Béghin L, Castera M, Manios Y, Gilbert C C, Kersting M, De Henauw S, Kafatos A, Gottrand F, Molnar D, Sjöström M, Leclercq C, Widhalm K, Mesana M I, Moreno L A, Libersa C
EA-3925, Lille 2 Law and Health University Faculty of Medicine, Lille, France.
Int J Obes (Lond). 2008 Nov;32 Suppl 5:S12-8. doi: 10.1038/ijo.2008.179.
Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries.
The main objective of the HELENA-CSS is to evaluate reliable and comparable data of nutritional habits and lifestyle in a representative sample of European adolescents. The aim of this paper is to present the methods relating to the ethical and regulatory issues of this study and to describe the current state of the medico-regulatory requirements involved in conducting this kind of study in each country.
Following the GCP-ICH guidelines, a protocol describing the HELENA-CSS was written and approved by all partners. In the pilot study, a case report form adapted to the study objectives and its manual of operation was constructed and used by all partners. All information letters to adolescents and their parents and consent forms were first written in English, then translated into the local language, and adapted to each local situation. All documents were then checked centrally for any deviation and corrected if required. An operation manual relating to ethical issues and other medico-regulatory requirements was also developed. This paper presents the current status of the medico-regulatory requirements from each HELENA-CSS participant country.
Before the beginning of the study, most centers had satisfied the medico-regulatory requirements of IEC approval and agreement with other national or local regulatory authorities/organizations. For a few centers, some problems were detected and corrective actions were taken to improve missing information to reach a high level of quality assurance of ethical issues.
The GCP-ICH guidelines about nontherapeutic biomedical research are interpreted and applied differently across Europe. This study shows that high-quality nontherapeutic biomedical research can address the ethical issues included in the GCP-ICH regulations and can be harmonized among the HELENA European partners.
涉及人类的研究由监管机构通过其特定要求和控制措施进行规范。欧洲青少年营养健康生活方式横断面研究（HELENA-CSS）是一项在欧洲几个具有代表性城市开展的针对青少年的多中心生物医学研究，该研究需要满足包括独立伦理委员会（IEC）批准以及国家或地方监管机构同意等医学监管要求。为了在伦理问题上实现高水平的质量保证，我们遵循了在国际协调会议（ICH）上描述的良好临床实践（GCP），并根据欧洲10个国家11个参与城市各自的国家和地方情况进行了调整。
HELENA-CSS的主要目的是在欧洲青少年的代表性样本中评估营养习惯和生活方式的可靠且可比的数据。本文的目的是介绍与本研究的伦理和监管问题相关的方法，并描述在每个国家开展此类研究时医学监管要求的现状。
遵循GCP-ICH指南，编写了一份描述HELENA-CSS的方案并得到所有合作伙伴的批准。在试点研究中，构建了一份适应研究目标的病例报告表及其操作手册，供所有合作伙伴使用。所有给青少年及其父母的信息信和同意书首先用英文撰写，然后翻译成当地语言，并根据每个地方的情况进行调整。然后对所有文件进行集中检查，查看是否有任何偏差，并在需要时进行纠正。还制定了一份关于伦理问题和其他医学监管要求的操作手册。本文介绍了HELENA-CSS每个参与国医学监管要求的现状。
在研究开始前，大多数中心已满足IEC批准以及与其他国家或地方监管机构/组织达成一致的医学监管要求。对于少数中心，发现了一些问题，并采取了纠正措施以完善缺失信息，从而在伦理问题上达到高水平的质量保证。
关于非治疗性生物医学研究的GCP-ICH指南在欧洲各地的解释和应用有所不同。本研究表明，高质量的非治疗性生物医学研究能够解决GCP-ICH法规中包含的伦理问题，并且可以在HELENA欧洲合作伙伴之间实现协调统一。
