European Union's Research Executive Agency, Brussels, Belgium.
Center for Evidence-Based Medicine and Healthcare, Catholic University of Croatia, Zagreb, Croatia.
PLoS One. 2021 Nov 4;16(11):e0259582. doi: 10.1371/journal.pone.0259582. eCollection 2021.
Horizon 2020 was the most significant EU Research and Innovation programme ever implemented and included the Marie Skłodowska-Curie Actions (MSCA). Proposals submitted to the MSCA actions awere subject to the Ethics Appraisal Procedure. In this work we explored the ethics appraisal procedure in MSCA H2020.
Using a retrospective analysis of pooled anonymized data, we explored the ethics appraisal procedure on proposals submitted to Marie Skłodowska-Curie Actions (MSCA) during the entire Horizon 2020 program period (N = 79,670).
Our results showed that one of the most frequently identified ethics categories was Data protection. We also detected slight differences between applicants' and the ethics reviewers' awareness of ethical issues. Trajectory analysis of all ethics screened proposals appearing on main lists showed that a minimal portion of all screened submissions required additional ethics checks in the project implementation phase.
Personal data protection is one of the most represented ethics categories indicated among MSCA actions which exhaust ethics assessment efforts and may lead to "overkills" in ethics requirements. Excluding the majority of personal data protection assessment from the ethics assessment, except for parts which are directly related to ethics like "Informed consent procedures", might be necessary in the future. A gap in understanding of ethics issues between applicants and reviewers' points to the necessity to further educate researchers on research ethics issues.
“地平线 2020”是欧盟有史以来实施的最重大的研究与创新计划,其中包括“玛丽·斯克沃多夫斯卡-居里行动”(MSCA)。提交给 MSCA 行动的提案都需要经过伦理评估程序。在这项工作中,我们探讨了 MSCA H2020 中的伦理评估程序。
我们使用对汇总的匿名数据进行回顾性分析,探讨了在整个“地平线 2020”计划期间(N=79670)提交给“玛丽·斯克沃多夫斯卡-居里行动”(MSCA)的提案的伦理评估程序。
我们的结果表明,最常被识别的伦理类别之一是数据保护。我们还发现申请人和伦理审查员对伦理问题的认识之间存在细微差异。对主要名单上出现的所有经过伦理审查的提案的轨迹分析表明,在项目实施阶段需要额外伦理审查的提案仅占所有经过审查提交提案的一小部分。
个人数据保护是 MSCA 行动中表示的最具代表性的伦理类别之一,它耗费了大量的伦理评估工作,可能导致伦理要求的“过度杀伤”。未来可能有必要将大多数个人数据保护评估排除在伦理评估之外,除非其与“知情同意程序”等直接相关的部分。申请人和审查员之间对伦理问题理解上的差距表明,有必要进一步教育研究人员研究伦理问题。