@article{oai:repo.qst.go.jp:00079836,
 author = {小池, 竜司 and 栗原, 千絵子 and 鈴木, 千惠子 and 佐藤, 弥生 and 星, 順子 and 渡邉, 裕司 and Kurihara, Chieko},
 issue = {4},
 journal = {臨床薬理},
 month = {Aug},
 note = {Background: Risks associated with conducting clinical trials include occurrence of unintended AEs which could potentially cause health impairment of study participants. Therefore mechanisms by which patients are compensated for trial-related injury must exist; however, actual cases of managing such compensation has not enough surveyed, especially in the case of investigator-initiated clinical trial (IIT).
Objectives: To find actual situation of managing compensation in IIT.
Method: Web-based questionnaire survey in the fiscal year 2017, responded by the offices of institutional review board (IRB) for good clinical practice (GCP)-regulated study and of ethics committee (EC) for governmental guideline-regulated study.
Findings: Main findings are as follows: (1) 5/21（24%）IRBs and 7/22（32%）ECs answered that they have a written institutional policy or procedure document; (2) 9/21（43%）IRBs and 1/22（5%）ECs answered that they have prepared a compensation-specific explanation sheet for research subjects, and 4/21（19%）IRBs and 1/22（5%）ECs have prepared such a document for the time when injury happens; (3) Only 1/21(5%) IRB and 2/22(9%)ECs answered that they have compensation-specific judge mechanism separately from IRB/EC; (4) Only a few number of institutions answered that they prepare for financial resource separately from insurance; (5) Several information about the cases of providing monetary compensation was obtained.
Conclusion: Institutional operating procedures and information sheet for subject have not been enough prepared but several institutions have prepared them. Problem is that institutional mechanism to judge about the necessity of compensation have been rarely established. Further survey is needed to find actual situation of managing compensation cases in IIT.},
 pages = {157--166},
 title = {医師主導治験・医学系研究における健康被害補償に関する調査},
 volume = {50},
 year = {2019}
}