Ethical review challenges and coping strategies in health care big data research
10.3760/cma.j.cn113565-20250117-00012
- VernacularTitle:健康医疗大数据研究的伦理审查挑战及应对策略
- Author:
Wenli ZHANG
1
;
Richeng JIANG
;
Lu CHEN
Author Information
1. 天津市肿瘤医院空港医院医学伦理委员会办公室 300308
- Publication Type:Journal Article
- Keywords:
Health data;
Big data;
Research ethics;
Privacy protection;
Informed consent;
Ethical review
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):387-393
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the challenges faced by ethical review in health care big data research and propose countermeasures, so as to provide a reference for the ethical review practice of such research.Methods:Based on the research of relevant domestic and foreign laws, regulations, literature, and other materials, combined with the work practice, analysis and summary were conducted.Results:Current ethics committees and research ethics guidelines are not applicable when dealing with health care big data research. Due to the lack of normative guidance, committees face challenges in assessing informed consent, privacy protection, and risk-benefit distribution of the research, and cross-institutional collaboration and data reuse are prone to be detached from review and supervision.Conclusions:It is urgent to construct and improve the review and supervision mechanism, innovate the informed consent model, and pay attention to the public interests and social values of research while effectively protecting the privacy of participants. In addition, it's important to promote the construction of multidisciplinary collaborative ability of ethics committees and supervise health care big data research by promoting the joint participation of stakeholders including the public.
