免除伦理审查的挑战和实施建议

Challenges and Implementation Suggestions for Exemption from Ethical Review

2023年2月,《涉及人的生命科学和医学研究伦理审查办法》发布,为减轻研究人员负担,第三十二条提出了可以免除审查。规范的免除审查不仅可减轻研究者负担,还可减轻伦理委员会的工作压力,将有限时间和精力用于高风险研究的审查和监管。先分析免除审查的4条标准,接着概述《涉及人的健康相关研究国际伦理准则》和美国有关免除审查的情况。鉴于中国之前并无免除审查的相关法规,虽曾有医疗卫生机构对一些研究实施了免除审查,但伦理委员会常缺乏免除审查的标准操作规程、相应文档和经验,研究者也缺少免除审查的培训,机构并无免除审查的配套措施。为有效落实免除审查,提出以下建议:需制定免除审查的标准操作规程,明确审查流程,可简化为秘书形式审查,资深秘书或办公室主任判断是否符合免除审查标准,主任委员审查并签字,传达审查决定;细化符合免除审查的标准,必要时提供案例和说明,有助于研究者准确理解每条标准的内涵,也供研究者自行初步判断时参考;加强对研究者培训免除审查标准;研究应先立项,提供科学性论证意见;探索跟踪审查的实施,机构应加快规范化建设生物样本库和数据库,确保提供合规的生物样本和信息数据的来源证明。免除审查不可被滥用,应平衡好为研究者减负与保证伦理审查质量之间的关系。

To reduce the burden of researchers,Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human issued in February 2023 proposed that the review could be exempted.Normative exemption from review can not only relieve the burden of researchers,but also reduce the work pressure of the ethics committee,and devote limited time and energy to the review and supervision of high-risk research.This paper analyzed the four criteria for exemption from review first,and then summarized the situation of exemption from ethics review in the International Ethical Guidelines for Health-related Research Involving Humans and in the United States.In view of the fact that there are no relevant regulations on exemption from ethics review,though some medical and health institutions have implemented exemption from ethics review for some studies,the ethics committee often lacks standard operating procedures,corresponding documents,and experience for exemption from ethics review,researchers lack training for exemption from ethics review,and institutions have no supporting measures for exemption from review.To effectively implement the exemption from review,this paper proposed the following suggestions:developing standard operating procedures for exemption from review,and clarifying the review process,which can be simplified to secretary reviews,with senior secretaries or office directors judging whether they meet the exemption criteria,and the chairman reviewing and signing to convey the review decision.Refining the criteria that meet the exemption from ethics review,and providing cases and explanations as necessary,which will help researchers accurately understand the connotation of each criterion,and also provide reference for researchers to make their own preliminary judgments.Strengthening the training of researchers exemption from review criteria.The study should obtain the project proposal first,and provide scientific demonstration opinions.To explore the implementation of continuing review,institutions should accelerate the standardized construction of biological sample banks and databases to ensure the provision of compliant sources of biological samples and information data.Exemption from ethics review should not be abused,and the relationship between reducing the burden on researchers and ensuring the quality of ethical review should be balanced.