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這事情有嚴重嗎 有啊 為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅 畢業威脅讓他們沒有執行同意 不能行使退出權誰讓這些孩子哭 而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情\", \"words\": [{\"word\": \"O\", \"start\": 218.815, \"end\": 218.935, \"score\": 0.541}, {\"word\": \"K\", \"start\": 218.935, \"end\": 218.955, \"score\": 0.0}, {\"word\": \"這\"}, {\"word\": \"事\", \"start\": 218.955, \"end\": 218.975, \"score\": 0.0}, {\"word\": \"情\", \"start\": 218.975, \"end\": 219.115, \"score\": 0.857}, {\"word\": \"有\", \"start\": 219.115, \"end\": 219.135, \"score\": 0.0}, {\"word\": \"嚴\"}, {\"word\": \"重\", \"start\": 219.135, \"end\": 219.155, \"score\": 0.0}, {\"word\": \"嗎\"}, {\"word\": \"有\", \"start\": 219.155, \"end\": 219.235, \"score\": 0.262}, {\"word\": \"啊\", \"start\": 219.235, \"end\": 219.255, \"score\": 0.0}, {\"word\": \"為\"}, {\"word\": \"什\", \"start\": 219.255, \"end\": 219.275, \"score\": 0.0}, {\"word\": \"麼\"}, {\"word\": \"這\"}, {\"word\": \"麼\"}, {\"word\": \"嚴\"}, {\"word\": \"重\", \"start\": 219.275, \"end\": 219.296, \"score\": 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\"score\": 0.736}, {\"word\": \"負\", \"start\": 1202.096, \"end\": 1202.176, \"score\": 0.748}, {\"word\": \"這\"}, {\"word\": \"個\"}, {\"word\": \"責\"}, {\"word\": \"任\", \"start\": 1202.176, \"end\": 1202.196, \"score\": 0.005}, {\"word\": \"謝\"}, {\"word\": \"謝\"}, {\"word\": \"好\", \"start\": 1202.196, \"end\": 1202.216, \"score\": 0.0}, {\"word\": \"謝\"}, {\"word\": \"謝\"}], \"language\": \"zh\"}","srt":"1\n00:00:03,644 --> 00:00:10,666\n謝謝主席主席你剛剛講了14分鐘好謝謝我請邱部長部長請部長是今天大家質詢很多台師大女足球隊的這個被教練周台英這樣強迫抽血不得退出的這一些這個事件是的是那\n\n2\n00:00:31,445 --> 00:00:50,267\n第一時間台師大可能違反研究倫理的這個案子你們的林靜儀次長很厲害馬上說這件事件的主角應該負責的是教育部不是衛福部依照人體研究法的確是這樣子沒有錯\n\n3\n00:00:52,529 --> 00:01:15,537\n然後接下來呢次長又說他個人的意見是說要關注利害關係權利不對等的狀況是非常重要的所以要特別注意這個倫理這樣子受試者應該要有明確的知情同意權不可以在被脅迫的狀況下為之而且要隨時退出了權利好話講得這麼好聽然後這樣講了以後好像\n\n4\n00:01:18,098 --> 00:01:20,539\n我就覺得說難道衛福部完全都沒有任何一丁點需要檢討的地方嗎這個事情完全跟衛福部都沒有關係嗎今天聽了一個早上你們的劉悅平司長喔很難聽今天終於來了\n\n5\n00:01:36,723 --> 00:01:56,903\n劉月平司長今天有講他的論述更簡單他說這個事情都應該要照研究計畫的主持的目的事業主管機關就是教育部他們有審查了IRB那要看這個研究人員有沒有遵守\n\n6\n00:01:57,503 --> 00:02:14,899\n他們應該遵循的法尊是像IRB計畫有沒有遵守這樣在執行然後第二個劉業平馬上說這個IRB計畫不是你們審的那內容你們也不知道所以也不知道他們有沒有遵守是吧大概你們就這樣講對吧\n\n7\n00:02:18,831 --> 00:02:25,422\n整齊都這樣說啊意思是說跟衛福部都沒關係啦是台師大的問題啦跟教育部的問題啦事實是不是這樣保庭你說一下\n\n8\n00:02:30,292 --> 00:02:43,815\n好謝謝委員的催省我想任何民眾有受到健康上的一個威脅你不要避重就輕你今天在這裡你們所值的理由就是說這個IRB不是你們審美主管機關是告有報這個研究界外的IRB內容你們不知道對嘛對嘛是不是我們都一切依法辦理\n\n9\n00:02:59,559 --> 00:03:08,066\n很好我現在就是要跟你講依法辦理的事情我今天要再跟你講今天國科會副主委出來講了一件事\n\n10\n00:03:08,997 --> 00:03:37,534\n國科會副主委說全台灣一百多個大學裡面而體育學門有申請人體試驗的計畫數台師大遠遠超過其他學校的總和國科會的人體試驗的補助計畫台師大萊爾申請了占了所有補助計畫裡面的六成以上這是一個非常不尋常的事情或許這是一個全面性在體育學門長期以來存在的問題\n\n11\n00:03:38,815 --> 00:03:41,077\nOK這事情有嚴重嗎有啊為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅畢業威脅讓他們沒有執行同意不能行使退出權誰讓這些孩子哭而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情\n\n12\n00:04:07,219 --> 00:04:15,766\n教育部在審查IRB的時候他們會知道他們會有足夠的專業去知道說IRB委員要聘請哪一些領域嗎他們會知道每天抽血三次連續抽血14天而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎教育部會有這個專業嗎教育部會有這個能力嗎你有給他任何行政指導嗎\n\n13\n00:04:37,043 --> 00:04:43,985\n你們衛福部不但沒有給他們任何行政指導我現在要講衛福部就是你所謂的依法行政裡面讓教育部讓台師大讓這些孩子這樣子在脅迫的狀況下恐懼的狀況下在那裡哭不得已才跑出來陳情讓他們哭的始作俑者我告訴你就是你們衛福部看這個公文\n\n14\n00:05:07,827 --> 00:05:09,047\n看這個公文來護理人員法解釋會編108年好那看你們的行政函式誰允許教育部來抽血不需要專業的人力然後誰認為這個不是輔助醫療行為非侵入性即便侵入性也沒關係是你們衛福部101年因為\n\n15\n00:05:37,234 --> 00:05:53,090\n人體研究法通過以後大量的人體研究然後大家講說誰可以執行抽血的動作大家就寫公文來問你衛福部衛福部告訴大家你們不要假裝你不知道啦這個事情你們都知道啦\n\n16\n00:05:54,131 --> 00:06:01,698\n衛福部人家所詢學校護理人員如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣他的釋法性應該是什麼最後一個所以你們說衛福部說研究計畫進行人體抽血抽樣非屬醫療行為也不是醫療輔助行為\n\n17\n00:06:20,134 --> 00:06:41,968\n讓他們可以亂找人有人來抽血抽到手發抖的不是校戶連不是校戶連叔叔伯伯阿姨是誰來抽血這些孩子都不知道抽到很痛在那裡哭一天抽三次連續抽14天讓孩子暴露在風險之下的就是這一張公文函式\n\n18\n00:06:43,349 --> 00:07:11,668\n這一張公文好像是有講說至學校護理人員如果是學校護理人員系授託協助校內研究計畫進行人體抽血採樣上階計畫應經人體研究法相關規定審查通過使得為之OK看起來是什麼意思不知道欸不知道欸他是說校務可以抽要放到計畫裡面審查通過就可以問題是你這張函是憑啥這樣子說\n\n19\n00:07:13,369 --> 00:07:31,112\n你的外服部的這一張公文等於是法規了命令了他有法律未接法律效力你們今天一直講依法依法你們幫助台師大逃避法律的規範就是你們這一張函式不要再多說了你們的你們都很清楚醫事司司長自己也很清楚\n\n20\n00:07:40,154 --> 00:07:44,138\n你們今天在這裡為七成這麼多你不敢說的就是因為你副師長講了副師長受訪劉玉京說研究中的抽血並不是醫療行為也不是醫療輔助行為但因攸關受試者保護必須要由校護或醫檢師執行\n\n21\n00:08:01,422 --> 00:08:24,718\n144就是根據這一張函釋來的啦好這個函釋的見解是這樣子我現在就講說奇怪了這個函釋合法嗎這個函釋合理嗎這個函釋最大的問題就是對於涉及需要抽血的研究計畫進行抽血的人是沒有任何資格條件的限制\n\n22\n00:08:25,518 --> 00:08:30,122\n而且是完全沒有規定的只要IRB計畫審查通過就可以了因為人家來問你說校戶可不可以抽你們說只要放在計畫裡面有就可以了那你們沒有說校戶以外的人不能抽事實上有你們就是說不是醫療行為不是醫療輔助行為每個人都可以來執行抽血的任務你校戶要來抽的話放在計畫裡面通過就可以了\n\n23\n00:08:52,875 --> 00:09:16,661\n阿貓阿狗來抽也可以放到IRB計畫裡面通過就可以了你們憑什麼這麼說憑什麼你們憑什麼把這一張公文還是法律的依據在哪裡讓你可以允許讓這些孩子這樣子讓這些人暴露在健康的風險之下\n\n24\n00:09:18,019 --> 00:09:25,185\n憑什麼連續一天抽三次連續十四天有風險的行為你們讓他合法化憑什麼來學長阿姨就可以抽\n\n25\n00:09:30,686 --> 00:09:58,084\n我先講一下第一件事情校護是護理人員也就是醫事人員我不講我不講校護了我現在你的這張函式是阿貓阿狗學長阿姨通通可以來抽沒有我覺得這是對於法令這邊我們在講的是本來人體研究法裡面的IRB就會進行受試者保護所以所有的東西必須程序這邊IRB這邊的在審查每一個計劃案的時候\n\n26\n00:10:00,926 --> 00:10:19,719\n我們人體研究法你們不需要訂出任何的行政指引給要做研究因為你把所有研究計畫的把關機制都交給要做研究的那個計畫的主持人的他的目的事業主管機關去核定去管理去監督IRB也交給他們\n\n27\n00:10:22,521 --> 00:10:27,225\n你們衛福部在人體研究法讓你們當主管機關之後你不用訂出任何的遵循的行政指導嗎你不用訂出任何的執法嗎來讓教育部搞不好還有體育部未來的體育部搞不好還有國科位\n\n28\n00:10:41,578 --> 00:11:01,721\n搞不好其他的農業部也可以來提研究計畫你認為他們有足夠的專業他們知道IRB要聘請哪種委員嗎你們衛福部作為人體研究法的主管機關難道不用訂出相關的行政指導給這一些\n\n29\n00:11:02,722 --> 00:11:12,907\n目的是業主管機關嗎?你剛才說的都不符合裡面你們怠惰了這麼久,從一百二零一一年是吧,完成立法\n\n30\n00:11:15,082 --> 00:11:43,501\n2011年完成立法到現在都沒有做出任何行政指導放任放任這一些目的世界主管機關不知道把關的住把關不住隨便你到這一次事件爆發才知道衛福部不但是這麼的瀆職而且台師大案件凸顯了這一個101年你們含釋的不合理且沒有辦法保護受試者權益的缺陷\n\n31\n00:11:44,981 --> 00:12:09,570\n這個事件凸顯了你們怠乎職責然後你們的韓式不但沒有保護到這些受試者的權益而且還推他們入火坑所以你們難道不應該針對執行人體研究特別是收案地點不是在醫療院所的研究涉及到抽血的行為人員的資格框定做出清楚明確\n\n32\n00:12:10,530 --> 00:12:38,393\n而且要符合受試者權益保障的任何規範來給目的事業主管機關當指導嗎而且基於衛福部作為人體研究法規的主管機關三讀以後當時學校啦其他部會啦其他研究機構啦他們的研究案例不像現在這麼多所以經過了十幾年了\n\n33\n00:12:40,094 --> 00:12:56,635\n你們還繼續拿舊的韓式出來舊地合法化台師大這一個根本就是聽不下去合法不合情也不合理的合理的舊的韓式法規啦但不合情也不合理\n\n34\n00:12:58,697 --> 00:13:25,640\n的這種狀況你們難道不用再檢討嗎還是像你們次長講的第一時間先甩鍋給教育部跟監察院不是我我沒有不關我的事跟衛福部無關就是台師大的這個案例才反映了你們這個含釋才了解到衛福部是今天讓這麼多孩子在你們那裡哭\n\n35\n00:13:27,239 --> 00:13:38,586\n然後才是今天這一種不違反倫理的假倫理的規範的這種研究案啦可以繼續在那裡執行\n\n36\n00:13:40,714 --> 00:14:00,786\n今天受試者參與研究是醫學研究進步的關鍵所有的受試者都應該在要知情同意的前提之下而且要理解自己參與研究的內容和權益今天還有你們的責任喔還有一個喔他不准他退出他不准人家退出\n\n37\n00:14:08,120 --> 00:14:31,792\n然後用受教權人權被威脅這個你們不用訂出任何的規範嗎所有的研究計畫都要他們都送一個執行同意書出來被迫了那他要檢舉要去哪裡檢舉\n\n38\n00:14:33,837 --> 00:14:59,224\n本來在計畫裡面都有所以我們會強調被迫了要去哪裡檢舉當他們被脅迫不能畢業會怕他要去檢舉這個其實回到檢舉機制在哪裡他敢向學校檢舉嗎本來就可以本來就可以要去哪裡然後連記者去年就幫他們開記者會還是六個月前就幫他們開記者會連立委都幫他們開過了\n\n39\n00:15:00,484 --> 00:15:04,246\n你們有看到嗎?立委開記者會的時候已經表示他們是被脅迫的為什麼你們沒有主動關心?當他說我人體研究計畫我被強迫抽血我用畢業學分被威脅而曝光了立委也在立法院質詢也開記者會了\n\n40\n00:15:21,860 --> 00:15:29,606\n已經好幾個月以前了,不是現在這一波請問你衛福部為什麼沒有作為?請問你劉岳平司長,都視若無睹捏很難受的,劉司長要來立法院這麼壞,很難受的啦\n\n41\n00:15:39,185 --> 00:15:55,539\n視若無睹捏這樣要怎麼做保證你怎麼視若無睹你做保證多久啊他開記者會的時候立委這個爆料的時候質詢的時候教育委員會的委員爆料開記者會的時候你們做了什麼事你們做了什麼事那時候已經違反人體研究法所有的規範了你做了什麼事\n\n42\n00:16:02,469 --> 00:16:14,498\n包委員這個要調查是要去調查我們計劃組織有沒有按照IRB對那你調查了嗎從第一次曝光開記者會曝光到現在你剛才劉悅平還在講這個IRB內容你們不知道要去調查已經經過半年了你現在還要去調查你們不動於衝啦不當一回事啦\n\n43\n00:16:27,368 --> 00:16:34,671\n你們就是不當一回事無動於衷那你告訴我那你告訴我那你告訴我他們的IRB內容審查有沒有問題他們內容說什麼然後他們開記者會叫立委開記者會說他們被強迫他們要退出他們被威脅你們又做了什麼你們做了什麼這半年多來你們做了什麼\n\n44\n00:16:53,851 --> 00:17:17,564\n第一件事情因為教育部已經開始做處理所以我們才會是說那這樣子的話應該是等教育部給我們他的報告然後整體的機制來做一期的檢討現在就是層層掩護層層的壓下來而才會有這一第二波的爆料和第二波的記者會\n\n45\n00:17:19,488 --> 00:17:36,755\n你還在講說第一波的時候教育部已經調查了所以你們就不管了你現在是在說笑的你在說笑的柏定你什麼時候再完成你們這一張不合理的韓式的漏洞的重新檢討柏定這一個韓式到現在還可以適用嗎還適當嗎第一個我們馬上來處理那個所有發生的問題包括這個韓式我們馬上\n\n46\n00:17:51,117 --> 00:18:04,345\n不用了我們一個月就來好很好那你們需不需要訂出更多的行政指導給其他的目的事業主管機關我們會再重申你們要不要再去重新的檢討檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規好的\n\n47\n00:18:13,931 --> 00:18:26,359\n其他目的事業主管機關在做監督在做IRB審查的時候他們可以有所依循你們是不是應該要主動做更多啊有沒有檢討空間有一定有檢討空間因為事情已經發生表示說我們所有的相關的單位都應該要盡責任的去把它改善\n\n48\n00:18:36,826 --> 00:18:41,927\n不要再有下一次的發生我看你們劉月餅好像就覺得不當一回事還很想變啦我現在講說善意的為醫學或為科學進步去貢獻自己的受試者不應該在醫院參與研究有合格的這個\n\n49\n00:18:58,523 --> 00:19:17,088\n醫療人員抽血而在醫院和在社區參與研究卻有任由沒有受過訓練還邊抽血邊發抖的這一些人來抽這不是回報善意而且熱心參與研究的受試者該得到的對待當然\n\n50\n00:19:18,988 --> 00:19:30,342\n我很熱心的我很善意的我要回饋我們的醫學研究了那我去醫院抽我就有合格的人幫我抽而我到醫院醫療院所以外的你們就容許他讓這種阿貓阿狗邊抽血邊發抖的人來幫他們抽\n\n51\n00:19:36,589 --> 00:20:02,216\n這是不應該的這不是回報這一些善意的人要參與研究願意參與研究的人該有的這個回饋是的是的我們如果一定會協助去調查如果有違反IRB的該設救責的一定ME的救責而且要我們一定會檢討整個制度怎麼樣把它改善得更好對人還有很多制度面是你們應該要扛起來要做更多沒問題我們應該要負這個責任謝謝好謝謝\n\n","tsv":"start\tend\ttext\n3644\t10666\t謝謝主席主席你剛剛講了14分鐘好謝謝我請邱部長部長請部長是今天大家質詢很多台師大女足球隊的這個被教練周台英這樣強迫抽血不得退出的這一些這個事件是的是那\n31445\t50267\t第一時間台師大可能違反研究倫理的這個案子你們的林靜儀次長很厲害馬上說這件事件的主角應該負責的是教育部不是衛福部依照人體研究法的確是這樣子沒有錯\n52529\t75537\t然後接下來呢次長又說他個人的意見是說要關注利害關係權利不對等的狀況是非常重要的所以要特別注意這個倫理這樣子受試者應該要有明確的知情同意權不可以在被脅迫的狀況下為之而且要隨時退出了權利好 話講得這麼好聽然後這樣講了以後好像\n78098\t80539\t我就覺得說難道衛福部完全都沒有任何一丁點需要檢討的地方嗎這個事情完全跟衛福部都沒有關係嗎今天聽了一個早上你們的劉悅平司長喔 很難聽 今天終於來了\n96723\t116903\t劉月平司長今天有講他的論述更簡單他說這個事情都應該要照研究計畫的主持的目的事業主管機關就是教育部他們有審查了IRB那要看這個研究人員有沒有遵守\n117503\t134899\t他們應該遵循的法尊是像IRB計畫有沒有遵守這樣在執行然後第二個 劉業平馬上說這個IRB計畫不是你們審的那內容你們也不知道所以也不知道他們有沒有遵守是吧 大概你們就這樣講 對吧\n138831\t145422\t整齊都這樣說啊 意思是說跟衛福部都沒關係啦是台師大的問題啦 跟教育部的問題啦事實是不是這樣 保庭你說一下\n150292\t163815\t好 謝謝委員的催省我想任何民眾有受到健康上的一個威脅你不要避重就輕你今天在這裡你們所值的理由就是說這個IRB不是你們審美主管機關是告有報這個研究界外的IRB內容你們不知道對嘛 對嘛 是不是我們都一切依法辦理\n179559\t188066\t很好我現在就是要跟你講依法辦理的事情我今天要再跟你講今天國科會副主委出來講了一件事\n188997\t217534\t國科會副主委說全台灣一百多個大學裡面而體育學門有申請人體試驗的計畫數台師大遠遠超過其他學校的總和國科會的人體試驗的補助計畫台師大萊爾申請了占了所有補助計畫裡面的六成以上這是一個非常不尋常的事情或許這是一個全面性在體育學門長期以來存在的問題\n218815\t221077\tOK 這事情有嚴重嗎 有啊 為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅 畢業威脅讓他們沒有執行同意 不能行使退出權誰讓這些孩子哭 而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情\n247219\t255766\t教育部在審查IRB的時候他們會知道他們會有足夠的專業去知道說IRB委員要聘請哪一些領域嗎他們會知道每天抽血三次連續抽血14天而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎教育部會有這個專業嗎教育部會有這個能力嗎你有給他任何行政指導嗎\n277043\t283985\t你們衛福部不但沒有給他們任何行政指導我現在要講衛福部就是你所謂的依法行政裡面讓教育部讓台師大讓這些孩子這樣子在脅迫的狀況下恐懼的狀況下在那裡哭不得已才跑出來陳情讓他們哭的始作俑者我告訴你就是你們衛福部看這個公文\n307827\t309047\t看這個公文來護理人員法解釋會編 108年好 那看你們的行政函式誰允許教育部來抽血 不需要專業的人力然後誰認為這個不是輔助醫療行為非侵入性 即便侵入性也沒關係是你們衛福部 101年因為\n337234\t353090\t人體研究法通過以後大量的人體研究然後大家講說誰可以執行抽血的動作大家就寫公文來問你衛福部衛福部告訴大家你們不要假裝你不知道啦這個事情你們都知道啦\n354131\t361698\t衛福部人家所詢學校護理人員如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣他的釋法性應該是什麼最後一個所以你們說衛福部說研究計畫進行人體抽血抽樣非屬醫療行為也不是醫療輔助行為\n380134\t401968\t讓他們可以亂找人有人來抽血抽到手發抖的不是校戶連不是校戶連叔叔伯伯阿姨是誰來抽血這些孩子都不知道抽到很痛在那裡哭一天抽三次連續抽14天讓孩子暴露在風險之下的就是這一張公文函式\n403349\t431668\t這一張公文好像是有講說至學校護理人員 如果是學校護理人員系授託協助校內研究計畫進行人體抽血採樣上階計畫應經人體研究法相關規定審查通過 使得為之OK看起來是什麼意思 不知道欸 不知道欸他是說校務可以抽 要放到計畫裡面審查通過就可以問題是 你這張函是憑啥這樣子說\n433369\t451112\t你的外服部的這一張公文等於是法規了命令了他有法律未接法律效力你們今天一直講依法依法你們幫助台師大逃避法律的規範就是你們這一張函式不要再多說了你們的你們都很清楚醫事司司長自己也很清楚\n460154\t464138\t你們今天在這裡為七成這麼多 你不敢說的就是因為你副師長講了 副師長受訪 劉玉京說研究中的抽血並不是醫療行為 也不是醫療輔助行為但因攸關受試者保護 必須要由校護或醫檢師執行\n481422\t504718\t144就是根據這一張函釋來的啦好 這個函釋的見解是這樣子我現在就講說奇怪了 這個函釋合法嗎這個函釋合理嗎這個函釋最大的問題就是對於涉及需要抽血的研究計畫進行抽血的人是沒有任何資格條件的限制\n505518\t510122\t而且是完全沒有規定的 只要IRB計畫審查通過就可以了因為人家來問你說校戶可不可以抽你們說只要放在計畫裡面有就可以了那你們沒有說校戶以外的人不能抽 事實上有你們就是說不是醫療行為 不是醫療輔助行為每個人都可以來執行抽血的任務你校戶要來抽的話放在計畫裡面通過就可以了\n532875\t556661\t阿貓阿狗來抽也可以放到IRB計畫裡面通過就可以了你們憑什麼這麼說 憑什麼你們憑什麼把這一張公文還是法律的依據在哪裡讓你可以允許讓這些孩子這樣子讓這些人暴露在健康的風險之下\n558019\t565185\t憑什麼連續一天抽三次 連續十四天有風險的行為你們讓他合法化 憑什麼來 學長阿姨就可以抽\n570686\t598084\t我先講一下第一件事情校護是護理人員也就是醫事人員我不講我不講校護了我現在你的這張函式是阿貓阿狗學長阿姨通通可以來抽沒有我覺得這是對於法令這邊我們在講的是本來人體研究法裡面的IRB就會進行受試者保護所以所有的東西必須程序這邊IRB這邊的在審查每一個計劃案的時候\n600926\t619719\t我們人體研究法你們不需要訂出任何的行政指引給要做研究因為你把所有研究計畫的把關機制都交給要做研究的那個計畫的主持人的他的目的事業主管機關去核定去管理去監督IRB也交給他們\n622521\t627225\t你們衛福部在人體研究法讓你們當主管機關之後你不用訂出任何的遵循的行政指導嗎你不用訂出任何的執法嗎來讓教育部搞不好還有體育部未來的體育部搞不好還有國科位\n641578\t661721\t搞不好其他的農業部也可以來提研究計畫你認為他們有足夠的專業他們知道IRB要聘請哪種委員嗎你們衛福部作為人體研究法的主管機關難道不用訂出相關的行政指導給這一些\n662722\t672907\t目的是業主管機關嗎?你剛才說的都不符合裡面你們怠惰了這麼久,從一百二零一一年是吧,完成立法\n675082\t703501\t2011年完成立法到現在都沒有做出任何行政指導放任放任這一些目的世界主管機關不知道把關的住把關不住隨便你到這一次事件爆發才知道衛福部不但是這麼的瀆職而且台師大案件凸顯了這一個101年你們含釋的不合理且沒有辦法保護受試者權益的缺陷\n704981\t729570\t這個事件凸顯了你們怠乎職責然後你們的韓式不但沒有保護到這些受試者的權益而且還推他們入火坑所以你們難道不應該針對執行人體研究特別是收案地點不是在醫療院所的研究涉及到抽血的行為人員的資格框定做出清楚明確\n730530\t758393\t而且要符合受試者權益保障的任何規範來給目的事業主管機關當指導嗎而且基於衛福部作為人體研究法規的主管機關三讀以後當時學校啦其他部會啦其他研究機構啦他們的研究案例不像現在這麼多所以經過了十幾年了\n760094\t776635\t你們還繼續拿舊的韓式出來舊地合法化台師大這一個根本就是聽不下去合法不合情也不合理的合理的舊的韓式法規啦但不合情也不合理\n778697\t805640\t的這種狀況 你們難道不用再檢討嗎還是像你們次長講的第一時間先甩鍋給教育部跟監察院不是我 我沒有 不關我的事跟衛福部無關就是台師大的這個案例才反映了你們這個含釋才了解到衛福部是今天讓這麼多孩子在你們那裡哭\n807239\t818586\t然後才是今天這一種不違反倫理的假倫理的規範的這種研究案啦可以繼續在那裡執行\n820714\t840786\t今天受試者參與研究是醫學研究進步的關鍵所有的受試者都應該在要知情同意的前提之下而且要理解自己參與研究的內容和權益今天還有你們的責任喔 還有一個喔他不准他退出他不准人家退出\n848120\t871792\t然後用受教權人權被威脅這個你們不用訂出任何的規範嗎所有的研究計畫都要他們都送一個執行同意書出來被迫了那他要檢舉要去哪裡檢舉\n873837\t899224\t本來在計畫裡面都有所以我們會強調被迫了要去哪裡檢舉當他們被脅迫不能畢業會怕他要去檢舉這個其實回到檢舉機制在哪裡他敢向學校檢舉嗎本來就可以本來就可以要去哪裡然後連記者去年就幫他們開記者會還是六個月前就幫他們開記者會連立委都幫他們開過了\n900484\t904246\t你們有看到嗎?立委開記者會的時候已經表示他們是被脅迫的為什麼你們沒有主動關心?當他說我人體研究計畫我被強迫抽血我用畢業學分被威脅而曝光了立委也在立法院質詢也開記者會了\n921860\t929606\t已經好幾個月以前了,不是現在這一波請問你衛福部為什麼沒有作為?請問你劉岳平司長,都視若無睹捏很難受的,劉司長要來立法院這麼壞,很難受的啦\n939185\t955539\t視若無睹捏這樣要怎麼做 保證你怎麼視若無睹 你做保證多久啊他開記者會的時候 立委這個爆料的時候 質詢的時候教育委員會的委員爆料開記者會的時候 你們做了什麼事 你們做了什麼事那時候已經違反人體研究法所有的規範了 你做了什麼事\n962469\t974498\t包委員 這個要調查是要去調查我們計劃組織有沒有按照IRB對 那你調查了嗎從第一次曝光開記者會 曝光到現在你剛才劉悅平還在講這個IRB內容你們不知道要去調查已經經過半年了 你現在還要去調查你們不動於衝啦 不當一回事啦\n987368\t994671\t你們就是不當一回事 無動於衷那你告訴我那你告訴我那你告訴我他們的IRB內容審查有沒有問題他們內容說什麼然後他們開記者會 叫立委開記者會說他們被強迫 他們要退出 他們被威脅你們又做了什麼你們做了什麼 這半年多來你們做了什麼\n1013851\t1037564\t第一件事情因為教育部已經開始做處理所以我們才會是說那這樣子的話應該是等教育部給我們他的報告然後整體的機制來做一期的檢討現在就是層層掩護 層層的壓下來而才會有這一第二波的爆料和第二波的記者會\n1039488\t1056755\t你還在講說第一波的時候教育部已經調查了所以你們就不管了你現在是在說笑的 你在說笑的柏定你什麼時候再完成你們這一張不合理的韓式的漏洞的重新檢討柏定這一個韓式到現在還可以適用嗎 還適當嗎第一個我們馬上來處理那個所有發生的問題 包括這個韓式我們馬上\n1071117\t1084345\t不用了 我們一個月就來好 很好那你們需不需要訂出更多的行政指導給其他的目的事業主管機關我們會再重申你們要不要再去重新的檢討檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規好的\n1093931\t1106359\t其他目的事業主管機關在做監督在做IRB審查的時候他們可以有所依循你們是不是應該要主動做更多啊有沒有檢討空間有一定有檢討空間因為事情已經發生表示說我們所有的相關的單位都應該要盡責任的去把它改善\n1116826\t1121927\t不要再有下一次的發生我看你們劉月餅好像就覺得不當一回事還很想變啦我現在講說善意的為醫學或為科學進步去貢獻自己的受試者不應該在醫院參與研究有合格的這個\n1138523\t1157088\t醫療人員抽血而在醫院和在社區參與研究卻有任由沒有受過訓練還邊抽血邊發抖的這一些人來抽這不是回報善意而且熱心參與研究的受試者該得到的對待當然\n1158988\t1170342\t我很熱心的我很善意的我要回饋我們的醫學研究了那我去醫院抽我就有合格的人幫我抽而我到醫院醫療院所以外的你們就容許他讓這種阿貓阿狗邊抽血邊發抖的人來幫他們抽\n1176589\t1202216\t這是不應該的這不是回報這一些善意的人要參與研究願意參與研究的人該有的這個回饋是的 是的我們如果一定會協助去調查如果有違反IRB的該設救責的一定 ME的救責而且要我們一定會檢討整個制度怎麼樣把它改善得更好對 人還有很多制度面是你們應該要扛起來要做更多沒問題我們應該要負這個責任謝謝好 謝謝\n","txt":"謝謝主席主席你剛剛講了14分鐘好謝謝我請邱部長部長請部長是今天大家質詢很多台師大女足球隊的這個被教練周台英這樣強迫抽血不得退出的這一些這個事件是的是那\n第一時間台師大可能違反研究倫理的這個案子你們的林靜儀次長很厲害馬上說這件事件的主角應該負責的是教育部不是衛福部依照人體研究法的確是這樣子沒有錯\n然後接下來呢次長又說他個人的意見是說要關注利害關係權利不對等的狀況是非常重要的所以要特別注意這個倫理這樣子受試者應該要有明確的知情同意權不可以在被脅迫的狀況下為之而且要隨時退出了權利好 話講得這麼好聽然後這樣講了以後好像\n我就覺得說難道衛福部完全都沒有任何一丁點需要檢討的地方嗎這個事情完全跟衛福部都沒有關係嗎今天聽了一個早上你們的劉悅平司長喔 很難聽 今天終於來了\n劉月平司長今天有講他的論述更簡單他說這個事情都應該要照研究計畫的主持的目的事業主管機關就是教育部他們有審查了IRB那要看這個研究人員有沒有遵守\n他們應該遵循的法尊是像IRB計畫有沒有遵守這樣在執行然後第二個 劉業平馬上說這個IRB計畫不是你們審的那內容你們也不知道所以也不知道他們有沒有遵守是吧 大概你們就這樣講 對吧\n整齊都這樣說啊 意思是說跟衛福部都沒關係啦是台師大的問題啦 跟教育部的問題啦事實是不是這樣 保庭你說一下\n好 謝謝委員的催省我想任何民眾有受到健康上的一個威脅你不要避重就輕你今天在這裡你們所值的理由就是說這個IRB不是你們審美主管機關是告有報這個研究界外的IRB內容你們不知道對嘛 對嘛 是不是我們都一切依法辦理\n很好我現在就是要跟你講依法辦理的事情我今天要再跟你講今天國科會副主委出來講了一件事\n國科會副主委說全台灣一百多個大學裡面而體育學門有申請人體試驗的計畫數台師大遠遠超過其他學校的總和國科會的人體試驗的補助計畫台師大萊爾申請了占了所有補助計畫裡面的六成以上這是一個非常不尋常的事情或許這是一個全面性在體育學門長期以來存在的問題\nOK 這事情有嚴重嗎 有啊 為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅 畢業威脅讓他們沒有執行同意 不能行使退出權誰讓這些孩子哭 而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情\n教育部在審查IRB的時候他們會知道他們會有足夠的專業去知道說IRB委員要聘請哪一些領域嗎他們會知道每天抽血三次連續抽血14天而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎教育部會有這個專業嗎教育部會有這個能力嗎你有給他任何行政指導嗎\n你們衛福部不但沒有給他們任何行政指導我現在要講衛福部就是你所謂的依法行政裡面讓教育部讓台師大讓這些孩子這樣子在脅迫的狀況下恐懼的狀況下在那裡哭不得已才跑出來陳情讓他們哭的始作俑者我告訴你就是你們衛福部看這個公文\n看這個公文來護理人員法解釋會編 108年好 那看你們的行政函式誰允許教育部來抽血 不需要專業的人力然後誰認為這個不是輔助醫療行為非侵入性 即便侵入性也沒關係是你們衛福部 101年因為\n人體研究法通過以後大量的人體研究然後大家講說誰可以執行抽血的動作大家就寫公文來問你衛福部衛福部告訴大家你們不要假裝你不知道啦這個事情你們都知道啦\n衛福部人家所詢學校護理人員如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣他的釋法性應該是什麼最後一個所以你們說衛福部說研究計畫進行人體抽血抽樣非屬醫療行為也不是醫療輔助行為\n讓他們可以亂找人有人來抽血抽到手發抖的不是校戶連不是校戶連叔叔伯伯阿姨是誰來抽血這些孩子都不知道抽到很痛在那裡哭一天抽三次連續抽14天讓孩子暴露在風險之下的就是這一張公文函式\n這一張公文好像是有講說至學校護理人員 如果是學校護理人員系授託協助校內研究計畫進行人體抽血採樣上階計畫應經人體研究法相關規定審查通過 使得為之OK看起來是什麼意思 不知道欸 不知道欸他是說校務可以抽 要放到計畫裡面審查通過就可以問題是 你這張函是憑啥這樣子說\n你的外服部的這一張公文等於是法規了命令了他有法律未接法律效力你們今天一直講依法依法你們幫助台師大逃避法律的規範就是你們這一張函式不要再多說了你們的你們都很清楚醫事司司長自己也很清楚\n你們今天在這裡為七成這麼多 你不敢說的就是因為你副師長講了 副師長受訪 劉玉京說研究中的抽血並不是醫療行為 也不是醫療輔助行為但因攸關受試者保護 必須要由校護或醫檢師執行\n144就是根據這一張函釋來的啦好 這個函釋的見解是這樣子我現在就講說奇怪了 這個函釋合法嗎這個函釋合理嗎這個函釋最大的問題就是對於涉及需要抽血的研究計畫進行抽血的人是沒有任何資格條件的限制\n而且是完全沒有規定的 只要IRB計畫審查通過就可以了因為人家來問你說校戶可不可以抽你們說只要放在計畫裡面有就可以了那你們沒有說校戶以外的人不能抽 事實上有你們就是說不是醫療行為 不是醫療輔助行為每個人都可以來執行抽血的任務你校戶要來抽的話放在計畫裡面通過就可以了\n阿貓阿狗來抽也可以放到IRB計畫裡面通過就可以了你們憑什麼這麼說 憑什麼你們憑什麼把這一張公文還是法律的依據在哪裡讓你可以允許讓這些孩子這樣子讓這些人暴露在健康的風險之下\n憑什麼連續一天抽三次 連續十四天有風險的行為你們讓他合法化 憑什麼來 學長阿姨就可以抽\n我先講一下第一件事情校護是護理人員也就是醫事人員我不講我不講校護了我現在你的這張函式是阿貓阿狗學長阿姨通通可以來抽沒有我覺得這是對於法令這邊我們在講的是本來人體研究法裡面的IRB就會進行受試者保護所以所有的東西必須程序這邊IRB這邊的在審查每一個計劃案的時候\n我們人體研究法你們不需要訂出任何的行政指引給要做研究因為你把所有研究計畫的把關機制都交給要做研究的那個計畫的主持人的他的目的事業主管機關去核定去管理去監督IRB也交給他們\n你們衛福部在人體研究法讓你們當主管機關之後你不用訂出任何的遵循的行政指導嗎你不用訂出任何的執法嗎來讓教育部搞不好還有體育部未來的體育部搞不好還有國科位\n搞不好其他的農業部也可以來提研究計畫你認為他們有足夠的專業他們知道IRB要聘請哪種委員嗎你們衛福部作為人體研究法的主管機關難道不用訂出相關的行政指導給這一些\n目的是業主管機關嗎?你剛才說的都不符合裡面你們怠惰了這麼久,從一百二零一一年是吧,完成立法\n2011年完成立法到現在都沒有做出任何行政指導放任放任這一些目的世界主管機關不知道把關的住把關不住隨便你到這一次事件爆發才知道衛福部不但是這麼的瀆職而且台師大案件凸顯了這一個101年你們含釋的不合理且沒有辦法保護受試者權益的缺陷\n這個事件凸顯了你們怠乎職責然後你們的韓式不但沒有保護到這些受試者的權益而且還推他們入火坑所以你們難道不應該針對執行人體研究特別是收案地點不是在醫療院所的研究涉及到抽血的行為人員的資格框定做出清楚明確\n而且要符合受試者權益保障的任何規範來給目的事業主管機關當指導嗎而且基於衛福部作為人體研究法規的主管機關三讀以後當時學校啦其他部會啦其他研究機構啦他們的研究案例不像現在這麼多所以經過了十幾年了\n你們還繼續拿舊的韓式出來舊地合法化台師大這一個根本就是聽不下去合法不合情也不合理的合理的舊的韓式法規啦但不合情也不合理\n的這種狀況 你們難道不用再檢討嗎還是像你們次長講的第一時間先甩鍋給教育部跟監察院不是我 我沒有 不關我的事跟衛福部無關就是台師大的這個案例才反映了你們這個含釋才了解到衛福部是今天讓這麼多孩子在你們那裡哭\n然後才是今天這一種不違反倫理的假倫理的規範的這種研究案啦可以繼續在那裡執行\n今天受試者參與研究是醫學研究進步的關鍵所有的受試者都應該在要知情同意的前提之下而且要理解自己參與研究的內容和權益今天還有你們的責任喔 還有一個喔他不准他退出他不准人家退出\n然後用受教權人權被威脅這個你們不用訂出任何的規範嗎所有的研究計畫都要他們都送一個執行同意書出來被迫了那他要檢舉要去哪裡檢舉\n本來在計畫裡面都有所以我們會強調被迫了要去哪裡檢舉當他們被脅迫不能畢業會怕他要去檢舉這個其實回到檢舉機制在哪裡他敢向學校檢舉嗎本來就可以本來就可以要去哪裡然後連記者去年就幫他們開記者會還是六個月前就幫他們開記者會連立委都幫他們開過了\n你們有看到嗎?立委開記者會的時候已經表示他們是被脅迫的為什麼你們沒有主動關心?當他說我人體研究計畫我被強迫抽血我用畢業學分被威脅而曝光了立委也在立法院質詢也開記者會了\n已經好幾個月以前了,不是現在這一波請問你衛福部為什麼沒有作為?請問你劉岳平司長,都視若無睹捏很難受的,劉司長要來立法院這麼壞,很難受的啦\n視若無睹捏這樣要怎麼做 保證你怎麼視若無睹 你做保證多久啊他開記者會的時候 立委這個爆料的時候 質詢的時候教育委員會的委員爆料開記者會的時候 你們做了什麼事 你們做了什麼事那時候已經違反人體研究法所有的規範了 你做了什麼事\n包委員 這個要調查是要去調查我們計劃組織有沒有按照IRB對 那你調查了嗎從第一次曝光開記者會 曝光到現在你剛才劉悅平還在講這個IRB內容你們不知道要去調查已經經過半年了 你現在還要去調查你們不動於衝啦 不當一回事啦\n你們就是不當一回事 無動於衷那你告訴我那你告訴我那你告訴我他們的IRB內容審查有沒有問題他們內容說什麼然後他們開記者會 叫立委開記者會說他們被強迫 他們要退出 他們被威脅你們又做了什麼你們做了什麼 這半年多來你們做了什麼\n第一件事情因為教育部已經開始做處理所以我們才會是說那這樣子的話應該是等教育部給我們他的報告然後整體的機制來做一期的檢討現在就是層層掩護 層層的壓下來而才會有這一第二波的爆料和第二波的記者會\n你還在講說第一波的時候教育部已經調查了所以你們就不管了你現在是在說笑的 你在說笑的柏定你什麼時候再完成你們這一張不合理的韓式的漏洞的重新檢討柏定這一個韓式到現在還可以適用嗎 還適當嗎第一個我們馬上來處理那個所有發生的問題 包括這個韓式我們馬上\n不用了 我們一個月就來好 很好那你們需不需要訂出更多的行政指導給其他的目的事業主管機關我們會再重申你們要不要再去重新的檢討檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規好的\n其他目的事業主管機關在做監督在做IRB審查的時候他們可以有所依循你們是不是應該要主動做更多啊有沒有檢討空間有一定有檢討空間因為事情已經發生表示說我們所有的相關的單位都應該要盡責任的去把它改善\n不要再有下一次的發生我看你們劉月餅好像就覺得不當一回事還很想變啦我現在講說善意的為醫學或為科學進步去貢獻自己的受試者不應該在醫院參與研究有合格的這個\n醫療人員抽血而在醫院和在社區參與研究卻有任由沒有受過訓練還邊抽血邊發抖的這一些人來抽這不是回報善意而且熱心參與研究的受試者該得到的對待當然\n我很熱心的我很善意的我要回饋我們的醫學研究了那我去醫院抽我就有合格的人幫我抽而我到醫院醫療院所以外的你們就容許他讓這種阿貓阿狗邊抽血邊發抖的人來幫他們抽\n這是不應該的這不是回報這一些善意的人要參與研究願意參與研究的人該有的這個回饋是的 是的我們如果一定會協助去調查如果有違反IRB的該設救責的一定 ME的救責而且要我們一定會檢討整個制度怎麼樣把它改善得更好對 人還有很多制度面是你們應該要扛起來要做更多沒問題我們應該要負這個責任謝謝好 謝謝\n","vtt":"WEBVTT\n\n00:03.644 --> 00:10.666\n謝謝主席主席你剛剛講了14分鐘好謝謝我請邱部長部長請部長是今天大家質詢很多台師大女足球隊的這個被教練周台英這樣強迫抽血不得退出的這一些這個事件是的是那\n\n00:31.445 --> 00:50.267\n第一時間台師大可能違反研究倫理的這個案子你們的林靜儀次長很厲害馬上說這件事件的主角應該負責的是教育部不是衛福部依照人體研究法的確是這樣子沒有錯\n\n00:52.529 --> 01:15.537\n然後接下來呢次長又說他個人的意見是說要關注利害關係權利不對等的狀況是非常重要的所以要特別注意這個倫理這樣子受試者應該要有明確的知情同意權不可以在被脅迫的狀況下為之而且要隨時退出了權利好話講得這麼好聽然後這樣講了以後好像\n\n01:18.098 --> 01:20.539\n我就覺得說難道衛福部完全都沒有任何一丁點需要檢討的地方嗎這個事情完全跟衛福部都沒有關係嗎今天聽了一個早上你們的劉悅平司長喔很難聽今天終於來了\n\n01:36.723 --> 01:56.903\n劉月平司長今天有講他的論述更簡單他說這個事情都應該要照研究計畫的主持的目的事業主管機關就是教育部他們有審查了IRB那要看這個研究人員有沒有遵守\n\n01:57.503 --> 02:14.899\n他們應該遵循的法尊是像IRB計畫有沒有遵守這樣在執行然後第二個劉業平馬上說這個IRB計畫不是你們審的那內容你們也不知道所以也不知道他們有沒有遵守是吧大概你們就這樣講對吧\n\n02:18.831 --> 02:25.422\n整齊都這樣說啊意思是說跟衛福部都沒關係啦是台師大的問題啦跟教育部的問題啦事實是不是這樣保庭你說一下\n\n02:30.292 --> 02:43.815\n好謝謝委員的催省我想任何民眾有受到健康上的一個威脅你不要避重就輕你今天在這裡你們所值的理由就是說這個IRB不是你們審美主管機關是告有報這個研究界外的IRB內容你們不知道對嘛對嘛是不是我們都一切依法辦理\n\n02:59.559 --> 03:08.066\n很好我現在就是要跟你講依法辦理的事情我今天要再跟你講今天國科會副主委出來講了一件事\n\n03:08.997 --> 03:37.534\n國科會副主委說全台灣一百多個大學裡面而體育學門有申請人體試驗的計畫數台師大遠遠超過其他學校的總和國科會的人體試驗的補助計畫台師大萊爾申請了占了所有補助計畫裡面的六成以上這是一個非常不尋常的事情或許這是一個全面性在體育學門長期以來存在的問題\n\n03:38.815 --> 03:41.077\nOK這事情有嚴重嗎有啊為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅畢業威脅讓他們沒有執行同意不能行使退出權誰讓這些孩子哭而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情\n\n04:07.219 --> 04:15.766\n教育部在審查IRB的時候他們會知道他們會有足夠的專業去知道說IRB委員要聘請哪一些領域嗎他們會知道每天抽血三次連續抽血14天而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎教育部會有這個專業嗎教育部會有這個能力嗎你有給他任何行政指導嗎\n\n04:37.043 --> 04:43.985\n你們衛福部不但沒有給他們任何行政指導我現在要講衛福部就是你所謂的依法行政裡面讓教育部讓台師大讓這些孩子這樣子在脅迫的狀況下恐懼的狀況下在那裡哭不得已才跑出來陳情讓他們哭的始作俑者我告訴你就是你們衛福部看這個公文\n\n05:07.827 --> 05:09.047\n看這個公文來護理人員法解釋會編108年好那看你們的行政函式誰允許教育部來抽血不需要專業的人力然後誰認為這個不是輔助醫療行為非侵入性即便侵入性也沒關係是你們衛福部101年因為\n\n05:37.234 --> 05:53.090\n人體研究法通過以後大量的人體研究然後大家講說誰可以執行抽血的動作大家就寫公文來問你衛福部衛福部告訴大家你們不要假裝你不知道啦這個事情你們都知道啦\n\n05:54.131 --> 06:01.698\n衛福部人家所詢學校護理人員如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣他的釋法性應該是什麼最後一個所以你們說衛福部說研究計畫進行人體抽血抽樣非屬醫療行為也不是醫療輔助行為\n\n06:20.134 --> 06:41.968\n讓他們可以亂找人有人來抽血抽到手發抖的不是校戶連不是校戶連叔叔伯伯阿姨是誰來抽血這些孩子都不知道抽到很痛在那裡哭一天抽三次連續抽14天讓孩子暴露在風險之下的就是這一張公文函式\n\n06:43.349 --> 07:11.668\n這一張公文好像是有講說至學校護理人員如果是學校護理人員系授託協助校內研究計畫進行人體抽血採樣上階計畫應經人體研究法相關規定審查通過使得為之OK看起來是什麼意思不知道欸不知道欸他是說校務可以抽要放到計畫裡面審查通過就可以問題是你這張函是憑啥這樣子說\n\n07:13.369 --> 07:31.112\n你的外服部的這一張公文等於是法規了命令了他有法律未接法律效力你們今天一直講依法依法你們幫助台師大逃避法律的規範就是你們這一張函式不要再多說了你們的你們都很清楚醫事司司長自己也很清楚\n\n07:40.154 --> 07:44.138\n你們今天在這裡為七成這麼多你不敢說的就是因為你副師長講了副師長受訪劉玉京說研究中的抽血並不是醫療行為也不是醫療輔助行為但因攸關受試者保護必須要由校護或醫檢師執行\n\n08:01.422 --> 08:24.718\n144就是根據這一張函釋來的啦好這個函釋的見解是這樣子我現在就講說奇怪了這個函釋合法嗎這個函釋合理嗎這個函釋最大的問題就是對於涉及需要抽血的研究計畫進行抽血的人是沒有任何資格條件的限制\n\n08:25.518 --> 08:30.122\n而且是完全沒有規定的只要IRB計畫審查通過就可以了因為人家來問你說校戶可不可以抽你們說只要放在計畫裡面有就可以了那你們沒有說校戶以外的人不能抽事實上有你們就是說不是醫療行為不是醫療輔助行為每個人都可以來執行抽血的任務你校戶要來抽的話放在計畫裡面通過就可以了\n\n08:52.875 --> 09:16.661\n阿貓阿狗來抽也可以放到IRB計畫裡面通過就可以了你們憑什麼這麼說憑什麼你們憑什麼把這一張公文還是法律的依據在哪裡讓你可以允許讓這些孩子這樣子讓這些人暴露在健康的風險之下\n\n09:18.019 --> 09:25.185\n憑什麼連續一天抽三次連續十四天有風險的行為你們讓他合法化憑什麼來學長阿姨就可以抽\n\n09:30.686 --> 09:58.084\n我先講一下第一件事情校護是護理人員也就是醫事人員我不講我不講校護了我現在你的這張函式是阿貓阿狗學長阿姨通通可以來抽沒有我覺得這是對於法令這邊我們在講的是本來人體研究法裡面的IRB就會進行受試者保護所以所有的東西必須程序這邊IRB這邊的在審查每一個計劃案的時候\n\n10:00.926 --> 10:19.719\n我們人體研究法你們不需要訂出任何的行政指引給要做研究因為你把所有研究計畫的把關機制都交給要做研究的那個計畫的主持人的他的目的事業主管機關去核定去管理去監督IRB也交給他們\n\n10:22.521 --> 10:27.225\n你們衛福部在人體研究法讓你們當主管機關之後你不用訂出任何的遵循的行政指導嗎你不用訂出任何的執法嗎來讓教育部搞不好還有體育部未來的體育部搞不好還有國科位\n\n10:41.578 --> 11:01.721\n搞不好其他的農業部也可以來提研究計畫你認為他們有足夠的專業他們知道IRB要聘請哪種委員嗎你們衛福部作為人體研究法的主管機關難道不用訂出相關的行政指導給這一些\n\n11:02.722 --> 11:12.907\n目的是業主管機關嗎?你剛才說的都不符合裡面你們怠惰了這麼久,從一百二零一一年是吧,完成立法\n\n11:15.082 --> 11:43.501\n2011年完成立法到現在都沒有做出任何行政指導放任放任這一些目的世界主管機關不知道把關的住把關不住隨便你到這一次事件爆發才知道衛福部不但是這麼的瀆職而且台師大案件凸顯了這一個101年你們含釋的不合理且沒有辦法保護受試者權益的缺陷\n\n11:44.981 --> 12:09.570\n這個事件凸顯了你們怠乎職責然後你們的韓式不但沒有保護到這些受試者的權益而且還推他們入火坑所以你們難道不應該針對執行人體研究特別是收案地點不是在醫療院所的研究涉及到抽血的行為人員的資格框定做出清楚明確\n\n12:10.530 --> 12:38.393\n而且要符合受試者權益保障的任何規範來給目的事業主管機關當指導嗎而且基於衛福部作為人體研究法規的主管機關三讀以後當時學校啦其他部會啦其他研究機構啦他們的研究案例不像現在這麼多所以經過了十幾年了\n\n12:40.094 --> 12:56.635\n你們還繼續拿舊的韓式出來舊地合法化台師大這一個根本就是聽不下去合法不合情也不合理的合理的舊的韓式法規啦但不合情也不合理\n\n12:58.697 --> 13:25.640\n的這種狀況你們難道不用再檢討嗎還是像你們次長講的第一時間先甩鍋給教育部跟監察院不是我我沒有不關我的事跟衛福部無關就是台師大的這個案例才反映了你們這個含釋才了解到衛福部是今天讓這麼多孩子在你們那裡哭\n\n13:27.239 --> 13:38.586\n然後才是今天這一種不違反倫理的假倫理的規範的這種研究案啦可以繼續在那裡執行\n\n13:40.714 --> 14:00.786\n今天受試者參與研究是醫學研究進步的關鍵所有的受試者都應該在要知情同意的前提之下而且要理解自己參與研究的內容和權益今天還有你們的責任喔還有一個喔他不准他退出他不准人家退出\n\n14:08.120 --> 14:31.792\n然後用受教權人權被威脅這個你們不用訂出任何的規範嗎所有的研究計畫都要他們都送一個執行同意書出來被迫了那他要檢舉要去哪裡檢舉\n\n14:33.837 --> 14:59.224\n本來在計畫裡面都有所以我們會強調被迫了要去哪裡檢舉當他們被脅迫不能畢業會怕他要去檢舉這個其實回到檢舉機制在哪裡他敢向學校檢舉嗎本來就可以本來就可以要去哪裡然後連記者去年就幫他們開記者會還是六個月前就幫他們開記者會連立委都幫他們開過了\n\n15:00.484 --> 15:04.246\n你們有看到嗎?立委開記者會的時候已經表示他們是被脅迫的為什麼你們沒有主動關心?當他說我人體研究計畫我被強迫抽血我用畢業學分被威脅而曝光了立委也在立法院質詢也開記者會了\n\n15:21.860 --> 15:29.606\n已經好幾個月以前了,不是現在這一波請問你衛福部為什麼沒有作為?請問你劉岳平司長,都視若無睹捏很難受的,劉司長要來立法院這麼壞,很難受的啦\n\n15:39.185 --> 15:55.539\n視若無睹捏這樣要怎麼做保證你怎麼視若無睹你做保證多久啊他開記者會的時候立委這個爆料的時候質詢的時候教育委員會的委員爆料開記者會的時候你們做了什麼事你們做了什麼事那時候已經違反人體研究法所有的規範了你做了什麼事\n\n16:02.469 --> 16:14.498\n包委員這個要調查是要去調查我們計劃組織有沒有按照IRB對那你調查了嗎從第一次曝光開記者會曝光到現在你剛才劉悅平還在講這個IRB內容你們不知道要去調查已經經過半年了你現在還要去調查你們不動於衝啦不當一回事啦\n\n16:27.368 --> 16:34.671\n你們就是不當一回事無動於衷那你告訴我那你告訴我那你告訴我他們的IRB內容審查有沒有問題他們內容說什麼然後他們開記者會叫立委開記者會說他們被強迫他們要退出他們被威脅你們又做了什麼你們做了什麼這半年多來你們做了什麼\n\n16:53.851 --> 17:17.564\n第一件事情因為教育部已經開始做處理所以我們才會是說那這樣子的話應該是等教育部給我們他的報告然後整體的機制來做一期的檢討現在就是層層掩護層層的壓下來而才會有這一第二波的爆料和第二波的記者會\n\n17:19.488 --> 17:36.755\n你還在講說第一波的時候教育部已經調查了所以你們就不管了你現在是在說笑的你在說笑的柏定你什麼時候再完成你們這一張不合理的韓式的漏洞的重新檢討柏定這一個韓式到現在還可以適用嗎還適當嗎第一個我們馬上來處理那個所有發生的問題包括這個韓式我們馬上\n\n17:51.117 --> 18:04.345\n不用了我們一個月就來好很好那你們需不需要訂出更多的行政指導給其他的目的事業主管機關我們會再重申你們要不要再去重新的檢討檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規好的\n\n18:13.931 --> 18:26.359\n其他目的事業主管機關在做監督在做IRB審查的時候他們可以有所依循你們是不是應該要主動做更多啊有沒有檢討空間有一定有檢討空間因為事情已經發生表示說我們所有的相關的單位都應該要盡責任的去把它改善\n\n18:36.826 --> 18:41.927\n不要再有下一次的發生我看你們劉月餅好像就覺得不當一回事還很想變啦我現在講說善意的為醫學或為科學進步去貢獻自己的受試者不應該在醫院參與研究有合格的這個\n\n18:58.523 --> 19:17.088\n醫療人員抽血而在醫院和在社區參與研究卻有任由沒有受過訓練還邊抽血邊發抖的這一些人來抽這不是回報善意而且熱心參與研究的受試者該得到的對待當然\n\n19:18.988 --> 19:30.342\n我很熱心的我很善意的我要回饋我們的醫學研究了那我去醫院抽我就有合格的人幫我抽而我到醫院醫療院所以外的你們就容許他讓這種阿貓阿狗邊抽血邊發抖的人來幫他們抽\n\n19:36.589 --> 20:02.216\n這是不應該的這不是回報這一些善意的人要參與研究願意參與研究的人該有的這個回饋是的是的我們如果一定會協助去調查如果有違反IRB的該設救責的一定ME的救責而且要我們一定會檢討整個制度怎麼樣把它改善得更好對人還有很多制度面是你們應該要扛起來要做更多沒問題我們應該要負這個責任謝謝好謝謝\n\n","segments":[{"start":3.644,"end":10.666,"text":"謝謝主席主席你剛剛講了14分鐘好謝謝我請邱部長部長請部長是今天大家質詢很多台師大女足球隊的這個被教練周台英這樣強迫抽血不得退出的這一些這個事件是的是那"},{"start":31.445,"end":50.267,"text":"第一時間台師大可能違反研究倫理的這個案子你們的林靜儀次長很厲害馬上說這件事件的主角應該負責的是教育部不是衛福部依照人體研究法的確是這樣子沒有錯"},{"start":52.529,"end":75.537,"text":"然後接下來呢次長又說他個人的意見是說要關注利害關係權利不對等的狀況是非常重要的所以要特別注意這個倫理這樣子受試者應該要有明確的知情同意權不可以在被脅迫的狀況下為之而且要隨時退出了權利好 話講得這麼好聽然後這樣講了以後好像"},{"start":78.098,"end":80.539,"text":"我就覺得說難道衛福部完全都沒有任何一丁點需要檢討的地方嗎這個事情完全跟衛福部都沒有關係嗎今天聽了一個早上你們的劉悅平司長喔 很難聽 今天終於來了"},{"start":96.723,"end":116.903,"text":"劉月平司長今天有講他的論述更簡單他說這個事情都應該要照研究計畫的主持的目的事業主管機關就是教育部他們有審查了IRB那要看這個研究人員有沒有遵守"},{"start":117.503,"end":134.899,"text":"他們應該遵循的法尊是像IRB計畫有沒有遵守這樣在執行然後第二個 劉業平馬上說這個IRB計畫不是你們審的那內容你們也不知道所以也不知道他們有沒有遵守是吧 大概你們就這樣講 對吧"},{"start":138.831,"end":145.422,"text":"整齊都這樣說啊 意思是說跟衛福部都沒關係啦是台師大的問題啦 跟教育部的問題啦事實是不是這樣 保庭你說一下"},{"start":150.292,"end":163.815,"text":"好 謝謝委員的催省我想任何民眾有受到健康上的一個威脅你不要避重就輕你今天在這裡你們所值的理由就是說這個IRB不是你們審美主管機關是告有報這個研究界外的IRB內容你們不知道對嘛 對嘛 是不是我們都一切依法辦理"},{"start":179.559,"end":188.066,"text":"很好我現在就是要跟你講依法辦理的事情我今天要再跟你講今天國科會副主委出來講了一件事"},{"start":188.997,"end":217.534,"text":"國科會副主委說全台灣一百多個大學裡面而體育學門有申請人體試驗的計畫數台師大遠遠超過其他學校的總和國科會的人體試驗的補助計畫台師大萊爾申請了占了所有補助計畫裡面的六成以上這是一個非常不尋常的事情或許這是一個全面性在體育學門長期以來存在的問題"},{"start":218.815,"end":221.077,"text":"OK 這事情有嚴重嗎 有啊 為什麼這麼嚴重誰讓這些學生要透過學分這樣威脅 畢業威脅讓他們沒有執行同意 不能行使退出權誰讓這些孩子哭 而只是這幾個孩子在哭嗎今天不是只有這些學生耶你看這很嚴重的可是我要問你一件事情"},{"start":247.219,"end":255.766,"text":"教育部在審查IRB的時候他們會知道他們會有足夠的專業去知道說IRB委員要聘請哪一些領域嗎他們會知道每天抽血三次連續抽血14天而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎教育部會有這個專業嗎教育部會有這個能力嗎你有給他任何行政指導嗎"},{"start":277.043,"end":283.985,"text":"你們衛福部不但沒有給他們任何行政指導我現在要講衛福部就是你所謂的依法行政裡面讓教育部讓台師大讓這些孩子這樣子在脅迫的狀況下恐懼的狀況下在那裡哭不得已才跑出來陳情讓他們哭的始作俑者我告訴你就是你們衛福部看這個公文"},{"start":307.827,"end":309.047,"text":"看這個公文來護理人員法解釋會編 108年好 那看你們的行政函式誰允許教育部來抽血 不需要專業的人力然後誰認為這個不是輔助醫療行為非侵入性 即便侵入性也沒關係是你們衛福部 101年因為"},{"start":337.234,"end":353.09,"text":"人體研究法通過以後大量的人體研究然後大家講說誰可以執行抽血的動作大家就寫公文來問你衛福部衛福部告訴大家你們不要假裝你不知道啦這個事情你們都知道啦"},{"start":354.131,"end":361.698,"text":"衛福部人家所詢學校護理人員如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣他的釋法性應該是什麼最後一個所以你們說衛福部說研究計畫進行人體抽血抽樣非屬醫療行為也不是醫療輔助行為"},{"start":380.134,"end":401.968,"text":"讓他們可以亂找人有人來抽血抽到手發抖的不是校戶連不是校戶連叔叔伯伯阿姨是誰來抽血這些孩子都不知道抽到很痛在那裡哭一天抽三次連續抽14天讓孩子暴露在風險之下的就是這一張公文函式"},{"start":403.349,"end":431.668,"text":"這一張公文好像是有講說至學校護理人員 如果是學校護理人員系授託協助校內研究計畫進行人體抽血採樣上階計畫應經人體研究法相關規定審查通過 使得為之OK看起來是什麼意思 不知道欸 不知道欸他是說校務可以抽 要放到計畫裡面審查通過就可以問題是 你這張函是憑啥這樣子說"},{"start":433.369,"end":451.112,"text":"你的外服部的這一張公文等於是法規了命令了他有法律未接法律效力你們今天一直講依法依法你們幫助台師大逃避法律的規範就是你們這一張函式不要再多說了你們的你們都很清楚醫事司司長自己也很清楚"},{"start":460.154,"end":464.138,"text":"你們今天在這裡為七成這麼多 你不敢說的就是因為你副師長講了 副師長受訪 劉玉京說研究中的抽血並不是醫療行為 也不是醫療輔助行為但因攸關受試者保護 必須要由校護或醫檢師執行"},{"start":481.422,"end":504.718,"text":"144就是根據這一張函釋來的啦好 這個函釋的見解是這樣子我現在就講說奇怪了 這個函釋合法嗎這個函釋合理嗎這個函釋最大的問題就是對於涉及需要抽血的研究計畫進行抽血的人是沒有任何資格條件的限制"},{"start":505.518,"end":510.122,"text":"而且是完全沒有規定的 只要IRB計畫審查通過就可以了因為人家來問你說校戶可不可以抽你們說只要放在計畫裡面有就可以了那你們沒有說校戶以外的人不能抽 事實上有你們就是說不是醫療行為 不是醫療輔助行為每個人都可以來執行抽血的任務你校戶要來抽的話放在計畫裡面通過就可以了"},{"start":532.875,"end":556.661,"text":"阿貓阿狗來抽也可以放到IRB計畫裡面通過就可以了你們憑什麼這麼說 憑什麼你們憑什麼把這一張公文還是法律的依據在哪裡讓你可以允許讓這些孩子這樣子讓這些人暴露在健康的風險之下"},{"start":558.019,"end":565.185,"text":"憑什麼連續一天抽三次 連續十四天有風險的行為你們讓他合法化 憑什麼來 學長阿姨就可以抽"},{"start":570.686,"end":598.084,"text":"我先講一下第一件事情校護是護理人員也就是醫事人員我不講我不講校護了我現在你的這張函式是阿貓阿狗學長阿姨通通可以來抽沒有我覺得這是對於法令這邊我們在講的是本來人體研究法裡面的IRB就會進行受試者保護所以所有的東西必須程序這邊IRB這邊的在審查每一個計劃案的時候"},{"start":600.926,"end":619.719,"text":"我們人體研究法你們不需要訂出任何的行政指引給要做研究因為你把所有研究計畫的把關機制都交給要做研究的那個計畫的主持人的他的目的事業主管機關去核定去管理去監督IRB也交給他們"},{"start":622.521,"end":627.225,"text":"你們衛福部在人體研究法讓你們當主管機關之後你不用訂出任何的遵循的行政指導嗎你不用訂出任何的執法嗎來讓教育部搞不好還有體育部未來的體育部搞不好還有國科位"},{"start":641.578,"end":661.721,"text":"搞不好其他的農業部也可以來提研究計畫你認為他們有足夠的專業他們知道IRB要聘請哪種委員嗎你們衛福部作為人體研究法的主管機關難道不用訂出相關的行政指導給這一些"},{"start":662.722,"end":672.907,"text":"目的是業主管機關嗎?你剛才說的都不符合裡面你們怠惰了這麼久,從一百二零一一年是吧,完成立法"},{"start":675.082,"end":703.501,"text":"2011年完成立法到現在都沒有做出任何行政指導放任放任這一些目的世界主管機關不知道把關的住把關不住隨便你到這一次事件爆發才知道衛福部不但是這麼的瀆職而且台師大案件凸顯了這一個101年你們含釋的不合理且沒有辦法保護受試者權益的缺陷"},{"start":704.981,"end":729.57,"text":"這個事件凸顯了你們怠乎職責然後你們的韓式不但沒有保護到這些受試者的權益而且還推他們入火坑所以你們難道不應該針對執行人體研究特別是收案地點不是在醫療院所的研究涉及到抽血的行為人員的資格框定做出清楚明確"},{"start":730.53,"end":758.393,"text":"而且要符合受試者權益保障的任何規範來給目的事業主管機關當指導嗎而且基於衛福部作為人體研究法規的主管機關三讀以後當時學校啦其他部會啦其他研究機構啦他們的研究案例不像現在這麼多所以經過了十幾年了"},{"start":760.094,"end":776.635,"text":"你們還繼續拿舊的韓式出來舊地合法化台師大這一個根本就是聽不下去合法不合情也不合理的合理的舊的韓式法規啦但不合情也不合理"},{"start":778.697,"end":805.64,"text":"的這種狀況 你們難道不用再檢討嗎還是像你們次長講的第一時間先甩鍋給教育部跟監察院不是我 我沒有 不關我的事跟衛福部無關就是台師大的這個案例才反映了你們這個含釋才了解到衛福部是今天讓這麼多孩子在你們那裡哭"},{"start":807.239,"end":818.586,"text":"然後才是今天這一種不違反倫理的假倫理的規範的這種研究案啦可以繼續在那裡執行"},{"start":820.714,"end":840.786,"text":"今天受試者參與研究是醫學研究進步的關鍵所有的受試者都應該在要知情同意的前提之下而且要理解自己參與研究的內容和權益今天還有你們的責任喔 還有一個喔他不准他退出他不准人家退出"},{"start":848.12,"end":871.792,"text":"然後用受教權人權被威脅這個你們不用訂出任何的規範嗎所有的研究計畫都要他們都送一個執行同意書出來被迫了那他要檢舉要去哪裡檢舉"},{"start":873.837,"end":899.224,"text":"本來在計畫裡面都有所以我們會強調被迫了要去哪裡檢舉當他們被脅迫不能畢業會怕他要去檢舉這個其實回到檢舉機制在哪裡他敢向學校檢舉嗎本來就可以本來就可以要去哪裡然後連記者去年就幫他們開記者會還是六個月前就幫他們開記者會連立委都幫他們開過了"},{"start":900.484,"end":904.246,"text":"你們有看到嗎?立委開記者會的時候已經表示他們是被脅迫的為什麼你們沒有主動關心?當他說我人體研究計畫我被強迫抽血我用畢業學分被威脅而曝光了立委也在立法院質詢也開記者會了"},{"start":921.86,"end":929.606,"text":"已經好幾個月以前了,不是現在這一波請問你衛福部為什麼沒有作為?請問你劉岳平司長,都視若無睹捏很難受的,劉司長要來立法院這麼壞,很難受的啦"},{"start":939.185,"end":955.539,"text":"視若無睹捏這樣要怎麼做 保證你怎麼視若無睹 你做保證多久啊他開記者會的時候 立委這個爆料的時候 質詢的時候教育委員會的委員爆料開記者會的時候 你們做了什麼事 你們做了什麼事那時候已經違反人體研究法所有的規範了 你做了什麼事"},{"start":962.469,"end":974.498,"text":"包委員 這個要調查是要去調查我們計劃組織有沒有按照IRB對 那你調查了嗎從第一次曝光開記者會 曝光到現在你剛才劉悅平還在講這個IRB內容你們不知道要去調查已經經過半年了 你現在還要去調查你們不動於衝啦 不當一回事啦"},{"start":987.368,"end":994.671,"text":"你們就是不當一回事 無動於衷那你告訴我那你告訴我那你告訴我他們的IRB內容審查有沒有問題他們內容說什麼然後他們開記者會 叫立委開記者會說他們被強迫 他們要退出 他們被威脅你們又做了什麼你們做了什麼 這半年多來你們做了什麼"},{"start":1013.851,"end":1037.564,"text":"第一件事情因為教育部已經開始做處理所以我們才會是說那這樣子的話應該是等教育部給我們他的報告然後整體的機制來做一期的檢討現在就是層層掩護 層層的壓下來而才會有這一第二波的爆料和第二波的記者會"},{"start":1039.488,"end":1056.755,"text":"你還在講說第一波的時候教育部已經調查了所以你們就不管了你現在是在說笑的 你在說笑的柏定你什麼時候再完成你們這一張不合理的韓式的漏洞的重新檢討柏定這一個韓式到現在還可以適用嗎 還適當嗎第一個我們馬上來處理那個所有發生的問題 包括這個韓式我們馬上"},{"start":1071.117,"end":1084.345,"text":"不用了 我們一個月就來好 很好那你們需不需要訂出更多的行政指導給其他的目的事業主管機關我們會再重申你們要不要再去重新的檢討檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規好的"},{"start":1093.931,"end":1106.359,"text":"其他目的事業主管機關在做監督在做IRB審查的時候他們可以有所依循你們是不是應該要主動做更多啊有沒有檢討空間有一定有檢討空間因為事情已經發生表示說我們所有的相關的單位都應該要盡責任的去把它改善"},{"start":1116.826,"end":1121.927,"text":"不要再有下一次的發生我看你們劉月餅好像就覺得不當一回事還很想變啦我現在講說善意的為醫學或為科學進步去貢獻自己的受試者不應該在醫院參與研究有合格的這個"},{"start":1138.523,"end":1157.088,"text":"醫療人員抽血而在醫院和在社區參與研究卻有任由沒有受過訓練還邊抽血邊發抖的這一些人來抽這不是回報善意而且熱心參與研究的受試者該得到的對待當然"},{"start":1158.988,"end":1170.342,"text":"我很熱心的我很善意的我要回饋我們的醫學研究了那我去醫院抽我就有合格的人幫我抽而我到醫院醫療院所以外的你們就容許他讓這種阿貓阿狗邊抽血邊發抖的人來幫他們抽"},{"start":1176.589,"end":1202.216,"text":"這是不應該的這不是回報這一些善意的人要參與研究願意參與研究的人該有的這個回饋是的 是的我們如果一定會協助去調查如果有違反IRB的該設救責的一定 ME的救責而且要我們一定會檢討整個制度怎麼樣把它改善得更好對 人還有很多制度面是你們應該要扛起來要做更多沒問題我們應該要負這個責任謝謝好 謝謝"}]}}},"gazette":{"lineno":755,"blocks":[["林委員淑芬：（10時56分）謝謝主席，主席，你剛剛講了14分鐘。好，謝謝，我請邱部長。"],["邱部長泰源：委員好。"],["林委員淑芬：部長，今天有很多委員質詢臺師大女足球隊被教練周台英強迫抽血而且不得退出的這個事件。"],["邱部長泰源：是的。"],["林委員淑芬：關於臺師大可能違反研究倫理的這個案子，你們的林靜儀次長很厲害，在第一時間馬上說這個事件的主角、應該負責的是教育部而不是衛福部，OK，依照人體研究法的規定，的確是這樣子沒有錯。然後接下來次長又說他個人的意見是認為要關注有利害關係權力不對等的狀況，這是非常重要的，所以要特別注意倫理，受試者應該要有明確的知情同意權，然後不可以在被脅迫的狀況下為之，而且要有隨時退出的權利。好，話講得這麼好聽，然後這樣講了以後，我就覺得難道衛福部完全都沒有任何一丁點需要檢討的地方嗎？這個事情完全跟衛福部都沒有關係嗎？我今天聽了一個早上，你們的劉越萍司長很難請，她今天終於來了，劉越萍司長今天有講，他的論述更簡單，他說這個事情都應該要照研究計畫的目的事業主管機關也就是教育部，他們有審查了IRB，要看這個研究人員有沒有遵守他們應該遵循的法遵事項，IRB計畫有沒有遵守然後這樣執行。然後第二個是劉越萍馬上說這個IRB計畫不是你們審的，那你們不知道內容，所以也不知道他們有沒有遵守，是吧？你們大概就是這樣講的，對吧？今天整個早上都是這樣講，意思就是說這跟衛福部都沒有關係，是臺師大的問題啦！是教育部的問題啦！事實是不是這樣？部長，你說明一下。"],["邱部長泰源：好，謝謝委員的垂詢，我想任何民眾的健康有受到威脅……"],["林委員淑芬：你不要避重就輕，你今天在這裡，你們所持的理由就是說這個IRB不是你們審的，主管機關是教育部，你們不知道這個研究計畫的IRB內容，是不是？"],["邱部長泰源：我們都一切依法辦理。"],["林委員淑芬：很好，我現在就是要跟你講依法辦理的事情，OK，我今天要再跟你講喔！今天國科會副主委出來講了一件事，國科會副主委說全臺灣一百多個大學裡面，而體育學門有申請人體試驗的計畫數，臺師大遠遠超過其他學校的總和，國科會的人體試驗補助計畫，臺師大申請的占了所有補助計畫裡面的六成以上，這是一個非常不尋常的事情，或許這是一個全面性在體育學門長期以來存在的問題。OK，這事情有嚴重嗎？有，為什麼這麼嚴重？誰讓這些學生要透過學分這樣的畢業威脅，讓他們沒有知情同意，不能行使退出權，誰讓這些孩子哭？而只是這幾個孩子在哭嗎？今天不是只有這些學生，你看這很嚴重，可是我要問你一件事情，教育部在審查IRB的時候，他們會有足夠的專業去知道IRB委員要聘請哪一些領域嗎？他們會知道每天抽血3次、連續抽血14天，而這樣子的抽血行為對被抽血人的健康風險會有什麼樣的影響嗎？教育部會有這個專業嗎？教育部會有這個能力嗎？你有給它任何行政指導嗎？你們衛福部不但沒有給他們任何行政指導，我現在要講，衛福部就是你所謂的依法行政裡面，讓教育部、讓臺師大、讓這些孩子這樣子在脅迫的狀況下、恐懼的狀況下，在那裡哭，不得已才跑出來陳情，讓他們哭的始作俑者，我告訴你就是你們衛福部。","看這個公文，護理人員法解釋彙編（108年版），好，然後看你們的行政函釋，誰允許教育部來抽血，不需要專業的人力？然後誰認為這個不是輔助醫療行為，非侵入性，即便侵入性也沒關係？是你們衛福部，101年因為人體研究法通過以後大量的人體研究，然後大家講說誰可以執行抽血的動作，大家就寫公文來問你衛福部，衛福部告訴大家，你們不要假裝你不知道，這個事情你們都知道，衛福部，人家所詢如果是由學校護理人員受託協助校內研究計畫進行人體抽血採樣，它的適法性應該是什麼？最後一個，所以你們衛福部說，研究計畫進行人體抽血抽樣非屬醫療行為，也不是醫療輔助行為，讓他們可以亂找人，有人來抽血抽到手發抖的，不是校護，連叔叔、伯伯、阿姨是誰來抽血，這些孩子都不知道，抽到很痛在那裡哭，一天抽3次，連續抽14天，讓孩子暴露在風險之下的就是這一張公文函釋。","這一張公文函釋又講說，至學校護理人員……如果是學校護理人員係受託協助校內研究計畫進行人體抽血採樣，上揭計畫應經人體研究法相關規定審查通過，始得為之。OK，看起來是什麼意思？不知道欸！它是說校護可以抽，要放在計畫裡面，審查通過就可以，問題是你這張函釋是憑啥這樣子說？衛福部的這一張公文等於是法規了、命令了，它有法律位階、法律效力，你們今天一直講依法、依法，你們幫助臺師大逃避法律的規範，就是你們這一張函釋，不要在這裡裝了，你們都很清楚，醫事司司長自己也很清楚，你們今天在這裡，有這麼多立委質詢，你們不敢說的就是因為你副司長講了，副司長受訪，劉玉菁說研究中的抽血並不是醫療行為，也不是醫療輔助行為，但攸關受試者保護，必須要由校護或醫檢師執行，醫事司就是根據這一張函釋來的。好，這個函釋的見解是這樣子，我現在就講說奇怪了，這個函釋合法嗎？這個函釋合理嗎？這個函釋最大的問題就是對於涉及需要抽血的研究計畫，進行抽血的人是沒有任何資格條件的限制，而且是完全沒有規定的，只要IRB計畫審查通過就可以了，因為人家打來問你說校護可不可以抽，你們說只要放在計畫裡面有就可以了，那你們沒有說校護以外的人不能抽，事實上有，你們就是說不是醫療行為、不是醫療輔助行為，每個人都可以來執行抽血的任務，你校護要來抽，放在計畫裡面通過就可以了，阿貓、阿狗來抽也可以，放到IRB計畫裡面通過就可以了，你們憑什麼這麼說？憑什麼？司長來，你來說，部長你來說，你們憑什麼把這一張公文的函釋……法律的依據在哪裡，讓你可以允許讓這些孩子這樣子，讓這些人暴露在健康的風險之下，憑什麼連續一天抽3次，連續14天，有風險的行為，你們讓它合法化，憑什麼？學長、阿姨就可以抽？"],["劉司長越萍：我先講一下，第一件事情，校護是護理人員，也就是醫事人員。"],["林委員淑芬：我不講校護了，你的這張函釋是阿貓、阿狗、學長、阿姨統統可以來抽。"],["劉司長越萍：沒有，我覺得這是對於法令這邊，我們在講的是本來人體研究法裡面的IRB就會進行受試者保護，所以所有的程序，IRB在審查每一個計畫案的時候就應該就這個地方來做處理。"],["林委員淑芬：你講得好聽，來，部長，我問你，人體研究法你們不需要訂出任何的行政指引給要做研究……因為你把所有研究計畫的把關機制都交給要做研究的計畫主持人的目的事業主管機關去核定、去管理、去監督，IRB也交給他們，你們衛福部在人體研究法讓你們當主管機關之後，你不用訂出任何遵循的行政指導嗎？你不用訂出任何的子法嗎？來讓教育部，搞不好還有未來的體育部，搞不好還有國科會，搞不好還有其他的農業部也可以來提研究計畫，你認為他們有足夠的專業，他們知道IRB要聘請哪種委員嗎？你們衛福部作為人體研究法的主管機關，難道不用訂出相關的行政指導給這一些目的事業主管機關嗎？你在這裡說話都不負責任，你們怠惰了這麼久，從2011年，是吧？完成立法，2011年完成立法，到現在都沒有做出任何行政指導，放任這一些目的事業主管機關，不知道把關得住、把關不住，隨便你，到這一次事件爆發才知道，衛福部不但是這麼地瀆職，而且臺師大案件凸顯了這個101年你們函釋的不合理，且沒有辦法保護受試者權益的缺陷，這個事件凸顯了你們怠忽職責，然後你們函釋不但沒有保護到這些受試者的權益，而且還推他們入火坑，所以你們難道不應該針對執行人體研究，特別是收案地點不是在醫療院所的研究，涉及到抽血的行為、人員的資格框定，做出清楚明確而且要符合受試者權益保障的任何規範，來給目的事業主管機關當指導嗎？而且基於衛福部作為人體研究法規的主管機關，三讀以後，當時學校啦、其他部會啦或其他研究機構啦，他們的研究案類不像現在這麼多，所以經過了十幾年了，你們還繼續拿舊的函釋出來，就地合法化，臺師大這一個根本就是聽不下去，合法、不合情也不合理的，合你的舊的函釋法規啦，但不合情也不合理的這一種狀況，你們難道不用再檢討嗎？還是像你們次長講的，第一時間先甩鍋給教育部跟監察院說「不是我，我沒有，不關我的事，跟衛福部無關」，就是臺師大的案例才反映了你們這個函釋，才了解到是衛福部今天讓這麼多孩子在那裡哭，然後才是今天這種不違反倫理的、假倫理規範的這種研究案可以繼續執行。部長，今天受試者參與研究是醫學研究進步的關鍵，所有的受試者都應該要在知情同意的前提之下，而且要理解自己參與研究的內容和權益，今天還有你們的責任喔！還有一個喔！部長，他不准他退出，他不准人家退出，然後讓他的受教權、人權被威脅，這個你們不用訂出任何的規範嗎？你們難道不要所有研究計畫都送知情同意書出來，如果被迫了，那他檢舉要去哪裡檢舉？"],["劉司長越萍：本來在計畫裡面都有，所以我們會強調協助……"],["林委員淑芬：被迫了要去哪裡檢舉？當他們被脅迫不能畢業會怕，他要去哪裡檢舉？"],["劉司長越萍：這個其實回到這件事情……"],["林委員淑芬：檢舉機制在哪裡？"],["劉司長越萍：這個事情……"],["林委員淑芬：他敢向學校檢舉嗎？"],["劉司長越萍：本來就可以，可是會有難度……"],["林委員淑芬：本來就可以，要去哪裡？連記者去年就幫他們開記者會，還是六個月前就幫他們開記者會，連立委都幫他們開過了，你們有看到嗎？立委開記者會的時候已經表示他們是被脅迫的，為什麼你們沒有主動關心？當他說人體研究計畫，我被強迫抽血，我畢業學分被威脅，而曝光了立委也在立法院質詢，也開記者會了，已經好幾個月以前囉！不是現在這一波，請問衛福部為什麼沒有作為？請問你劉越萍司長都視若無睹，好難請！劉司長要來立法院這裡備詢，好難請啦！視若無睹，這樣要怎麼辦？","部長，你怎麼會視若無睹？你當部長多久了？他開記者會的時候、立委爆料的時候、質詢的時候、教育委員會的委員爆料開記者會的時候，你們做了什麼事？你們做了什麼事？"],["邱部長泰源：報告委員，因為……"],["林委員淑芬：那時候已經違反人體研究法所有的規範了，你做了什麼事？"],["邱部長泰源：報告委員，這個要調查是要去調查計畫主持人有沒有按照IRB……"],["林委員淑芬：對，那你調查了嗎？"],["邱部長泰源：如果……"],["林委員淑芬：從第一次開記者會曝光到現在，剛才劉越萍還在講這個IRB內容你們不知道，要去調查，都已經經過半年多了，你現在還在調查，你們無動於衷啦！"],["邱部長泰源：報告委員，據了解所有……"],["林委員淑芬：不當一回事啦！"],["邱部長泰源：所有這些像教育部他們的IRB……"],["林委員淑芬：你們就是不當一回事，無動於衷！"],["邱部長泰源：他們的IRB委員都是學有專精的……"],["林委員淑芬：那你告訴我，他們的IRB內容審查有沒有問題、他們內容說什麼？然後他們叫立委開記者會，說他們被強迫，他們要退出，他們被威脅，你們又做了什麼？這半年多來，你們做了什麼？"],["劉司長越萍：第一件事情，因為教育部已經開始處理，所以我們才會說這樣子的話，應該是等教育部給我們他的報告，然後整體的機制再來一起做檢討。"],["林委員淑芬：現在就是層層掩護、層層壓下來，才會有第二波的爆料和第二波的記者會，你還在講第一波的時候教育部已經調查了，所以你們就不管了，你現在是在裝肖仔。","部長，你什麼時候可以完成你們這一張不合理的函釋漏洞的重新檢討？"],["邱部長泰源：好，跟委員報告，我們馬上……"],["林委員淑芬：這一個函釋到現在還可以適用嗎？還適當嗎？"],["邱部長泰源：第一個，我們馬上亡羊補牢來處理所有發生的問題……"],["林委員淑芬：函釋，我要講制度面……"],["邱部長泰源：包括這個函釋我們馬上一個月就來檢討……"],["林委員淑芬：好，很好，那你們需不需要訂出更多的行政指導給其他目的事業主管機關？"],["邱部長泰源：我們會再重申人體……"],["林委員淑芬：你們要不要再去重新的檢討、檢視你們人體研究法有沒有更多其實是需要衛福部訂出來的法規……"],["邱部長泰源：沒問題，好的。"],["林委員淑芬：給其他目的事業主管機關做監督、做IRB審查的時候可以有所依循，你們是不是應該要主動做更多啊？"],["邱部長泰源：好，我們來檢討。"],["林委員淑芬：有沒有檢討空間？"],["邱部長泰源：有，一定有檢討空間，因為事情已經發生，表示我們所有相關單位都應該要盡責任的去改善。"],["林委員淑芬：對，你們劉越萍還在這邊爭辯啊！"],["邱部長泰源：不要再有下一次的發生。"],["林委員淑芬：我看你們劉越萍好像就覺得不當一回事，還很想辯啦！我現在講說善意的為醫學或為科學進步去貢獻自己的受試者，不應該在醫院參與研究有合格的醫療人員抽血，而在醫院以外及在社區參與研究，卻任由沒有受過訓練還邊抽血邊發抖的這一些人來抽，這不是回報善意且熱心參與研究的受試者該得到的對待啦！"],["邱部長泰源：當然，當然。"],["林委員淑芬：我很熱心的、很善意的，我要回饋我們的醫學研究，那我去醫院抽就有合格的人幫我抽，而我到醫院、醫療院所以外的，你們就容許讓這種阿貓、阿狗邊抽血邊發抖的人來幫他們抽，這是不應該的，這不是回報這一些善意的人、要參與研究、願意參與研究的人該有的回饋。"],["邱部長泰源：是的、是的，我們一定會協助調查，如果有違反IRB的，該究責的一定嚴厲究責。"],["林委員淑芬：全部。"],["邱部長泰源：而且我們一定會檢討整個制度，我們會把它改善得更好。"],["林委員淑芬：對，還有很多制度面是你們應該要扛起來、要做更多，謝謝。"],["邱部長泰源：沒問題，我們應該要負這個責任，謝謝。"],["主席：謝謝林淑芬委員，謝謝部長。","你用了19分鐘。"],["林委員淑芬：不好意思，但是制度要改正最重要。"],["邱部長泰源：沒問題。"],["主席：這個應該要有專業證照的醫療人員才可以，應該的啦！這樣是不對的啦！","我們請陳冠廷質詢。"]],"agenda":{"page_end":398,"meet_id":"委員會-11-3-26-21","speakers":["蘇清泉","陳昭姿","陳菁徽","王育敏","涂權吉","賴惠員","邱鎮軍","林淑芬","陳冠廷","劉建國","黃秀芳","林月琴","許宇甄","徐欣瑩","王正旭","陳瑩","陳永康","楊曜","廖偉翔","盧縣一"],"page_start":325,"meetingDate":["2025-07-17"],"gazette_id":"1146701","agenda_lcidc_ids":["1146701_00007"],"meet_name":"立法院第11屆第3會期社會福利及衛生環境委員會第21次全體委員會議紀錄","content":"邀請衛生福利部部長、勞動部部長、財政部部長、農業部針對「因應嚴重災情、緊急重大事件，\n醫療院所承擔救護量能困境及因應台美關稅談判對台灣食品安全相關影響」進行專題報告，並備\n質詢","agenda_id":"1146701_00006"}}}