Terui-Kohbata Hiroko, Ueda Hiyori, Yoshida Masayuki
Life-Science and Bioethics Research Center, Institute of Science Tokyo, Tokyo, Japan.
Department of Life Sciences and Bioethics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8510, Japan.
J Community Genet. 2025 Jul 17. doi: 10.1007/s12687-025-00820-4.
Pediatric research in rare diseases relies on sharing biological specimens, clinical data, and analytical information among researchers. Re-consent is essential in longitudinal biobank (BB) research to ensure that pediatric participants remain informed and willing to continue. However, the issue of re-consent-obtaining consent once participants reach adulthood-remains a significant ethical concern. This study examined the current practices of re-consent acquisition in Japanese BBs and explores stakeholder opinions regarding genomic data sharing. A survey of 41 BBs revealed that only 25% of those handling pediatric samples obtained re-consent, all via written informed consent. Although 71% of respondents recognized the necessity of re-consent, the methods used to obtain it varied. Stakeholders identified ethical and logistical challenges, including privacy concerns and administrative burden. Various re-consent methods were suggested, with preferences depending on feasibility and ethical considerations. The findings highlight the need for policy discussions to balance data-sharing benefits with participant rights and privacy protection in pediatric genomic research. Determining optimal re-consent methods requires continued stakeholder engagement, including research participants and the public.
罕见病的儿科研究依赖于研究人员之间共享生物样本、临床数据和分析信息。在纵向生物样本库（BB）研究中，再次获得同意至关重要，以确保儿科参与者始终了解情况并愿意继续参与。然而，再次获得同意这一问题——即参与者成年后再次获得同意——仍然是一个重大的伦理问题。本研究调查了日本生物样本库中再次获得同意的当前做法，并探讨了利益相关者对基因组数据共享的意见。对41个生物样本库的调查显示，在处理儿科样本的机构中，只有25%获得了再次同意，均通过书面知情同意的方式。尽管71%的受访者认识到再次获得同意的必要性，但获得同意的方法各不相同。利益相关者指出了伦理和后勤方面的挑战，包括隐私问题和行政负担。有人提出了各种再次获得同意的方法，具体偏好取决于可行性和伦理考量。研究结果凸显了在儿科基因组研究中进行政策讨论以平衡数据共享益处与参与者权利及隐私保护的必要性。确定最佳的再次获得同意的方法需要利益相关者持续参与，包括研究参与者和公众。
