2019 年 50 巻 4 号 p. 157-166
Background: Risks associated with conducting clinical trials include occurrence of unintended adverse events which could potentially cause health impairment of study participants.Therefore mechanisms by which patients are compensated for trial-related injury must exist. However, the actual situation of such compensation has not been adequately surveyed, especially for investigator-initiated clinical trials (IITs).
Objectives: To examine the actual situation of managing compensation in IITs.
Methods: A web-based questionnaire survey was conducted in 2017. Responses were obtained from institutional review boards (IRBs) for good clinical practice (GCP)-regulated studies and from ethics committees (ECs) for government guideline-regulated studies.
Findings: Main findings were as follows: (1) 5 of 21 (24％) IRBs and 7 of 22 (32％) ECs responded that they had a written institutional policy or procedural document; (2) 9 of 21 (43％) IRBs and 1 of 22 (5％) ECs responded that they had prepared an explanation sheet concerning compensation for research subjects, and 4 of 21 (19％) IRBs and 1 of 22 (5％) ECs had prepared an explanation sheet in the case of occurrence of injury; (3) only 1 of 21 (5％) IRBs and 2 of 22 (9％) ECs responded that they had a compensation-specific assessment mechanism separately from IRB/EC ; (4) only a few institutions responded that they had financial resource for compensation separately from insurance; (5) information on cases of awarding monetary compensation was obtained.
Conclusion: Institutional operation manual and information sheet for research subjects concerning compensation for trial-related injuries are not adequately prepared, but several institutions have produced these documents. One issue is that institutional mechanism to assess the need for compensation is rarely established. Further survey is required to elucidate the actual situation of managing compensation in IITs.
