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(Japanese)"},{"key":"ref22","unstructured":"Association of the British Pharmaceutical Industry (ABPI) (1991) Clinical trial compensation guidelines."},{"key":"ref23","unstructured":"Association of the British Pharmaceutical Industry (ABPI) (1988) Guidelines for medical experiments in non-patient human volunteers."},{"key":"ref24","unstructured":"The Association of the British Pharmaceutical Industry (ABPI) (2007) Guidelines for phase 1 clinical trials."},{"key":"ref25","unstructured":"The Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association, Clinical Contract Research Association (2012) Insurance and compensation in the event of injury in Phase I clinical trials."},{"key":"ref26","unstructured":"Japanese Pharmaceutical Industry Legal & Business Affairs Association (2009) Result of questionnaire survey of compensation. Legal Mind Supplement 35: 60\u2013118. 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NMEC Recommendations on clinical trials: Update focusing on phase 1 trials."},{"key":"ref35","unstructured":"The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Office of the Secretary, U. S. Department of Health, Education, and Welfare (1979) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research."}],"container-title":["PLoS ONE"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pone.0084998","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,8]],"date-time":"2020-05-08T21:04:29Z","timestamp":1588971869000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0084998"}},"subtitle":[],"editor":[{"given":"David Joseph","family":"Diemert","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2014,1,8]]},"references-count":35,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2014,1,8]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0084998","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,1,8]]}}}