公共卫生研究项目伦理初始审查现状分析

Analysis on Status Quoof Initial Ethical Reviews for Public Health Research Project

目的为了解公共卫生研究的受试者权益是否得到有效保护,对机构开展的公共卫生研究项目伦理初始审查材料进行分析。方法采用现场调查法,对2011-2016年期间机构开展的伦理审查项目存档资料进行评估,对问题的原因进行深入分析。结果受理的伦理审查项目以申报局级、流行病学科类项目为主,超过一半以上项目受试者包括弱势人群。初始审查一次性通过率为32.5%,修改意见中知情同意书修改的比重高于研究方案。知情同意书的主要问题集中于研究内容告知、语言表达、风险考虑方面,主要原因包括"表达不充分""语言专业化"和"要素不完整"。结论受试者的保护仍需要研究者和伦理委员会能力的共同提高,加快公共卫生伦理理论发展和完善审查规范建设,强化信息安全管理,加强对年轻科研人员的伦理培训以及机构伦理委员会的能力建设。

Objective: To explore whether the rights and interests of subjects in public health research are effectively protected, this paper analyzed the initial ethical review materials of public health research projects carried out by institutions. Methods: The archived data of ethical review projects carried out by institutions in the period of 2011-2016 was evaluated by means of on-the-spot investigation, and an in-depth analysis of the causes of the problems was made. Results: It was found that the ethical review projects accepted were mainly for the reporting of bureau level and epidemiological subjects, and more than half of the subjects included the vulnerable groups. The initial review had a one-time pass rate of 32.5%, and the proportion of informed consent changes in the revised opinion was higher than that of the research program. Main problems in informed consent focused on the research content notification, language expression, and risk consideration. Main reasons included insufficient expression, language specialization and elements incompletion. Conclusion: The protection of subjects still needs to be improved by both researchers and ethics committees.It was suggested to accelerate the development of public health ethics theory and improve the construction of censorship standards, strengthen information security management, strengthen ethical training for young researchers and the capacity building of institutional ethics committees.