首页|基于伦理审查链条式梳理和探索研究参与者招募的全周期管理

基于伦理审查链条式梳理和探索研究参与者招募的全周期管理

Full-cycle management of research participant recruitment based on ethical review chain combing and explora-tion

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目的 基于伦理审查链条式梳理研究参与者招募的问题,探索应对策略,做好全周期管理.方法 通过政策解读、文献回顾,分析和讨论招募原则、招募途径、招募方案和招募广告相关问题,为主要研究者招募前制定恰当计划、招募中高质量实施、招募后总结完善提供参考,促进研究高质量完成.结果 招募的各个阶段存在各种问题,如招募前对代表性的关注不足,缺乏招募计划,招募广告的设计和发布不合理,招募时缺乏对公平性、自愿性的关注,未正视可能的风险与获益,存在胁迫或误解,不恰当使用专业医学术语,未进行充分的知情同意,未注意隐私和个人信息保护,招募后未及时总结完善,对招募团队培训和人才培养不够关注,对第三方招募公司和不规范行为缺乏监管等.结论 为提升研究参与者招募的质量和效率,招募前应制定恰当计划,规避代表性不足,选择合适的招募方式,制定科学的招募方案.设计规范的、合理的招募广告,适当增加招募广告的发布频率,明确是否委托第三方招募公司;招募中应高质量实施,严格落实招募的公平性和自愿性,正视潜在的风险和获益,避免胁迫或误解,使用通俗易懂的非专业医学术语,进行充分的知情同意,重视隐私和个人信息保护,识别并规避"职业研究参与者",关注孕妇、儿童和危急重症患者等群体的招募;招募后应总结完善,开发并推广系统化的招募工具,加强招募团队培训和人才培养,提升互联网招募的转化率,给予研究参与者或其监护人适当补偿,重点监管不规范行为,搭建第三方招募公司资质认定和监管体系.
Objective This study aimed to sort out the problems of research participant recruitment based on the chain of ethical review,exploring coping strategies,and managing the whole cycle.Methods Through policy interpretation and litera-ture review,we analyzed and discussed issues related to recruitment principles,recruitment pathways,recruitment programs,and recruitment advertisements,so as to provide references for the principal investigator to make appropriate plans before re-cruitment,implement them with high quality during recruitment,and summarize and improve them after recruitment,so as to facilitate the completion of the study with high quality.Results There were various problems at various stages of recruitment,such as insufficient attention to representativeness before recruitment,lack of a recruitment plan,irrational design and release of recruitment advertisements,lack of attention to fairness and voluntariness during recruitment,failure to face up to possible risks and benefits,coercion or misunderstanding,inappropriate use of specialized medical terminology,insufficient informed consent,lack of attention to the protection of privacy and personal information,failure to summarize and improve the recruit-ment in a timely manner,lack of attention to the training of recruitment teams and talent development,and lack of regulation of third-party recruitment companies and unregulated behaviors.summarize and improve,insufficient attention to recruitment team training and talent development,and lack of regulation of third-party recruitment companies and irregularities.Conclusions In order to improve the quality and efficiency of research participant recruitment,proper planning should be made before re-cruitment to avoid under-representation,select appropriate recruitment methods,formulate a scientific recruitment plan,design standardized and reasonable recruitment advertisements,appropriately increase the frequency of publication of recruitment ad-vertisements,and clarify whether to commission a third-party recruitment company.Recruitment should be carried out with high quality,strictly implement fair and voluntary recruitment,face the potential risks and benefits,avoid coercion or misun-derstanding,use easy-to-understand layman's medical terminology,give full informed consent,pay attention to the protection of privacy and personal information,identify and avoid"professional research participants",and pay attention to the recruitment of pregnant women,children,and patients with critical illnesses,etc..After recruitment,the recruitment should be summa-rized and perfected,and the recruitment team training and human resources training should be strengthened.After recruit-ment,we should summarize and improve the recruitment tools,develop and promote systematic recruitment tools,strengthen the training of the recruitment team and talent cultivation,improve the conversion rate of Internet recruitment,give appropriate compensation to the research participants or their guardians,focus on the supervision of irregularities,and set up a system for qualification and supervision of third-party recruitment companies.

Life sciences and medical research involving human beingsResearch participant recruitmentEthical re-viewFull-cycle management

周维佳、周吉银

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四川省肿瘤医院电子科技大学附属肿瘤医院伦理委员会办公室,成都 610041

陆军军医大学第二附属医院临床医学研究中心,重庆 400037

涉及人的生命科学和医学研究 研究参与者招募 伦理审查 全周期管理

陆军军医大学人文社会科学基金重点项目(2022)

2022XRW02

2024

中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
年,卷(期):2024.37(4)