in setting an Informed Consent Form (ICF) for registries, allowing reuse of data for research purposes. The aim of this work is to develop an adaptable ICF for research purposes to be used in ERN registries.
To work on this challenge, a team was established within the European Joint Programme on Rare Diseases (EJP RD) to develop a patients' registry ICF template allowing easy adaptation to ERNs, country, and site-level specificities. ERN and patients' representatives validated the choice of developing a GDPR-compliant template for research purposes. The feedback received from 34 Ethics Committees on the Clinical Patient Management System ICF, including the submission of patients' data to the ERN registries and the EU consent regulatory framework were analyzed along with existing ontologies for data access and reuse. An adaptable ICF was developed following iterative cycles of consultation and review by clinicians, research experts, ethics and regulatory advisors, and patients' representatives. The development of pediatric material for minor participants was also undertaken.
Research oriented ICF templates for adults and for parents/legal representatives of patients were released in 26 national languages. This adaptable ICF aims to foster, according to patients' preferences, the reuse of registries data for research purposes in compliance with the applicable laws and standards. Pediatric material is being finalized to collect minors' assent. ICF machine-readability is also progressing to enhance data discovery and facilitate its access and reuse conditions.
欧盟伦理委员会评估标准缺乏协调性，导致参与多中心非干预性研究的研究机构收到的伦理审查不一致。《欧洲通用数据保护条例》（GDPR）在国家层面的实施似乎在解释上存在很大差异。欧洲参考网络（ERNs）在为注册机构制定知情同意书（ICF）方面遇到困难，该知情同意书允许将数据用于研究目的。这项工作的目的是开发一种适用于研究目的的可改编知情同意书，供ERN注册机构使用。
为应对这一挑战，在欧洲罕见病联合计划（EJP RD）内成立了一个团队，以开发一个患者注册机构ICF模板，使其易于适应ERNs、国家和机构层面的特殊性。ERNs和患者代表认可了为研究目的开发符合GDPR模板的选择。分析了从34个伦理委员会收到的关于临床患者管理系统ICF的反馈，包括向ERN注册机构提交患者数据和欧盟同意监管框架，并结合现有的数据访问和再利用本体进行分析。经过临床医生、研究专家、伦理和监管顾问以及患者代表的反复咨询和审查，开发出了一种可改编的ICF。还为未成年参与者开发了儿科材料。
以研究为导向的成人及患者父母/法定代表人ICF模板以26种国家语言发布。这种可改编的ICF旨在根据患者的偏好，促进在符合适用法律和标准的情况下将注册机构数据用于研究目的。儿科材料正在定稿，以获取未成年人的同意。ICF的机器可读性也在不断提高，以增强数据发现并便利其访问和再利用条件。
