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@@2@”íŒąŽŇ•ŰŒě­ô‚ĚŠT‹ľ@[’6]

@@ ”íŒąŽŇ•ŰŒě­ô‚Í”íŒąŽŇ‚̐ś–˝‚đ•ŰŒě‚ˇ‚é‚ą‚ƁAŒ —˜E•ŸŽƒ‚đŒüă‚ˇ‚é‚ą‚Ć‚Ě—ź•ű‚đ–Ú“I‚Ć‚ľ‚˝­ô‚Ĺ‚ ‚éB‚ť‚Ě‚˝‚ß‚É”íŒąŽŇŒ¤‹†iResearch@involving Human Subjectsj‚đ‚ˇ‚éę‡‚É‚ÍIRB‚ĚŽ–‘OR¸‚ƁA‚ť‚Ě”FŘ‚Ş‹`–ą‚Ă‚Ż‚Ä‚˘‚éB”FŘR¸‚Ě‚ł‚˘‚É”íŒąŽŇ‚âŽŔŒą‚Š‚ç—\‘z‚ł‚ę‚鐏‰Ę‚ĚƒŠƒXƒNE•Ö‰v•]‰żA“KŘ‚ČƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒgAu‚‚Ť‚₡‚˘lXv(vulnerable people)‚Ö‚Ě”z—ś‚Č‚Ç‚Ĺ‚ ‚éB

@@ ‚ą‚̐­ô‚Í’ĘĚhthe Common Ruleh(‹¤’Ę‹K’č)‚ĆŒÄ‚Î‚ę‚é‹K’č‚Ɓu21 CFR 50 ‚¨‚ć‚Ń 56v‚Ć‚˘‚¤‚Q‚Â‚Ě˜A–M‹K§Šî€(Code of Federal Regulations, CFRj‚đ–@“IŞ‹’‚Ć‚ľ‚Ä‚˘‚éB‚ť‚Ě‚¤‚żu21 CFR 50 ‚¨‚ć‚Ń 56v‚Í1991”N‚ÉFDA(H•iˆă–ň•i‹Ç,Food and Drug Administration)‚ސ§’č‚ľ‚˝‹K’č‚ŁA’…F—ż‚âH•i“Y‰Á•¨‚đŠÜ‚Ţ–ň•iAH•iA‹@Ší‚Č‚Ç‚đ—p‚˘‚é”íŒąŽŇŒ¤‹†‚É“K—p‚ł‚ę‚é‹K’č‚Ĺ‚ ‚é@[’7]B‚Ü‚˝­•{‚Ě‹K’č‚đIRB‚ŞŒľ–§‚É“K—p‚ˇ‚é‚Č‚ç‚΁A‚ą‚ę‚ç‚Ě‹K’č‚͐­•{‹@ŠÖ‚É‚ć‚é’źÚŽŔŒą‚Š‚Ü‚˝‚́A‚Ü‚˝‚͐­•{‹@ŠÖ‚ŞŒ¤‹†Ž‘‹ŕ‚đŽx‰‡‚ľ‚˝”íŒąŽŇŒ¤‹†A‚¨‚ć‚ѐH•i‚â–ň•i‚đ—p‚˘‚é”íŒąŽŇŒ¤‹†‚ÉŒŔ’č‚ł‚ę‚éB‚‚܂čŠeŒ¤‹†‹@ŠÖ‚Ş“ĆŽŠ‚ĚŒ¤‹†Ž‘‹ŕ‚ÉŠî‚Ă‚˘‚Ä”íŒąŽŇŒ¤‹†‚ŁA‚Š‚H•i‚â–ň•i‚đ—p‚˘‚Č‚˘ę‡‚ɂ́gthe Common Ruleh‚Ş’źÚ“K—p‚ł‚ę‚é‚ą‚Ć‚Í‚Č‚˘B‚ľ‚Š‚ľ‘˝‚­‚Ěę‡‚ą‚¤‚ľ‚˝”íŒąŽŇŒ¤‹†‚ŕŠeŒ¤‹†‹@ŠÖ‚ĚIRB‚Ş“ĆŽŠ‚ɍ쐬‚ˇ‚é‹K’č‚ł͐R¸‚Ě‘ÎŰ‚Ć‚ł‚ę‚Ä‚˘‚éB‚ť‚ľ‚Ä‚ť‚ę‚ç‚Ě“ĆŽŠ‹K’č‚̍쐬‚É‚ł‚˘‚ľ‚Ä‚ÍŠeIRB‚Ɉę’č‚ĚŮ—ĘŒ ‚Ş‚ ‚é‚ŕ‚̂́Agthe Common Ruleh‚âŒăq‚ˇ‚éƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒgA‚ł‚ç‚É‚ÍIRB‚Ě“ĆŽŠ‹K’č‚ť‚Ě‚ŕ‚Ě‚đ”FŘ‚ˇ‚é‹K’č‚Č‚Ç‚É‚ć‚Á‚āA‚Ů‚Ć‚ń‚Ç‚ˇ‚×‚Ä‚Ě”íŒąŽŇŒ¤‹†‚Í‚ą‚̐­ô‚Ě‘ÎŰ‚Ć‚ł‚ę‚Ä‚˘‚éB

@@ ŒťÝA”íŒąŽŇ•ŰŒě­ô‚̓AƒƒŠƒJ•ŰŒ’ŽĐ‰ď•ŸŽƒČ (Department of Health and Human Services: HHS)‚̉ş•”‘gD‚Ĺ‚ ‚é”íŒąŽŇŒ¤‹†‹Ç (Office for Human Research Protections: OHRP)‚Ş‚ą‚̐­ô‚ĆŠe‘gD‚ĚIRB‚ĚŠÄ“ÂŒ ŒŔ‚đ—L‚ľ‚Ä‚˘‚éBOHRP‚ÍHHS‚ɐ­ô‚̐V‚ľ‚˘Šé‰ć‚âî•ń’ń‹Ÿ‚đs‚¤‚Ć‚Ć‚ŕ‚ɁAIRB‚̐\ż‚ɉž‚ś‚Ä”íŒąŽŇ•ŰŒě‚Ě˜A–M”FŘ(Federal Wide Assurance of Protection for Human Subjects: FWA)‚ĚŒ ŒŔ‚đ‚ŕˆŹ‚Á‚Ä‚˘‚é@[’8]B‚ą‚ĚFWA”FŘ‚đŽć“ž‚ˇ‚é‚Š”Ű‚Š‚ÍŠeIRB‚Ě”ť’f‚É”C‚š‚ç‚ę‚Ä‚˘‚é‚ŕ‚̂́A‚ą‚Ě”FŘ‚Ş‚Č‚˘IRB‚ɂ͐­•{‹@ŠÖ‚ĚŒ¤‹†Žx‰‡‚đŽó‚Ż‚é”íŒąŽŇŒ¤‹†‚̐R¸Œ ŒŔ‚Ş‚Č‚˘B‚ť‚Ě‚˝‚ß‚ť‚̐R¸‚đ‚đOHRP‚ÉˆĎ‚Ë‚Č‚Ż‚ę‚΂Ȃç‚Č‚˘‚Ě‚Ĺ‚ ‚éB‚‚܂čŠeIRB‚É‚ÍFWA”FŘ‚đŽó‚Ż‚é‚ą‚Ć‚Ş§—ă‚ł‚ę‚Ä‚¨‚čAŽ–ŽŔăIRBR¸Šî€‚ĚŒ Œ´‚Ć‚Č‚Á‚Ä‚˘‚é‚Ć‚˘‚Ś‚éBFWA”FŘR¸‚Ĺ‚ÍIRB‚Ě“ĆŽŠ‹K’č‚Şhthe Common Ruleh‚âƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚Č‚Ç“ĽP‚ľ‚Ä‚˘‚é‚ą‚Ć‚âAIRBˆĎˆőE”íŒąŽŇŒ¤‹†‚ÉŒg‚í‚錤‹†ŽŇ‘Sˆő‚É‚ą‚̐­ô‚ĚŠT—v‚âŽč‘ą‚Ť‚ɂ‚˘‚Ä‚Ě‹łˆç‚Ş“O’ę‚ł‚ę‚Ä‚˘‚é‚Š‚Č‚Ç‚Ş’˛¸‚ł‚ę‚éB‚Ü‚˝FWA‚Ě—LŒřŠúŠÔ‚Í3”N‚Ĺ‚ ‚é‚˝‚߁A‚ť‚̍XV‚É‚ÍOHRP‚̍ĐR¸‚Ş‰Ű‚š‚ç‚ę‚Ä‚˘‚éB‚ą‚̂悤‚ɍĄ“ú‚Ě”íŒąŽŇ•ŰŒě­ô‚ÍŠeIRB‚Ě“ĆŽŠ‹K’č‚ĆFWA”FŘ‚đ’Ę‚ś‚āAŒ¤‹†•Ş–ě‚⌤‹†Ž‘‹ŕ‚̏oˆ‚đ–â‚킸‚ ‚ç‚ä‚é”íŒąŽŇŒ¤‹†‚đ‘ÎŰ‚Ć‚ľ‚Ä‚˘‚é‚Ě‚Ĺ‚ ‚éB‚Ĺ‚Í‚ť‚Ě’†S“I‚Č‹K’č‚Ĺ‚ ‚éhthe Common Ruleh‚Ƃ͂ǂ̂悤‚Č‹K’č‚Ĺ‚ ‚é‚Ě‚Š‚đŽŸ‚ĚÍ‚ĹŒŸ“˘‚ˇ‚éB

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@@3@gthe Common Ruleh‚͉˝‚đ–ÚŽw‚ľ‚Ä‚˘‚é‚Ě‚Š

@@ hthe Common Ruleh‚ÍHHS‚̉ş•”‘gD‚Ĺ‚ ‚鍑—§•ŰŒ’Œ¤‹†Š (National Institute of Health: NIH)‚ށA1981”N‚Ƀxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚ÉŠî‚Ă‚˘‚Ч’č‚ł‚ę‚˝45CFR46‹K’č‚Ěˆę•”‚Ĺ‚ ‚é@[’9]B45CFR45‚Ć‚ÍHHS‚ĚŒ ŒŔ”ÍˆÍ‚Ĺ‚Ě‚Ý’Ę—p‚ˇ‚é‹K’č‚Ĺ‚ ‚čA‚ť‚Ěˆę•”(Subpart A)‚Ş1991”N‚ÉHHS‚đŠÜ‚Ţ16‚̐­•{‹@ŠÖ‚Ě‹¤’Ę‹K’č‚Ć‚ľ‚ÄĚ—p‚ł‚ę‚˝‚ą‚Ć‚đŒ_‹@‚Ɂ@[’10]@hthe Common Ruleh‚Ć‚˘‚¤’ĘĚ‚Ć‚Č‚Á‚˝@[’11]B‹K’č‚Ě“ŕ—e‚Ć‚ľ‚āA‘ÎŰ‚Ć‚Č‚éŒ¤‹†‚Ć—áŠO‚Ć‚Č‚éŒ¤‹†‚ɂ‚˘‚āA—pŒę‚Ě’č‹`AŒ¤‹†Œv‰ć‚Ě”FŘ‚ɂ‚˘‚āAIRBˆĎˆő‚̍\ŹAv‘ŹR¸Žč‘ą‚Ťiexpedited review procedurejAIRBR¸‚ĚŠî€‚ĆŽč‘ą‚ŤA‹¤“ŻŒ¤‹†‚ɂ‚˘‚āAƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ɂ‚˘‚āAŒ¤‹†‚Ě’†Ž~A”FŘ‚Ě—áŠO‹K’č‚Č‚Ç‚Ş‹K’č‚ł‚ę‚Ä‚˘‚éB‚ť‚Ě‚¤‚żIRBR¸‚ĆƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ɂ‚˘‚Ä‚Í“Á‚ÉÚ×‚Č‹K’č‚Ş‚ ‚é‚ą‚Ć‚Š‚çA”íŒąŽŇ•ŰŒě­ô‚É‚¨‚˘‚Ä‚ą‚Ě“ń‚‚̎葹‚Ť‚Ş“Á‚ɏdŽ‹‚ł‚ę‚Ä‚˘‚é‚ą‚Ć‚Ş•Ş‚Š‚éB‚ž‚Ş‚ą‚́hCommon Ruleh‚đĹ‚ŕ“Á’Ľ•t‚Ż‚Ä‚˘‚é‚́u˜A–M­•{Ž‘‹ŕ‚ĚŽg“rv(46.122)‚Ĺ‚ ‚éB‚Č‚ş‚Č‚ç‚ą‚Ě×‘Ľ‚ɂ́u‚ą‚̐­ô‚Ě—v‹‚đ–ž‚˝‚ł‚Č‚Š‚Á‚˝ę‡‚ɂ́A”íŒąŽŇŒ¤‹†‚Ě‚˝‚߂ɘA–M­•{Ž‘‹ŕ‚đ—p‚˘‚é‚ą‚Ć‚Í‹–‚ł‚ę‚Č‚˘v‚Ć‹L‚ł‚ę‚Ä‚˘‚é‚˝‚ß‚Ĺ‚ ‚é@[’12]B‚‚܂肹‚̐­ô‚ÍŒ¤‹†Ž‘‹ŕ‚ސ­•{‚đŕŒš‚Ć‚ˇ‚é‚Š”Ű‚Š‚ĹŠÄ“ÂŒ ŒŔ‚ŞˆŮ‚Č‚é‚Ě‚Ĺ‚ ‚éB

@@ ‚ą‚ą‚Š‚ç‚́hThe Common Ruleh‚É‚¨‚Ż‚éd—v€–ځAIRBR¸‚ĆƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ɂ‚˘‚ÄŒŸ“˘‚ˇ‚éB‚Ü‚¸ gThe@Common@Ruleh‚Ě’č‹`‚ˇ‚éu”íŒąŽŇv‚Ć‚ÍŽŔŒą‚ÉŽQ‰Á‚ˇ‚éŒÂl‚̐g‘Ě‚ž‚Ż‚Ĺ‚Í‚Č‚­AuŒ¤‹†ŽŇ‚Ş’˛¸‚Ě‘ÎŰ‚Ć‚ľ‚Ä‚˘‚鐜‚Ť‚˝ŒÂl‚Ě‚ą‚Ć‚đŽw‚ľA‚Š‚ÂŽŔŒą‚ÉŽQ‰Á‚ˇ‚éŒÂl‚Ö‚ĚŠąÂ‚â‘ŠŒÝ‚Ě‚â‚čŽć‚č‚Ě’†‚Ĺ“ž‚˝î•ńA‚ˇ‚Č‚í‚żŒÂl‚̐gŒł‚đ“Á’č‚Ĺ‚Ť‚éî•ń(identifiable private information)‚ŕŠÜ‚ށv‚Ć‹L‚ł‚ę‚Ä‚˘‚é@[’13]B‚ł‚ç‚ÉŒ¤‹†ŽŇ‚Ş‹L˜^‚đ—\‚ľ‚Ä‚˘‚Č‚˘‚Ć‚ą‚ë‚Ĺ‚ĚŒÂl‚̍s“Ž‚âA“–‰‚Š‚ço”Ĺ‚â”­•\‚đˆÓ}‚ľ‚Ä‚˘‚Č‚˘î•ń‚ɂ‚˘‚Ä‚ŕŠÜ‚Ü‚ę‚éB‚ą‚̂悤‚Ɂu”íŒąŽŇv‚ĚŠT”O‚́AlŠi‚╨Žż“Ió‹ľ‚ž‚Ż‚Ĺ‚Í‚Č‚­As“Ž‚⌞“Ž‚Š‚ç“ž‚ç‚ę‚éî•ń‚Ü‚Ĺ‚ŕŠÜ‚ß‚˝L‚˘ŠT”O‚Ĺ‚ ‚é‚ą‚Ć‚Ş‚í‚Š‚éB‚Č‚ş‚Č‚ç‚ť‚ę‚ÍŒ¤‹†Œ‹‰Ę‚ĚŒö•\‚É‚ć‚Á‚Ä”íŒąŽŇ‚É—^‚Ś‚¤‚é“ńŽŸ“I‚ȉe‹ż‚ŕl—ś‚ľ‚Ä‚˘‚é‚˝‚ß‚Ĺ‚ ‚éBŽŸ‚ɁuŒ¤‹†v(Research)‚Ě’č‹`‚É‚ć‚é‚ƁuŽŔ—p‰ť‚ˇ‚é‚˝‚ß‚ĚŽŽŒą‚â•]‰ż‚đŠÜ‚ß‚˝‘ĚŒn“I’˛¸‚Ĺ‚ ‚čAˆę”ʉť‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚é’mŽŻ(generalizable knowledge)‚Ö‚ĚvŒŁ‚ŞŒŠ’Ę‚ł‚ę‚Ä‚˘‚鎖v‚Ş•K—v‚Ć‚ł‚ę‚Ä‚˘‚éB‚‚܂čuŒ¤‹†v‚Ƃ́A‚ ‚é’mŽŻ‚Ě••Ő‰ť‚ÉŠń—^‚ˇ‚鐏‰Ę‚đŠl“ž‚ˇ‚邤‚Ś‚Ĺ‚Ě‡—“I‚Č— ‚Ă‚Ż‚Ć‚˘‚¤ˆĘ’u•t‚Ż‚Ş‚Č‚ł‚ę‚Ä‚˘‚éB‚ą‚̂悤‚ɐ­ô‚Ě‘ÎŰ‚đŽŚ‚ˇu”íŒąŽŇvuŒ¤‹†v‚Ć‚˘‚¤ŠT”O‚͍L”Í‚Č’č‹`‚ĹŽŚ‚ł‚ę‚Ä‚¨‚čA‚ą‚¤‚ľ‚˝ŠT”O‚ސ­ô‚́uŠg’Łv‚đ—eˆŐ‚É‚ľ‚˝‰“ˆö‚Ĺ‚Í‚Č‚˘‚Š‚ƍl‚Ś‚ç‚ę‚éB

@@ ŽŸ‚Ɂu­ô‚Ě“K—p”͈́v(45CFR46.101)‚ć‚ę‚΁AIRBR¸‚đ–Əœ‚ˇ‚鍀–Ú‚Ş‹L‚ł‚ę‚Ä‚˘‚éB‚ЂƂ‚߂͋łˆç‚đ–Ú“I‚Ć‚ľ‚˝”íŒąŽŇŒ¤‹†‚Ĺ‚ ‚éB‚ą‚ę‚ÍŒ¤‹†‚Ě–Ú“I‚Ş’mŽŻ‚Ěˆę”ʉť‚Ĺ‚Í‚Č‚­AŠwś‚␜“k‚Ě’mŽŻE‹Zp‚ĚŒüă‚đ–Ú“I‚ĆŒŠ‚Č‚ł‚ę‚Ä‚˘‚é‚Š‚ç‚Ĺ‚ ‚éB‚˝‚ž‚ľ‹łˆç‚đ–Ú“I‚Ć‚ˇ‚錤‹†‚Ĺ‚ ‚Á‚Ä‚ŕAŒÂlî•ń‚âgŒł‚đ“Á’č‚Ĺ‚Ť‚éî•ńA‚Ü‚˝‚͌l‚ŞŽĐ‰ď“IE”Ćß“IEŒoĎ“IEŒŮ—pE•]”ť‚ÉŠÖ‚ľ‚Ä•s—˜‰v‚É‚Č‚č‚Š‚Ë‚Č‚˘î•ń‚đˆľ‚¤‚Ć‚Ť‚ɂ́A‚˝‚Ć‚Ś‹łˆç–Ú“I‚Ĺ‚ ‚Á‚Ä‚ŕR¸‘ÎŰ‚Ć‚Č‚éBŽŸ‚ɐgŒł‚đ“Á’č‚Ĺ‚Ť‚Č‚˘î•ń‚âAˆę”Ę‚É“üŽč‰Â”\‚Č•ś‘E‹L˜^E•a—•W–{Ef’f•W–{‚ŕR¸‚Ě‘ÎŰŠO‚Ć‚ł‚ę‚Ä‚˘‚éB‚Ü‚˝Œ¤‹†Ź‰Ę‚ŞŠú‘Ň‚Ĺ‚ŤA‚Š‚ŠŻŒö’Ą‚Ě’ˇ‚Ş”F’č‚ľ‚˝Œö‰vŤ‚̍‚‚˘’˛¸‚âƒfƒ‚ƒ“ƒXƒgƒŒ[ƒVƒ‡ƒ“‚â’†“ŐŤ‚Ş‚Č‚­AFDA‚âŠÖ˜A‹@ŠÖ‚É‚ć‚Á‚ĈŔ‘S‚ŞŠm”F‚ł‚ę‚Ä‚˘‚éHŢ‚ōě‚ç‚ę‚˝H•i‚đ—p‚˘‚˝Á”ďŽŇi”íŒąŽŇj‚ĚšnDŽŔŒą‚â–{l‚ŞŽó‚Ż“ü‚ę‚Ä‚˘‚é’˛¸‚ŕ‘Ώ۩O‚Ĺ‚ ‚é@[’14]B‚ą‚̂悤‚É”íŒąŽŇ‚̐gŒł‚đ“Á’č‚Ĺ‚Ť‚Č‚˘î•ńA‹łˆç‚Č‚Ç’mŽŻ‚Ěˆę”ʉť‚đ”O“Ş‚É‚¨‚˘‚Ä‚˘‚Č‚˘’˛¸A‚Ť‚í‚ß‚ÄŠëŒŻŤ‚̒ႢŒ¤‹†A‘ź‚̐­•{‹@ŠÖ‚Ş”F’č‚ľ‚˝Œ¤‹†‚Č‚Ç‚ŞR¸‚Ě—áŠO‚Ć‚ł‚ę‚Ä‚˘‚é‚ą‚Ć‚Ş‚í‚Š‚éB

@@ gThe@Common@Ruleh‚Ě‚Č‚Š‚ĹŒö‰vŤ‚͏d—v‚ČŠT”O‚Ĺ‚ ‚éB‚Č‚ş‚Č‚ç‚ť‚ę‚Şu•Ö‰vv(benefit(s))‚Ć‚˘‚¤ŠT”O‚ɏW–ń‚ł‚ę‚Ä‚˘‚é‚Š‚ç‚Ĺ‚ ‚éBuIRB‚Ě”FŘŠî€v(46.111‚¨‚ć‚Ń46.102(i))‚Ć‚˘‚¤×‘Ľ‚ł́uƒŠƒXƒN‚đĹŹ‰ťv‚Ć‚˘‚¤€–Ú‚É‚¨‚˘‚āuƒŠƒXƒNv(Risks)‚Ɓu•Ö‰vv‚ƑΔ䂳‚š‚é•ű–@‚ŏq‚ׂç‚ę‚Ä‚˘‚éB‚ť‚ę‚É‚ć‚é‚ƁAƒŠƒXƒN‚Ć•Ö‰v‚Ć‚Ě•]‰ż‚Í”íŒąŽŇ‚ŞŒ¤‹†Œă‚ÉŸTÇó‚Č‚Ç’ˇŠú‚É‚í‚˝‚鐸_“IƒŠƒXƒN‚𕉂¤‰Â”\Ť‚ŕl—ś‚É“ü‚ę‚Č‚Ş‚çƒŠƒXƒN‚đĹŹŒŔ‚É•Ű‚żA‚Š‚‡—“I‚ÉŠú‘Ň‚ł‚ę‚錤‹†‚̐Ź‰Ę‚É‚ć‚Á‚Ä“ž‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éˆę”ʉť‰Â”\‚Č’mŽŻ‚Ş‚Ç‚ę‚ž‚Żd—v‚Č‚ŕ‚Ě‚Ĺ‚ ‚é‚Š‚Ć‚˘‚¤•]‰ż‚ƁA‰Â”\‚ČŒŔ‚č”íŒąŽŇ‚Ö•Ö‰v‚Ć‚đŠ¨ˆÄ‚ľ‚Ä•]‰ż‚ł‚ę‚é‚ׂŤ‚ž‚ƍl‚Ś‚ç‚ę‚Ä‚˘‚é@[’15]B]‚Á‚āuƒŠƒXƒN‚̍ŏŹ‰ťv‚́u’˛¸‚É‚¨‚˘‚Ä—\Šú‚ł‚ę‚éŠëŠQ‚Ć•s‰őŠ´‚ĚŒŠž‚Ý(probabilities)‚Ć‚ť‚Ě‘ĺ‚Ť‚ł(magnitude)‚ށA¸_“IE“÷‘Ě“IƒeƒXƒg‚â’˛¸‚ĚŽč‘ą‚Ť‚đ‹s‚ˇ‚é‰ß’ö‚É‚¨‚˘‚Ä“úíśŠˆ‚Ĺ’Ęí‘˜‹ö‚ˇ‚é‚Ů‚Ç‚É‚Í‘ĺ‚Ť‚­‚Č‚˘‚ą‚Ɓv‚Ć’č‚ß‚ç‚ę‚Ä‚˘‚éB‚Ü‚˝‘—§‰ČŠwŕ’c (The National Science Foundation: NSF)‚̉đŽß‚É‚ć‚é‚ƁAƒŠƒXƒNŠT”O‚ސś‚ś‚錊ž‚Ý‚Ć‘ĺ‚Ť‚ł‚Ć‚Í–žŠm‚É•Ş‚Ż‚čl‚Ś‚ç‚ę‚é‚ׂŤ‚Ĺ‚ ‚čA”­ś‚ˇ‚錊ž‚Ý‚Ş‚‚­‚Ć‚ŕŠëŠQ‚ޏŹ‚ł‚˘ę‡‚͒჊ƒXƒN‚ž‚Ć‚Ý‚Č‚ł‚ę‚Ä‚˘‚é@[’16]B‚ą‚̂悤‚ɃŠƒXƒN‚ĚŠT”O‚Í”íŒąŽŇ‚Ě“÷‘̂␸_‚ÉŠëŠQ(harm)‚đ‰Á‚Ś‚é‚Ć‚˘‚¤‚ž‚Ż‚Ĺ‚Í‚Č‚­A•s‰őŠ´E•sˆŔ(discomfort)‚Ć‚˘‚¤L‹`‚ĚŠëŠQ‚ŕŠÜ‚Ü‚ę‚Ä‚˘‚éB‹K’č‚Ě‚Č‚Š‚Ĺ‚Í–žŠm‚ÉŽŚ‚ł‚ę‚Ä‚˘‚é‚í‚Ż‚Ĺ‚Í‚Č‚˘‚ށA‚ą‚ę‚ç‚Ě‹K’č‚Š‚ç•Ö‰v‚Ć‚ÍŒ¤‹†‚̐Ź‰Ę‚Š‚獇—“I‚ÉŠú‘Ň‚Ĺ‚Ť‚éˆę”ʉť‚ˇ‚é‚ą‚Ć‚Ě‚Ĺ‚Ť‚é’mŽŻ‚ĚŠl“ž‚đˆÓ–Ą‚ľAƒŠƒXƒN‚Ć‚Í”íŒąŽŇ‚Ş”í‚é‚ŕ‚Ě‚Ĺ‚ ‚čA‚ť‚ę‚đĹŹŒŔ‚É—Ż‚ß‚é‚ą‚Ć‚Ş”íŒąŽŇ•ŰŒě‚Ě–Ú“I‚Ć‚ľ‚Ä‚˘‚é‚ą‚Ć‚Ş‚í‚Š‚éB

@@ hthe Common ruleh‚É‚ÍIRB‚Ě–đŠ„‚âR¸Šî€‚ɂ‚˘‚ÄĹ’áŒŔ“x…Žç‚ł‚ę‚é‚ׂŤ‹K’č‚ŞŽŚ‚ł‚ę‚Ä‚˘‚éBIRB‚Í‚ą‚ę‚ç‚Ě‹K’č‚đ…Žç‚ľ‚Č‚Ş‚ç“ĆŽŠ‚Ě‹K’č‚đěŹ‚ľA”íŒąŽŇŒ¤‹†‚ĚŒv‰ć‚đ’čŠú“I‚ɐR¸‚ľ‚Ä‚˘‚éB“úí“I‚ÉIRB‚ޏˆ—‚ˇ‚é”C–ą‚Í–c‘ĺ‚Ĺ‚ ‚éB‹łˆőAŠwśA‘ĺŠw‰@ś‚Č‚Ç‚ť‚ĚŽ{Ý‚ÉŠÖ˜A‚ˇ‚錤‹†ŽŇ‚Ş”íŒąŽŇŒ¤‹†‚đ‚ˇ‚éę‡‚É‚Í‚Ů‚Ú‚ˇ‚ׂĂސR¸‚Ě‘ÎŰ‚Ć‚Č‚éB‚Ü‚˝ˆę“x”FŘ‚ľ‚˝Œ¤‹†‚Ĺ‚ ‚Á‚Ä‚ŕA“ŕ—e•ĎX‚̐R¸‚⌤‹†‚ސ””N‚É‚í‚˝‚éę‡‚É‚Í”NŽŸ•ń‚đ’ńo‚ľ‚čĐR¸‚đŽó‚Ż‚Č‚Ż‚ę‚΂Ȃç‚Č‚˘BIRB‚ÍŒv‰ć”FŘ‚̍ŏI“I‚ČŒˆ’čŒ ‚đŽ‚Â‚Ć“ŻŽž‚ɐӔC‚ŕ’S‚Á‚Ä‚˘‚é@[’17]B‚ť‚Ě‚Ů‚Š‚É‚ŕIRB‚É‚Í—\Šú‚š‚ʏd‘ĺ‚ČŽ–‘Ô‚â—v‹Ž–€‚ɍ‡’v‚ľ‚Ä‚˘‚Č‚˘‚ą‚Ć‚Ş”ť–ž‚ľ‚˝Ű‚Ě”FŘ‚ĚŽć‚艺‚°‚⌤‹†‚Ě’âŽ~–˝—߁AŒ¤‹†Œv‰ćŽŇ‚âŠÖŒW‚ˇ‚鐭•{‹@ŠÖ‚Ö‚Ě•ńAŠÖ˜A•ś‘‚Ě‹L˜^E•Ű‘ś‚Č‚Ç‘˝Šň‚É‚í‚˝‚é”C–ą‚Ş‰Ű‚š‚ç‚ę‚Ä‚˘‚éB‚ł‚ç‚ÉIRBˆĎˆő‚̍\Ź‚É‚ŕÚ×‚Č‹K’č‚Ş‚ ‚éB‚ť‚Ě–Ú“I‚ÍˆĎˆő‚̐ę–ĺ’mŽŻ‚âŽĐ‰ď“I—§ę‚Ɂu•Î‚čv‚Ş‚Č‚˘lˆő”z’u‚đ‹‚ß‚é‚ą‚ƂŐR¸‚́uŒö•˝Ťv‚đŘ‚ˇ‚éˆÓ}‚đ”`‚¤‚ą‚Ć‚Ş‚Ĺ‚Ť‚é@[’18]B

@@ ‚ą‚¤‚ľ‚˝IRB‚Ě”C–ą‚đŒyŒ¸‚ˇ‚é‚ą‚ƂƁA\ż‚Č‚Ç‚ĚŽč‘ą‚Ť‚đŠČ‘f‰ť‚ˇ‚é‚˝‚߂ɐv‘ŹR¸Žč‘ą‚Ť(Expedited review procedures)‚ŞÝ‚Ż‚ç‚ę‚Ä‚˘‚é@[’19]B‚ą‚ĚŽč‘ą‚Ť‚́A‰ß‹Ž‚ÉIRB‚Ě”FŘ‚đŽó‚Ż‚˝Œ¤‹†Œv‰ć‚âAĹŹŒŔ‚ĚƒŠƒXƒN‚ľ‚Š—\Šú‚Ĺ‚Ť‚Č‚˘Œv‰ćA”NŽŸ‚ĚŒp‘ąR¸‚É‚¨‚˘‚ĉߔN“x‚ĚŒv‰ć‚Ć”äŠr‚ľ‚Ä‘ĺ‚Ť‚Č•ĎX“_‚Ş‚Č‚˘Œv‰ć‚đ‘ÎŰ‚Ć‚ľ‚āAR¸‚đŠČ—މť‚ˇ‚鐧“x‚Ĺ‚ ‚éB‹ď‘Ě“I‚É‚ÍIRBˆĎˆő’ˇ‚Ü‚˝‚ÍˆĎˆő’ˇ‚É”C–˝‚ł‚ę‚˝”l‚ĚIRBˆĎˆő‚É‚ć‚éR¸‚đIRB‘S‘̂ŐR¸‚ł‚ę‚˝‚ŕ‚Ě‚Ć‚Ý‚Č‚ł‚ę‚éB‚ą‚̐v‘ŹR¸Žč‘ą‚Ť‚𕁋y‚ł‚š‚é‚˝‚ß‚É‚˘‚­‚‚Š‚ĚIRB‚Ĺ‚Í‹ď‘Ě“I‚ČŽč‘ą‚Ť‚Ě•ű–@‚âA‰ß‹Ž‚É”FŘ‚đŽó‚Ż‚˝Œ¤‹†“ŕ—e‚đƒf[ƒ^ƒx[ƒX‰ť‚ľ‚ăEƒFƒuă‚ĹŒöŠJ‚ľ‚Ä‚˘‚é@[’20]B

@@ ”íŒąŽŇŽŔŒąŒv‰ć‚Ě‚Č‚Š‚ĹƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ĚŽŔŽ{‚Ş•K{‚ĚđŒ‚Ć‚ł‚ę‚Ä‚˘‚é@[’21]B‚ť‚ľ‚Ä”íŒąŽŇ‚ĚŽŠ”­“I“ŻˆÓ‚đ‚Ć‚č‚‚Ż‚é‚˝‚߂́u“KŘ‚ȁvî•ń’ń‹Ÿ‚ɂ‚˘‚čׂŠ‚­’č‚ß‚ç‚ę‚Ä‚˘‚éB‚ť‚Ě–Ú“I‚́u“KŘ‚ȁvƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ć‚˘‚¤Žč‘ą‚Ť‚đĚ‚é‚ą‚Ć‚É‚ć‚Á‚āA”íŒąŽŇ‚ĚŽŠŒČŒˆ’č‚Ş‚ť‚ĚŒ¤‹†‚ƐR¸‚̐ł“–Ť‚đŠî‘b•t‚Ż‚é‚˝‚ß‚Ĺ‚ ‚éB‹K’č‚É‚ć‚é‚ƁA”íŒąŽŇ‚É’ń‹Ÿ‚ł‚ę‚é‚ׂŤî•ń‚Ć‚ľ‚āA’˛¸‚Ě–Ú“IA”íŒąŽŇ‚đS‘Š‚ˇ‚é’˛¸‚ĚŽžŠÔA’˛¸‚ĚŽč‘ą‚ŤA—\‘Ş‚ł‚ę‚郊ƒXƒN‚â•s‰őŠ´A”íŒąŽŇ‚Ö‚Ě•Ö‰v‚⌤‹†‚Š‚çŠú‘Ň‚Ĺ‚Ť‚鐏‰ĘA”íŒąŽŇ‚É—L—˜‚Ć‚Č‚éŽč‘ą‚Ť‚âŽć‚čˆľ‚˘ŕ–žA‹L˜^”͈́AŽż–â“ŕ—e‚Č‚Ç‚Ş–ž‹L‚ł‚ę‚Ä‚˘‚éB‚ť‚ľ‚Ä‚ą‚ę‚ç‚̏î•ń‚đŕ–ž‚ˇ‚é‚ą‚ƁA“ŻˆÓ‚đŽć‚č•t‚Ż‚é‚ą‚Ć‚đ‚ˇ‚×‚Ä•ś‘‰ť‚ˇ‚é‚ą‚Ć‚Ş‹`–ą•t‚Ż‚ç‚ę‚Ä‚˘‚éB‚˝‚Ć‚Ś‚΍בĽ‚ɂ悤‚é‚ƁA”íŒąŽŇ–{l‚Ü‚˝‚Í–@“I‚Č‘ă•\ŽŇ‚̏–ź‚É‚ć‚é“ŻˆÓ‚đ•śÍ‚ĹŠm”F‚ľA‚ť‚Ě•ĄŽĘ‚đ–ź‚ľ‚˝“–Ž–ŽŇ‚É‚ŕ“n‚ł‚Š‚Ë‚ę‚΂Ȃ炸A‚Ü‚˝–ź‚ɐ旧‚Âŕ–ž‚đ•śÍ‰ť‚ľ‚˝Ž‘—ż‚Ĺ”íŒąŽŇ‚É“Ç‚Ţ‹@‰ď‚đ—^‚ŚAŒű“Ş‚Ĺ‚ŕŠČ—Ş‚Éŕ–ž‚ľ‚Č‚Ż‚ę‚΂Ȃç‚Č‚˘‚ĆŽŚ‚ł‚ę‚Ä‚˘‚é@[’22]B

@@ ‚ą‚̐­ô‚Ě45CFR46‹K’č‚É‚ÍSubpart A(gthe Common Ruleh)‚ž‚Ż‚Ĺ‚Í‚Č‚­ASubpartB,C,D‚Ć‚˘‚¤“Á—á‚ŞÝ‚Ż‚ç‚ę‚Ä‚˘‚éB‚ť‚Ě“Á—áu‚‚Ť‚₡‚˘lXvh vulnerable people h‚Ć‚Í•ž–đŽúA‘ŮŽ™AVśŽ™AŽq‹ŸA”D•w‚Č‚Ç‚đˆÓ–Ą‚ˇ‚éB‚˝‚Ć‚Ś‚Εž–đŽú‚Ě—§ę‚É‚ ‚é‚ŕ‚̂͐^‚ÉŽŠ”­“I‚Ĺ”ń‹­§“I‚ČŒˆ’f‚đ‰ş‚š‚Č‚˘‰Â”\Ť‚Ş‚ ‚čA‚ť‚Ě‚˝‚ߒljÁ“I‚Č•ŰŒě‚Ş•K—v‚Ĺ‚ ‚é‚Ć‚ą‚Ć‚Č‚Ç‚Şq‚ׂç‚ę‚Ä‚˘‚é@[’23]Bćq‚ľ‚˝‚悤‚É‚ą‚̐­ô‚Ĺ‚Í”íŒąŽŇ‚ĚŽŠ”­“I‚Č“ŻˆÓ‚đĹd—vŽ‹‚ľ‚Ä‚˘‚āA‚ť‚̉„’ˇă‚Ć‚ľ‚Ä‚ą‚¤‚ľ‚˝lX‚ĚŽŠ”­Ť‚É‚Í“Á•Ę‚Č”z—ś‚Ş•K—v‚Ĺ‚ ‚é‚ĆŒŠ‚Č‚ł‚ę‚Ä‚˘‚é‚Ć‚˘‚Ś‚é@[’24]B

@@ ‚ą‚̂悤‚Ɂhthe Common Ruleh‚ÍIRB‚̐R¸§“x‚đ’Ę‚ś‚Ä”íŒąŽŇ•ŰŒě‚đ•ŰŘ‚ľ‚Ä‚˘‚éB‚ť‚ĚŽč‘ą‚Ť‚Ć‚ľ‚ÄŒ¤‹†‚̉ߒö‚␏‰Ę‚Ĺ‘z’č‚ł‚ę‚郊ƒXƒNE•Ö‰v‚đ•]‰ż‚ˇ‚é‚ą‚ƁAu“KŘv‚ČƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚É‚ć‚鎊”­“I‚Č“ŻˆÓ‚đ‚Ć‚č‚‚Ż‚é‚ą‚ƁAu‚‚Ť‚₡‚˘lXv‚ɑ΂ˇ‚é”z—ś‚đs‚¤‚ą‚Ć‚Ş‹‚ß‚ç‚ę‚Ä‚˘‚é‚Ě‚Ĺ‚ ‚éBƒAƒƒŠƒJ”íŒąŽŇ•ŰŒě­ô‚É‚¨‚Ż‚é‚ą‚¤‚ľ‚˝uŒ¤‹†—Ď—Ł‚Ě˜g‘g‚Ý‚Í6Í‚ĹŽć‚čă‚°‚éƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚đ“ĽP‚ľ‚Ä‚˘‚éBŽŸÍ‚ł͎Љď‰ČŠwŒn‚ĚŠwp’c‘Ě‚Ş‚ą‚Ě‹K§‚ɂǂ̂悤‚Č”˝‰ž‚đŽŚ‚ľ‚˝‚Ě‚Š‚đŒŸ“˘‚ˇ‚éB

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@@4@”íŒąŽŇ•ŰŒě­ô‚đuŠg’Łv‚ˇ‚é‚ą‚Ƃ͎Љď‰ČŠw‚ĚŠw–â‚ĚŽŠ—R‚đNŠQ‚ˇ‚é‚Ě‚Š@]AAUPƒŒƒ|[ƒg‚Š‚ç‚Ě–â‘č’ń‹N

@@ 2001”NH‚ÉAAUP‚́uƒqƒg”íŒąŽŇ‚Ě•ŰŒě]IRBR¸§“x‚ƎЉď‰ČŠwŒ¤‹†v‚Ć‚˘‚¤•ń‘‚đ‚Ü‚Ć‚ß‚˝@[’25]B–`“Ş‚ĹĐ‰î‚ľ‚˝‚悤‚ɁA‚ą‚ę‚͎Љď‰ČŠwŒn‚Ě‚UŠwp’c‘Ě‚Ş”íŒąŽŇ•ŰŒě­ô‚ɑ΂ˇ‚é‘Ô“x•\–ž‚đ‚ľ‚˝•ń‚Ĺ‚ ‚éB‚ť‚Ě—vŽ|‚́AŒťs‚̐­ô‚ސś•¨ˆăŠwŒ¤‹†‚đ‹K§‚ˇ‚é‚ą‚Ć‚đ”O“ނɍě‚ç‚ę‚˝‚ŕ‚Ě‚Ĺ‚ ‚čAŽĐ‰ď‰ČŠwŒ¤‹†‚É‚ť‚Ě‚Ü‚Ü“K—p‚ˇ‚é‚ą‚Ć‚Í•s“K“–‚Ĺ‚ ‚é‚ą‚ƁB‚Ü‚˝‚ą‚Ě‹K’č‚É‚ć‚Á‚ÄŠw–â‚ĚŽŠ—R‚ސNŠQ‚ł‚ę‚Š‚Ë‚Č‚˘‚Ć‚˘‚¤”ᔝ“I‚ČŽĺ’Ł‚Ɛ­ô‚ɑ΂ˇ‚é’ńˆÄ‚ޏq‚ׂç‚ę‚˝B

@@ AAUP‚Í2000”Nt‚ɎЉď‰ČŠwŒnŒ¤‹†ŽŇ‚Ö‚Ě•ˇ‚ŤŽć‚č’˛¸‚đs‚Á‚Ä‚˘‚éB•ń‘‚Ĺ‚Í‚ť‚Ě’˛¸Œ‹‰Ę‚ÉŠî‚Ă‚˘‚āA§“x‚ɑ΂ˇ‚é–â‘č’ń‹N‚ޏq‚ׂç‚ę‚Ä‚˘‚éB‚ť‚ę‚É‚ć‚é‚Ɛś•¨ˆăŠw‚Ě”íŒąŽŇŒ¤‹†‚É‚¨‚Ż‚éIRBR¸‚Ć”äŠr‚ľ‚āAŽĐ‰ď‰ČŠw‚ĚŒ¤‹†R¸‚Ĺ‚ÍIRBR¸‰ß’ö‚Ě’˜‚ľ‚˘’x‘؁A’˛¸‚âŒűq—đŽjŽ‘—ż‚đ‹K’č‚ÉĆ‰ď‚ˇ‚é‚ł‚˘‚ĚIRB‘¤‚ĚŒë‰đAIRBˆĎˆő‚̎Љď‰ČŠw‚ɂ‚˘‚Ä‚Ě’mŽŻ•s‘Ť‚Č‚Ç‚Ş‹“‚°‚ç‚ę‚Ä‚˘‚éB‚Ü‚˝”íŒąŽŇ‚ւ́uƒŠƒXƒN‚̍ŏŹ‰ťv‚̉đŽß‚đ„‚é–â‘č‚ɂ‚˘‚āA“úíśŠˆ‚Ĺ’Ęí‘˜‹ö‚ˇ‚é’ö“x‚̐S”zA•s‰őŠ´A‚Ü‚˛‚‚Ť‚Ć‚˘‚Á‚˝’ö“x‚ĚƒŠƒXƒN‚ŞŽĐ‰ď‰ČŠwŒ¤‹†‚Ě”íŒąŽŇ‚Ć‚Č‚é‚ą‚Ć‚Ĺ‘ĚŒą‚ˇ‚é‰Â”\Ť‚Ş‚ ‚é‚ą‚Ƃ͔ےč‚Ĺ‚Ť‚Č‚˘B‚ľ‚Š‚ľ‚ť‚ę‚͐ś•¨ˆăŠwŒ¤‹†‚̐l‘ĚŽŔŒą‚Ĺ‘z’č‚ľ‚Ä‚˘‚é”íŒąŽŇ‚â“Á‚ɢ‚‚Ť‚₡‚˘lXŁ‚É—^‚Ś‚é‰Â”\Ť‚Ş‚ ‚éuƒŠƒXƒNv‚Ć‚Í‹ć•Ę‚ľ‚čl‚Ś‚é‚ׂŤ‚ž‚Ć‚˘‚¤Žĺ’Ł‚Ĺ‚ ‚éB

@@ •ń‘‚É‚ć‚é‚ĆƒŠƒXƒNE•Ö‰v•]‰żAƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒgAv‘ŹR¸Žč‘ą‚ŤAIRBˆĎˆő‚̍\ŹAIRB‚Ö‚Ě•s•ž\—§‚Ä‚Ě‹@‰ď‚ɂ‚˘‚āhthe Common Ruleh‚Ş‘z’股‚éŠT”O‚ƎЉď‰ČŠwŒ¤‹†‚ĚŽŔî‚Ć‚Ě‚ ‚˘‚ž‚ɐś‚ś‚Ä‚˘‚éę’ę—‚đŽw“E‚ľ‚Ä‚˘‚éB‚ť‚ľ‚Ä•ń‘‚ĚĹŒă‚É‚ÍIRB§“xEŽĐ‰ď‰ČŠw‚ĚŒ¤‹†ŽŇEIRBˆĎˆő‚ť‚ę‚ź‚ę‚ÉŒü‚Ż‚ç‚ę‚˝u’ńŒžv(Recommendations)‚Ş•t‚ł‚ę‚Ä‚˘‚éB‚ť‚ę‚É‚ć‚é‚Ɛ§“xŽŠ‘̂ɂ‚˘‚ÄIRB‚Ě‹­—Í‚ČŒ ŒŔ‚ɈӋ`\—§‚Ä‚đ‚ˇ‚é‹@‰ď‚đÝ‚Ż‚é‚ą‚ƁAŒ¤‹†‹@ŠÖ‚ÉŽĺ“ąŒ ‚đŽ‚˝‚š‚ÄŒ¤‹†ŽŇ‚ĚŒ —˜‚ŕ‚Ü‚˝•ŰŒě‚ˇ‚é‚ą‚ƁAŒ¤‹†Œv‰ć‚ށuv‘ŹR¸v‚âuR¸‚Ě—áŠOv‚ÉŠY“–‚ˇ‚é‚Š‚Ç‚¤‚Š‚Ě”ť’f‚Č‚ÇIRBR¸‚đĄˆČă‚É“IŠm‚Š‚v‘Ź‚ɍs‚¤‚ą‚ƁA‚ť‚ľ‚ÄIRB‚ޘ_“_‚Ć‚ľ‚Ä‚˘‚é‚ą‚Ƃ𖞊m‚É‚ˇ‚é‚˝‚ß‚ÉŒ¤‹†ŽŇ‚ÉŒü‚Ż‚˝î•ń‚ĚŒöŠJ‚đĎ‹É“I‚ɍs‚¤‚ą‚ƂȂǂ̉ü‘P—v‹‚ޏq‚ׂç‚ę‚Ä‚˘‚éBŽĐ‰ď‰ČŠw‚ĚŒ¤‹†ŽŇ‚ÉŒü‚Ż‚˝’ńŒž‚É‚ÍŠw–â‚ĚŽŠ—R‚Ö‚ĚŠëœœ‚Ć‚˘‚¤ŒťÝ‚Ěó‹ľ‚đ‘ź‚ĚŒ¤‹†ŽŇ‚Ć‹¤—L‚ľ‚ÄŠel‚ސş‚đ‚ ‚°‚é‚ׂŤ‚Ĺ‚ ‚é‚ą‚ƁAIRBˆĎˆő‚ɑ΂ľ‚Ä‚Í‘O—á‚Ě‚Č‚˘”íŒąŽŇŒ¤‹†Œv‰ć‚É‚¨‚Ż‚éÓ”C‚̏ŠÝ‚âAŽĐ‰ď‰ČŠw‚ĚŒ¤‹†Œv‰ć‚ސR¸–Əœ‚Ć‚ˇ‚锝’f‚đŠw•”“–‹Ç‚Ć˜b‚ľ‡‚¤‚ׂŤ‚ž‚Əq‚ׂâ‚éBĹŒă‚É‘ĺŠw“–‹Ç‚ŕ‚Ü‚˝Œ¤‹†Œv‰ć‚Ěƒf[ƒ^ƒx[ƒX‰ť‚đi‚߂āAŒ¤‹†ŽŇ‚âŠwś‚ސR¸‚Ě•K—v‚ɉž‚ś‚ÄŽQĆ‚Ĺ‚Ť‚éŽd‘g‚Ý‚đě‚é‚ą‚Ć‚ĹŒťs‚̐§“x‚đŽĐ‰ď‰ČŠwŒ¤‹†‚É“K‡‚ˇ‚é‘̐§ě‚č‚đ‚ˇ‚×‚Ť‚ž‚ą‚Ć‚đ—v‹‚ľ‚Ä‚˘‚éB

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@@5@IRB”­ƒEƒFƒuƒTƒCƒg‚É‚ć‚éî•ń’ń‹Ÿ‚ĚŽŽ‚Ý

@@ ‚ą‚ę‚Ü‚Ĺq‚ׂĂŤ‚˝‹K§‚â–â‘č’ń‹N‚đ“Ľ‚Ü‚Ś‚āAƒAƒƒŠƒJ‚ĚŠeŒ¤‹†‹@ŠÖ‚â‘˝‚­‚Ě‘ĺŠw‚Ĺ‚ÍIRBę—p‚ĚƒEƒFƒuƒTƒCƒg‚đŠJÝ‚ľ‚Ä‚¨‚čA“ĆŽŠ‹K’č‚âgthe Common Ruleh‚Ö‚ĚƒŠƒ“ƒN‚Č‚Ç•K—vĹŹŒŔ‚̏î•ń‚Í•”ŠOŽŇ‚Ĺ‚ŕ‰{——‚Ĺ‚Ť‚é‚悤‚ɏî•ń”­M‚ľ‚Ä‚˘‚éB‚˝‚ž‚ľƒCƒ“ƒ^[ƒlƒbƒgă‚ĹŒöŠJ‚ł‚ę‚Ä‚˘‚éî•ń‚â•ű–@A‚‚܂č‘ĺŠw‚ރEƒFƒuƒTƒCƒg‚É‚Š‚Ż‚éˆÓ‹Cž‚Ý‚É‚Í’ö“xˇ‚Ş‘ĺ‚Ť‚˘‚Ě‚ŕŠm‚Š‚Ĺ‚ ‚éB

@@ ‘OÍ‚ĹŽć‚čă‚°‚˝AAUP‚Ě•ń‘‚É‚ć‚é‚ƁAƒAƒƒŠƒJ‘“ŕ‚Ĺ4000ƒ–ŠˆČă‚ ‚éIRB‚Ě‚¤‚żAIRB“ĆŽŠ‚Ě‹K’č–ń4•Ş‚Ě3‚É‚¨‚˘‚Ä•Ş–ě‚⌤‹†Ž‘‹ŕ‚̏oŠ‚ÉŒŔ‚炸‚ ‚ç‚ä‚é”íŒąŽŇŒ¤‹†‚ŞIRBR¸‘ÎŰ‚É‚Ä‚˘‚éB‚Ü‚˝‘ĺŠw‚É‚ć‚Á‚Ä‚Í•Ą‘w“I‚ȐR¸‹@ŠÖ(IRBs)‚đÝ‚ŻAŽŔŽż“I‚ȐR‹c‚đ‚ˇ‚éŹˆĎˆő‰ď(Panel)‚Ć‚ť‚Ě•ń‚đŽó‚Ż‚é‹łŽö‰ď‚âŠw•”’ˇ‰ďA‚ť‚ľ‚ÄŠw“ŕ§“x‘S”Ę‚Ě‹K’č‚ƐR¸‚̍ŏI“I‚ČŒˆ‹c‹@ŠÖ‚Ĺ‚ ‚闝Ž–‰ď‚Č‚Ç‚É–đŠ„‚đ•ŞŠ„‚ľ‚Ä‚˘‚é‹K’č‚ŕ‚ ‚éB‚ą‚Ě‚Ů‚Š‚É‚ŕ•úŽËŤ•¨Žż‚ĚˆŔ‘SŤ(Radiological Safety)Aś•¨ŠwŒ¤‹†‚ĚˆŔ‘SŤ(Biosafety)A—˜ŠQ‘Η§(Conflict of Interest‚“)‚ɂ‚˘‚Ä‚ÍIRB“ĆŽŠ‚Ě”ť’f‚Ĺ‚Í‚Č‚­AŠw“ŕ‚Ě‘ź‚ĚˆĎˆő‰ď‚Ć˜AŒg‚ľ‚Ä‹Ś‹c‚ˇ‚é‚ą‚Ć‚Ş’č‚ß‚ç‚ę‚Ä‚˘‚é‚ŕ‚Ě‚ŕ‚ ‚éB2000”N6ŒŽ‚É‚Í‚m‚hH‚Ş’źÚs‚¤‚Š‚Ü‚˝‚ÍŒ¤‹†Ž‘‹ŕ‚ĚŽx‰‡‚đ‚ľ‚˝”íŒąŽŇŒ¤‹†‚đ‘ÎŰ‚Ć‚ľ‚āA‚ť‚ĚŒ¤‹†‚ÉŒg‚í‚錤‹†ŽŇ‘Sˆő‚ɐ­ô‚Ɛ§“xă‚ĚŽč‘ą‚Ť‚ɂ‚˘‚Ä‚Ě‹łˆç‚đ‹`–ą•t‚Ż‚˝B‚ą‚Ě‹łˆçƒvƒƒOƒ‰ƒ€‚Í“–‰NIH‚ɐR¸‚̐\ż‚đ‚ˇ‚éŒ¤‹†‚ÉŒŔ‚ç‚ę‚˝‚ŕ‚Ě‚Ĺ‚ ‚Á‚˝B‚ľ‚Š‚ľĄ“ú‚Ĺ‚ÍFWA”FŘ‚ĚđŒ‚É‘g‚ݍž‚Ü‚ę‚Ä‚¨‚čAIRB“ĆŽŠ‚Ě‹K’č‚É‚ŕĚ—p‚ł‚ęŽn‚ß‚Ä‚˘‚éB‚ť‚ľ‚ĐR¸‹K’č‚ĹŒ¤‹†ŽŇ‘Sˆő‚É‹łˆç‹`–ą‚đ‰Ű‚ľ‚Ä‚˘‚éIRB‚ł́A­ô‚Ě“ŕ—e‚â”wŒi‚đŠw‚Ô‚˝‚ß‚Ěƒ`ƒ…[ƒgƒŠƒAƒ‹ŽŽ‚Ě‹łŢ‚đƒEƒFƒuă‚É—pˆÓ‚ľ‚āAŠm”FƒeƒXƒg‚ɍ‡Ši‚ˇ‚é‚ą‚Ć‚đR¸\ż‚ĚđŒ‚Ć‚ľ‚Ä‚˘‚é‚ŕ‚Ě‚ŕ­‚Č‚­‚Č‚˘@[’26]B‚Ü‚˝‚ą‚¤‚ľ‚˝‚ą‚̂悤‚Č‹łŢŠJ”­‚É”MS‚Č‘ĺŠw‚Ĺ‚ÍŠJ”­‚ľ‚˝‹łŢ‚đ‘ź‘ĺŠw‚ɔ̔„‚ľ‚Ä‚˘‚é‘gD‚ŕ‚ ‚é@[’27]BIRB‚É‚Í”FŘ‚đŽó‚Ż‚˝Šwś‚ĚŒ¤‹†Œv‰ć‚đƒf[ƒ^ƒx[ƒX‰ť‚ľ‚˝‚čŠÖ˜A‚ˇ‚éƒjƒ…[ƒX‚đŒfÚ‚ˇ‚é‚Č‚Ç‚Ěî•ńŒöŠJ‚đ‚ˇ‚ˇ‚ß‚Ä‚˘‚éƒTƒCƒg‚ŕ‚ ‚éBƒf[ƒ^ƒx[ƒX‰ť‚ÍNIH‚ŕi‚ß‚Ä‚¨‚čA”FŘĎ‚Ý‚ĚˆăŠwŒn”íŒąŽŇŒ¤‹†‚ĚŠT—v‚âÓ”CŽŇ‚Č‚Ç‚ŞŒöŠJ‚ł‚ę‚Ä‚˘‚é@[’28]B

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@@6@­ô‚Í”íŒąŽŇ‚đ•ŰŒě‚ˇ‚éu–h”g’çv‚Ć‚Č‚č‚Ś‚˝‚Ě‚Š@[’29]

@@ ŒRˆă‘ŠÄStewart‚Ş1966”N‚É‹L‚ľ‚˝Šo‘‚É‚ÍNIH‚đŠÜ‚ߌöO‰qś‹Ç (Public Health Services: PHS)‚ĚŽ‘‹ŕŽx‰‡‚đŽó‚Ż‚Ä‚˘‚錤‹†‚ɂ‚˘‚āA”íŒąŽŇ‚Ě•ŰŒě‚Ş”z—ś‚ł‚ę‚Ä‚˘‚銈“Ž‚Ĺ‚ ‚é‚ą‚Ć‚đŒö“I‚É”FŘ‚ˇ‚é•K—v‚Ş‚ ‚é‚Ć‚˘‚¤“ŕ—e‚ޏq‚ׂç‚ę‚Ä‚˘‚˝@[’30]B‚ą‚Ě’ńˆÄ‚đŽó‚Ż‚Ä”íŒąŽŇŒ¤‹†Žş(The Office of Human Subjects Research: OHSR)‚ÍHH‚r‚Ě‘Og‚Ĺ‚ ‚éDHEW(Department of Health, Education and Welfare)‚ĚŒ ŒŔ”͈͓ŕ‚ÉŒŔ’č‚ľ‚Ä”íŒąŽŇ•ŰŒě‚đ–Ú“I‚Ć‚ľ‚˝­ô‚𐧒肾‚˝@[’31]B‚ą‚ę‚Ş”íŒąŽŇ•ŰŒě­ô‚Ě‚Í‚ś‚Ü‚č‚Ĺ‚ ‚éB‚ł‚ç‚Ƀ^ƒXƒL[ƒMŒ¤‹†(1972)‚Ş”­Šo‚ˇ‚é‚ƁA‚ť‚̑Ήžô‚Ć‚ľ‚č‘‰ĆŒ¤‹†‹K§–@(the National Research Act)‚ސ§’č‚ł‚ę‚˝@[’32]B

@@ ‚ą‚ĚÍ‚Ĺ‚Í”íŒąŽŇ•ŰŒě­ô‚ĚŒoˆÜ‚ɂ‚˘‚ÄŠTŠĎ‚ˇ‚éBĄ“ú‚̐­ô‚Ě‘ĺ‚Ť‚Č“]‹@‚Í1979”N‚Ěƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚ĚŒö•\‚Ĺ‚ ‚éB‚Ü‚˝‚ą‚̐­ô‚Ě‘ÎŰ‚ŞˆăŠwEś•¨Šw‚Š‚çl•śĽŽĐ‰ď‰ČŠwŒ¤‹†‚ÉŠg‘ĺ‚ł‚ę‚˝“]‹@‚Ć‚ľ‚Ä1999”N‚Ć2000”N‚É‹N‚Ť‚˝2Œ‚Ě”íŒąŽŇŽ€–SŽ–Œ‚đŽć‚čă‚°‚éB‚Í‚ś‚ß‚É‚ą‚̐­ô‚̏‰Šú‚̐Ź—§‰ß’ö‚đ’H‚é‚˝‚߂ɁAl‘ĚŽŔŒą‚ÉŠÖ‚ˇ‚éŽć‚čŒˆ‚ß‚Ş‚Í‚ś‚߂č‘Ű“I‚É”FŽŻ‚ł‚ę‚˝ƒjƒ…ƒ‹ƒ“ƒxƒ‹ƒNEƒR[ƒh(1947)‚Š‚猟“˘‚đŽn‚ß‚éB

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6.1@”íŒąŽŇ‚Ć‚ľ‚Ắu‚‚Ť‚₡‚˘lXv

@@ ‘ć“ńŽŸ˘ŠE‘ĺíIŒ‹ŒăAƒjƒ…ƒ‹ƒ“ƒxƒ‹ƒO‘ŰŒRŽ––@’ě(1946)‚É‚¨‚˘‚ăAƒƒŠƒJŒR‚̓iƒ`ƒX‚ĹŽw“ą“I‚Č—§ę‚É‚ ‚Á‚˝‰ČŠwŽŇ‚ĆˆăŽt23l‚đ”­‚ľ‚˝B‚ť‚ĚŒ‹‰ĘA—Lß16–źA‹ÉŒY7–ź‚Ě”ťŒˆ‚މş‚ł‚ę‚˝B‚ť‚̍ߏó‚Í‹­§Žű—eŠ‚ōs‚í‚ę‚˝l‘ĚŽŔŒą‚ɑ΂ľ‚Đ푈”Ćß‚Ćl“šă‚̍ß(war crimes and crimes against humanity)‚đŞ‹’‚Ć‚ľ‚˝@[’33]B—‚”NAƒAƒƒŠƒJ‚Ě”ťŽ–‚ç‚͐l‘ĚŽŔŒą‚ÉŠÖ‚ˇ‚鏉‚ß‚Ä‚Ě‘Ű“I‚ČŽć‚čŒˆ‚ß‚Ĺ‚ ‚éƒjƒ…ƒ‹ƒ“ƒxƒ‹ƒNEƒR[ƒh (the Nuremberg Code)‚đěŹ‚ľ‚˝@[’34]BŽŔ‚É‘O”N‚Ě”ťŒˆŽž“_‚܂ł͐l‘ĚŽŔŒą‚̍‘Ű“I‚Č‹K’č‚Í‘śÝ‚ľ‚Ä‚˘‚Č‚Š‚Á‚˝‚Ě‚Ĺ‚ ‚éB‚ą‚Ě‹K’č‚͐l‘ĚŽŔŒą‚đ‚ˇ‚éŒ¤‹†ŽŇ‚ޏ…Žç‚ˇ‚ׂŤ10€–Ú‚ĚŽwj‚Š‚ç\Ź‚ł‚ę‚Ä‚¨‚čAŽŔŒą‚ÉŰ‚ľ‚Ä”íŒąŽŇ‚ĚŽŠ”­“I‚Č“ŻˆÓ(The voluntary consent of the human subject)‚Ş•s‰ÂŒ‡‚Ĺ‚ ‚é‚ą‚Ć‚Ş‹­’˛‚ł‚ę‚Ä‚˘‚é@[’35]B‚ť‚ľ‚Ä‚ť‚Ě•ű–@˜_‚Ć‚ľ‚Ä”íŒąŽŇ‚ɏ\•Ş‚Č’mŽŻ‚Ć—‰đ‚Ş•K—v‚Ĺ‚ ‚é‚ą‚Ć‚ŞŽŚ‚ł‚ę‚Ä‚˘‚éB‚ą‚ę‚͍Ą“ú‚ĚƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚̐ć‹ě‚Ć‚˘‚Ś‚é@[’36]B

@@ 1940”N‚Š‚ç50”N‘ă‚É‚Š‚Ż‚ăAƒƒŠƒJl—ŢŠw‰ď‚âS—Šw‰ď‚ȂǎЉď‰ČŠwŒn‚ĚŠw‰ď‚Ĺ‚ÍŒ¤‹†“ŕ—e‚â•ű–@‚đ“ĆŽŠ‚É‹K§‚ˇ‚é‹K’č‚ŞěŹ‚ł‚ę‚˝B‚ą‚ę‚̓tƒB[ƒ‹ƒhƒ[ƒNEƒCƒ“ƒ^ƒ”ƒ…[’˛¸E—Տ°ŽŔŒą‚Č‚Ç‚Ě”íŒąŽŇŒ¤‹†‚Ě’~Ď‚đ‚ŕ‚Ć‚É‚ľ‚ÄŒ¤‹†ŽŇ‚ލl—ś‚ˇ‚ׂŤŽ–•ż‚đ‚Ü‚Ć‚ß‚˝ŽŠŽĺ‹K§‚Ĺ‚ ‚éB‚ť‚ľ‚Ä‘˝”‚̎Љď‰ČŠwŽŇ‚ŞŠÖ—^‚ľ‚˝ƒLƒƒƒƒƒbƒgŒv‰ć(the Project Camelot)‚Ş1965”N‘OŒă‚É”­Šo‚ľA‘S•Ä‚Š‚ç”ń“ď‚𗁂тé‚ƁAŠwp’c‘Ě‚ÍŽŠŽĺ‹K§˜Hü‚đ‹ł‰ť‚ľ‚˝@[’38]B‚Ü‚˝ś•¨ˆăŠw•Ş–ě‚ł͐­•{‚𒆐S‚Ć‚ľ‚˝–@§‰ť‚ސi‚ß‚ç‚ę‚˝B1950”N‘ă‚É•\–ʉť‚ľ‚˝ƒTƒŠƒhƒ}ƒCƒhŽ–Œ@[’39]@‚đŽó‚Ż‚āA1962”N‚ɂ́uH•iA–ň•i‚¨‚ć‚щťĎ•i‚ÉŠÖ‚ˇ‚é–@—Ľv‚̉ü’čˆÄ‚Ĺ‚ ‚éƒL[ƒtƒH[ƒ”ƒ@[Cłđ€(Kefauver Amendments)‚މŒˆ‚ł‚ę‚˝B‚ą‚Ě–@‰üł‚É‚ć‚Á‚Đť–ň‰ďŽĐ‚ŞŽŠŽĐť•i‚đ”Ě”„‚ˇ‚é‘O‚ÉŒř—Í‚ĆˆŔ‘SŤ‚ɂ‚˘‚Ă̐H•iˆă–ň•i‹Ç (Food and Drug Administration: FDA)”FŘ‚đ‹`–ą•t‚Ż‚ç‚ę‚é‚ą‚Ć‚Ć‚Č‚Á‚˝B1964”N‚ɂ͐˘ŠEˆăŽt‰ď(World Medical Association: WMA)‚Ş”íŒąŽŇ‚ĚŠÖ—^‚ˇ‚éˆăŠwś•¨ŠwŽŔŒą‚ĚŽwj‚đ”­•\‚ľ‚˝B‚ť‚ľ‚Ä‚ť‚ĚŽwj‚Í1975”N‚Ěƒwƒ‹ƒVƒ“ƒL‘ĺ‰ď‚ĹŠe‘‚ÉĚ‘đ‚ł‚ę‚˝‚Ě‚ĹĄ“úƒwƒ‹ƒVƒ“ƒLéŒž(the Declaration of Helsinki)‚ĆŒÄ‚Î‚ę‚Ä‚˘‚é@[’40]B‚ą‚ĚéŒž‚̓jƒ…ƒ‹ƒ“ƒxƒ‹ƒNEƒR[ƒh‚đ“ĽP‚ľ‚āAƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚̐§“x‰ť‚đ‹­‰ť‚ˇ‚é‚ŕ‚Ě‚Ĺ‚ ‚Á‚˝B‚ą‚¤‚ľ‚˝ŽŠŽĺ‹K§‚â–@§‰ť‚Ě”wŒi‚ɂ͐l‘ĚŽŔŒą‚É‚ć‚Á‚Ä‘˝‚­‚Ě”íŒąŽŇ‚đo‚ľ‚˝Ž–Œ‚ɑ΂ˇ‚é”ᔝ‚Ş‚ ‚éB

@@ 1946”N‚Š‚ç1956”N‚É‚Š‚Ż‚āAƒn[ƒ”ƒ@[ƒh‘ĺŠw‚Ćƒ}ƒTƒ`ƒ…[ƒZƒbƒcH‰Č‘ĺŠw‚ĚŒ¤‹†ˆő‚̓}ƒTƒ`ƒ…[ƒZƒbƒcB‚Ě‚ ‚éŠwZ‚É‚¨‚˘‚ÄŽ™“ś‚đ”íŒąŽŇ‚Ć‚ľ‚˝•úŽËü‚̐l‘ĚŽŔŒą‚đs‚Á‚˝B‚ť‚Ě–Ú“I‚͐l‘Ě‚ĚÁ‰ť”\—Í‚đŒ¤‹†‚ˇ‚é‚ą‚Ć‚É‚ ‚čAŒ¤‹†ŽŇ‚Í“S‚âƒJƒ‹ƒVƒEƒ€‚Ě•úŽËŤ“ŻˆĘ‘Ě‚đŹ“ü‚ľ‚˝‹“ű‚đ19l‚̏­”N‚É—^‚Ś‚Ä’˛¸‚đs‚Á‚˝B­”N‚˝‚ż‚ÉŒ¤‹†‚Ě“ŕ—e‚â–Ú“I‚Íŕ–ž‚ł‚ę‚Ä‚¨‚炸A”Ţ‚ç‚͉ȊwƒNƒ‰ƒu‚É‹Ś—Í‚ľ‚Ä‚˘‚é‚‚ŕ‚č‚Ĺ‚˘‚˝‚Ć‚˘‚¤Ž–Œ‚Ş”­Šo‚ľ‚˝B

@@ ƒ~ƒ‹ƒOƒ‰ƒ€(Milgram Study)Œ¤‹†‚Í1963”N‚ɍs‚í‚ę‚˝“d‹CŽhŒƒ‚É‚ć‚él‘ĚŽŔŒą‚Ĺ‚ ‚éBŹŃ•sU‚̏W’c‚đ”íŒąŽŇ‚Ć‚ľ‚āA”Ţ‚ç‚É“d‹CƒVƒ‡ƒbƒN‚É‚ć‚Á‚Ä‹L‰Ż—Í‚Ş‚ć‚­‚Č‚é‚ƐM‚śž‚Ü‚š‚˝‚¤‚Ś‚ĹŽŔŒą‚ލs‚í‚ę‚˝B‚ž‚ŞŽŔŰ‚Ě–Ú“I‚ÍŒ ˆĐ‚Ö‚Ě]‘Ž‚đŠm‚Š‚ß‚éS—“I‚ČŽŔŒą‚Ĺ‚ ‚Á‚˝BŽŔŒą‚Ĺ‚ÍŽŔŰ‚ÉŽhŒƒ‚đ—^‚Ś‚Ä‚˘‚Č‚˘‚É‚ŕ‚Š‚Š‚í‚炸A‹C‚đŽ¸‚¤”íŒąŽŇ‚Ş‚ ‚ç‚í‚ę‚˝B‚ą‚¤‚ľ‚˝ŽŔŒą‚É‚ć‚Á‚Đ[‚ȐS—“I—}ˆł‚Ş—^‚Ś‚é‰e‹ż‚ɂ‚˘‚Ă̐Ź‰Ę‚Ş‚ŕ‚˝‚ç‚ł‚ę‚˝BŽŔŒąŒăA”íŒąŽŇ‚Š‚ç‚Ě•ˇ‚ŤŽć‚č’˛¸‚É‚ć‚é‚ƁA‘˝‚­‚Ě”íŒąŽŇ‚ÍŽŔŒą‚ɍDˆÓ“I‚ž‚Á‚˝B‚ľ‚Š‚ľ‚ť‚ĚŒăA”íŒąŽŇ‚É•¨—“I‚ČŽŔŠQ‚đ‰Á‚Ś‚Č‚˘‚Ć‚ľ‚Ä‚ŕAƒCƒ“ƒtƒH[ƒ€ƒhƒRƒ“ƒZƒ“ƒg‚𔺂í‚Č‚˘”íŒąŽŇŒ¤‹†‚ĚŽč–@‚ɂ‚˘‚Ä•¨‹c‚đ‚Š‚ŕ‚ľ‚˝B

@@ ƒEƒBƒ[ƒuƒ‹ƒbƒN(Willowbrook)Œ¤‹†‚́A1960”N‘ă’†{‚Š‚ç1970”N‚Ě‚Í‚ś‚ß‚˛‚ë‚Ü‚Ĺƒjƒ…[ƒˆ[ƒNBƒEƒBƒ[ƒuƒ‹ƒbƒN‚É‚ ‚鐸_”–ŽăŽ™“ś‚đ”íŒąŽŇ‚Ć‚ľ‚čs‚í‚ę‚˝l‘ĚŽŔŒą‚Ĺ‚ ‚é@[’41]B‚ť‚Ě–Ú“I‚͊̉Š‚ĚŠ´ő—Í‚ĆƒÁ]ƒ}ƒOƒƒuƒŠƒ“‚Ě—LŒřŤ‚ɂ‚˘‚ÄŒ¤‹†‚ˇ‚é‚ą‚Ć‚É‚ ‚Á‚˝BŠĚ‰ŠŠ´őŽŇ‚Ě”r•Ö‚Š‚ç’Šo‚ľ‚˝¸ť•¨‚ސ¸_”–ŽăŽ™“ś‚É—^‚Ś‚ç‚ę‚˝‚˝‚߁A”Ţ‚ç‚͑ϐŤ‚Ě‹­‚˘ƒEƒCƒ‹ƒX‚ÉŠ´ő‚ľ‚˝BŒ¤‹†ŽŇ‚ç‚Í‚ą‚ĚŽŔŒą‚đ‰B•Á‚ľ‚‚ÂŻ‚˝B”íŒąŽŇ‚Ě•ŰŒěŽŇ‚ɑ΂ľ‚ÄŽq‹Ÿ‚đŠĚ‰Š‚Ě•a“‚É“ü‚ę‚é‚ą‚Ć‚đ‹‘‚ń‚ž‚΂ ‚˘‚ɂ͏B—§¸_•a‰@‚Ö‚Ě“ü‰@‚đ‹–‰Â‚ľ‚Č‚˘‚Ć‚˘‚¤đŒ‚đ‚‚ŻuŒű••‚śv‚đ‚Í‚Š‚Á‚˝B‚Ü‚˝‹ß—ׂ̊wZ‹łˆő‚ŞŠĚ‰Š‚ÉŠ´ő‚ľ‚˝‚ą‚Ć‚Ş”­‚ł‚ę‚é‚ƁAŒ¤‹†ŽŇ‚ç‚Í”ń‰qś“I‚Ȋ‹Ť‰ş‚Ĺ‹N‚Ť‚˝ŽŠ‘R”­ś“I‚ČŠ´ő‚Ć‚ľ‚ÄŽ–Œ‚đ‰B•Á‚ľ‚˝B‚ť‚ľ‚Ä‚ą‚̍”­ˆČŒăAŒ¤‹†ŽŇ‚ç‚ÍŽŔŒą‚É‚¨‚Ż‚é‰qśŠÂ‹Ť‚ɍאS‚Ě’ˆÓ‚đ•Ľ‚¤‚ą‚Ć‚Ş\‚ľ‡‚í‚š‚˝‚˝‚߁AŽüˆÍ‚Ö‚ĚŠ´ő‚ÍŒ¸­‚ľ‚˝B

@@ 1932”N‚Š‚ç1972”N‚Ü‚Ĺ‚É‚Š‚Ż‚Ä‚¨‚ą‚Č‚í‚ę‚˝ƒ^ƒXƒL[ƒM(Tuskeegee)Œ¤‹†‚Ě”­Šo‚͎Љď‚É‘ĺ‚Ť‚ČŐŒ‚‚đ—^‚Ś‚˝@[’42]B‚ą‚ĚŒ¤‹†‚Ĺ‚Í’áŠ“žŽŇ‘w‚ĚƒAƒƒŠƒJ•l’jŤi”~“ĹŠ´őŽŇ399lA”ńŠ´őŽŇ201lAŽĺ‚ɃCƒ“ƒfƒBƒAƒ“‚Ěƒ^ƒXƒL[ƒM‘°‚Ş”íŒąŽŇ‚Ć‚Č‚Á‚˝j‚ވă—ÁCH—żA–„‘’•ŰŒŻ(burial insurance)‚đ–ł—ż‚ĹŽó‚Ż‚ç‚ę‚é‚ą‚Ƃ́uŒŠ‚Š‚Ś‚čv‚Ć‚ľ‚āA”~“ĹŒ¤‹†‚Ě”íŒąŽŇ‚Ć‚ł‚š‚ç‚ę‚˝‚Ě‚Ĺ‚ ‚éBŽŔŒą‚Í”íŒąŽŇ‚Ě”~“ŁA•nŒŒA”ć˜J‚đŽĄ—Ă‚ˇ‚é‚Ć‚˘‚¤ŕ–ž‚Ş‚Č‚ł‚ę‚˝‚ŕ‚̂́AŽŔŰ‚É‚Í“KŘ‚ČŽĄ—Ă‚ÍŽ{‚ł‚ꂸ‚É•aó‚ĚŒo‰ßŠĎŽ@‚ލs‚í‚ę‚˝B‚ť‚ľ‚ăyƒjƒVƒŠƒ“‚Ş”­ŒŠ(1943)‚ł‚ę‚˝Œă‚஡—Ă‚Í•ú’u‚ł‚ę‘ą‚Ż‚˝BX‚ÉŐŒ‚‚đ—^‚Ś‚˝‚Ě‚Í‚ą‚ĚŒ¤‹†‚ސ­•{‹@ŠÖ‚ĚŽx‰‡‚đŽó‚Ż‚Ä‚˘‚˝‚ą‚Ć‚É‚ ‚Á‚˝B‚ą‚ĚŒ¤‹†Œv‰ć‚Í“–‰A”ź”N‚ŏI—š‚ˇ‚é—\’č‚ž‚Á‚˝‚ŞŽŔŰ‚É‚Í40”NŠÔ‚É‚í‚˝‚Á‚ÄŒp‘ą‚ł‚ę‚˝‚Ě‚Ĺ‚ ‚éB

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@@6.2@ƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚ŞŽŚ‚ľ‚˝u3‚‚̊î–{“I‚Č—Ď—v@[’43]

@@ 1972”Nƒ^ƒXƒL[ƒMŒ¤‹†‚ÉŠÖ‚ˇ‚é“ŕ•””­‚É‚ć‚Á‚āA’˛¸‚Ş‚Í‚ś‚ß‚ç‚ę‚˝B‚ť‚Ě—‚”N‚É’ńo‚ł‚ę‚˝’˛¸•ń‘‚É‚ć‚é‚ƁA‰ČŠwŠE‚Ě”­“W‚ɑ΂ľ‚Ȑl‚ĚŒ —˜‚đŽĐ‰ď‘S‘Ě‚ŞŒŠ‰ß‚˛‚ˇ‚ą‚Ć‚Í‚ŕ‚Í‚â‚Ĺ‚Ť‚Č‚˘‚ĆŒ‹˜_•t‚ŻA‚ą‚ĚŒ¤‹†‚đu“š“ż“I•sł‹`v‚Ĺ‚ ‚é‚Ć‚ľ‚Ä”ń“ď‚ľ‚˝B‚ł‚ç‚É‚ą‚ĚŽ–Œ‚đŒ_‹@‚É1974”N‚ɂ͍‘‰ĆŒ¤‹†‹K§–@(the National Research Act)‚ސ§’č‚ł‚ęAÍ‚Ě–`“Ş‚Ć‚č‚ ‚°‚˝OHSR ‚ŞěŹ‚ľ‚˝”íŒąŽŇ•ŰŒě­ô‚ÍDHEW‚̐­ô‚Ć‚ľ‚āuŠiă‚°v‚ł‚ę‚˝B‚ą‚Ě–@—Ľ‚Ĺ‚ÍŒöO‰qś‹ÇiPublic Health Service:@PHSj‚ĚDHEW‚ÉŠÖ‚í‚é”íŒąŽŇ‚ɃCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚đs‚¤‚ą‚Ć‚Ş’č‚ß‚ç‚ę‚é‚Ć‚Ć‚ŕ‚ɁAuś•¨ˆăŠw‚¨‚ć‚эs“ŽŒ¤‹†‚É”ş‚¤”íŒąŽŇ•ŰŒě‚Ě‚˝‚ß‚Ě‘‰ĆˆĎˆő‰ďv‚ŞÝ’u‚ł‚ę‚˝@[’44]B‚ą‚ĚˆĎˆő‰ď‚Í1974”N‚Š‚ç1978”N‚É‚Š‚Ż‚Ч“x‚ĚŠî–{•űj‚ɂ‚˘‚Ä‹c˜_‚¨‚ą‚Č‚˘A1979”N‚Ƀxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg(the Belmont Report)‚đ”­•\‚ľ‚˝B‚Ü‚˝1978”N‚ɂ̓Cƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě‘ÎŰ‚Ş­•{‹@ŠÖ‚ĚŠÖ—^‚ˇ‚é‚ ‚ç‚ä‚é”íŒąŽŇ‚ÉŠg’Ł‚ł‚ę‚˝B

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@@ 1999”N5ŒŽ‚ÉNIH‚ĚŠÇŠ‘gD‚Ĺ”íŒąŽŇ•ŰŒě­ô‚đ’S“–‚ľ‚Ä‚˘‚˝Œ¤‹†ƒŠƒXƒN•ŰŒě‹Ç(the Office for Protection from Research Risks: OPRR)‚̓fƒ…[ƒN‘ĺŠw(Duke Univ.)‚ɑ΂ľ‚Đ­•{‚ĚŒ¤‹†Ž‘‹ŕŽx‰‡‚đ‘S–Ę“I‚É’âŽ~‚ˇ‚é‚Ć”­•\‚ľ‚˝B‚ą‚ę‚ÍOPRR‚Ş‘O”N12ŒŽ‚É“Ż‘ĺŠw‚đ’˛¸‚ľ‚˝Œ‹‰ĘAƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě•ś‘‰ť‚Ş•s“O’ę‚Ĺ‚ ‚é‚ą‚ƁA‘ĺŠw‚Ě“s‡‚ɍ‡‚í‚š‚ĐR¸Žč‡‚Ş•ĎX‚ł‚ę‚Ä‚˘‚é‚ą‚ƁAIRBˆĎˆő‚Ş‹K’č‚Ĺ’č‚ß‚ç‚ę‚Ä‚˘‚él”‚đ–ž‚˝‚ľ‚Ä‚˘‚Č‚˘‹^‚˘‚Ş‚ ‚é‚ą‚Ć‚Č‚ÇIRBR¸‚ĚŒ`Š[‰ť‚Ş”­Šo‚ľ‚˝‚ą‚Ƃɑ΂ˇ‚鐧Ů‘[’u‚ž‚Á‚˝@[’50]B“Ż‘ĺŠw‚Í”NŠÔ–ń‚P‰­7500–œƒhƒ‹‚ĚˆăŠwŒ¤‹†”ď‚đŽó‚Ż‚Ä‚˘‚é‘S•Ä‚Ĺ‚ŕĹ‘勉‚ĚŒ¤‹†Žx‰‡Šz‚Ĺ‚ ‚Á‚˝B

@@ “Ż‚ś”N‚Ě9ŒŽ‚É‹N‚Ť‚˝”íŒąŽŇŽ€–SŽ–Œ‚É‚ć‚Á‚ÄIRB‚ĚŒ`Š[‰ť‚đ‚ł‚ç‚ɈóŰ•t‚Ż‚ç‚ę‚˝B‚ť‚ę‚Í“–Žž18Î‚ž‚Á‚˝Jesse Gelsinger‚ރyƒ“ƒVƒ‹ƒ”ƒFƒjƒA‘ĺŠw(University of Pennsylvania)‚ōs‚í‚ę‚˝ˆâ“`ŽqŽĄ—ĂŽŔŒą’źŒă‚ÉŽ€–S‚ľ‚˝Ž–Œ‚Ĺ‚ ‚é@[’51]BGelsinger‚Í‹H‚ČÇ—á‚ĚŠĚŽžŠłŽŇ‚Ĺ‚ ‚Á‚˝‚ŕ‚̂́A’ź‚ż‚ɐś–˝‚đ‹ş‚Š‚ˇ•aó‚Ĺ‚Í‚Č‚Š‚Á‚˝B‚ť‚ę‚É‚ŕ‚Š‚Š‚í‚炸ˆâ“`ŽqŽŔŒą‚Ě”íŒąŽŇ‚Ć‚Č‚Á‚˝‚̂́A”Ţ‚ŞŽĄ—Ă‹ZpŒüă‚ĚŠń—^‚Ɂu“ŻˆÓv‚ˇ‚é‚˝‚ß‚Ĺ‚ ‚Á‚˝B“Ż‘ĺŠw‚ÍŽ–‘O‚ĚƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚É‚¨‚˘‚āAˆâ“`ŽqŽŔŒą‚É‚ć‚é•›ě—p‚͈Ť‚­o‚˝ę‡‚Ĺ‚ŕŠ´–`‚É—Ţ‚ˇ‚é’›Œó‚Ş‚PTŠÔ‘ą‚­’ö“x‚Ć‚˘‚¤ŒŠ’Ę‚ľ‚Ě‚ŕ‚Ć‚Éŕ–ž‚Ş‚Č‚ł‚ę‚˝B‚Ü‚˝17‚Ě—Ţ—á‚Ĺ‚Í•a“I‚Č•›ě—p‚Í‚Ů‚Ć‚ń‚Ç•ń‚ł‚ę‚Ä‚˘‚Č‚˘‚Ć‚ľ‚Ä‚˘‚˝B‚ľ‚Š‚ľŽŔŒą‚Š‚ç24ŽžŠÔ‚ŕŒo‚˝‚Č‚˘‚¤‚ż‚É•aó‚Í‹}•Ď‚ľ‚˝‚˝‚߁A”ނ͐f—Ă‚đŽó‚Ż‚éŠÔ‚ŕ‚Č‚­‹}Ž€‚ľ‚˝‚Ě‚Ĺ‚ ‚éB‚ą‚ę‚ɑ΂ľ‚ÄFDA‚Í“Ż‘ĺŠw‚ĚŽŔŒą‚𒆎~‚ˇ‚é‚Ć‚Ć‚ŕ‚ɁA˜A–M­•{‚Ě‹K’čˆá”˝‚Ć”íŒąŽŇ‚Ĺ‚ ‚銳ŽŇ‚̐ś–˝‚đ•ŰŒě‚Ĺ‚Ť‚Č‚Š‚Á‚˝‚ą‚Ć‚đ”ń“ď‚ľ‚˝B‚ť‚ľ‚Ä10ŒŽ‚É‚Í’vŽ€ŤE’†“ŐŤ•¨Žż‚ÉŠÖ—^‚ľ‚Č‚˘‚˝‚߂ɐV–ň‚␜‘Ě‚ÉŠÖ˜A‚ˇ‚é–ň‚ÉŒř‰Ę‚đŠm‚Š‚ß‚é•K—v‚Ş‚ ‚é‚Ć‚Ť‚ɂ͐lŠÔ‚đ—p‚˘‚é‚ą‚Ć‚đ—Ď—“I‚É‹ÖŽ~‚ˇ‚é‹K’č‚Şě‚ç‚ę‚˝@[’52]B‚Ü‚˝NIH‚Í‘ź‚ĚŒ¤‹†‹@ŠÖ‚É‚¨‚˘‚Ä‚ŕ1993”NˆČ—ˆ600ŒˆČă‚Ěˆâ“`ŽqŽĄ—Ă‚ĚŽ¸”s—á‚ ‚Á‚˝‚ą‚ƁA‚Ü‚˝‚ť‚Ě•ń‚Ş’x‘Ř‚ľ‚āuĹ‹ßv‚É‚Č‚Á‚Ä“Ż‹Ç‚ŞŽó‚Ż‚Ä‚˘‚˝Ž–ŽŔ‚đ–ž‚ç‚Š‚É‚ľ‚˝BFDA‚Ě’†ŠÔ“š\‚ł́A“Ż—l‚ĚŽč‡‚É‚ć‚Á‚ăTƒ‹‚ŞŽ€–S‚ľ‚Ä‚˘‚˝“Ž•¨ŽŔŒą‚ĚŒ‹‰Ę‚âA‚˝‚Ć‚ŚˆŔ‘S‚ŞŠm”F‚ł‚ę‚Ä‚˘‚˝‚Ć‚ľ‚Ä‚ŕŽŔŒą‚É‚ć‚Á‚ďd‘ĺ‚Č•›ŽŸ“I‚ČŠëŒŻ‚̉”\Ť‚đ”íŒąŽŇ‚É’m‚ç‚š‚é•K—v‚Ş‚ ‚Á‚˝‚Ć‚ľ‚Ä“Ż‘ĺŠw‚ĚƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ş•s“KŘ‚Ĺ‚ ‚é‚ĆŒ‹˜_•t‚Ż‚˝B‚ľ‚Š‚ľ‚ą‚¤‚ľ‚˝î•ń‚đ‘ĺŠw‘¤‚Ş”cˆŹ‚ľ‚Ä‚˘‚Č‚Š‚Á‚˝‚ą‚Ć‚ŞŠeŒ¤‹†‹@ŠÖ‚ĚIRB‚đŠÄ“‚ˇ‚é—§ę‚É‚ ‚éNIH‚âFDA‚̐ӔC‚Ĺ‚ ‚é‚Ć‚ľ‚āAă‰@‚̐ę–ĺˆĎˆő‰ď‚Í‚ą‚Ě–â‘č‚đ‚ł‚ç‚ÉŒ@‚艺‚°‚˝’˛¸‚đŽwŽŚ‚ľ‚˝B–{—ˆ‚ą‚ę‚ç‚Ě‹@ŠÖ‚É‚Í‘ź‚ĚŒ¤‹†‹@ŠÖ‚ōs‚í‚ę‚˝ˆâ“`ŽqŒ¤‹†‚ĚŒ‹‰Ę‚âAŠÖ˜Aî•ń‚đŒ¤‹†ŽŇŠÔ‚Ĺ‹¤—L‚Ĺ‚Ť‚é‚悤‚ɁAĹVî•ń‚Ě’ń‹Ÿ‚Ć‚˘‚¤–đŠ„‚Ş‹`–ą•t‚Ż‚ç‚ę‚Ä‚˘‚˝B‚ľ‚Š‚ľ’˛¸Œ‹‰Ę‚É‚ć‚é‚ĆFDA‚âNIH‚ť‚Ě‚ŕ‚Ě‚Ě‹@”\‚ŞŒ`Š[‰ť‚ľ‚Ä‚˘‚é‚ą‚Ć‚Ş–ž‚ç‚Š‚É‚ł‚ę‚˝‚Ě‚Ĺ‚ ‚éB‚Ü‚˝‚ą‚ĚŽ–Œ‚Ĺ‚Í‚ŕ‚¤‚ЂƂ•ʂ̖â‘č‚ŕ–ž‚é‚݂ɏo‚˝B‚ą‚ĚŒ¤‹†‚Ĺ’†S“I‚Č–đŠ„‚đ‰Ę‚˝‚ľ‚Ä‚˘‚˝Œ¤‹†ŽŇ‚ސś•¨HŠwŠé‹Ć‚đŒo‰c‚ľ‚Ä‚¨‚čA‚ą‚ĚŠé‹Ć‚ĆŒ¤‹†ŽŇA‚Ü‚˝‘ĺŠw‚Ć‚ĚŠÔ‚Ĺ‹ŕ‘K“I‚Č—˜ŠQŠÖŒW‚Ş‚ ‚Á‚˝‚Ć‚˘‚¤Žw“E‚Ş‚Č‚ł‚ę‚˝‚Ě‚Ĺ‚ ‚éB

@@ 2001”N‚ɃWƒ‡ƒ“ƒYEƒzƒvƒLƒ“ƒX‘ĺŠw(Johns Hopkins Univ.) ‚ōs‚í‚ę‚˝šb‘§Œ¤‹†‚Ĺ‚Í”íŒąŽŇRoche‚ރwƒLƒTƒƒgƒjƒEƒ€‚đ‹z“ü‚ł‚š‚ç‚ę‚˝Œă‚ÉŽ€–S‚ľ‚˝@[’53]BŒ’N‘Ě‚Ě”íŒąŽŇ‚Ě”x‚É‘ĺ‚Ť‚Č‘š‚đ—^‚Ś‚˝‚ą‚Ě–ňÜ‚ÍFDA‚Ě”F‰Â‚đ“ž‚Ä‚˘‚Č‚˘Œ€–ň‚Ĺ‚ ‚Á‚˝BOHRP‚͈ăŠwŒ¤‹†Šˆ“Ž‚Ě’†Ž~‚đ–˝—ß‚ľ‚ÄFDA‚Ć‚Ć‚ŕ‚É’˛¸‚ɏć‚čo‚ľ‚˝B‚ť‚ĚŒ‹‰ĘA–ň‚ĚŠëŒŻŤ‚đ\•Ş‚É‹Lq‚ľ‚Ä‚˘‚Č‚˘‚܂܂ɃCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ލs‚í‚ę‚˝‚ą‚ƁA‚ť‚ľ‚Ä‚ť‚ŕ‚ť‚ŕ‚ą‚Ě”íŒąŽŇŒ¤‹†‚đ”FŘ‚ľ‚˝IRB‚̐ӔC‚Ş–â‘莋‚ł‚ę‚˝‚Ě‚Ĺ‚ ‚éBOHRP‚͍Ĕ­–hŽ~ô‚đ‘ĺŠw‘¤‚É‹‚߁A‘ĺŠw“–‹Ç‚Í‚ ‚ç‚ä‚éöÝ“IŠëŒŻŤ‚đ€–Ú‰ť‚ľ‚˝•ś‘‚É‚ć‚éƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ĆIRBˆĎˆő‚ĆŒ¤‹†ŽŇ‚É“O’ę‚ľ‚˝‹łˆç‚đŽ{‚ˇ‚ą‚Ć‚đ”­•\‚ľ‚˝B‚ą‚ę‚ç‚Ě”íŒąŽŇŽ€–SŽ–Œ‚ɑ΂ˇ‚é”ᔝ“I‚Ȋ֐S‚ލ‚‚Ü‚é‚ɂ‚ę‚āAŒťs‚ĚIRB§“x‚ĚŒ`Š[‰ť‚ւ̔ᔝ‚Ɛ§“x‚ť‚Ě‚ŕ‚Ě‚đüV‚ˇ‚ׂŤ‚ž‚Ć‚˘‚¤”FŽŻ‚Ş‹c‰ďA­•{AŒ¤‹†‹@ŠÖ‚Ě‚ ‚˘‚ž‚Ĺ‹¤—L‚ł‚ę‚˝BŽŸ‚ĚÍ‚Ĺ‚Í”‘˝‚­‚̔ᔝ‚Ć’ńˆÄ‚Ć‚Ě‚Č‚Š‚Ĺ”íŒąŽŇ•ŰŒě­ô‚Ş‚Ç‚Ě‚ć‚¤‚ÉŒŠ’ź‚ł‚ę‚˝‚Ě‚ŠA‚Ü‚˝ŽĐ‰ď‰ČŠwŒn‚ĚŠwp’c‘Ě‚Ş§“xŒŠ’ź‚ľ‚ɂǂ̂悤‚Č”˝‰ž‚đŽŚ‚ľ‚˝‚Ě‚Š‚ɂ‚˘‚ÄŒŸ“˘‚ˇ‚éB

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@@7@”íŒąŽŇ•ŰŒě­ô‚͂ǂ̂悤‚ÉŒŠ’ź‚ł‚ę‚˝‚Ě‚Š@[’54]

@@ ‚Ó‚˝‚Â‚Ě”íŒąŽŇŽ€–SŽ–Œ‚É‚ć‚Á‚āAŒťs‚ĚIRBR¸§“x‚Ş”íŒąŽŇ‚Ě•ŰŒě‚Ć‚˘‚¤–Ú“I‚đ‰Ę‚˝‚ľ‚Ä‚˘‚Č‚˘‚ą‚Ć‚Ş–ž‚ç‚Š‚Ć‚Č‚Á‚˝B‚ž‚ސ­•{‹@ŠÖEŠwp‘gDE‹c‰ď‚ÍIRB§“x‚ť‚Ě‚ŕ‚Ě‚Ě—§‚Ä’ź‚ľ‚Ş•K—v‚Ĺ‚ ‚é‚ƍl‚Ś‚Ä‚˘‚˝‚ŕ‚̂́A‚ť‚̉ü‘Pô‚Í•K‚¸‚ľ‚ŕˆę’v‚ľ‚Ä‚˘‚˝‚í‚Ż‚Ĺ‚Í‚Č‚Š‚Á‚˝B‚ą‚ĚÍ‚Ĺ‚Í­•{‚ĚŽ–â‹@ŠÖ‚Ĺ‚ ‚鍑‰Ćś–˝—Ď—Ž–âˆĎˆő‰ď(the National Bioethics Advisory Commission: NBAC)‚ƍ‘‰Ć”íŒąŽŇ•ŰŒě­ôŽ–âˆĎˆő‰ď(the National human Research Protections Advisory Committee: NHRPAC)A”ń­•{‘gD‚Ĺ‚ ‚č7‚‚̊wp’c‘Ě‚ŞÝ—§‚ľ‚˝V‘gD”íŒąŽŇ•ŰŒěŒv‰ć‹Ś‰ď(the Association for the Accreditation of Human Research Protection Programs: AAHRPP @[’55])‚𒆐S‚Ć‚ľ‚Ä”íŒąŽŇ•ŰŒě­ô‚Ě“ŽŒü‚đŒŸ“˘‚ˇ‚éB‚˝‚ž‚ľ‚ą‚ę‚ç‚Ě‹@ŠÖ‚Í‚ť‚ę‚ź‚ę‚ĚŠˆ“Ž•űj‚đŒf‚°‚Ä‚˘‚˝‚ށAIRBR¸§“x‚ĚŒŠ’ź‚ľ‚đ“ĆŽŠ‚ɐi‚ß‚Ä‚Ť‚˝‚Ě‚Ĺ‚Í‚Č‚˘B­•{‚ĚˆĎˆő‰ď‚Ĺ‚ ‚éNHRPAC‚É‚Í”ń­•{‘gD‚Ĺ‚ ‚éŠwp’c‘Ě‚Ě‘ă•\‚đˆĎˆő‚ŞŒ}‚Ś‚ç‚ęA“Ż‚ś‚­”ń­•{‘gD‚ĚAAHRPP‚Í‘Ţ–đŒRlČ(department of Veterans Affairs: VA)‚Ć‹¤“Ż‚ĹIRBR¸‚đs‚Á‚Ä‚˘‚鎖—á‚Ş‚ ‚éBĄ“ú‚Ě”íŒąŽŇ•ŰŒě­ô‚͐­•{Ž–âˆĎˆő‰ď‚Ě“š\AŠwp’c‘Ě‚É‚ć‚é“ĆŽŠ‚Ě’ńŒž‚Ć‹K’čAŠeIRB‚Ě“ĆŽŠ‹K’č‚ĚŽOŽŇ‚Ş‘ŠŒÝ‚ÉŠÖ˜A‚ľ‚Č‚Ş‚çŹ‚č—§‚Á‚Ä‚˘‚é‚ĆŽ„‚͍l‚Ś‚Ä‚˘‚éB‚˝‚ž‚ľ­•{‹@ŠÖ‚Ć”ń­•{‘gD‚Ě‚ ‚˘‚ž‚É‚Í‹Ś’˛ŠÖŒW‚Ş•Ű‚˝‚ę‚Ä‚Ť‚˝‚Ć‚˘‚¤‚ć‚č‚́A­•{Ž–â‹@ŠÖ‚Ě“š\‚ɑ΂ľ‚ĎЉď‰ČŠwŒn‚ĚŠwp’c‘Ě‚ŞˆŮ‹c‚đĽ‚Ś‘ą‚Ż‚Ä‚Ť‚˝‚Ć•\Œť‚ˇ‚é‚Ů‚¤‚Ş“KŘ‚Š‚ŕ‚ľ‚ę‚Č‚˘B‚ą‚¤‚ľ‚˝ŒoˆÜ‚đ‚ą‚Ě•ń‚Ě•\‘č‚ÉŽć‚čă‚°‚˝gFault Lineh i•Ş’füA’f‘wüj‚Ć‚˘‚¤ŠT”O‚ɏW–ń‚Ĺ‚Ť‚éB‚ą‚ĚŒž—t‚͐l‘ĚŽŔŒą‚Ě‹K§‚Š‚çŽn‚Ü‚Á‚˝Œťs‚Ě”íŒąŽŇ•ŰŒě­ô‚đŽĐ‰ď‰ČŠwŒ¤‹†‚É‚ť‚Ě‚Ü‚Ü‚ĚŽč–@‚Ĺ“K—p‚ˇ‚é‚ą‚ƁAś•¨ˆăŠw‚Ě•ś–Ź‚ōě‚ç‚ę‚˝‹K’č‚◝˜_‚đ’Pƒ‚ɎЉď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚ĚŒťę‚É‚ ‚Ă͂߂悤‚Ć‚ˇ‚é‚ą‚Ć‚Ě•s“KŘ‚ł‚đŰ’Ľ‚ľ‚Ä‚˘‚é@[’56]B‚ą‚ĚÍ‚Ĺ‚Í‚ą‚ĚŒž—t‚đƒL[Eƒ[ƒh‚Ć‚ľ‚āA2000”NˆČ~‚̎Љď‰ČŠwŒ¤‹†‚É‚¨‚Ż‚é”íŒąŽŇ•ŰŒě­ô‚ĚŒo‰ß‚đ‚˝‚Ç‚éB

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7.1@”íŒąŽŇŽ€–SŽ–Œ‚ť‚ĚŒă

@@ IRBR¸§“x‚É‚¨‚˘‚Ä–â‘莋‚ł‚ę‚˝‚ą‚Ƃ́A­•{‚É‚ć‚錤‹†Ž‘‹ŕ‚ĚŽx‰‡‚đŽó‚Ż‚Č‚˘”íŒąŽŇŒ¤‹†‚ސ­ô‚́u”˛‚Ż“šv‚Ć‚Č‚Á‚Ä‚˘‚é‚ą‚Ć‚ž‚Á‚˝B‚Ü‚˝‚ť‚Ě‚Ů‚Š‚É‚ŕƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě•ś‘‰ť‚Ş“O’ę‚ł‚ę‚Ä‚˘‚Č‚˘‚ą‚ƁANIH‚âFDA‚Ȃǐ­ô‚đŽĺ“ą‚ˇ‚鐭•{‹@ŠÖ‚Ş‚˘‚­‚Â‚ŕ‚ ‚é‚˝‚߈ęŠŃŤ‚Ş‚Č‚˘‚ą‚Ƃɔᔝ‚ޏW’†‚ľ‚˝B‚ť‚ľ‚ÄIRB§“x‚ĚŒŠ’ź‚ľ‚Ć‹­‰ť‚Ě‚˝‚ß‚É‚Í—\ŽZ‚Ě‘Šz‚Ş•K—v‚Ĺ‚ ‚é‚Ć‚˘‚¤ŒŠ‰đ‚Ş‘ĺ¨‚đč‚ß‚˝@[’57]B2000”N6ŒŽ‚ÉHHS‚Í”íŒąŽŇ•ŰŒě­ô‚ÉŠÖ‚ˇ‚é‹@\‚đ•ŇŹ‚ľ‚Ä”íŒąŽŇŒ¤‹†•ŰŒě‹ÇiOffice for Human Research ProtectionsFOHRPCłŽŽ–ź‚ÍOPRR, Office for Protection from Research Risksj‚đHHS’źŠ‚Ě‹@ŠÖ‚Ć‚ľ‚Ä”­‘Ť‚ľ‚˝@[’58]B‚ą‚ę‚É‚ć‚Á‚ÄHHS‚ÍIRB‚ĚŠÄ“ÂŒ ŒŔ‚â”íŒąŽŇ•ŰŒě­ô‚Ě‘S”ʂɂ‚˘‚ĉ^‰c‚đOHRP‚Ɉę–{‰ť‚ľ‚˝B‚ť‚ę‚Í“ŻŽž‚ɏ]—ˆ‚ą‚̐­ô‚đŠÇŠ‚ľ‚Ä‚˘‚˝HIN‚Ěˆę‹@ŠÖ‚Ĺ‚ ‚éOPRR‚Ě–đŠ„‚ŞuŠiă‚°v‚ł‚ę‚˝‚ą‚Ć‚đˆÓ–Ą‚ˇ‚éB

@@ ‚ą‚¤‚ľ‚˝­•{‹@ŠÖ‚Ě“Ž‚Ť‚Ě‚Ů‚Š‚É2000”N‚Š‚ç2001”N‚É‚Š‚Ż‚ÄIRB§“x‚đŒŠ‚Č‚¨‚ˇ’ńˆÄ‚â•ń‚͘A˝“I‚É‘Ĺ‚żo‚ł‚ę‚˝B2000”N‚ÉHHS‚ĚˆăŠwŒ¤‹†‚ÉŠÖ‚ˇ‚鎐–â‹@ŠÖIOM(Institute of Medicine)‚ĆŒ¤‹†ŽŇ‚É‚ć‚éŠwp‘gDPRIM•R(Public Responsibility in Medicine and Research)‚Í‹¤“Ż‚Ĺ”íŒąŽŇ‚ŞŠÖ—^‚ˇ‚錤‹†‚̐R¸Œv‰ć‚Ě‘ˆÄ‚đ”­•\‚ľ‚˝B‚Ü‚˝“Ż”N6ŒŽ‚ɂ́AƒAƒƒŠƒJ‘ĺŠw‹Ś‰ď(the Association of American Universities: AAU)‚ސći“I‚Č‘ĺŠwŒo‰c‚đŽQl‚ÉŠÄ“ÂŒ ŒŔ‚đ‹­‰ť‚ˇ‚é‚ą‚Ć‚É‚ć‚Á‚āA‘ĺŠw“ŕ‚Ĺ‚ĚŒ¤‹†‚É‚¨‚Ż‚é”íŒąŽŇ•ŰŒě‚đ‚ć‚萄i‚ˇ‚é’ńˆÄ‚đ”­•\‚ľ‚˝@[’59]B‚ť‚Ě‚Č‚Š‚ĹIRBˆĎˆő‚ĆˆăŠwŒ¤‹†ŽŇ‘Sˆő‚ÉŒ¤C‚đ‰Ű‚ˇ‚ą‚ƁA‚ ‚ç‚ä‚é”íŒąŽŇŒ¤‹†‚ÉŽŠ”­“I‚Č”FŘ‚đ‚ŕ‚Ć‚ß‚é‚ą‚ƁA‘ĺŠw‚Ěŕ–žÓ”C‚𖞊m‚É‚ˇ‚é‚˝‚ß‚Ěî•ńŒöŠJ‚Ȃǂɂ‚˘‚ėᎌ‚ł‚ę‚Ä‚˘‚é@[’60]B‚Ü‚˝“Ż”N“ŻŒŽDiana Degotte ,Henry Waxmani‚Ć‚ŕ‚É–ŻŽĺ“}‰ş‰@‹cˆőj,John Micai‹¤˜a“}‰ş‰@‹cˆőj‚ç‚ÍIRB§“x‚ɑ΂ˇ‚é”ᔝ‚̏W‘吏‚Ć‚˘‚˘‚¤‚éu”íŒąŽŇ•ŰŒě–@ˆÄ2000v(the Human Research Subjectsf Protections Act of 2000,H.R.4605)‚đ‹c‰ď‚É’ńo‚ľ‚Ä‚˘‚éB–@ˆÄ‚Ĺ‚ÍŒ¤‹†Ž‘‹ŕ‚̏oŠ‚đ–â‚킸the Common Rule‚đˆă—Ă•Ş–ě‚Ě”íŒąŽŇŒ¤‹†‚É“K—p‚ˇ‚é‚ą‚ƁA‚ť‚Ě‚˝‚߂ɂ̓Cƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě•ś‘‰ť‚đ“O’ę‚ł‚š‚é‚ą‚ƁAÚ×‚ȏî•ń‚Ě’ń‹ŸAIRB§“x—\ŽZ‚ĚŠg[AIRBˆĎˆő‚ĆŒ¤‹†ŽŇ‚Ö‚Ě‹łˆç‚đ‹‚ß‚é‚ą‚Ć‚Ş–@ˆÄ‚ɐˇ‚荾‚Ü‚ę‚˝@[’61]B‚ą‚Ě–@ˆÄ‚É‘S–Ę“I‚ČŽxŽ‚đ•\–ž‚ľ‚˝ˆă‰Č‘ĺŠw‹Ś‰ď(the Association of American Medical Colleges: AAMC)‚Í2001”N1ŒŽ‚Ɂhthe Common Ruleh‚đ‚ ‚ç‚ä‚é”íŒąŽŇŒ¤‹†‚É‘ÎŰ‚đL‚°‚é‚ą‚Ć‚đNBAC‚É’ńŒž‚ľ‚Ä‚˘‚éB‚Ü‚˝“Ż‹Ś‰ď‚̐ę–ĺˆĎˆő‰ď‚͈ăŠwŒ¤‹†‚É‚¨‚Ż‚é‹ŕ‘K“I—˜ŠQ‚ɂ‚˘‚ÄAAU‚Ě’ńŒž‚Ć“Ż—l‚É‹ŕ‘K“I—˜‰v‚𔺂¤Œ¤‹†ŽŇ‚ÍŽŔŒ ‚ɉÁ‚í‚é‚ׂŤ‚Ĺ‚Í‚Č‚­AŠeŒ¤‹†‹@ŠÖ‚ÍŒ¤‹†ŽŇ‚Ş‹ŕ‘K“I—˜ŠQ‚ɉÁ‚í‚é‰Â”\Ť‚đ‚ ‚ç‚ä‚éŠp“x‚Š‚ç–ž‚ç‚Š‚É‚ˇ‚é•K—v‚Ş‚ ‚é‚Əq‚ׂâ‚éB

@@ 2000”N10ŒŽANIH‚Í“Ż‹@ŠÖ‚É”íŒąŽŇŒ¤‹†‚Ě”FŘ‚đ‹‚ß‚éę‡‚ɂ́AŒv‰ć‚ÉŒg‚í‚錤‹†ŽŇ‘Sˆő(key personnel)‚É”íŒąŽŇ•ŰŒě‚ÉŠÖ‚ˇ‚é‹łˆç‚Ş•K—v‚Ĺ‚ ‚é‚Ć‚Ě’Ę’B‚đo‚ľ‚˝B‚‚܂čNIH‚ŞŠÖ—^‚ˇ‚é”íŒąŽŇŒ¤‹†ŽŇ‚͐l‘ĚŽŔŒą‚Ě—đŽj‚â‚ą‚̐­ô‚Ě–Ú“IAR¸‚Ě‘ÎŰ‚É‚Č‚éŒ¤‹†‚ĚŠî€AIRB‚Ě‹@”\‚ƐR¸Žč‘ą‚Ť‚Č‚Ç‚Ě—\”ő’mŽŻ‚đŽ‚Â‹`–ą‚Ş‰Ű‚š‚ç‚ę‚˝@[’63]B

@@ 2001”N‚PŒŽ‚ɃAƒƒŠƒJ‘ĺ“—Ě‚ÉƒuƒbƒVƒ…‚ޏA”C‚ˇ‚é‚ƁAƒNƒŠƒ“ƒgƒ“­Œ ‰ş‚ōs‚í‚ę‚Ä‚˘‚˝45CFR46 ‰ü’ů‚Ě“ŕ—e‚Éˆę•”•ĎX‚މÁ‚Ś‚ç‚ę‚˝BŽĺ‚Č•ĎX“ŕ—e‚Í”D•w‚â‘ŮŽ™‚đ”íŒąŽŇ‚Ć‚ˇ‚é‚ł‚˘‚Éœu“x‚É‚ć‚é“ŻˆÓ(paternal consent)‚Ş‹‚ß‚ç‚ę‚é‚ׂŤ‚Ć‚ˇ‚éđ€‚Ş•t‚Ż‰Á‚Ś‚ç‚ę‚˝@[’64]B“Ż”N”N5ŒŽ‚É‚ÍGAO(General Accounting Office)‚ÍHHS‚ɐ­ô‚̐§“x‰üŠv‚đX‚ɉÁ‘Ź‚ˇ‚é‚ą‚Ć‚đ‹‚ß‚é•ń‘‚đ’ńo‚ľ‚Ä‚˘‚é@[’65]B

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@@7.2 @NBAC(‘‰Ćś–˝—Ď—Ž–âˆĎˆő‰ď)‚É‚ć‚éĹI•ń‘‚ć‚č@[’66]

@@ 1995”N10ŒŽAƒNƒŠƒ“ƒgƒ“‘ĺ“—Ě‚ÍNBAC(‘‰Ćś–˝—Ď—Ž–âˆĎˆő‰ď)‚đŠJ‚˘‚˝@[’67]B‚ą‚ĚˆĎˆő‰ď‚Í”íŒąŽŇ•ŰŒě­ô‚ɂ‚˘‚Ä‚Ě—Ď—“I‰Ű‘č‚ɂ‚˘‚Ä‘ĺ“—́iƒzƒƒCƒgƒnƒEƒXj‚âŠe­•{‹@ŠÖ‚É“š\‚đ‚ˇ‚éŽg–˝‚Ş‚ ‚Á‚˝BˆĎˆő‰ď‚Í2001”N10ŒŽ‚Ě”CŠú–ž—š‚Ü‚Ĺ‚É6‚‚̕ń‘‚Ć’ńŒž‚đ‚Ü‚Ć‚ß‚Ä‚˘‚é@[’68]B1997”N6ŒŽ‚É’ńo‚ł‚ę‚˝•ń‘‚ł́Aˆâ“`Žq‹Zp‚đ‹ěŽg‚ľ‚˝ƒNƒ[ƒ““Ž•¨‚âƒNƒ[ƒ“lŠÔ‚ŞŽć‚čă‚°‚ç‚ę‚Ä‚˘‚éB‚ą‚ę‚Í“Ż‚ś”N‚Ě2ŒŽ‚ɃCƒMƒŠƒXEƒXƒRƒbƒgƒ‰ƒ“ƒh‚ĚƒƒXƒŠƒ“Œ¤‹†Š‚É‚¨‚˘‚āAƒNƒ[ƒ“—rƒhƒŠ[‚Ş’aś‚ľ‚˝‚ą‚Ć‚ÉŒÄ‰ž‚ľ‚āAƒAƒƒŠƒJ­•{‚ލ‘“ŕ‚Ěˆâ“`ŽqŒ¤‹†‚đ‚ǂ̂悤‚É•ń•t‚Ż‚é‚Š‚Ɋ֐S‚ޏW’†‚ľ‚˝‚Ć‚˘‚¤”wŒi‚ލl‚Ś‚ç‚ę‚éB1998”N‚Ě•ń‘‚ł͐¸_áŠQŽŇ‚Ȃǂ́u‚‚Ť‚₡‚˘lXv‚ޘ_“_‚ÉŽćă‚°‚ç‚ęA”íŒąŽŇ‚ĚŽŠŒČŒˆ’č‚Ö‚Ě\•Ş‚Č”z—ś‚ɂ‚˘‚ďq‚ׂç‚ę‚Ä‚˘‚éB‚Ü‚˝1999”N‚Ě2–{‚Ě•ń‘@[’69]@‚Ć2001”N4ŒŽ‚É’ńo‚ł‚ę‚˝•ń‘@[’70]@‚Ĺ‚Í”íŒąŽŇ•ŰŒě‚Ě‚˝‚ß‚É45CFR46‚đ…Žç‚ˇ‚é‚ą‚Ć‚ŞÄ“x‹­’˛‚ł‚ę‚Ä‚˘‚éB‚ą‚ę‚ç‚Ě•ń‚Ĺ‚Í]—ˆ‚ĚŽŔŒąŽş‚Ě’†‚Ě”íŒąŽŇŒ¤‹†‚Š‚çŒťę‚Ĺ‚Ě—Ő°Œ¤‹†‚ցA‚Ü‚˝‘“ŕŒ¤‹†‚Š‚çŠCŠOE‘˝‘ŠÔŒ¤‹†‚Ö‚Ć‚˘‚¤”íŒąŽŇ•ŰŒě‚Ě˜_“_‚̕ωť‚ĆŽžŽ––â‘č‚ւ̑Ήžô‚Ş–â‘č‚Ć‚ľ‚ÄŽć‚čă‚°‚ç‚ę‚Ä‚˘‚é‚ą‚Ć‚Ş‚í‚Š‚éB‚ž‚Ş‚ą‚ę‚ç‚Ě•ń‘‚Ĺ‚Ě”íŒąŽŇ•ŰŒě‚Ƃ͐ś•¨ˆăŠwŒ¤‹†‚Ě–â‘č‚Ć‚ľ‚Ę_‚ś‚ç‚ę‚Ä‚Ť‚˝‚Ě‚Ĺ‚ ‚éB

@@ NBAC‚Í2001”N1ŒŽ‚ɍŏI•ń‘‚Ě‘ˆÄ‚đŽć‚č‚Ü‚Ć‚ß‚˝B“ŻˆĎˆő‰ď‚Í‚ą‚Ě‘ˆÄ‚Ĺ‚Í‚ś‚߂ĎЉď‰ČŠwŒ¤‹†‚É‚¨‚Ż‚é”íŒąŽŇ•ŰŒě‚đŽć‚čă‚°‚Ä‚˘‚é@[’71]B“ŻŒŽAƒAƒƒŠƒJŽĐ‰ďŠw‰ď(American Sociological Association:@ASA)‰ď’ˇFelice J. Levine‚ÍNBACˆĎˆő’ˇHarolf Shapiro‚É‚ą‚Ě‘ˆÄ‚ɑ΂ˇ‚éˆÓŒŠ‘‚đ‘—‚Á‚Ä‚˘‚é@[’72]B‚ť‚ą‚ĹLevine‚Í”íŒąŽŇ•ŰŒě­ô‚ސś•¨ˆăŠwŒ¤‹†‚đ‘z’č‚ľ‚˝‹K§‚Ĺ‚ ‚é‚Ě‚É‚ŕ‚Š‚Š‚í‚炸A‚Č‚şŽĐ‰ď‰ČŠwŒ¤‹†‚É“K—p‚ˇ‚é‚Ě‚ŠA‚Ü‚˝‚ǂ̂悤‚ɐ§“x‚đ‰ü•Ň‚ˇ‚é‚Ě‚Š‚ɂ‚˘‚Ä‚Ěŕ–ž‚đ‹‚ß‚Ä‚˘‚éB‚ť‚ľ‚Ä‚ą‚ĚˆÓŒŠ‘‚Ě‚Č‚Š‚Ĺ”ń­•{‘gD‚Ĺ‚ ‚éŠwp’c‘Ě‚Ě’ńŒž‚â”FŘ§“x‚ɐ­•{‹@ŠÖ‚͐ϋɓI‚ÉŽ¨‚đŒX‚Ż‚é‚ׂŤ‚ž‚ĆŽĺ’Ł‚ľA‚ą‚Ě‘ˆÄ‚Ĺ’ńˆÄ‚ł‚ę‚Ä‚˘‚é“Ć—§Ť‚̍‚‚˘V‘gD(‰źĚthe National Office for Human Research Oversight)‚Ě‘nÝ‚É‚ć‚Á‚āA­ô‚Ş‚ć‚č’†‰›WŒ ‰ť‚ľ‚Ä‚˘‚­‚ą‚Ć‚đŠëœœ‚ľ‚Ä‚˘‚éB‘ˆÄ‚Í—\’č’Ę‚č“Ż”N8ŒŽ‚ɍŏI•ń‘uƒqƒg”íŒąŽŇ‚ŞŠÖ—^‚ˇ‚錤‹†‚Ĺ‚Ě—Ď—‚ĆŽwj‚̏”–â‘čv(gEthical and Policy Issues in Research involving Human Participantsh)‚Ć‚˘‚¤•\‘č‚ĹŒö•\‚ł‚ęANBAC‚Í10ŒŽ‚ɉđŽU‚ľ‚˝B

@@ ĹI•ń‘‚ĹNBAC‚͍‘“ŕ‚Ě”íŒąŽŇ•ŰŒě‚ÉŠÖ‚ˇ‚é‹K’č‚âƒCƒMƒŠƒXEƒJƒiƒ_Eƒjƒ…[ƒW[ƒ‰ƒ“ƒhEƒI[ƒXƒgƒ‰ƒŠƒAEƒfƒ“ƒ}[ƒN‚Č‚ÇŠe‘‚Ě”íŒąŽŇ•ŰŒě­ô‚ɂ‚˘‚ĐR¸§“x‚Ě‘ÎŰEˆĎˆő\ŹEŒoˆÜ‚Ȃǂ𕪐͓I‚ÉŒž‹y‚ľ‚Ä‚˘‚é@[’73]BŠCŠO‚̐­ô‚Ě‘˝‚­‚̓wƒ‹ƒVƒ“ƒLéŒž‚ɉe‹ż‚đŽó‚ŻAś•¨ˆăŠw‚Ě”íŒąŽŇŒ¤‹†‚ɂ‚˘‚Ä‚ĚŽŠŽĺ“I‚Č‹K’č‚Ş1990”N‘ă‘OŒă‚É–@§‰ť‚ł‚ę‚˝‚ŕ‚Ě‚Ĺ‚ ‚éB‚ť‚ľ‚Ä‚ą‚ę‚ç‚̐­ô‚͐ś•¨ˆăŠwŒ¤‹†‚Š‚ç‚ ‚ç‚ä‚é”íŒąŽŇ•ŰŒěŒ¤‹†‚ÉŠg’Ł‚ł‚ę‚éŒXŒü‚É‚ ‚é‚ŕ‚Ě‚Ş­‚Č‚­‚Č‚˘B‚Ü‚˝NBAC‚͍‘“ŕ‚ōs‚í‚ę‚Ä‚Ť‚˝S—ŠwŒ¤‹†‚É’–Ú‚ˇ‚éB‚˝‚Ć‚Ś‚Î1970”N‘ă‚ÉPhilip G. Zimbardo‚ފč–‚É‚¨‚˘‚ÄŽúl‚đ”î掂ľ‚˝‚Ć‚Ť‚́uŽŠ”­“Iv‚Č”˝‰ž‚𒲂ׂ˝Œ¤‹†‚âAƒ~ƒ‹ƒOƒ‰ƒ€Œ¤‹†‚đ—á‚É‹“‚°‚ĎЉď‰ČŠwŒ¤‹†‚ŕ‚Ü‚˝”íŒąŽŇ‚É‹­‚˘‰e‹ż‚đ‹y‚Ú‚ľ‚Ä‚˘‚é‚É‚ŕ‚Š‚Š‚í‚炸A‚ť‚Ě’–Ú“x‚Ş’á‚˘‚ą‚Ć‚ÉŠë‹@Š´‚đ•\–ž‚ľ‚Ä‚˘‚éB‚ť‚ľ‚ăAƒƒŠƒJS—Šw‰ď(the American Psychological Association: APA)‚Ě“ĆŽŠ‹K’č‚ɐG‚ęAŠw‰ď‚Í”íŒąŽŇ‚Ě“ŻˆÓ‚â”z—ś‚đŒ¤‹†ŽŇ‚É‹‚ß‚Ä‚˘‚é‚ŕ‚̂́A—L‰v‚Č’mŽŻ‚ĚŠl“ž‚ŞŠú‘Ň‚Ĺ‚Ť‚é‚Ć‚Ť‚ɂ́u‹•‹U‚̏î•ń’ń‹Ÿv(deception)‚͐ł“–‰ť‚ł‚ę‚é‚Ć‚ľ‚Ä‚˘‚é‚Ć‚ľ‚Ä‚ą‚Ě‹K’č‚đ–â‘莋‚ľ‚Ä‚˘‚éB‚ť‚ľ‚āu‹•‹Uv‚Ě‘ă•\—á‚Ć‚ľ‚ĐS—ŠwŽŇLaud Humphreys‚ލs‚˘A‚ť‚̐Ź‰Ę‚ŞŒă‚ÉŠwˆĘ˜_•ś‚Ć‚ľ‚ÄŠ§s‚ł‚ę‚˝ŽŔŒą‚ÉŒž‹y‚ľ‚Ä‚˘‚éB‚ą‚ę‚ÍHumphreys‚ŞŒxŠŻ‚É•Ď‘•‚ľ‚ÄŒöOƒgƒCƒŒ‚Í‚ś‚ߊeŠ‚ŐE–ąŽż–â‚đs‚Á‚˝Œ¤‹†‚Ĺ‚ ‚éB”­•\Žž‚ɂ͏î•ń‚Í“˝–ź‚Ć‚ł‚ę‚˝‚ށA•`ŽĘ‚ŞÚ×‚Ĺ‚ ‚Á‚˝‚˝‚ߐl•¨“Á’č‚Ş‰Â”\‚Ĺ‚ ‚Á‚˝‚ą‚Ć‚Ş–â‘莋‚ł‚ę‚˝Œ¤‹†‚Ĺ‚ ‚éB“–Žž‚ĚƒAƒƒŠƒJ‚Ě”íŒąŽŇ•ŰŒě­ô‚Ĺ‚Í“˝–ź‚Ĺ‚ ‚ę‚Έę”Ę‚ÉIRBR¸‚̏œŠO‚Ć‚ł‚ę‚Ä‚˘‚˝B‚ą‚¤‚ľ‚˝—ᎌ‚Š‚çNBAC‚ÍŒťs‚̐­ô‚ĹˆęŠŃŤ‚đŽ‚˝‚š‚錠ŒŔ‚Ş‘śÝ‚ľ‚Č‚˘‚˝‚߁A­•{‹@ŠÖ‚̐­ô‚Ö‚Ě•ŕ’˛‚đ‡‚í‚é‚ą‚Ć‚Ş“ď‚ľ‚˘‚ą‚ƁA”íŒąŽŇ•ŰŒě‚ĚŠĎ“_‚Š‚ç‹^–â‚Ě—]’n‚ĚŽc‚錤‹†‚𐧓x‚ĆŠÖ˜A•t‚Ż‚Ä“ˆę“I‚ɉđŽß‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚Č‚˘‚ą‚Ƃɂ‚˘‚ďq‚ׂâ‚éB‚ť‚ľ‚đΉž‚ˇ‚鐧“x‚𑁋}‚ɐŽ‚Ś‚é‚ą‚Ć‚Í˘“ď‚Ĺ‚ ‚é‚ŞA‚ą‚ę‚ç‚ĚŒ¤‹†—Ěˆć‚đŒŠ“Ś‚ˇ‚í‚Ż‚É‚Í‚˘‚Š‚Č‚˘‚ĆŒ‹˜_•t‚Ż‚Ä‚˘‚éB•ń‘‚Ě’ńŒž(Recommendation 7.2)‚ł́A­•{‚ސś•¨ˆăŠw‚âŽĐ‰ď‰ČŠw‚ĚŒ¤‹†ŽŇE–@—Ľ‰ĆE—đŽj‰Ć‚Č‚Ç‚Ĺ‘gD‚ł‚ę‚Ä‚˘‚éŠwp’c‘Ě‚âŒ¤‹†‘gD‚Ć˜AŒg‚ľ‚āAŒ¤‹†‚Ě—Ď—‚ÉŠÖ‚ˇ‚鏔–â‘č‚Ć”íŒąŽŇ•ŰŒě–â‘č‚̏ŠÝ‚ɂ‚˘‚Ęb‚ľ‡‚¤‚ׂŤ‚ą‚Ć‚đ’ńˆÄ‚ˇ‚éB‚‚܂čNBAC‚͈ă—Ă‹L˜^‚âŽĐ‰ď‰ČŠw‚ĚŒ¤‹†‚É‚ć‚éƒf[ƒ^ƒx[ƒX‚ȂǁAƒqƒgś‘Ě“IŽ‘—ż(human biological materials)‚Ě’~Ď‚âoś‘O‚Ěˆă—Ísˆ×Eˆâ“`Žqf’f‚Č‚Ç‚Ě‘¤–Ę‚Š‚猊‚˝u‚‚Ť‚₡‚˘lXv‚Ö‚Ě”z—ś‚Č‚Ç‚Ě—á‚đ‹“‚°‚āA‚ą‚¤‚ľ‚˝”íŒąŽŇŒ¤‹†‚Ş‚ł‚ç‚ɐ[‚Č”íŒąŽŇ‚Ö‚ĚŠëŠQ‚É”­“W‚ˇ‚é‚ą‚Ć‚đ—J—ś‚ľA‚ť‚́ućŽčv‚đ‘Ĺ‚Ć‚¤‚Ć‚ľ‚˝B@

@@ ‚ą‚̂悤‚ÉNBAC‚̍ŏI•ń‘‚Š‚ç‚ÍŠCŠO‚Ě”íŒąŽŇ•ŰŒě­ô‚đŽQĆ‚ľ‚Č‚Ş‚çś•¨ˆăŠwŒ¤‹†ŽŇŠÔ‚̐\‚ľ‡‚í‚š‚Š‚ç‚Č‚é‹K§‚ÍŠłŽŇ‚ĚŠÖ—^‚ˇ‚錤‹†‚ÉŠg’Ł‚ł‚ęA‚â‚Ş‚Ä”íŒąŽŇŒ¤‹†‘S‘Ě‚Ş‹K§‚Ě‘ÎŰ‚Ć‚Č‚Á‚Ä‚˘‚Á‚˝‚Ě‚Í•K‚¸‚ľ‚ŕƒAƒƒŠƒJ“Á—L‚Ě“Ž‚Ť‚Ĺ‚Í‚Č‚­A1990”N‘OŒă‚Ě‚˘‚­‚‚Š‚̍‘‚ĚŠwp‰ď‚̐–¨‚Ĺ‚ ‚é‚Ć‚˘‚Ś‚é‚ž‚낤B‚˝‚ž‚ľ‚ą‚¤‚ľ‚˝‹c˜_‚ރAƒƒŠƒJ‚̐ś–˝—Ď—Ž–âˆĎˆő‰ď‚Ě•ń‚Ć‚ľ‚Ä•\‚ę‚˝‚̂́Aăq‚ľ‚˝”íŒąŽŇŽ€–SŽ–Œ‚Ö‚Ě”ń“ď‚Ć‚ť‚ą‚Š‚ç•Ś‚Ť‹N‚ą‚Á‚˝IRBR¸§“x‚Ě‘S–Ę“I‚ČŒŠ’ź‚ľ‚đ‹‚ß‚éş‚ÉŒă‰Ÿ‚ľ‚ł‚ę‚˝‚ŕ‚Ě‚ž‚ƍl‚Ś‚ç‚ę‚éB

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@@7.3”íŒąŽŇ•ŰŒě‚ĚŠĎ“_‚Š‚çŽĐ‰ď‰ČŠw‚͂ǂ̂悤‚ɉž‚Ś‚ç‚ę‚é‚Ě‚Š|NHRPAC (‘‰Ć”íŒąŽŇŒ¤‹†Ž–âˆĎˆő‰ď)‚ĆSBS(ŽĐ‰ď‰ČŠw‚¨‚ć‚эs“Ž‰ČŠwě‹ĆƒOƒ‹[ƒv)

@@ 2001”N10ŒŽANBAC‚Í”CŠú–ž—š‚ʼnđŽU‚ľ‚˝‚ ‚ƁAƒuƒbƒVƒ…‘ĺ“—Ě‚Í—‚ŒŽ‚ɃzƒƒCƒgƒnƒEƒXś–˝—Ď—ˆĎˆő‰ď(White house Council on Bioethics)‚đÝ’u‚ľ‚˝B‚ą‚ĚˆĎˆő‰ď‚ĚŽg–˝‚ÍNBAC‚Ě‹c˜_‚đˆř‚ŤŒp‚˘‚ŁA‘ĺ“—́iƒzƒƒCƒgƒnƒEƒXj‚Éăó‚âŠĚ×–EŒ¤‹†‚̩踁AśBAƒNƒ[ƒ“Aˆâ“`‹ZpA_Œo‰ČŠw‚Ȃǐś–˝‰ČŠw‚Ě—Ď—“I‚Č–â‘č‚ÉŠÖ‚ˇ‚é“š\‚đ‚ˇ‚é‚ą‚Ć‚Ĺ‚ ‚Á‚˝Bˆę•űA”íŒąŽŇ•ŰŒě­ô‚âhthe Common Ruleh‚Ě‹c˜_‚ÍŽ–ŽŔăNHRPAC‚ÉŒpł‚ł‚ę‚˝@[’74]B‚ą‚ĚˆĎˆő‰ď‚Í2000”N6ŒŽ‚ÉHHS‚̉ş•”‘gD‚Ć‚ľ‚Đݒu‚ł‚ęAHHS’ˇŠŻDonna Shalala, ŽŸŠŻ(Assistant Secretary of Health, ASH)AOHRP‚Ů‚Š”íŒąŽŇ•ŰŒě‚ÉŠÖŒW‚ˇ‚é‘˝”‚̐­•{‹@ŠÖ‚ĚŽ–â‹@ŠÖ‚ž‚Á‚˝@[’75]BˆĎˆő‰ď‚É‚ÍŽq‹ŸAˆâ“`AŽĐ‰ďEs“Ž‰ČŠwAŽŠŒČŒˆ’č‚Ş˘“ď‚ČŽŇ(decisionally impaired)AƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒgA—˜ŠQ‘Η§‚ɂ‚˘‚ĐR‹c‚ˇ‚邢‚­‚‚Š‚̍ě‹ĆƒOƒ‹[ƒv‚Ş‚ ‚čA‚ť‚ą‚Ĺ‹c˜_‚ł‚ę‚˝“ŕ—e‚đNHRPAC‚Ě‘S‘̉ď‹c‚ōŏI“I‚ÉŒŸ“˘‚ł‚ę’ńŒž‚Ş‚Ü‚Ć‚ß‚ç‚ę‚˝B‚Ü‚˝‘SˆĎˆő12–ź‚Ě‚¤‚ż‘唟‚Í”íŒąŽŇ•ŰŒě­ô‚ÉŠÖ˜A‚ˇ‚鐭•{‹@ŠÖ‚Ě‘ă•\ŽŇ‚Ĺ‚ ‚čAŽĐ‰ďĽs“Ž‰ČŠw•Ş–ě‚đ‘ă•\‚ˇ‚éˆĎˆő‚Í•ś‰ťl—ŢŠwŽŇ‚ĚJennie R.Joe‚Ě‚Ý‚Ĺ‚ ‚Á‚˝BŽĐ‰ď‰ČŠwŒn‚ĚŠwp’c‘Ě‚đ‘ă•\‚ˇ‚éŽĐ‰ď‰ČŠw‹Ś‰ď˜A‡ithe Consortium of Social Science Associations: COSSA)‚Í‚ą‚ĚˆĎˆő‚̍\Ź‚đ–â‘莋‚ľ‚āAHHS’ˇŠŻ‚ɑ΂ľŽĐ‰ď‰ČŠwŒn‚ĚˆĎˆő‚đ‘‚â‚ˇ‚悤‚É‹­‚­—vż‚ľ‚˝@[’76]B2001”N‚PŒŽ‚ÉNHRPAC‚͐V‚˝‚É”C–˝‚ľ‚˝ˆĎˆő5–ź‚¤‚żAASA‰ď’ˇFelice J.Levine‚đŒ}‚Ś“ü‚ę‚˝@[’77]BLevine‚Í‘O”N12ŒŽ‚ÉNHRPAC‚ŎЉďEs“Ž‰ČŠwŒ¤‹†ŽŇ‚Š‚ç‚ĚŒťó”FŽŻ‚ɂ‚˘‚Ä•ń‚ľ‚Ä‚˘‚˝B”ޏ—‚͍Ą‚ą‚ť”íŒąŽŇ‚Ě•ŰŒě‚Ć—Ď—‚ĆŒ¤‹†‚ĚŽż‚Ş–â‚í‚ę‚Ä‚¨‚čAˆĎˆő‰ď‚ŞŽĐ‰ď‰ČŠwŒ¤‹†‚̐R¸‚Ć”FŘ‚É‚¨‚Ż‚éŽwj‚ĆŒťó‚Ć‚Ěa‚đ–„‚ß‚é‚˝‚ß‚ÉIRB§“x‚ť‚Ě‚ŕ‚Ě‚đŒŠ‚Č‚¨‚ˇ•űŒü‚É–Ú‚đŒü‚Ż‚é‚ׂŤ‚ą‚Ć‚ÉŒž‹y‚ľ‚˝B

@@ 2001”N10ŒŽAHNRPAC‚Í2“úŠÔ‚É‚í‚˝‚é•ń‘ěŹ‚ÉŒü‚Ż‚˝‰ď‹c‚đŠJ‚˘‚˝B‚ť‚ą‚Ĺ‚Í‹ŕ‘K“I—˜ŠQŠÖŒWEƒwƒ‹ƒVƒ“ƒLéŒž‚̉đŽßEˆâ“`ŠwE‰Ć‘°‚Ć”íŒąŽŇEŽq‹ŸA‚ť‚ľ‚ĎЉď‚Ě”íŒąŽŇŒ¤‹†‚Ɛ”‘˝‚­‚Ě‹c‘č‚ŞŽć‚čă‚°‚ç‚ę‚˝BŽĐ‰ď‰ČŠwŒ¤‹†‚Í”íŒąŽŇ•ŰŒě‚đl—ś‚ˇ‚ׂŤ‚Ć‚Ěl‚Ś‚ÍˆĎˆő‚É‹¤—L‚ł‚ę‚Ä‚˘‚˝B‚ť‚ę‚Í–žŠm‚ȍ€–Ú‚É•Ş‚Ż‚Ä‹c˜_‚ł‚ę‚Ä‚˘‚é‚í‚Ż‚Ĺ‚Í‚Č‚˘‚ŕ‚̂́AŒ¤‹†‚̉ߒö‚Őś‚ś‚éŒö“I—p“rî•ń(Public use data files)E‘ćŽOŽŇ‹@ŠÖ‚É‚ć‚éî•ńithird Parties,î•ń‚ĚÄ•ŞÍjE—˜ŠQŠÖŒW(risk and harm)Eiƒvƒ‰ƒCƒoƒV[‚́jŽç”鐍(confidentiality)‚Č‚Ç‚Ě–â‘č‚É‚ć‚Á‚Ä”íŒąŽŇ‚ÉŠëŠQ‚Ş‹y‚Ô‚Ć‘z’č‚ł‚ę‚Ä‚˘‚éB‚Ć‚­‚É‹c˜_‚ł͐”NŠú‚Ü‚Ĺ‚đŠÜ‚ŢŽq‹Ÿ‚Ş”íŒąŽŇ‚Ć‚Č‚éę‡‚̉e‹ż‚ŞŒœ”O‚ł‚ę‚Ä‚˘‚éBLevine‚͎Љď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚Ş‹y‚Ú‚ˇŠëŠQ‚â‰e‹ż‚Ě’ö“x‚𐜕¨ˆăŠwŒ¤‹†‚Ĺ‘z’č‚ł‚ę‚Ä‚˘‚éŠëŠQ‚Əd‚ˍ‡‚í‚š‚é‚ą‚Ć‚Í‚Ĺ‚Ť‚Č‚˘‚ĆŒJ‚č•Ô‚ľq‚ׁAŒ¤‹†•ű–@‚ÉŒŠ‡‚Á‚˝ŠĎ“_‚Š‚ç”íŒąŽŇ•ŰŒě‚đ’Ç‹‚ˇ‚ׂŤ‚ž‚ĆŽĺ’Ł‚ľ‚˝B”ޏ—‚͎Љď‰ČŠw‚É‚¨‚Ż‚é”íŒąŽŇŒ¤‹†‚Ě•ś–Ź‚𖞊m‚É‚ľ‚āAŒ¤‹†‚ɒljÁ“I‚Č•‰’S‚đ‹­‚˘‚é‚ą‚Ć‚Č‚­”íŒąŽŇ•ŰŒě‚đŽŔ‘H‚Ĺ‚Ť‚é•ű–@‚đ‚ą‚ę‚Š‚ç‚̉ۑč‚Ć‚ľ‚čl‚Ś‚é‚ׂŤ‚ž‚Əq‚ׂ˝B‚ą‚̂悤‚ɐś•¨ˆăŠwŒ¤‹†‚ƎЉď‰ČŠwŒ¤‹†A‚ť‚ľ‚Ä”íŒąŽŇ•ŰŒě‚Ě—”O‚Ć‚ť‚ĚŽŔŽ{‚đ“ŻˆęŽ‹‚ˇ‚é‚ą‚Ƃ́gFault Linehi’f‘wüE•Ş’füj‚Ş‚ ‚é‚Ć‚˘‚¤‚Ě‚Ĺ‚ ‚éB

@@ Levine‚ÍNHRPAC‚̍ě‹ĆƒOƒ‹[ƒv‚Ĺ‚ ‚éuŽĐ‰ď‰ČŠw‚¨‚ć‚эs“Ž‰ČŠwě‹ĆƒOƒ‹[ƒvvithe Social and Behavioral Sciences Working Group: SBS)‚Ě‹c’ˇ‚đŒ“–ą‚ľ‚˝@[’78]B”ޏ—‚ÍASA‚ĚŒ¤‹†—Ď—ˆĎˆő‰ď(Committee on Professional codes of ethics: COPR)‚Ĺ‚ĚŒoŒą‚đŠî‚Ă‚­‹c˜_‚đ‚ľ‚˝‚ą‚ƂɂŁAƒOƒ‹[ƒv‚Ě’ńˆÄ‚͎Љď‰ČŠw‚ĚŒ¤‹†‚É“Y‚Á‚˝‚ŕ‚Ě‚Ć‚Č‚Á‚˝‚Ć‚˘‚í‚ę‚Ä‚˘‚éBăq‚ľ‚˝ŽĐ‰ď‰ČŠwŒ¤‹†‚É‚¨‚Ż‚é”íŒąŽŇ•ŰŒě‚Ě4‚Â‚Ě˜_“_‚Í“–‰SBS‚Ĺ‹c˜_‚ł‚ę‚Ä‚˘‚˝“ŕ—e‚ž‚Á‚˝@[’79]B‚Ü‚˝SBS‚Í’ńŒž‚đ‚ˇ‚é‚ž‚Ż‚Ĺ‚Í‚Č‚­AŽĐ‰ď‰ČŠwŒn‚ĚŒ¤‹†ŽŇ‚⌤‹†‘gD‚ƐϋɓI‚ɐڐG‚đ}‚Á‚˝Bƒ^ƒEƒ“Eƒ~[ƒeƒBƒ“ƒO‚âƒVƒ“ƒ|ƒWƒEƒ€‚đŠJ‚˘‚Ä”íŒąŽŇ•ŰŒě‚âŽĐ‰ď‰ČŠwŒ¤‹†‚ÉŒŠ‡‚Á‚˝—Ď—‚Ě•K—vŤ‚đ‘i‚Ś‚銈“Ž‚đ‚ľ‚˝‚čA”íŒąŽŇŒ¤‹†‚Ĺ‚Ě—Ď—‚đI“ú‚É‚í‚˝‚Á‚ÄŒ¤C‚đ‚¤‚Ż‚éuŔ(day-long course)‚Č‚Ç‚đŽĺĂ‚ľ‚Ä‚Ť‚˝B

@@ ‚ž‚Ş2002”N8ŒŽ‚ɃuƒbƒVƒ…­Œ ‰ş‚ĚHHS’ˇŠŻThompson ‚ÍNHRPAC ‚Ě10ŒŽ‚É—\’č‚ł‚ę‚Ä‚˘‚˝’č—á‰ď‚𒆎~‚ˇ‚é‚Ć‚Ć‚ŕ‚ɁA“ŻˆĎˆő‰ď‚Ě”CŠú–ž—š‘O‚ɉđŽU‚đ–˝‚ś‚˝‚ą‚Ƃ́uÂ“V‚ĚčĆč́v‚ž‚Á‚˝@[’81]BEdward Kennedy‚ĆHillary Clintoni‚Ć‚ŕ‚É–ŻŽĺ“}ă‰@j‚Í‚ą‚ĚŒˆ’č‚đ•s•ž‚Ć‚ľ‚āAHHS’ˇŠŻ‚Ɉś‚ĂĉđŽU‚ĚŽćÁ‚ľ‚đ‹‚ß‚é’QŠč‘‚đ’ńo‚ľ‚˝‚ŕ‚̂́A‚ą‚ĚŒˆ’č‚Ş•˘‚é‚ą‚Ć‚Í‚Č‚Š‚Á‚˝BSBS‚Í‚ť‚ĚŒă‚ŕNIH‚̎Љď‰ČŠws“Ž‰ČŠwŒ¤‹†‹Ç(Office of Behavioral and Social Sciences Research)‚ĚŽx‰‡‚đŽó‚ŻA‚Ü‚˝AAHRPP‚âFOHRP(the Federal Office of Human Research Protections)‚Č‚Ç‚Ě‹@ŠÖ‚Ć˜AŒg‚ľ‚ďI“úŒ¤C‚Č‚Ç“ĆŽŠ‚ĚŠˆ“Ž‚đ‘ą‚Ż‚Ä‚˘‚éB“Ż”N10ŒŽAHHS‚ÍNHRPAC ‚É‘ă‚í‚鐭•{‚ĚŽ–â‹@ŠÖ‚Ć‚ľ‚Ä11–ź‚ĚˆĎˆő‚Š‚ç‚Č‚éu”íŒąŽŇ•ŰŒě‚ÉŠÖ‚ˇ‚鎐–âˆĎˆő‰ďv(the Secretaryfs Advisory Committee on Human Subject Protections: SACHRP)‚đÝ’u‚ľ‚˝@[’82]B‚ą‚ĚˆĎˆő‰ď‚ÍNHRPAC‚Ě–â‘č’ń‹N‚đ“ĽP‚ľ‚ĐVśŽ™‚đŠÜ‚ŢŽ™“śEŽúlEŽŠŒČŒˆ’č‚̍˘“ď‚ȎҁE”D•wEŽó¸ăóE‘ŮŽ™EŠCŠOŒ¤‹†‚Ĺ‚ĚŒÂl‚ƏW’cEgŒł‚đ“Á’č‚Ĺ‚Ť‚éî•ńEŒ¤‹†ŽŇ‚Ě—˜ŠQ‚Ȃǂɂ‚˘‚ĐR‹c‚đ‘ą‚Ż‚Ä‚˘‚éB

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@@7.4@”ń­•{‘gDEŠwp’c‘Ě‚Š‚ç‚̉ž“š|AAHRPP(”íŒąŽŇ•ŰŒěŒv‰ć”FŘ‹Ś‰ď)‚Ě”FŘ§“x

@@ 1990”N‘ăŒă”ź‚Š‚ç”íŒąŽŇ•ŰŒě‚̊֐S‚ލ‚‚Ü‚é‚ɂ‚ę‚āA“ĆŽŠ‚Ě‹K’č‚đ’č‚ß‚Ä‚Ť‚˝7Šwp’c‘Ě‚Í2001”N4ŒŽ‚É”íŒąŽŇ•ŰŒěŒv‰ć”FŘ‹Ś‰ď(the Association for the Accreditation of Human Research Protection Programs: AAHRPP)‚đ‹¤“Ż‚Ĺ”­‘Ť‚ľ‚˝@[’83]B‚ą‚Ě‘gD‚Í”­‘Ť“–‰‚Š‚çCOSSA(ŽĐ‰ď‰ČŠwŠwp’c‘Ě˜A‡,the Consortium of Social Science Associations) ‚ŞŽQ‰Á‚đ•\–ž‚ľ‚Ä‚˘‚˝‚ą‚Ć‚É‚ć‚Á‚āAŽĐ‰ď‰ČŠwŒ¤‹†‚É“K‰ž‚Ĺ‚Ť‚éL”Í‚Ĺ_“î‚Č’ńˆÄ‚މ”\‚É‚Č‚Á‚˝‚Ć‚˘‚í‚ę‚Ä‚˘‚é@[’84]B2001”N2ŒŽ‚É‚ÍAAHRPP‚ÍŒ¤‹†ŽŇ‚Ě‘¤‚Š‚çL”ÍˆÍ‚ČŒ¤‹†•Ş–ě‚Ĺ“K—p‚ˇ‚é‚ą‚Ć‚đ‘z’č‚ľ‚˝“ĆŽŠ‚Ě‹K’č‚đ’ńˆÄ‚ľAOHRP‚ŞFWA”FŘ‚đs‚¤‚Ě‚Ć“Ż—l‚ÉŠeIRB‚ÉAAHRPP‚Ě”FŘ(AAHRPP®)‚đ’ńˆÄ‚ľ‚Ä‚˘‚é@[’85]BÝ—§’c‘̂̂ЂƂ‚ł ‚éPRIM&R(uˆă—ÁEŒ¤‹†‚É‚¨‚Ż‚éŒö“IÓ”CvŽĐFPublic Responsibility in Medicine and Research, Inc)‚Í‚ą‚Ě”FŘ‚ɂ‚˘‚āu‚ą‚Ě”FŘ‚Ş–Ú“I‚Ć‚ľ‚Ä‚˘‚é‚ą‚Ƃ́A‚ą‚ĚƒvƒƒOƒ‰ƒ€‚É‚ć‚Á‚Ä“–ŠY•Ş–ě‚É‚¨‚Ż‚éĹ‘P‚ĚŽŔ‘Hhbest practicesh‚ŞŽć‚č“ü‚ę‚ç‚ę‚é‚ą‚Ć‚đŠŠ‚ß‚Ä‚­‚ę‚é‚悤‚ȍs“ŽŠî€‚đŠJ”­‚ľ‚Ä‚˘‚­‚ą‚ƁA‚ť‚ľ‚Ä‚ą‚ę‚ç‚ĚŠî€‚ÉŒŠ‡‚Á‚˝ƒvƒƒOƒ‰ƒ€‚đł”F‚ˇ‚é‚ą‚Ć‚É‚ć‚Á‚Ä”íŒąŽŇ‚Ě•ŰŒě‚𑣐i‚ˇ‚é‚ą‚Ć‚É‚ ‚é‚Ě‚Ĺ‚ˇv‚ĆĐ‰î‚ľ‚Ä‚˘‚é@[’86]B‚‚܂肹‚Ě”ń­•{‹@ŠÖ‚ŞŽĺĂ‚ˇ‚é”FŘ§“x‚́A­•{‚Ě‹K’č‚đ…Žç‚ˇ‚é‚ą‚Ć‚É‚ć‚Á‚Ä”íŒąŽŇ‚ĚŒ —˜‚¨‚ć‚Ń•ŸŽƒ‚ĚŒüă‚đ’BŹ‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚é‚Ć‚˘‚¤‚ą‚ę‚Ü‚Ĺ‚Ě”FŽŻ‚đ‰ü‚ß‚éB‚ť‚ľ‚ÄŽŔŰ‚É‹N‚Ť‚Ä‚˘‚é–â‘č‚đŽŠ”­“I‚ČŽŠŒČ‹K§gVoluntary Self-Regulationh‚Ć‚Ě‘o•űŒü“I‚ČŒŠ’ź‚ľ‚Ě‚Č‚Š‚ĹIRBR¸‚â‹łˆçƒvƒƒOƒ‰ƒ€‚đˆĘ’u‚Ă‚Ż‚é‚ą‚Ć‚đ–ÚŽw‚ľ‚Ä‚˘‚é‚Ě‚Ĺ‚ ‚é@[’87]B2002”N10ŒŽ‚É‚Í‘Ţ–đŒRlČ(department of Veterans Affairs: VA)‚ŞIRBR¸‚đAAHRPP‚Ć‚Ć‚ŕ‚ɍs‚¤‚ą‚Ć‚đ”­•\‚ľ‚˝BVA‚͏]—ˆNCQA(the national Committee for Quality Assurance)‚ĚIRB‚đ”FŘ‹@ŠÖ‚Ć‚ľ‚Ä‚˘‚˝‚ށA‚ą‚ęˆČŒăVAANCQAAAAHRPP‚ލ‡“Ż‚ĹVA‚ɐ\ż‚ł‚ę‚˝IRBR¸‚đ’S“–‚ˇ‚é‚ą‚Ć‚É‚Č‚Á‚˝‚Ě‚Ĺ‚ ‚éB‚Ü‚˝•Ä‘Žž•a‘΍ô‚¨‚ć‚Ń—\–hƒZƒ“ƒ^[(American Centers for Disease Control and Prevention: CDC)‚ÍAAHRPP”FŘ‚đCDC‚Ě”FŘ§“x‚Ć‚ľ‚Ä”F’股‚é‚ą‚Ć‚đ”­•\‚ľ‚Ä‚˘‚éB‚ą‚̂悤‚ÉAAHRPPÝ—§‚Ě”wŒi‚É‚ÍŒ¤‹†‚́u—Ď—v‚ɂ‚˘‚Ä‚ą‚ę‚Ü‚Ĺ‚ĚŒ¤‹†•Ş–삲‚Ć‚ĚŠľ—á‚đŒŠ‚Č‚¨‚ľA‚Ü‚˝”íŒąŽŇ•ŰŒě‚ÉŠÖ‚ˇ‚鐭•{‚Ě‹K’č‚𖳔ᔝ‚ɒǏ]‚ˇ‚é‚ą‚Ć‚ŕR‚ľ‚˝Šwp’c‘Ě‚Ě“ĆŽŠ‚ĚŽp¨‚đŒŠ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éB‚ť‚ľ‚Ä”ń­•{‚Ĺ‚ ‚éAAHRPP‚Ě”FŘ‚͐­•{‹@ŠÖ‚ĚIRB‚â”ń­•{‚ĚŒ¤‹†‹@ŠÖ‚É”F‚ß‚ç‚ę‚Ä‚˘‚é@[’88]B

@@ 2002”N4ŒŽ‚É‘ć23‰ńŒúśE‹łˆçE”N‹ŕ˜J“­ă‰@ˆĎˆő‰ď‚ŞŠJ‚Š‚ę‚˝B‚ť‚ĚŒö’Ž‰ď‚Ĺ‚ÍEdward Kennedy(–ŻŽĺ“}ă‰@)‚ÍNBAC‚âHHS‚Ě•ń‚đŽć‚čă‚°AŒťs‚Ě˜A–M­•{‚ސi‚ß‚é”íŒąŽŇ•ŰŒě­ô‚Ş’v–˝“I‚ČŒ‡Š×‚đ‚Í‚ç‚ń‚Ĺ‚˘‚é‚ą‚Ć‚đŽw“E‚ľ‚˝B”ނ͐§“x‰üł‚Ě–@ˆÄ(S.3060)‚đ’ńo‚ľ‚ÄOHRP ‚Ě–@“I‚ČŒ ŒŔ‚đ‹­‰ť‚ˇ‚é‚ą‚Ć‚ĹIRB‚Ě”FŘ‚đ‹`–ą‰ť‚ľAˆá”˝ŽŇ‚É‚Í”ą‹ŕ‚đ‰Č‚ˇ‚ą‚Ć‚Č‚Ç‚đŽĺ’Ł‚ľ‚˝BS. 3060‚Ć‚Í‘ÎĆ“I‚ÉAiana L.DeGettei–ŻŽĺ“}‰ş‰@‹cˆőj‚ĆJim Greenwood‚Íŕ­Žx‰‡‚Ě—L–ł‚É‚Š‚Š‚í‚炸ŽŠŽĺ“I‚ÉIRBR¸§“x‚đ“K—p‚ˇ‚é‚ą‚Ć‚đ–@ˆÄ‰ť‚ˇ‚é‰üłˆÄ(H.R.4697)‚đ’ńˆÄ‚ľ‚˝@[’89]B—ź–@ˆÄ‚ĚŒˆ’č“I‚Čˆá‚˘‚ÍIRBR¸‚đŒ¤‹†ŽŇ‚ĚŽŠ”­Ť‚É”C‚š‚é‚ŠA’Ś”ą‚Ě‘ÎŰ‚Ć‚Č‚é‹`–ą‰ť‚đ‚ˇ‚é‚ą‚Ć‚Š‚Ć‚˘‚¤“_‚Ĺ‚ ‚Á‚˝BˆĎˆő‰ď‚ĚŽQll‚Ć‚ľ‚ÄAAHRPPŽ––ą‹Ç’ˇMarjorie Speers‚ÍNBACĹI•ń‘‚Ě’ńŒž‚đŽć‚čă‚°Al•śEŽĐ‰ďAś•¨ˆăŠw‚Č‚Ç‘˝‚­‚Ě—Ěˆć‚Ş”íŒąŽŇŒ¤‹†‚ĆŠÖ˜A‚ľ‚Ä‚¨‚čA‘E’n•ű‚Ě‚ ‚ç‚ä‚郌ƒxƒ‹‚Ĺ‚Ě”íŒąŽŇ•ŰŒě‚Ě•K—vŤ‚đ‹­’˛‚ľ‚˝B‚ť‚ľ‚ÄŒťó‚Ĺ‚ÍFDA‹K’č‚ÉŠY“–‚ľ‚Č‚˘Œ¤‹†‚âgthe Common Ruleh‚đ‹¤’Ę‹K’č‚Ć‚ľ‚ÄĚ—p‚ľ‚Ä‚˘‚Č‚˘­•{‹@ŠÖ‚ĚŽx‰‡‚É‚ć‚é”íŒąŽŇŽŔŒą‚ȂǐR¸§“x‚́u”˛‚Ż“šv‚ވˑR‘śÝ‚ľ‚Ä‚˘‚é‚ą‚Ć‚đŽw“E‚ľ‚Ä‚˘‚éBSpeers‚ÍAAHRPP‚ĚŠî–{•űj‚Ĺ‚ ‚鎊”­“I‚ČŽŠŒČ‹K§‚ĚˆÓ‹`‚đ‹­’˛‚ľA‚ą‚ę‚ÉŠî‚Ă‚˘‚˝IRB§“x‚𕁋y‚ł‚š‚é‚ׂŤ‚ž‚Əq‚ׂâ‚é@[’90]B

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@@‚W •ń‚đI‚Ś‚é‚É‚ ‚˝‚Á‚ā]gFault Lineh‚Ć‚˘‚¤”ᔝ‚ɉž‚Ś‚é‚ą‚Ć‚Í‚Ĺ‚Ť‚˝‚Ě‚Š

@@ ‘O‚ĚÍ‚ĹŒŠ‚Ä‚Ť‚˝‚悤‚ÉFelice J.Levine‚Í”íŒąŽŇ•ŰŒě‚đŽĐ‰ď‰ČŠw‚ĚŒ¤‹†‚Ě•ś–Ź‚ōl‚Ś‚Č‚¨‚ˇ‚ׂŤ‚ž‚Ć‚˘‚¤Žĺ’Ł‚đhFault Lineh‚Ć•\Œť‚ľ‚˝B‚ť‚ľ‚Ä‚ą‚ĚŒž—t‚ɂ́u˜_—‚Ě”ň–ôv‚ɑ΂ˇ‚é‹­‚˘•Ž‚č‚Şž‚ß‚ç‚ę‚Ä‚˘‚˝‚Ě‚Ĺ‚Í‚Č‚˘‚Š‚ĆŽ„‚͍l‚Ś‚éBŽĐ‰ď‰ČŠw‚ĚŠwp’c‘̂͐ś•¨ˆăŠw‚ƎЉď‰ČŠw‚ĚŒ¤‹†‚đ“Żˆę‚ĚŠî€‚Ĺ‹K§‚ˇ‚é‚ą‚ƁA‚Ü‚˝”íŒąŽŇ‚Ě•ŰŒě‚Ć‚˘‚¤—”O‚đŽŔŰ‚ĚŒ¤‹†Œťę‚É‚ť‚Ě‚Ü‚Ü“K—p‚ˇ‚é‚ą‚Ć‚Ě•s“KŘ‚ł‚đŽĺ’Ł‚ľ‚Ä‚Ť‚˝Bƒyƒ“ƒVƒ‹ƒ”ƒFƒjƒA—đŽjE”Ž•¨ŠŮˆĎˆő‰ď(Pennsylvania Historical and Museum Commission)ˆĎˆő‚Ĺ‚ ‚Á‚˝Linda Shopes‚ŕ‚Ü‚˝ś•¨ˆăŠwŒ¤‹†‚đ‘z’č‚ľ‚˝‹K§‚â‰đŽß‚đŽĐ‰ď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚ɏd‚ˍ‡‚í‚š‚é‚ą‚Ć‚É‚ć‚Á‚āAŽĐ‰ď‰ČŠwŒ¤‹†‚Í’v–˝“I‚ČŠąÂ‚Ć‚Č‚č‚Š‚Ë‚Č‚˘‚ą‚Ć‚đŽĺ’Ł‚ľ‚Ä‚˘‚é@[’91]B

@@ NBAC‚ŞŽĐ‰ď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚ÉŒž‹y‚ľ‚˝‚Ě‚Í2001”N‚̍ŏI•ń‘‚Ş‚Í‚ś‚ß‚Ä‚Ĺ‚ ‚éBăq‚ľ‚˝‚悤‚É”íŒąŽŇ•ŰŒě‚̓AƒƒŠƒJ“ĆŽŠ‚̐­ô‚Ĺ‚Í‚Č‚­AŒ¤‹†R¸‚Ě‘ÎŰuŠg’Łv‚ÍŽž‘ă‚̐–¨‚ž‚Á‚˝‚Ć‚Ü‚Ć‚ß‚é‚ą‚Ć‚ŕ‚Ĺ‚Ť‚é‚Š‚ŕ‚ľ‚ę‚Č‚˘B‚ž‚ŞĹI•ń‘‚Ő­ô‚́uŠg’Łv‚ŞŒž‹y‚ł‚ę‚˝‚Ě‚É‚Í”íŒąŽŇŽ€–SŽ–Œ‚ƁA‚ť‚ę‚É‚ć‚Á‚Ä•\–ʉť‚ľ‚˝IRBR¸§“x‚ւ̔ᔝ‚Ć‚˘‚¤ƒAƒƒŠƒJ“Á—L‚Ě”wŒi‚Ş‚ ‚éB‚ť‚ľ‚Ä•ń‘‚ł͉ߋŽ‚ɍs‚í‚ę‚˝S—Šw‚Ě”íŒąŽŇŒ¤‹†‚đ—ᎌ‚ľ‚Č‚Ş‚ç”íŒąŽŇ‚ւ̐[‚ČŠëŠQ‚đ‹y‚Ú‚ˇŤ—ˆ‚ĚŒœ”O‚đ——R‚Ć‚ľ‚āA‹K§‚Ě‘ÎŰ‚đŽĐ‰ď‰ČŠw‘S”Ę‚ÉŠg’Ł‚ľ‚Ä‚˘‚éB‚ť‚ĚŒă‚̐­ô‚͎Љď‰ČŠwŒ¤‹†‚Ö‚Ě“K—p‚Ě‘Ă“–Ť‚ŞˆÓŽŻ“I‚ÉŒŸ“˘‚ł‚ę‚é‚ą‚Ć‚Č‚­AIRB§“x‚đ‹K§‚Ě‹­‰ť‚ƐR¸‘ÎŰ‚ĚŠg’Ł‚É‚ć‚Á‚ĉđÁ‚ˇ‚é•űŒü‚Ĺ‹c˜_‚ސi‚ß‚ç‚ę‚˝B‚ž‚ŞAAUP‚ĚƒŠƒ|[ƒg‚ĹŽć‚čă‚°‚˝‚悤‚ɁAŽĐ‰ď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚ւ́uŠg’Łv‚ɑ΂ľ‚āA”íŒąŽŇ‚Ě•ŰŒě‚ĆŠw–â‚ĚŽŠ—R‚Ć‚˘‚¤Œ¤‹†‚́u—Ď—v‚ɂ‚˘‚ĐV‚˝‚Č–â‘č’ń‹N‚Ş‚Č‚ł‚ę‚˝B‚˝‚Ć‚Ś‚΁u“KŘv‚ȏî•ń’ń‹Ÿ‚É‚ć‚Á‚ďî•ń‚đŽ‚Â”íŒąŽŇ‚Ć‚Č‚é“ŻˆÓiƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒgj‚đŽć‚čŒđ‚킡‚ł‚˘‚ɁAu“úí“I‚ȁvƒŠƒXƒN‚đ”íŒąŽŇ‚É—^‚Ś‚Š‚Ë‚Č‚˘‚Ć‚˘‚¤——R‚ĹƒtƒB[ƒ‹ƒhƒ[ƒN‚âƒCƒ“ƒ^ƒ”ƒ…[’˛¸‚đ’f”O‚š‚´‚é‚đ“ž‚Č‚˘‚Ć‚ˇ‚ę‚΁Al—ŢŠw‚âŽĐ‰ďŠw‚ĚŒ¤‹†‚Ě’v–˝‚Ć‚Č‚č‚Š‚Ë‚Č‚˘B‚Ü‚˝ƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚đ’Ę‚ś‚ÄŒ¤‹†ŽŇ‚Ć”íŒąŽŇ‚Ě‘o•ű‚ŞŒ¤‹†“ŕ—e‚đ—‰đ‚ˇ‚é‚ą‚Ć‚Íd—v‚ČŽč‘ą‚Ť‚Ĺ‚ ‚é‚Ć‚˘‚Ś‚é‚ŕ‚̂́Aˆę”ʉť‚ˇ‚é‚ą‚Ć‚Ě‚Ĺ‚Ť‚é’mŽŻ‚đ’Ç‹†‚ˇ‚é‚˝‚ß‚Ě’˛¸EŽŔŒą‚Ě‘O’iŠK‚É‚¨‚˘‚āA‚Ç‚ę‚ž‚Ż‚̏î•ń‚đŒ¤‹†ŽŇ‚Ş’ń‹Ÿ‚Ĺ‚Ť‚é‚Ě‚Š‚Ć‚˘‚¤–â‘č‚ŕ‚ ‚éB‚‚܂肝‚ą‚Ĺ‹‚ß‚ç‚ę‚Ä‚˘‚éî•ń‚́u“KŘ‚łv‚ށA‚ť‚ĚŒ¤‹†‚ސŹŒ÷‚ľ‚˝ę‡‚É‚Ě‚Ý’BŹ‚ł‚ę‚é‚Ć‚˘‚¤‚Ě‚Ĺ‚ ‚ę‚΃Cƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ť‚Ě‚ŕ‚Ě‚Ş”j’]‚ˇ‚é‚ĆŒž‚í‚´‚é‚đ‚Ś‚Č‚˘B‚ť‚ľ‚ÄĹ‚ŕŞ–{“I‚Č–â‘č‚Ć‚ľ‚Đś•¨ˆăŠwŒ¤‹†‚Ĺ‘z’č‚ł‚ę‚郊ƒXƒNE•Ö‰v‚ƎЉď‰ČŠw‚Ě”íŒąŽŇŒ¤‹†‚Ĺ‚ĚƒŠƒXƒNE•Ö‰v‚ĚŠT”O‚ǂ̂悤‚É‹ć•Ę‚ľA”äŠr‚ˇ‚é‚Ě‚ŠB‚Ü‚˝Œ¤‹†‚É‚ć‚Á‚Ä“ž‚˝î•ń‚ĚŽć‚čˆľ‚˘‚ŕ‘ĺ‚Ť‚Č˜_“_‚Ĺ‚ ‚éB”íŒąŽŇ‚Š‚çŽćŢ‚ľ‚˝gŒł‚đ“Á’股‚éî•ń(identifiable data)‚đo”Ĺ‚âŒű“Ş”­•\‚ĹŒöŠJ‚ˇ‚é‚˝‚߂ɁAŒ¤‹†ŽŇ‚Ş‚ť‚ę‚ç‚̏î•ń‚đ“˝–ź‰ť‚ľAŒ¤‹†‚Ě‚ ‚Ć‚É‹L˜^•Ű‘ś‚ľ‚˝ƒe[ƒv‚âƒf[ƒ^‚đ”jŠü‚ˇ‚é‚ą‚Ć‹`–ą•t‚Ż‚é‚Ć‚˘‚¤‹K§‰ş‚É‚¨‚˘‚ÄŒ¤‹†‚ĚŽŔŘŤ‚đŽĺ’Ł‚ˇ‚é‚ą‚Ć‚Í‚Ĺ‚Ť‚é‚Ě‚ŠBgFault@Lineh‚Í‚ą‚¤‚ľ‚˝—lX‚Č˜_“_‚đ’Iă‚°‚ľ‚Ä‹K§‚́uŠg’Łv‚đ‚ˇ‚×‚Ť‚Ĺ‚Í‚Č‚˘‚Ć‚˘‚¤Žĺ’Ł‚ž‚Ć‚˘‚Ś‚é‚ž‚낤B

@@ ‚ą‚ę‚ɑ΂ľ‚ÄŠwp’c‘̂͂ЂƂ‚̉ž“š‚đ‚ľ‚˝B‘O‚ĚÍ‚ĚĹŒă‚ĹŽć‚čă‚°‚˝AAHRPP‚Ć‚˘‚¤”ń­•{‘gD‚É‚ć‚錤‹†Œv‰ć‚Ě”FŘŠî€‚̍쐬‚Ĺ‚ ‚éB‚ą‚ę‚͎Љď‰ČŠwŒ¤‹†‚É“Á‰ť‚ľ‚˝‚ŕ‚Ě‚Ĺ‚Í‚Č‚˘BÝ—§’c‘Ě‚â”FŘ‚ĚĚ‘đ‹@ŠÖ‚đŒŠ‚ę‚΂킊‚é‚悤‚ɁA­•{‚̐­ô‚Ć“Ż—l‚É‚ą‚̐R¸Šî€‚ŕ‚Ü‚˝Œ¤‹†•Ş–ě‚đ–â‚킸•ďŠ‡“I‚Č”íŒąŽŇ•ŰŒě‚đ–ÚŽw‚ľ‚Ä‚˘‚éB‚˝‚ž‚ľ­ô‚Ć‚Ě‘Šˆá“_‚Í‚ą‚Ě”FŘŠî€‚ŞŽŠŽĺŤ‚ÉˆĎ‚Ë‚ç‚ę‚Ä‚˘‚é‚ą‚ƁA‚ť‚ľ‚Ä”íŒąŽŇ•ŰŒě‚Ö‚ĚˆÓŽŻ‚đŒ¤‹†ŽŇ‚É“ŕ–ʉť‚ł‚š‚é‚˝‚ß‚É’iŠK‚đ“Ľ‚ń‚ž‹łˆçƒvƒƒOƒ‰ƒ€‚â”FŘŠî€‚đÝ‚Ż‚Ä‚˘‚é‚ą‚Ć‚đ‹“‚°‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éB‚ť‚ľ‚Ä‚ą‚ĚŠî€‚̍쐬‚É‚ ‚˝‚Á‚Ä–ÚŽw‚ł‚ę‚Ä‚˘‚é‚ą‚Ć‚Í—\‚ß—pˆÓ‚ł‚ę‚˝Šî€‚đ…Žç‚ˇ‚é‚Ě‚Ĺ‚Í‚Č‚­AŒ¤‹†ŽŇŽŠg‚ɁuĹ‘P‚ĚŽŔ‘Hv‚đ‘I‚Ô‚ą‚Ć‚ŞŠú‘Ň‚ł‚ęAŠî€‚ť‚Ě‚ŕ‚Ě‚ŕu”­“W“răv‚Ĺ‚ ‚é‚ą‚Ć‚ÉŽŠŠo“I‚Ĺ‚ ‚é‚Ć‚˘‚¤“_‚Ĺ‚ ‚éB

@@@@‚ą‚̂悤‚ɐl‘ĚŽŔŒą‚Ě‹K§‚Š‚çŽn‚Ü‚Á‚˝”íŒąŽŇ•ŰŒě­ô‚́A­•{Žĺ“ą‚É‚ć‚é‹K§‚đ…Žç‚ˇ‚é‚ą‚Ć‚Ĺ”íŒąŽŇ•ŰŒě‚Ě’BŹ‚Ć‚ˇ‚é‚Ě‚Ĺ‚Í‚Č‚­AŽĐ‰ď‰ČŠwŒnŠwp’c‘Ě‚É‚ć‚Á‚Ä“ĆŽŠ‚ĚŠî€ě‚č‚Ş–͍ő‚ł‚ę‚Ä‚˘‚é‚Ě‚Ĺ‚ ‚éB‚ť‚ľ‚āhFault Lineh‚Ć‚˘‚¤”ᔝ‚͈ę‹`“I‚Č‹K§‚Ĺ‚Í‚Č‚­AR¸Šî€‚ť‚Ě‚ŕ‚̂̉ü•Ň‚̉”\Ť‚đŠÜ‚ß‚˝ŽŠ”­“I‚ČŒ¤‹†‚́u—Ď—v‚đ–͍ő‚ľŽn‚ß‚Ä‚˘‚éB


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’1@Œ´‘č‚Í"Protecting Human Beings-Institutional Review Boards and Social Science Research" Œ´•ś‚ÍAAUP(http://www.aaup.org/statements/Redbook/repirb.htm)‚Ü‚˝‚Í(http://www.cddc.vt.edu/aoir/ethics/public/IRBSS.pdf)‚ʼn{——‚Ĺ‚Ť‚éB‚ą‚Ě•ń‘‚Í1999”N11ŒŽ‚Ć2000”N5ŒŽ‚É‹c˜_‚ł‚ę‚˝“ŕ—e‚ŞŽű‚ß‚ç‚ę‚Ä‚˘‚éB‚ť‚Ě‚˝‚ß‚ą‚Ě•ń‘‚Ş‘z’č‚ľ‚Ä‚˘‚é45CFR46iŒăqj‚Í2001”N‰ü’ů”ŁiŒťsj‚Ěˆę‚‘O‚Ě”Ĺ(1991”N‰ü’ů”Ĺ)‚Ĺ‚ ‚é‚Ć‘z’č‚ł‚ę‚éB‚ľ‚Š‚ľ‚ą‚Ě•ń‘‚ĚŽĺ’Ł‚ÍŒťs‚Ě‹K’č‚đŠÜ‚ß‚˝‚ą‚̐­ô‘S‘̂ɑ΂ˇ‚é–â‘č’ń‹N‚Ć‚ľ‚ď\•Ş‚É—LŒř‚Ĺ‚ ‚é‚Ć•MŽŇ‚͍l‚ŚA‚ą‚Ě•ń‚ĹŽć‚čă‚°‚é‚ą‚Ć‚Ć‚ľ‚˝B •ń‘‚đ‘ă•\‚ľ‚˝6Šwp’c‘͉̂ş‹L‚Ě’Ę‚čB
AAA(ƒAƒƒŠƒJl—ŢŠw‰ď,the American Anthropological Association)/ AHA (ƒAƒƒŠƒJ—đŽjŠw‰ď,the American Historical Association)/ APSA (ƒAƒƒŠƒJ­ô‰ČŠw,the American Political Science Association)/ ASA (ƒAƒƒŠƒJŽĐ‰ďŠw, the American Sociological Association)/ OHA (Œűł—đŽjŠw,the Oral History Association)/ OAH (ƒAƒƒŠƒJ—đŽj‰Ć‹Ś‰ď,the Organization of American Historians)/ (http://www.oah.org/pubs/nl/2001aug/newsprof.html)ŽQĆB

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Œúś‰ČŠwR‹c‰ď‰ČŠw‹Zp•”‰ď(http://www.mhlw.go.jp/sNIHgi/2002/07/s0724-2.html)
ƒqƒgƒQƒmƒ€Eˆâ“`Žq‰đÍŒ¤‹†‚ÉŠÖ‚ˇ‚é—Ď—ŽwjiƒqƒgƒQƒmƒ€Eˆâ“`Žq‰đÍ‚ÉŠÖ‚ˇ‚é—Ď—R¸ˆĎˆő‰ď“o˜^ˆę——j(http://www2.ncc.go.jp/elsi/html/rinri_committee.htm)

’6@ ƒAƒƒŠƒJ”íŒąŽŇ•ŰŒě­ô‚É‚Í56 FR(Federal Regulation) 28003‚Ć‚˘‚¤’Ę‚ľ”ԍ†‚ނ‚Ż‚ç‚ę‚Ä‚˘‚éB

’7@u21 CFR 50 ‚¨‚ć‚Ń 56v‚͐ś•¨ˆăŠwŒnAH•iŒnŒ¤‹†‚Ĺ‚Íd—v‚Č”íŒąŽŇ•ŰŒě­ô‚Ě‹K’č‚Ĺ‚ ‚é‚ŞA‚ą‚Ě•ń‘‚ł͎Љď‰ČŠwŒn‚Ě”íŒąŽŇ•ŰŒě­ô‚ÉĹ“_‚đ“–‚Ä‚é‚˝‚ß“–ŠY‹K’č‚ɂ‚˘‚Ă͏ڂľ‚­G‚ę‚Č‚˘B’Žß47ŽQĆB
u21 CFR 50 ‚¨‚ć‚Ń 56v‚Í‚ť‚ę‚ź‚ęˆČ‰ş‚ĚƒTƒCƒg‚Ȃǂʼn{——‚Ĺ‚Ť‚éB 21 CFR 50(http://www.va.gov/orca/docs/compendium_1/Files/21CFR50.htm)/ 21 CFR 56( http://www.va.gov/orca/docs/compendium_1/Files/21CFR56.htm)
@‚Ü‚˝FDA‚É‚Í—Ő°ŽŽŒąŽŔŽ{‚ÉŠÖ‚ˇ‚éŠî€iGCPj‚Ć‚˘‚¤Œ¤‹†ŽŇ‚â‚ť‚ĚŽx‰‡ŽŇ‚â’c‘Ě‚Ě‹K’čW‚Ş‚ ‚éBGCP‚𕁋y‚ł‚š‚悤‚Ć‚˘‚¤ŒoˆÜ‚̓ˆ[ƒƒbƒpŠe‘‚â“ú–{‚Ĺ‚ŕ‹N‚ą‚č‚‚‚ ‚čA“ú•Ä‰˘ˆă–ň•i‹K§ƒn[ƒ‚ƒiƒCƒ[[ƒVƒ‡ƒ“‘Ű‰ď‹ciICHj‚ĆŒÄ‚Î‚ę‚Ä‚˘‚éB

’8@DHHS(http://ohrp.osophs.dhhs.gov/humansubjects/assurance/filasurt.htm)‚đŽQĆB

’9@ ‚ą‚Ě‹K’č‚Í1981”N‚ɐ§’č‚ł‚ę‚Ä‚Š‚ç1983, 1989, 1991”N‚ɉü’ů‚ł‚ę‚Ä‚¨‚čAŒťÝ‚Í2001”N”Ĺ‚ŞĹV‚Ě‹K’č‚Ĺ‚ ‚éB‚ą‚ĚÍ‚Ĺ‚Ě"the Common Rule"‚Í2001”N‰ü’ůiŒťsj‚Ě‹K’č‚đŽQl‚É‚ľ‚Ä‚˘‚éBUniversity of Wisconsin (http://www.uwgb.edu/irb/current_regulations.htm)‚đŽQĆ‚ľ‚˝B
‚Ü‚˝45CFR46‚Ě–{•ś‚Í‘˝”‚ĚƒTƒCƒg‚ʼn{——‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éB OHRP(Office on Human Research Protection) (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm)/ Harvard Univ.( http://www.fas.harvard.edu/%7Eresearch/45CFR46.html)/ The University of Michigan Health System(http://www.med.umich.edu/irbmed/FederalDocuments/hhs/HHS45CFR46.html)

’10@ 45CFR46‚đ‹¤’Ę‹K’č‚Ć‚ľ‚ÄĚ—p‚ľ‚˝16‚Ě˜A–M­•{‹@ŠÖ‚͉ş‹L‚Ě’Ę‚č‚Ĺ‚ ‚éB
U.S. Agency for International Development/ Consumer Product Safety Commission/ U.S. Department of Agriculture/ U.S. Department of Commerce/ U.S. Department of Defense/ U.S. Department of Education/ U.S. Department of Energy/ U.S. Department of Health and Human Services/ Centers for Disease Control/ Food and Drug Administration/ Office of the Secretary/ National Institutes of Health/ U.S. Department of Housing and Urban Development/ U.S. Department of Justice/ U.S. Department of Veterans Affairs/ U.S. Department of Transportation/ Environmental Protection Agency/ National Aeronautics and Space Administration/ National Science Foundation/

’11@ 45CFR46‚ĚSubpart A‚ÍĹ‚ŕ’†S‚Ć‚Č‚é‹K’č‚Ĺ‚ ‚é‚ŞA‚ť‚Ě‚Ů‚Š‚É“Á’č‚Ě”íŒąŽŇ‰ž‚ś‚ÄSubpartB,C,D‚Ş‚ ‚éBSbpartB,C,D‚Í‚ť‚ę‚ź‚ę‘ŮŽ™(fetuses)‚ƐVśŽ™(neonates)‚Ć”D•w(pregnant women)A•ž–đŽú(prisoners)AŽq‹Ÿ(Children)‚ƐeŽq‚Ü‚˝‚ÍŽq‹Ÿ‚Ć‚ť‚Ě•ŰŒěŽŇ(their parents or guardians)‚Ş”íŒąŽŇ‚Ć‚Č‚éę‡‚Ě‹K’č‚Ĺ‚ ‚éB‚ą‚ę‚ç‚Ě‹K’č‚Ĺ’č‚ß‚ç‚ę‚Ä‚˘‚él‚đŠÜ‚ß‚Ä”íŒąŽŇ•ŰŒě­ô‚Ĺ‚Í”íŒąŽŇ‚ĚŽŠŒČŒˆ’č‚Ş—eˆŐ‚ɍs‚Ś‚Č‚˘‚Ćœu“x‚ł‚ę‚élX‚đu‚‚Ť‚₡‚˘vlX(vulnerable people)‚Ć‚ľ‚Ä‹K’č‚ľ‚Ä“Á•Ę‚Č”z—ś‚đ‚ˇ‚é‚悤–ž‹L‚ľ‚Ä‚˘‚éB
‚Ü‚˝@"the Common Rule"‚ÍSubpart A‚Ě‚Ý‚đ‹¤’Ę‹K’č‚Ć‚ľ‚Ä‚˘‚é‚̂ŁA“Á•Ę‚É‚Ů‚Š‚ĚSubpart‚đĚ‘đ‚ľ‚Ä‚˘‚Č‚˘ŒŔ‚čSubpart B,C,D‚đ…Žç‚ˇ‚é‹`–ą‚Í‚Č‚˘B‚˝‚ž‚ľSubpart A‚Ě’†‚É‚ŕu‚‚Ť‚₡‚˘vlX‚ɑ΂ˇ‚é”z—ś‹`–ą‚Ş–ž‹L‚ł‚ę‚Ä‚˘‚éB

’12@ (45CFR46.122)‚ć‚蔲ˆB(Use of Federal funds)Federal funds administered by a Department or Agency may not be expended for research Involving human subjects unless the requirements of this policy have been satisfied. (45CFR46.122)‚ć‚蔲ˆB

’13@(45CFR46.102)‚ć‚蔲ˆBHuman subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

’14@‚ť‚Ě‚Ů‚Š‚É‚ŕ˜A–M­•{‹@ŠÖ‚Ě’ˇ‚ŞĹI“I‚Č”ť’f‚đ‰ş‚ˇŒ ŒŔ‚đŽ‚Â‚ą‚Ć‚âA’˛¸EŒ¤‹†‚ŞŽŔŒą‚Ě“ŕ—e‚ޏB–@‚ť‚Ě‘ź‚Ě–@—Ľ‚Éˆá”˝‚ľ‚Č‚˘‚ą‚ƁA‚Ü‚˝ŠCŠO‚Ĺ’˛¸EŒ¤‹†‚ɂ‚˘‚Ä‚Č‚Ç‚Ě—áŠO‹K’č‚Ş‚ ‚éB

’15@45CFR46.111i2jŽQĆ

’16@ NSF‚É‚ć‚éFrequently Asked Question(http://www.nsf.gov/bfa/dga/policy/hsfaqs.htm)ŽQĆ

’17@ 45CFR46.110ŽQĆ

’18@ ‚ľ‚Š‚ľ‚ą‚̐lˆő”z’uu•Î‚čv‚Ě‚Č‚ł‚ށu•Î‚čv‚ž‚Ć‚ľ‚ÄŒăq‚ˇ‚éAAAU‚ĚƒŠƒ|[ƒg‚Ĺ‚Í–â‘莋‚ł‚ę‚éiŒăq‚ĚAAUP•ń‘‚đŽQĆBjB‹K’č‚É‚ć‚é‚Ć IRB‚̍\Źˆő‚Í5lˆČă‚Ĺ‚ ‚é‚ą‚ƁBŽĐ‰ď“IŤ•Ę(gender)AlŽíAŽĐ‰ď“I—š—đ‚Ȃǂɕ΂肪‚Č‚˘‚悤l—ś‚ˇ‚é‚ą‚ƁBR¸‚ˇ‚é‚Ě‚É\•Ş‚ČŒŠŽŻ‚đŽ‚żA”íŒąŽŇ‚ĚŒ —˜‚Ć•ŸŽƒ‚đ‘i‚ł‚š‚é•Ş•Ę‚đŽ‚Á‚Ä‚˘‚é‚ą‚ƁB‰ČŠw‚đęU‚ˇ‚éŽŇ‚ƐęU‚ľ‚Č‚˘ŽŇ‚Ş‚ť‚ę‚ź‚ęĹ’á1–ź‚˘‚é‚ą‚ƁBe‘°‚đŠÜ‚ߌ¤‹†‹@ŠÖ‚Ě•”ŠOŽŇ‚ŞĹ’á1–ź‚˘‚é‚ą‚ƁBR¸‚ˇ‚éŒv‰ć‚É—˜ŠQ‚Ě‚ ‚é‚ŕ‚Ě‚đœ‚­‚ą‚Ć‚Č‚Ç‚Ş’č‚ß‚ç‚ę‚Ä‚˘‚éi45CFR46.107‚đŽQĆjB

’19@ŽĐ‰ď‰ČŠwŒn‚ĚŠwp’c‘Ě‚ÍƒtƒB[ƒ‹ƒhƒ[ƒN‚âƒCƒ“ƒ^ƒ”ƒ…[’˛¸‚Ş”íŒąŽŇ‚Ö‚ĚƒŠƒXƒN‚ŞŒŔ‚č‚Č‚­­‚Č‚˘‚ą‚Ć‚ž‚Ć‚ľ‚āA‚ą‚ę‚ç‚ĚŒ¤‹†Œv‰ć‚đv‘ŹR¸Žč‘ą‚Ť‚Ě‘ÎŰ‚Ć‚ľ‚Ä—v‹‚ľ‚Ä‚˘‚éB

’20@OHRP(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htmj/ Stanford@Univ.(http://www.stanford.edu/dept/DoR/hs/admin/index.html)/ EML(Environmental measurements Laboratory)(http://www.eml.doe.gov/hsrd/)/ NIH(http://grants1.nih.gov/grants/policy/hsrea/hsrea.htm#queries)
Wisconsin-Madison Univ.(http://www.rsp.wisc.edu/html/queries.html)ŽQĆ ‚Ü‚˝ŠeŒ¤‹†‹@ŠÖ‚ĚƒEƒFƒuă‚Ĺ‚Ěî•ń”­M‚ɂ‚˘‚Ä‚Í‘ć‚TÍŽQĆB

’21@ ‹K’č‚É‚ÍIRB‚Ş‘Ă“–‚ČƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ĺ‚ ‚é‚Ć”ť’f‚ˇ‚éŠî€‚Ć‚ľ‚āA”íŒąŽŇ‚Ö‚ĚƒŠƒXƒN‚ŞĹŹŒŔ‚É‚Ć‚Ç‚ß‚ç‚ę‚Ä‚˘‚é‚ŠA”íŒąŽŇ‚ĚŒ —˜‚Ć•ŸŽƒ‚É”˝‚ľ‚Č‚˘‚ŠAŽQ‰ÁŒă‚É”íŒąŽŇ‚É‚Í“K‹Xd—v‚ȏî•ń‚Ş’ń‹Ÿ‚ł‚ę‚é‚Ě‚Š‚Č‚Ç‚Ş‹“‚°‚ç‚ę‚Ä‚˘‚éB‚ą‚Ě‚Ů‚Š‚É‚ŕƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ޘA–M–@AB–@A’n•ű‚Ě–@—Ľ‚É”˝‚ˇ‚é‚ŕ‚Ě‚Ĺ‚Č‚˘‚ą‚ƁB˜A–M–@AB–@A’n•ű‚Ě–@—Ľ’č‚ß‚é”͈͓ŕ‚Ĺ“ŕ‰Čˆă‚É‹–‚ł‚ę‚Ä‚˘‚鉞‹}ˆ’u‚ĚŒ ŒŔ‚đ–W‚°‚é‚ŕ‚Ě‚Ĺ‚Í‚Č‚˘‚ą‚ƁB•Ę‚̍€–ڂɂ͏B­•{‚â’n•ű­•{‚ŞŒö‹¤“I‚Č—˜‰v‚đ–Ú“I‚Ć‚ˇ‚é‚˝‚ß‚É‹–‰Â‚ľ‚˝ƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ɂ‚˘‚Ä‚Ě—áŠO‹K’č‚Ş‚ ‚éB46.116ŽQĆ

’22@45CFR46.120‚đŽQĆB—áŠO“IŽ–—á‚Ć‚ľ‚āAƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě•ś‘‰ťŽč‘ą‚Ť‚đ“Ľ‚Ţ‚ą‚Ć‚É‚ć‚Á‚ĐM—ŠŠÖŒW‚Ş‘š‚Č‚í‚ę‚é‰Â”\Ť‚Ş‚ ‚éę‡A‚Ü‚˝”íŒąŽŇ‚É‚Ů‚Ć‚ń‚ǃŠƒXƒN‚Ş”ş‚í‚Č‚˘ŽŔŒą‚Ěę‡‚âA•ś‘‚É‚ć‚é“ŻˆÓ‚Ş’˛¸‚Ě•ś–Ź‚Ĺ‚ ‚éę‡‚Č‚Ç‚Ş‹“‚°‚ç‚ę‚Ä‚˘‚éB

’23@45CFR46.302 Purpose@ŽQĆ

’24@”íŒąŽŇ•ŰŒě­ô‚Ě”wŒi‚Ć‚Č‚Á‚Ä‚˘‚él‘ĚŽŔŒą‚ł́u‚‚Ť‚₡‚˘lXv‚Ş”ńŽŠ”­“I‚É”íŒąŽŇ‚Ć‚ł‚ę‚Ä‚Ť‚˝B‚ą‚¤‚ľ‚˝ŒoˆÜ‚ɂ‚˘‚Ä‚Í‘ć‚UÍŽQĆB

’25@’Žß‚PŽQĆ

’26@NIH(http://cme.cancer.gov/c01/)/ Stanford Univ.(http://humansubjects.stanford.edu/education/)/ Florida Univ.(http://irb.ufl.edu/education/needsassess.htm)/ Nebraska Univ.(http://www.unmc.edu/irb/education/)/ Yale Univ.(http://info.med.yale.edu/irbtraining/)/ Indiana Univ(http://www.iupui.edu/~resgrad/Human%20Subjects/HumanSubjectsCourse.html/ Washington Univ.(http://www.washington.edu/research/gci/)/ California Univ()http://www.rgs.uci.edu/researchprotections/irb/trainingandeducation.htm)/ Danya International, Inc.(http://www.theresearchassistant.com/research/intro.asp)/ University of Rochester Medical Center(http://www.urmc.rochester.edu/datalab/datareq.htm)/ DOE(Department of Energy) (http://www.er.doe.gov/production/ober/humsubj/index.html)/ Johns Hopkins University School of Medicine (http://www.hopkinscme.org/cme/events/core.html)‚Č‚ÇŽQĆB

’27@CITI(http://jaguar.ir.miami.edu/~citireg/citi_information.html)ŽQĆ

’28@NIH (http://grants1.nih.gov/grants/policy/hsrea/hsrea.htm)

’29@‚ą‚ĚÍ‚Ě—đŽj“IŒoˆÜ‚ɂ‚˘‚Ä‚ÍˆČ‰ş‚ĚƒTƒCƒg‚đŽQl‚É‚ľ‚Ä‚˘‚éB‚ą‚Ě‚Ů‚Š‚ą‚ĚÍ‚Ě•Ę‚Ě’Žß‚Ĺ‚ĚƒŠƒ“ƒNć‚đŽQĆ‚ľ‚˝B
the American Association for the Advancement of ScienceiAAASj(http://www.aaas.org/spp/cstc/briefs/humsub/humsublinks.shtml)/ Alliancefor Human Research Protection (http://www.researchprotection.org/history/chronology.html)/ American Political Science Association (APSA)(http://www.apsanet.org/PS/june01/hauck.cfm)/ American Sociological Association (ASA net)(http://www.asanet.org/media/report0201.html)/ Centers for Disease Control and Prevention (http://www.cdc.gov/nchstp/od/tuskegee/time.htm)/ Delaware Univ.(http://www.udel.edu/OVPR/humans/history.html)/ Eastern Michigan Univ.(http://www.rcr.emich.edu/module1/a_7part1.html)/ Emory Univ.(http://www.emory.edu/ACAD_EXCHANGE/2002/aprmay/humsubj.html)/ Indiana Univ.(http://www.iupui.edu/~resgrad/Human%20Subjects/ethics3A.html)/ Minnesota Univ.(http://www.research.umn.edu/consent/mod1med/mod1sec4.html)/ Nebraska Univ.(http://www.unmc.edu/irb/source_documents/faqoprr.htm)/ Public Broadcasting Service (PBS)(http://www.pbs.org/newshour/bb/health/jan-june00/gene_therapy_2-2.html)/ Sherman, Silverstein, Kohl, Rose & Podolsky(law Office)(http://www.sskrplaw.com/bioethics/chronology.html)/ Stanford Univ.(http://www.stanford.edu/dept/DoR/hs/History/his01.html)(http://humansubjects.stanford.edu/manual/chapters/ch2_1a_ethics.html)/ The National Coalition for PKU & Allied Disordersihttp://www.pku-allieddisorders.org/research2.htm/ WasNIHgton Univ.(http://courses.wasNIHgton.edu/pabio550/Tuskegee%20Study.htm)

’30@Stanford Univ.(http://humansubjects.stanford.edu/manual/chapters/ch1_2a_intro.html)ŽQĆB

’31@ (http://www.udel.edu/OVPR/humans/history.html)ŽQĆ

’32@­•{‚Ş”íŒąŽŇ•ŰŒě­ô‚đŠg’Ł‚ľ‚Ä‚˘‚­‰ß’ö‚Í(http://pw2.netcom.com/~alalli/BillSite_analysis/cr_chaange/html)ŽQĆ

’33@ƒjƒ…ƒ‹ƒ“ƒxƒ‹ƒNŮ”ť‚ɂ‚˘‚Ä‚Í(http://law.umkc.edu/faculty/projects/ftrials/) (http://www.jlaw.com/Articles/NaziMedEx.html)ŽQĆ

’34@ 1948”N‚É‹N‘‚ł‚ę‚˝‚Ć‚ˇ‚鎑—ż‚ŕ‚ ‚éB ƒjƒ…ƒ‹ƒ“ƒxƒ‹ƒNEƒR[ƒhˆČ‘O‚Š‚çA‹L˜^‚ÉŽc‚ł‚ę‚Ä‚˘‚é‚ž‚Ż‚Ĺ‚ŕ‚¨‚Ń‚˝‚ž‚ľ‚˘”‚̐l‘ĚŽŔŒą‚ލs‚í‚ę‚Ä‚Ť‚˝Bul“šă‚̍߁v‚Ć‚˘‚¤‚ą‚Ƃ΂Ől‘ĚŽŔŒą‚ށu‘Ű“Iv‚Č–â‘č‚ÉŽć‚čă‚°‚ç‚ę‚˝‚̂́Aí‘ˆ‚̏ŸŽŇ‚Ş”sŽŇ‚đŮ‚­‰ß’ö‚Ĺ‹N‚Ť‚˝‚ą‚Ć‚É’–Ú‚ˇ‚ׂŤ‚Ĺ‚Í‚Č‚Š‚낤‚ŠB‚Ü‚˝ƒiƒ`ƒX‚Ć“ú–{ŒR‚̐l‘ĚŽŔŒą‚ĆŒoˆÜ‚ɂ‚˘‚Ä‚Í“y‰Ž ‹MŽuEƒCƒ“ƒ^[ƒlƒbƒguŔ ul‘ĚŽŔŒą‚Ě—Ď—Šwv(http://www.lit.osaka-cu.ac.jp/~tsuchiya/index.html)‚đŽQĆ‚ľ‚˝B

’35@ ‚ť‚Ě‚Ů‚Š‚ɏ\•Ş‚ɐŹ‰Ę‚ĚŠú‘Ň‚Ĺ‚Ť‚錋‰Ę‚ÉŠî‚Ă‚˘‚˝Œ¤‹†Œv‰ć‚Ş—§‚Ä‚ç‚ę‚é‚ׂŤ‚Ĺ‚ ‚čAŒ¤‹†‚đ‚¨‚ą‚Č‚¤‚¤‚Ś‚Ĺ‚Ě‹`–ą‚Ć”íŒąŽŇ‚Ě•ŸŽƒ‚đ•ŰŒě‚ˇ‚é‚˝‚ß‚ĚŒ¤‹†ŽŇ‚̐ӔC‚ɂ‚˘‚ÄŒž‹y‚ł‚ę‚Ä‚˘‚éB‘ć‚QđˆČ‰ş‚ĚŠT—v‚ÍŽŸ‚Ě’Ę‚čB‚QDŽĐ‰ď‚Ě‘P‚É‚Ć‚Á‚Ä—L‰v‚ČŒ‹‰Ę‚Ş‚ŕ‚˝‚ç‚ł‚ę‚éŽŔŒąE’˛¸B‚RAl‘ĚŽŔŒą‚ɐ旧‚Á‚Ä“Ž•¨ŽŔŒą‚â‘O’ń’mŽŻ‚ÉŠî‚Ă‚­‚ą‚ƁB‚SD¸_“IA“÷‘Ě“I‚Ö‚Ě•s•K—v‚ȉÁŠQ‚Ě‹ÖŽ~B‚TD’v–˝“I‚ČŽŔŒą‚Ě‹ÖŽ~B‚UDl“š“Id—vŤ‚đˆí’E‚ľ‚˝ŽŔŒą‚Ě‹ÖŽ~B‚VD”íŒąŽŇ•ŰŒě‚Ě‚˝‚ß‚Ě\•Ş‚ČŽ–‘O€”őB‚WD‚“x‚Ě‹Zp‚Ć”z—ś‚Ě•K—vŤB‚XD”íŒąŽŇ‚̐¸_“IA“÷‘Ě“Ió‹ľ‚đ——R‚Ć‚ľ‚Ä”íŒąŽŇ‚ŞŽŔŒą’†Ž~‚đŒˆ‚ß‚ç‚ę‚é‚ą‚ƁB10D‚Ç‚Ě’iŠK‚É‚¨‚˘‚Ä‚ŕŽŔŒą‚Ě’†Ž~‚Ş‚Ĺ‚Ť‚鎖‘O€”őB

’36@ ‚ž‚Ş‚ą‚ĚƒR[ƒh‚Ě•śÍ‚Ĺ‚Í"Informed consent"‚â"Ethic(s)"‚Ć‚˘‚¤Œę‚Í—p‚˘‚ç‚ę‚Ä‚˘‚Č‚˘

’37@ American Anthropological Association(http://www.aaanet.org/committees/ethics/ethics.htm)/ American Association for Public Opinion Research (http://www.aapor.org/default.asp?page=survey_methods/standards_and_best_practices)/ American Historical Association.(http://www.theaha.org/PUBS/STANDARD.htm)/ American Sociological Association (http://www.asanet.org/members/ecoderev.html)/ National Association of Social Workers(http://www.socialworkers.org/pubs/code/default.asp)/ Oral History Association (http://omega.dickinson.edu/organizations/oha/pub_eg.html)/ Society for ResearcNIH Child Development (http://www.srcd.org/about.html#standards)
‚Ü‚˝Society of Professional Journalists (http://www.spj.org/ethics.asp)‚ɂ̓tƒB[ƒ‹ƒhƒ[ƒN‚âƒCƒ“ƒ^ƒ”ƒ…[‚ɂ‚˘‚Ä‚ĚÚ×‚ČŽwj‚ŞŒfÚ‚ł‚ę‚Ä‚˘‚éB “Ż—l‚ÉAmerican Psychological Association(http://www.apa.org/ethics/)‚É‚ŕ“Ž•¨ŽŔŒą‚â“d˜bAƒCƒ“ƒ^[ƒlƒbƒg‚đ’Ę‚ś‚˝ƒCƒ“ƒ^ƒ”ƒ…[‚ɂ‚˘‚Ä‚ĚŽwj‚ŞŒfÚ‚ł‚ę‚Ä‚˘‚éB

’38@ ƒLƒƒƒƒƒbƒgŒv‰ć‚Ć‚ÍƒAƒƒŠƒJ—¤ŒR‚ރˆ[ƒƒbƒp”‘‚¨‚ć‚ŃƒAƒWƒAƒAƒtƒŠƒJ31ƒJ‘‚ĹŠv–˝‚â“ŕ—‚Č‚Ç‚Ş‹N‚ą‚é‰Â”\Ť‚Ɛ­•{‚Ş‚ť‚ę‚đ’Áˆł‚ˇ‚é—Í‚đŽ‚Â‚Š‚Ç‚¤‚Š‚Ě•ŞÍ‚đ—\‘Ş‚ˇ‚éŒv‰ć‚Ĺ‚ ‚Á‚˝Bƒxƒgƒiƒ€í‘ˆ‚É‚¨‚Ż‚é“ŕ—‚Ě•ŞÍ‚É‚Í‘˝‚­‚̎ЉďŠwŽŇ‚Ş“Žˆő‚ł‚ę‚˝B‚ą‚ĚŒv‰ć‚Ş”­Šo‚ˇ‚é‚ĆƒAƒƒŠƒJl—ŢŠw‰ď‚ȂǎЉď‰ČŠwŒn‚ĚŠwp’c‘Ě‚Í‚ą‚ę‚đ”ᔝ‚ľŒv‰ć‚͓ڍÁ‚ľ‚˝B
’r“c@Œő•ä(uŒ’N‚ĚŠJ”­vŽj\\ˆă—ĂŽx‰‡‚Ɖž—pl—ŢŠw)(http://www.let.kumamoto-u.ac.jp/cs/cu/dhealth.html)
ƒ‰ƒeƒ“ƒAƒƒŠƒJ‚̐­ŽĄ(http://www10.plala.or.jp/shosuzki/chronology/chile/chile2.htm)‚đŽQĆ‚ľ‚˝B‚ľ‚˝B
Harvard Univ.(http://www.hsph.harvard.edu/bioethics/guidelines/ethical.html)‚đŽQĆ‚ľ‚˝B
‚Ü‚˝1968”N‚É‚ÍOHA(Oral History Association)‚ރCƒ“ƒ^ƒ”ƒ…[‚É‚¨‚Ż‚é”íŒąŽŇ‚Ö‚Ě—Ď—“I”z—ś‚đŠÜ‚ß‚˝Žwj‚đ’č‚ß‚Ä‚˘‚éB

’39@ ƒTƒŠƒhƒ}ƒCƒh–ň(thalidomide)‚Í–{—ˆ‚Ä‚ń‚Š‚ńŠłŽŇ‚̍Rázš–ň‚Ć‚ľ‚Đť‘˘‚ł‚ę‚˝–ň‚Ĺ‚ ‚éB‚ą‚ę‚đ•ž—p‚ľ‚˝”D•w‚Š‚琜‚Ü‚ę‚˝—cŽ™‚ĚŽč‘Ť‚ŞŠďŒ`‰ť‚ˇ‚éÇó‚Ş”­Šo‚ľA–â‘艝‚ľ‚˝BƒAƒƒŠƒJ‚Ĺ‚Í–ń12,000l‚Ě—cŽ™‚ɏáŠQ‚Ş•\‚ę‚˝‚Ć‚˘‚í‚ę‚Ä‚˘‚éB ˛“ĄŽ^ŽĄd-inf.org (http://d-inf.org/drug/yakugai3.html) .Indiana Univ. (http://www.iupui.edu/~resgrad/Human%20Subjects/ethics3A.html)‚đŽQĆ‚ľ‚˝B

’40@ ƒwƒ‹ƒVƒ“ƒLéŒž‚Í‚ť‚ĚŒă1983,1989,1996,2000,2002”N‚ɉü’ů‚ł‚ę‚ÄŒťÝ‚ÉŽŠ‚Á‚Ä‚˘‚éB‚ą‚ĚéŒžĚ‘đ‘‚Ěś•¨ˆăŠw‚ĚŒ¤‹†‚ł́A”íŒąŽŇ‚ĚŒ —˜‚Ć•ŸŽƒ‚Ş•ŰŒě‚ł‚ę‚Ä‚˘‚é‚Š‚ɂ‚˘‚Ä‘ćŽOŽŇˆĎˆő‰ď‚Ě”FŘAŽ–‘O‚Ě“Ž•¨ŽŔŒąA\•Ş‚ČƒCƒ“ƒtƒH[ƒ€ƒhƒRƒ“ƒZƒ“ƒgA”ń‰c—˜–Ú“I‚Č‚Ç‚Ş‹`–ą•t‚Ż‚ç‚ę‚˝B
Œ´•ś‚đ‰ş‹LƒTƒCƒg‚Ů‚Š‘˝”‚ʼn{——‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éB(http://www.windsor.igs.net/%7Enhodgins/helsinki.html)/ WMA(Medical Associations)(http://www.wma.net/e/policy/b3.htm)/ CIRP(The Circumcision Information and Resource Pages)(http://www.cirp.org/library/ethics/helsinki/)
‚Ü‚˝ƒwƒ‹ƒVƒ“ƒLéŒž‚͍Ą“ú‚Ĺ‚ŕś•¨ˆăŠwŒ¤‹†‚ĚŽwj‚Ć‚ľ‚čL‚­ŽQĆ‚ł‚ę‚Ä‚˘‚éB1993”N‚ɂ͍‘Űˆă‰ČŠw‹@\•]‹c‰ďiCIOMSj‚É‚ć‚Á‚Ä”íŒąŽŇ‚𔺂¤ś•¨ŽŔŒą‚̍‘Ű“I—Ď—Žwj‚Ş”­•\‚ł‚ę‚˝B‚ą‚ę‚̓wƒ‹ƒVƒ“ƒLéŒž‚đŽó‚Ż‚Ä”­“W“ră‘‚Ĺ‚Ě”íŒąŽŇ‚𔺂¤’˛¸EŒ¤‹†‚ɂ‚˘‚Ä‚Ě—Ď—Žwj‚Ĺ‚ ‚éBłŽŽ–źĚInternational Ethical Guidelines for Biomedical Research@involving Human Subjects (http://www.cioms.ch/frame_1993_texts_of_guidelines.htm)ŽQĆB

’41@SAN DIEGO STATE UNIV.(http://gra.sdsu.edu/cphs/tutorial/m2s2.htm)‚đŽQĆ‚ľ‚˝B

’42@l‘ĚŽŔŒą‚Ě—đŽj‚ɂ‚˘‚Ä(http://www.dc.peachnet.edu/~shale/humanities/composition/assignments/experiment.html)/ Japan-lifeissues (http://www.japan-lifeissues.net/writers/kee/kee_01cloningandchurch-ja.html)/ CCD(http://www.cdc.gov/nchstp/od/tuskegee/time.htm)‚Č‚Ç‚đŽQĆ‚ľ‚˝B

’43@Œ´•ś‚ÍOHRP(http://CCD(http://www.cdc.gov/nchstp/od/tuskegee/time.htm)ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)‚Ȃǂʼn{——‚ˇ‚é‚ą‚Ć‚Ş‚Ĺ‚Ť‚éB‚Ü‚˝•ń‘‚ɂ‚˘‚Ä‚Ě‹c˜_‚̓Xƒ~ƒ\ƒjƒAƒ“Eƒxƒ‹ƒ‚ƒ“ƒgEƒJƒ“ƒtƒ@ƒŒƒ“ƒXEƒZƒ“ƒ^[‚ōs‚í‚ę‚˝‚˝‚߃xƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚Ć–˝–ź‚ł‚ę‚˝B
ƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚̍\Ź

Ethical Principles and Guidelines for ResearcNIHvolving Human Subjects

Boundaries between Practice and Researchi’˛¸‚ĆŽŔ‘HiŽĄ—Áj‚Ć‚Ě‚ ‚˘‚ž‚̐üˆř‚Ťj

Basic Ethical Principlesi—Ď—‚ĚŠî–{Œ´‘Ľj
1.Respect for PersonsilŠi‚Ě‘¸dj
2.Beneficencei•Ö‰vEŽœ”߁Hj
3.Justiceił‹`j

Applicationsi‰ž—pj

Informed Consentiŕ–ž‚đŽó‚Ż‚˝ă‚Ĺ‚Ě“ŻˆÓj

Assessment of Risk and BenefitsiƒŠƒXƒN‚Ć•Ö‰v‚Ě•]‰żj

Selection of Subjectsi”íŒąŽŇ‚Ě‘Ioj

’44@the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research‚Í1974 ”N‚Š‚ç1978”N‚Ü‚Ĺ‚ĚŠúŠÔ‚Ě’č‚ß‚ç‚ę‚˝ˆĎˆő‰ď‚ž‚Á‚˝B

’45@ ƒxƒ‹ƒ‚ƒ“ƒgEƒŒƒ|[ƒg‚Ć45CFR46‚Ć‚ĚŠÖ˜A‚ɂ‚˘‚ẮANSF‚É‚ć‚éFrequently Asked Questions(FAQ)‚đŽQĆ‚ľ‚˝B (http://www.nsf.gov/bfa/dga/policy/hsfaqs.htm)B

’46@"Beneficence"‚Ěˆę”Ę“I‚Č–óŒę‚́u‘Ps@‰śŒb@Žœ‘P@Ž{‚ľ•¨v‚Č‚Ç‚Ć‚ł‚ę‚Ä‚˘‚éB‚ž‚Ş“ŕ—e‚Š‚çĆ‚ç‚ľ‚Ä‚Ý‚é‚ƍŏŹ‚ĚƒŠƒXƒN‚Š‚çĹ‘ĺŒŔ‚Ě•Ö‰v(benefit)‚đ“ž‚é‘‡“I‚Č•Ö‰v‚đ•]‰ż‚ľ‚Ä‚˘‚é‚˝‚߁A"benefit"‚Ě–źŽŒŒ`‚Ć‚ľ‚Ä‚ť‚̂܂܁u•Ö‰vv‚Ć‚ľ‚˝B

’47@‚ť‚ę‚Ć“ŻŽž‚ɃCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě–Ćœ‹K’č‚ŕ‚Ü‚˝ě‚ç‚ę‚Ä‚˘‚éB

’48@Stanford Univ.‚Ěƒy[ƒW‚đŽQĆ‚ľ‚˝B(http://humansubjects.stanford.edu/manual/chapters/ch2_2c_ethics.html)

’49@‚Ü‚˝‚ą‚Ě”N(1991”N)‚É‚ÍFDA (H•iEˆă–ň•i‹ÇFthe Food and Drug Administration)‚É‚ć‚Á‚Ä"the Common Rule"‚Ć‚Í“Ć—§‚ľ‚˝‹K’č‚Ĺ‚ ‚éu21 CFR 50 and 21 CFR 56v‚ސ§’č‚ł‚ę‚˝B‚ą‚ę‚Í–ň•iAś•¨ťÜA‚ť‚ę‚ç‚ÉŠÖ˜A‚ˇ‚é‘•’u‚đˆľ‚¤”íŒąŽŇŒ¤‹†‚É“K—p‚ł‚ę‚é‹K’č‚Ĺ‚ ‚éB’Žß7ŽQĆB 45CFR46‚Ć‚Ěˆá‚˘‚Í‚PD’˛¸‚ˇ‚él‚ŞIRB‚đ’Ę‚ł‚¸‚ÉFDA‚É’źÚ”FŘ‚đŽó‚Ż‚é‚ą‚ƁA‚QDIRB‚Ě‹K’č‚ć‚č‚ŕFDA‚Ě‹K’č‚ŞŒľŠi‚Ĺ‚ ‚é‚ą‚ƁBƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚ÉŠY“–‚ˇ‚é’˛¸‚Ě“ŕ—eAŽč‘ą‚Ť‚É—v‹‚ł‚ę‚é“ŕ—e‚âŽč‡‚Ě‘ŠˆáA‚RD[‚ĹŒp‘ą“I‚ȏ…Žçˆá”˝‚ÍŒYŽ–”ą‚Ě‘ÎŰ‚Ć‚Č‚é‚ą‚ƁBFDA‚ŞIRB‚â’˛¸ŽŇ‚𒟐ڎ撲‚ׂłŤ‚é‚ą‚Ć‚Č‚Ç‚Ş‚ ‚éB ‚Ü‚˝1994”N‚É‚ÍFDA”F‰Â‚ľ‚˝ƒqƒgˆâ“`Žq‘g‘Ö‚ŚŽŔŒą‚Ě•ń‚ĆƒCƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒg‚Ě‹`–ą‚Ş–Ćœ‚ł‚ę‚Ä‚˘‚éB

’50@ABCNEWSCOM(http://abcnews.go.com/sections/living/DailyNews/duke_humantests990512.html)/ wasnihgtonpost.com (http://www.wasNIHgtonpost.com/wp-srv/national/daily/may99/duke12.htm) ŽQĆB

’51@‚ą‚ĚŽ–Œ‚ĚŒoˆÜ‚ɂ‚˘‚Ä‚ÍˆČ‰ş‚ĚƒTƒCƒg‚đŽQĆ‚ľ‚˝B Public Broadcasting Service (PBS).(http://www.pbs.org/newshour/bb/health/jan-june00/gene_therapy_2-2.html)

’52@2001”N‚É‚ÍPublic Health Security and Biothrrorism Response Act of 2001‚ސ§’č‚ł‚ę‚Ä‚˘‚éB‚ť‚ę‚É‚ć‚é‚ĆHHS‚͐V–ň‚¨‚ć‚ѐś‘Ě‚ÉŠÖ‚ˇ‚é–ň‚̐ť‘˘‚đ”F‚ß‚éŽč‡‚đ–@§‰ť‚ˇ‚é‚ą‚Ć‚Ş‹L‚ł‚ę‚Ä‚˘‚éB

’53@ Emory@Univ.( http://www.emory.edu/EMORY_REPORT/erarchive/2001/August/erAug.6/8_06_01research.html)/ FDA(http://www.fda.gov/fdac/features/2001/501_john.html)

’54@ AAAS(http://www.aaas.org/spp/cstc/briefs/humsub/) Emory Univ..(http://www.emory.edu/ACAD_EXCHANGE/2002/aprmay/humsubj.html) ŽQĆ

’55@ the Association for the Accreditation of Human Research Protection Programs, Inc.(http://www.aahrpp.org/index.html)

’56@ ‚SÍ‚ĚAAUP‚Ě•ń‘ŽQĆB

’57@‚ą‚ĚŽ–Œ‚Ě”­ŠoˆČ‘O‚Š‚çIRBR¸§“x‚Ě‹@”\•s‘S‚ÍŽw“E‚ł‚ę‚Ä‚˘‚˝B1996”N‚ɂ͉ďŒvŒŸ¸‰@(The General Accounting Office :GAO: http://www.gao.gov/)‚ÍŒ¤‹†ŽŇ‚ĚŽŠŒČł”F‚Ɉˋ’‚ľ‚Ä‚˘‚鐧“x‚đ–â‘莋‚ˇ‚é‚Ć‚Ć‚ŕ‚ɁA”íŒąŽŇ‚𔺂¤Œ¤‹†‚ÉŒxŕ‚đ–‚炾‚‚ÂŻ‚é•K—vŤ‚đŽw“E‚ľ‚Ä‚˘‚éB‚Ü‚˝1998”N‚É‚ÍHHS¸Ž@ŠŻ@(The DHHS Inspector General,IG)‚Í4‚‚̕ń‘‚đ‚Ü‚Ć‚ß‚Ä‚˘‚éB‚ť‚Ě‚Č‚Š‚Ĺ‚ÍIRB‚Ö‚Ě•‰’S‚މߏč‚Ĺ‚ ‚čAˆęŒŠ‚É‚Š‚Ż‚鎞ŠÔ‚ޏ­‚Č‚­Aę–名‚ŕ–R‚ľ‚˘‚ą‚Ć‚Şq‚ׂç‚ę‚Ä‚˘‚éB (http://pw2.netcom.com/~alalli/BillSite_Documents/Sum_Feform_IRB_0698.html)

’58@ (http://pw1.netcom.com/~alalli/BillSite_Documents/OHRP.html) OHRP(http://ohrp.osophs.dhhs.gov/) AAASihttp://www.aaas.org/spp/cstc/briefs/humsub/jŽQĆ

’59@‚ľ‚Š‚ľ‚ť‚Ě‘ˆÄ‚͎Љď‰ČŠwŒn‚ĚŠwp’c‘Ě‚Š‚ç"Common Rule"‚đŽĐ‰ď‰ČŠwEs“Ž‰ČŠwŒ¤‹†‚É‚Ü‚Ĺ’Pƒ‚ÉŠg’Ł‚ľ‚˝‚ŕ‚Ě‚Ĺ‚ ‚čAŽŔî‚Ć‚Š‚Ż—Ł‚ę‚Ä‚˘‚é‚Ć‚ľ‚Ĕᔝ‚đŽó‚Ż‚˝B‚V

’60@AAU‚Í2001”N10ŒŽ‚É‚ŕ‹ŕ‘K“I—˜ŠQ‚ÉŠÖ‚ˇ‚é•ń‘‚đ”­•\‚ľ‚Ä‚˘‚éB‚ť‚ą‚Ĺ‚ÍŒÂl(the individual investigator)‚ĆŒ¤‹†‹@ŠÖ(the institution)‚Ě—˜‰v‚ĚƒŒƒxƒ‹‚đ‹ć•Ę‚ľ‚čl‚Ś‚é‚ׂŤ‚Ĺ‚ ‚é‚ą‚ƁB‚Ü‚˝‘ĺŠw‚É‚ÍŠw“ŕ‚Ě‚ ‚ç‚ä‚錤‹†‚Ĺ‚Ě‹ŕ‘K“I—˜ŠQ‚đŠÇ—‚ľ,ŒöŠJ‚ˇ‚é‚ą‚Ć‚Ş‹‚ß‚ç‚ę‚˝B‚Â‚Ü‚čŒ¤‹†‚É‚ć‚Á‚Ä“ž‚˝‹ŕ‘K“I—˜‰v‚Í‘ĺŠw‚̏ł”F‚đ•K—v‚Ć‚ˇ‚鐧“x‚đ‹‚ß‚é’ńŒž‚Ş‚Č‚ł‚ę‚˝B

’61@Washington Fox(http://www.washingtonfax.com/samples/2000/20000614a.html)/ AAMC(http://www.aamc.org/newsroom/pressrel/2000/000608.htm)

’62@ (http://www.pku-allieddisorders.org/research2.htm) Washingtonfax.com(http://www.washingtonfax.com/samples/2000/20000614a.html) ŽQĆ

’63@ ŠeŒ¤‹†‹@ŠÖ‚ĚIRBƒTƒCƒg‚đŽQĆB—á‚Ś‚Î Eastern Michigan Univ.(http://www.rcr.emich.edu/index.html) NIH(http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html)

’64@ (http://alpha.ddm.uci.edu/zotmail/archive/2002/20020124101.html)

’65@OLPA(http://olpa.od.nih.gov/legislation/107/pendinglegislation/humansubjects.asp)

’66@ the National Bioethics Advisory Commission (http://www.georgetown.edu/research/nrcbl/nbac/)

’67@NBAC‚Ě‘Og‚ƂȂ鎐–âˆĎˆő‰ď‚Í1978”N‚ɐݗ§‚ł‚ę‚Ä‚˘‚éB

’68@NBAC‚Ş”­•\‚ľ‚˝•ń‘‚Í (http://www.georgetown.edu/research/nrcbl/nbac/pubs.html)‚Č‚Ç‚đŽQĆB

’69@uƒqƒgś‘Ô•¨Žż‚đŠÜ‚ŢŒ¤‹†]‚ť‚Ě—Ď—“I”–â‘č‚Ɛ­ôŽwjv("Research Involving Human Biological Materials: Ethical Issues and Policy Guidance")‚ƁuƒqƒgŠĚ×–EŒ¤‹†‚É‚¨‚Ż‚é—Ď—“I”–â‘čv("Ethical Issues in Human Stem Cell Research")’3ŽQĆB

’70@u”­“W“ră‘‚ōs‚í‚ę‚鎥—ĂŽŔŒą(—Տ°ŽŔŒą)‚Ĺ‚Ě—Ď—‚ĆŽwj‚ɂ‚˘‚Ä‚Ě”–â‘čv("Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries")

’71@‚ť‚ę‚Ü‚Ĺ‚Ě•ń‘‚ł́uŽĐ‰ď‚̊֐S(Social concern)vuŽĐ‰ď“I‰ż’l(Social Value)v‚Ć‚˘‚¤Œž—t‚ŎЉď‚đŠî’ꂡ‚é‚ą‚Ć‚Í‚ ‚Á‚˝‚ށAŽĐ‰ď‰ČŠw(Social Science)‚Ć‚˘‚¤Œž—t‚Í‚Ů‚Ć‚ń‚ÇŠm”F‚Ĺ‚Ť‚Č‚˘B NBACihttp://www.georgetown.edu/research/nrcbl/nbac/pubs.htmljŽQĆ

’72@ASAnet(http://www.asanet.org/media/report0201.html)

’73@ Š‡ŒĘ“ŕ‚Í‚ť‚ę‚ź‚ę‚̐­ô‚̐§’č”N“xB
‚Ü‚˝Œž‹y‚ł‚ę‚Ä‚˘‚鐭ô‚Ě—á‚Ć‚ľ‚āAƒI[ƒXƒgƒ‰ƒŠƒA‚ĚHRECs (Human Research Ethics Committees)§“x‚Ćƒfƒ“ƒ}[ƒN‚ĚREC(The Danish Research Ethics Committee )§“x‚É’–Ú‚ľ‚Ä‚˘‚éBHRECs‚Í—Ď—“IŠĎ“_‚É‚ć‚鎊”­“I‚ȐR¸§“x‚Ĺ1982”N‚Š‚çŽŔŽ{‚ł‚ę‚Ä‚˘‚˝‚ŕ‚Ě‚Ĺ‚ ‚Á‚˝B‚ą‚̐§“x‚Í1992”N‚ÉNHMRC(the National Health and Medical Research Council) –@§’č‚É‚Ć‚ŕ‚Č‚Á‚ĐR¸‚Ş‹`–ą‰ť‚ł‚ę‚Ä‚˘‚é‚ŞA‚ť‚Ě‚Č‚Š‚ł͐R¸‰ď‚Ĺ‚ÍŠe•Ş–ě‚̐ę–ĺ‰Ć‚đ‹ĎŽż‚ɍ\Ź‚ˇ‚é‚ą‚ƁA‚ť‚ľ‚ĎЉď‰ČŠwŒ¤‹†‚đŠÜ‚Ţ‚ ‚ç‚ä‚é•Ş–ě‚Ě”íŒąŽŇŒ¤‹†‚ސR¸‚Ě‘ÎŰ‚Ć‚ł‚ę‚Ä‚˘‚éB‚Ü‚˝REC‚Í1992”N‚É–@§‰ť‚ł‚ę‚˝§“x‚Ĺ‚ ‚é‚ŞA‚ť‚Ě‘Og‚Í1970”N‘ă‚É‚ł‚Š‚Ě‚Ú‚éBƒfƒ“ƒ}[ƒN‚ĚˆăŠwE•a‰@Š—LŽŇEˆăŠwŒ¤‹†‚ĚŠeˆĎˆő‰ď‚ސ\‚ľ‡‚í‚š‚đ‚ľ‚ÄA1980”N‘ă‚Š‚çŽŔŽż“I‚É‹@”\‚ľŽn‚ß‚˝RECR¸§“x‚Ĺ‚ ‚Á‚˝B1996”N‚̐§“x‰ü’ů‚É‚ć‚Á‚Đś•¨ˆăŠwŒ¤‹†‚É‚¨‚˘‚ĉߋŽ‚ÉŠłŽŇ‚ž‚Á‚˝‚ŕ‚Ě‚ŕŠÜ‚Ţ‚ ‚ç‚ä‚銳ŽŇ‚ÉŠÖ‚ˇ‚錤‹†‚ÉRECR¸‚Ě‘ÎŰ‚ŞL‚°‚ç‚ę‚Ä‚˘‚éB

’74@NBAC‚âuƒzƒƒCƒgƒnƒEƒXś–˝—Ď—ˆĎˆő‰ďv‚Ş‘ĺ“—Ě‚ĚŽ–â‹@ŠÖ‚Ĺ‚ ‚é‚̂ɑ΂ľ‚ÄNHRPAC‚ÍHHS‚ĚŽ–â‹@ŠÖ‚Ĺ‚ ‚éB

’75@ NHRPAC (http://ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm) AERA.net(http://www.aera.net/humansubjects/)(http://www.asanet.org/footnotes/septoct01/fn1.html)ŽQĆB

’76@COSSA‚Í1981”N‚̐ݗ§ˆČ—ˆA100ˆČă‚ĚŠwp’c‘́A‘ĺŠwAŒ¤‹†‹@ŠÖ‚Č‚ÇƒAƒƒŠƒJ‚̎Љď‰ČŠwŒnŒ¤‹†ŽŇ‚đ‘ă•\‚ľ‚Đ­•{‚É“­‚Ť‚Š‚Ż‚é‘gD‚Ĺ‚ ‚éBCOSSA(http://www.cossa.org/)ŽQĆB

’77@ASAnet(http://www.asanet.org/footnotes/mar01/fn2.html)

’78@SBS(http://www.aera.net/humansubjects/index.htm)

’79@ ‹cŽ–˜^OHRP(http://ohrp.osophs.dhhs.gov/nhrpac/mtg04-01/0410mtg.txt)/ COSSA(http://www.cossa.org/jan15.html)/ ASAnet(http://www.asanet.org/footnotes/septoct01/fn1.html) ŽQĆ
@‚Ü‚˝2002”N1ŒŽ‚ɍs‚í‚ę‚˝NHRPA‚̉ď‹c‚ł͐V‚˝‚ÉconfidentialityiŽç”鐍j‚ޘ_“_‚Ć‚ł‚ę‚Ä‚˘‚éB ]—ˆ‚Ě”íŒąŽŇ•ŰŒě­ô‚Ĺ‚Í\•Ş‹c˜_‚ł‚ę‚Ä‚ą‚Č‚Š‚Á‚˝˜_“_‚ɂ‚˘‚Ä“Á‚ɁuŒö“I—p“rî•ńvuŽç”鐍v‚ɂ‚˘‚ÄĐ‰î‚ˇ‚éB

Œö“I—p“rî•ń'(Public Use Data)
@]—ˆ‚Š‚猤‹†—˜—p‚ł‚ę‚éî•ń‚ĚŒöŠJ‚Ş‘Ă“–‚Ĺ‚ ‚é‚Š‚Ç‚¤‚Š‚Ě”ť’f‚ÍIRBR¸‚ÉˆĎ‚Ë‚ç‚ę‚Ä‚Ť‚˝B“Á‚ÉU.S. Census data, General Social Survey Panel Study of Income Dynamics‚Č‚Ç‚Ěî•ń‚đŒ¤‹†–Ú“I‚ĹŽg—p‚ˇ‚éŰ‚É‚ÍŽ–‘O‚̐\ż‚ĆIRBR¸‚Ş—v‹‚ł‚ę‚Ä‚Ť‚˝B‚Ü‚˝‚˝‚Ć‚Śˆę“xIRB‚Ě”FŘ‚đŽó‚Ż‚˝Œ¤‹†‚Ĺ‚ ‚Á‚Ä‚ŕA‘ź‚ĚŒ¤‹†‚Ĺ“ńŽŸ“IŽ‘—ż‚Ć‚ľ‚ĕސ͂ł‚ę‚é‚΂ ‚˘‚É‚ŕÄ“xR¸‚Ş•K—v‚Ĺ‚ ‚Á‚˝B
]—ˆ‚Š‚çASA‚Í‚ś‚ߊwp‘gD‚ÍNBACAIOMANHRPAC‚Č‚Ç‚É‚ą‚¤‚ľ‚˝–â‘č‚đŽw“E‚ľ‘ą‚Ż‚Ä‚Ť‚˝BNHRPAC‚Í2001”Nă{‚Š‚ç‚ą‚Ě–â‘č‚đ‚Ć‚č‚ ‚°‚āA—‚”N‚Ě1ŒŽ‚ÉŒö“I—p“rî•ń'(Public Use Data)‚ɂ‚˘‚Ä‚Ě•ń‘‚Ş‚Ü‚Ć‚ß‚ç‚ę‚˝ B•ń‘‚Ĺ‚Í‚Ü‚¸uî•ńŽ‘—żv(data files)‚đu‚ť‚̏î•ń‚Š‚çŒÂl“I‚Ȑl•¨“Á’č‚Í‚ł‚ę‚Č‚­‚Ć‚ŕ—eˆŐ‚ɐgŒł‚đ“Á’č‚Ĺ‚Ť‚éŒ`ŽŽ‚Ĺ‚ ‚čA‘ćŽOŽŇ‚ޕސ͖ړI‚ĹŒ¤‹†ŽŇ‚Ü‚˝‚͏î•ń‚Ě’ń‹ŸŽŇ‚Š‚ç‚ŕ‚˝‚ç‚ł‚ę‚é‚ŕ‚́v‚Ć’č‹`‚ľ‚˝B‚ť‚ľ‚ÄIRB‚Ü‚˝‚͐­•{‚Ě“Œvî•ńŽűW‹@ŠÖ‚Ş‚ą‚́uî•ńv‚đugŒł‚đ“Á’股‚é‚ÉŽŠ‚ç‚Č‚˘v(de-identified)‚Ć”F‚ß‚é‚ą‚Ć‚ĹŒö“I—p“rî•ń(Public Use Data)‚Ć‚ľ‚ÄŒ¤‹†—˜—p‚މ”\‚Ĺ‚ ‚é‚Ć‚˘‚¤”ť’f‚މş‚ł‚ę‚˝B‚Ü‚˝Œö“I—p“rî•ń‚Ě“ńŽŸ—˜—p‚ɂ‚˘‚Ă͐R¸‚Ě•K—v‚Í‚Č‚˘‚Ć‚ł‚ę‚˝B

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Žç”鐍(Confidentiality) @
Žç”鐍‚đƒŠƒXƒN‚Ć“Ż“™‚̏d—v“x‚Ć‚ľ‚ÄIRB‚Í”FŽŻ‚ˇ‚é‚ą‚ƁA–@—ß‚â‹K’č‚É‚ć‚éŽç”é‚Ě”F’č‚Ş‚ ‚Á‚˝‚Ć‚ľ‚Ä‚ŕOHRP‚Í‚Č‚¨”é–§‚ŞŽç‚ç‚ę‚Ä‚˘‚é‚Š‚đŠm‚Š‚ß‚é‚ą‚ƁAOHRP‚ÍŽç”鐍‚ĚŒŔ“x‚ĆŽç”鐍‚đŽç‚é‚˝‚ß‚Ě‘Îô‚ɂ‚˘‚ÄŒ¤‹†ŽŇ‚ÍIRB‚ÉŽw“ą‚ˇ‚é‚ą‚ƁAŒ¤‹†‹@ŠÖ‚͏î•ń‚Ě˜R‰k‚đ–h‚ŽŒ¤‹†ŽŇ‚đŽx‰‡‚ˇ‚é–đ‚É“O‚ˇ‚é‚ą‚ƁAIRB‚⌤‹†ŽŇ‚͐gŒł‚đ“Á’č‚Ĺ‚Ť‚éî•ń‚ŞŒ¤‹†ŽŇŠÔ‚ɏo‰ń‚é‚Ć‚ľ‚˝‚çAă‚Ć‚ł‚ę‚Ä‚˘‚é‚Ě‚Í‚ť‚̏î•ń‚ž‚Ż‚Ĺ‚Í‚Č‚­–{—ˆ‚ ‚é‚ׂŤŽç”é‹`–ą‚ސN‚ł‚ę‚Ä‚˘‚é‚ą‚Ć‚Č‚Ç‚đ’ńŒž‚É‚Ü‚Ć‚ß‚˝B@

’80@ SBS‚̓Cƒ“ƒtƒH[ƒ€ƒhEƒRƒ“ƒZƒ“ƒgEŠCŠO‚Ĺ‚ĚŒ¤‹†Eu‹`‚Ĺ‚ĚŒ¤‹†EŒö‹¤‹@ŠÖ‚Ĺ‚ĚŠĎŽ@‚ĆƒtƒB[ƒ‹ƒhƒ[ƒNE–Ż‘°Ž“I‚ĹŽż‚̍‚‚˘Œ¤‹†‚ȂǐV‚ľ‚˘˜_“_‚ŕ’ń‹N‚ľ‚Ä‚˘‚éB

’81@ “ŻŽžŠú‚ÉSAGGTithe Secretary's Advisory Committee on Genetic Testingj‚ŕHHSŽ–â‹@ŠÖ‚Š‚çŠO‚ł‚ę‚Ä‚˘‚éBƒƒVƒ“ƒgƒ“ƒ|ƒXƒgŽ†‚É‚ć‚é‚ƁAˆę˜A‚̐­•{‚Ě•űj“]Šˇ‚́A‚˝‚Ć‚Ś‚Î”íŒąŽŇ‚Ć‚ľ‚Ä‘ŮŽ™‚ĚŒ —˜‚đ‘ă•Ů‚ˇ‚鐭ô‚đ–ÚŽw‚ˇ•ŰŽç”h‚É‚ć‚éˆł—Í‚Ĺ‚Í‚Č‚˘‚Š‚Ɛ„‘Ş‚ľ‚Ä‚˘‚éBCOSSA (http://www.cossa.org/21.17.htm)ŽQĆB

’82@OHRP(http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm)/ SACHRP(http://ohrp.osophs.dhhs.gov/sachrp/sachrp.htm)
2003”N‚PŒŽ‚É‚ÍSACHRP‚ĆSACGHS(Secretary 's Advisory Committee on Genetics, Health and Society)‚ĚˆĎˆő‚đ”C–˝‚ľ‚˝BNHRPAC‚Ě‚¤‚ż3–ź‚ŞSACHRP‚ĚˆĎˆő‚Ć‚ľ‚ĐV‚˝‚É”C–˝‚ł‚ę‚˝B‚Ü‚˝SACGHS‚Í12–ź‚ĚˆĎˆő‚Š‚ç‚Č‚čAŽĺ‚Ɉâ“`HŠw‚ƐV‚ľ‚˘ˆă—Ă‚Ě”­“W‚Ɖž—p‚ɂ‚˘‚Ä‹ZpA—Ď—A–@AŽĐ‰ď‚ւ̉e‹ż‚ɂ‚˘‚ÄŒŸ“˘‚ľHHS‚ÉŽ–₡‚é‘gD‚Ć‚ľ‚Ä—\’č‚ł‚ę‚Ä‚˘‚éB

’83@Œ`ŽŽă‚Í2000”N‚Ě6ŒŽ‚ɐݗ§‚ł‚ę‚Ä‚˘‚éB‚Ü‚˝Ý—§’c‘Ě•ę‘Ě‚Ć‚Č‚Á‚˝7Šwp’c‘Ě‚ÍˆČ‰ş‚Ě’Ę‚čB
AAMC(Association of American Medical Colleges)/ AAU(Association of American Universities)/ COSSA(Consortium of Social Science Associations)/ FASEB(Federation of American Societies for Experimental Biology)/ NASULGC(National Association of State Universities and Land Grant Colleges)/ NHC(National Health Council)/ PRIM&R(Public Responsibility in Medicine and Research)

’84@COSSA‚Í1981”N‚̐ݗ§ˆČ—ˆA100ˆČă‚ĚŠwp’c‘́A‘ĺŠwAŒ¤‹†‹@ŠÖ‚Č‚ÇƒAƒƒŠƒJ‚̎Љď‰ČŠwŒnŒ¤‹†ŽŇ‚đ‘ă•\‚ˇ‚é‘gD‚Ĺ‚ą‚ę‚Ü‚Ĺ‚ŕ­•{‚É“­‚Ť‚Š‚Ż‚Ä‚Ť‚˝ŽŔŃ‚Ş‚ ‚éBCOSSA(http://www.cossa.org/)

’85@AAHRPP(http://www.aahrpp.org/standards.htm)ŽQĆ

’86@ PRIM&R(http://primr.org/aahrpp.html)‚ć‚čˆř—pB
The overall goal of accreditation is to improve protection of human research subjects by developing performance standards that encourage programs to adopt "best practices" in this area, and by recognizing the programs that meet those standards.

’87@‚˝‚Ć‚Ś‚ÎAAHRPP‚Ě”FŘŠî€‚ɂ‚˘‚āAŽŠŒČ•]‰ż‚Ć×•”‚É‚í‚˝‚éŠÄŽ‹‚Ě‚Č‚Š‚ĹŽŔŰ‚Ɋ‚đ‰^—p‚ľ‚Ä”­“W‚ˇ‚é‚ą‚ƁAŠÄŽ‹ŽŇ‚Ě‹łˆç‚Ć•â[A”íŒąŽŇ•ŰŒěŒv‰ć‚̏î•ń‚Ć“Œv“Iî•ń‚ĚŽűWA‹łˆç‚ÉŒü‚Ż‚˝‹łŢ‚̏oŠ‚đŠm”F‚ˇ‚é‚ą‚Ć‚Ćˆę——•\‚̍쐬‚Ć‚˘‚¤dŽ‹‚ˇ‚ׂŤ‚S‚‚̉ߒö‚ŞŽŚ‚ł‚ę‚Ä‚˘‚éB(http://www.aahrpp.org/steps.htm)ŽQĆB

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’91@ƒyƒ“ƒVƒ‹ƒ”ƒFƒjƒA—đŽjE”Ž•¨ŠŮˆĎˆő‰ď(Pennsylvania Historical and Museum Commission)B”ޏ—‚́uiŒűqj—đŽjŒ¤‹†‚É•sˆÄ“ŕ‚ȐlX‚ލ\Ź‚ˇ‚éŒXŒü‚É‚ ‚éIRB‚Í–â‘č‚đ[‰ť‚ł‚š‚év‚ĆŒž‚¤B—á‚Ś‚ΈăŠwŒ¤‹†‚Ě”íŒąŽŇ‚ƎЉď‰ČŠwŒ¤‹†‚ĚŒę‚čŽč(narrator)‚Ć‚Ĺ‚Í‚ť‚ę‚ÉŠÜ‚Ü‚ę‚éî•ń‚â“ŻˆÓ‚đ“ž‚éó‹ľ‚ɂ‚˘‚ĉń‚郊ƒXƒN‚Ş‚Ü‚Á‚˝‚­ˆŮ‚Č‚é‚ą‚ƁA‚ ‚ç‚ä‚鎿–â‚É‚ÍIRB‚ĚŽ–‘OR¸‚Ş•K—v‚Ĺ‚ ‚é‚ą‚ƁA‚Ü‚˝Œ¤‹†‚đ‚ľ‚˝Œă‚ɂ͘^‰šƒe[ƒv‚Č‚Ç’˛¸‹L˜^‚Ě”jŠü‚Ć‹@–§‚Ě•ŰŽ‚đ“O’ꂡ‚é‚ą‚Ć‚ÍŒűq—đŽjŠwŒ¤‹†‚ĚŒë‰đ‚đľ‚Ť‚Š‚Ë‚Č‚˘‚ľA—đŽjŒ¤‹†‚ĚŞŠ˛‚đ—h‚é‚Ş‚ˇ‚ą‚Ć‚ž‚Əq‚ׂâ‚éBOAH(http://www.oah.org/pubs/nl/2000may/bioethics.html)





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