Course for Health Care Management and Public Health, Graduate School of Health Management, Keio University, 4411 Endo, Fujisawa-shi, Kanagawa, 252-0882, Japan.
Graduate School of Public Health, Shizuoka Graduate University of Public Health, Aoi-ku, Shizuoka, 420-0881, Japan.
BMC Med Ethics. 2022 Sep 12;23(1):92. doi: 10.1186/s12910-022-00830-8.
The Act Regarding the Promotion of the Appropriate Supply of Hematopoietic Stem Cells for Transplant regulates only how public banks store and provide umbilical cord blood (UCB) for research or transplantation. Japan had no laws to regulate how the private banks manage the procedures, harvesting, preparation, and storage of such blood. As a result, the status of UCB distribution remains unknown. We conducted a survey to investigate the current status of UCB storage and provision to private biobanks by Japanese institutions that handle childbirth.
Questionnaire forms were mailed to 3,277 facilities handling childbirth that were registered in the Japan Council for Quality Health Care website.
Of the 1,192 institutions handling childbirth that participated in the survey (response rate: 36.7%), 34.4% responded that they currently provide UCB to private biobanks, while 16.1% of facilities did so in the past. Moreover, some institutions currently provide or formerly provided UCB to medical treatment facilities (2.6%), research institutions (5.9%), companies (2.2%), or overseas treatment facilities, research institutions, or companies (0.3%). A certain number of institutions handling childbirth did not even provide explanations or obtain consent when the UCB was harvested from private bank users.
This is the first study to determine the status of UCB provision to private banks by Japanese institutions handling childbirth. Future studies will need to examine in detail how institutions handling childbirth provide explanations to private bank users and UCB providers as well as how these institutions obtain consent.
《促进适当供应造血干细胞用于移植法》仅规定了公共银行如何储存和提供脐带血（UCB）用于研究或移植。日本没有法律来规范私人银行如何管理此类血液的采集、制备和储存程序。因此，UCB 的分配情况仍不清楚。我们进行了一项调查，以调查日本处理分娩的机构目前对私人生物银行储存和提供 UCB 的情况。
向在日本医疗质量改进协会网站上注册的 3277 家处理分娩的医疗机构邮寄了问卷调查表。
在参与调查的 1192 家处理分娩的医疗机构中（应答率：36.7%），34.4%的机构表示目前向私人生物银行提供 UCB，而 16.1%的机构过去曾提供过。此外，一些机构目前向医疗机构（2.6%）、研究机构（5.9%）、公司（2.2%）或海外治疗设施、研究机构或公司（0.3%）提供或曾经提供过 UCB。一些处理分娩的医疗机构在从私人银行用户采集 UCB 时，甚至没有提供解释或获得同意。
这是首次确定日本处理分娩的机构向私人银行提供 UCB 的情况的研究。未来的研究需要详细研究处理分娩的机构如何向私人银行用户和 UCB 提供者解释情况，以及这些机构如何获得同意。
