• 总裁寄语
  • 本土研发
  • 本土企业研发联盟
  • 礼来亚洲风险投资基金
  • 高品质的制造
  • 企业社会责任
  • 我们的方法
  • 共享价值
  • 研究、报告和倡导
  • 关爱社会 心手相连
  • 研究的方法
  • 新药发明与研发
  • 研究伦理道德
  • 生物伦理
  • 动物护理和使用
  • 医学研究的相关原则
  • 临床研究数据的透明性
  • 与合格研究人员分享数据
  • 临床研究报告(CSR)摘要
  • 发布政策
  • 求贤纳士
  • 创新起点
  • 礼来制药创新研究奖项目
  • 申请流程
  • 礼来制药研究奖项目(LRAP)
  • 礼来制药研究奖项目接受人
  • bioethics

    礼来制药生物伦理项目:一个全球性框架

    1999 NIAN,WEIXITONGXINGDISHIBIE、PINGGUHECHUANBOSHENGWULUNLIWENTI,LILAICHENGWEISHOUPISHELISHENGWULUNLICHANGSHEWEIYUANHUIDEZHIYAOGONGSIZHIYI。2008NIAN,LILAIZHIYAOSHELILILAIZHIYAOSHENGWULUNLIXIANGMU,LVXIANNULIZHIDINGGENGWEIZHUANMENDESHENGWULUNLICELVE。GAIXIANGMUWEIZHEIYILINGYUTOURUZHUANZHIZIYUAN,ZHILIYUCUJINLUNLIDAODEDEZHUOYUEBIAOXIAN。GAIXIANGMUSHIYIGEDULIDEZUZHIBUMEN,YOUZHUANMENDEGAOCENGLINGDAO——QUANQIUHUANZHEANQUANHESHENGWULUNLIFUZONGCAIFUZE。GAIXIANGMUDEQUANZHIYUANGONGJUNJIESHOUGUOSHENGWULUNLIPEIXUN,FUZEGAIXIANGMUDEFAZHAN、JIANDUHEKEJIAOFUCHENGGUO。CIWAI,LILAIZHIYAOSHENGWULUNLIZIXUNWEIYUANHUI(BEAC)HELILAIZHIYAOSHENGWULUNLIWANGLUO(BEN)YEHUIWEIGAIXIANGMUTIGONGZHICHI。

    SHELILILAIZHIYAOSHENGWULUNLIXIANGMUDEZONGZHI,SHIWEILEJIEJUEZAIDANGQIANFEISUFAZHANDESHENGWUGONGCHENGHUANJINGZHONGQUANQIUYAOWUYANFASUOMIANLINDERIYIFUZADELUNLITIAOZHAN。GAIXIANGMUSHIYIGEQUANQIUXINGKUANGJIA,SHIYONGYULILAIZHIYAODEQUANBUYANFAHUODONG。TATICHANGHEHULUNLIDEYANJIUHEYAOPINYANFA,HANWEIKEXUELIUCHENGDECHENGXINBINGBAOHUHUANZHEDEJIANKANG。GAIXIANGMUDEZONGZHISHIXIEZHUYUANGONGSHIBIEHEJIEJUEYOUGUANLILAIYANJIUSHIYANSHI(LRL)YANFAHUODONGDESHENGWULUNLIWENTI。GAIXIANGMUDEYUANGONGHAIHUIJIUGUANYUGONGSIYEWUQITAFANGMIANDESHENGWULUNLISHIYI,ZIXUNLILAIZHIYAODEQITABUMEN。

    SHENGWULUNLIXIANGMUYOUSIDAHEXINHUODONGZUCHENG:

  • 确立公司在主要生物伦理问题方面的立场
  • 咨询礼来制药内部的员工
  • 开展有关生物伦理的内部教育和培训活动
  • 为能够将生物伦理融入研发运营的内部协作项目,以及有助于推进药物应用有关的生物伦理的外部项目做出贡献
  • 礼来制药生物伦理咨询委员会

    LILAIZHIYAOSHENGWULUNLIZIXUNWEIYUANHUISHIYIGEKUAZHINENGZHIYUANZHEWEIYUANHUI,CHENGYUANZHUYAOLAIZIYANFABUMENNEIWAIGEZHINENGLINGYUDEZISHENRENSHI,BAOKUOYILIAO、HUANZHEANQUAN、FAMINGYANJIU、SHOUYIZIYUAN、FAWU、GONGSISHIWUYIJIQUANQIUPINPAIFAZHANDENG,QIZHONGHAIYOULIANGMINGWAIBUSHENGWULUNLIXUEJIA。ZHEIXIECHENGYUANJUNXUJIESHOUSHENGWULUNLIJICHUPEIXUN,FUZETIGONGSHENGWULUNLIZIXUNFUWU,BINGWEIGONGSIDESHENGWULUNLIXIANGMUTIGONGYIJIAN,LIRUQUELILILAIZHIYAOGUANYUSHENGWULUNLIWENTIDEGUANFANGLICHANG。

    LILAIZHIYAOSHENGWULUNLIZIXUNWEIYUANHUIQUELIDELICHANG,KEWEIWOMENDEQUANQIUYANFABUMEN——LILAIYANJIUSHIYANSHIDEXIANGGUANZHENGCE、BIAOZHUN、CHENGXUHESHIJIANTIGONGXINXI。LINCHUANGYANJIUZHONGSHEJIDEYUANGONGXUYAOJIESHOUZHEIXIEFANGMIANDEPEIXUN,BINGZAIXIANGGUANZHENGCE、BIAOZHUNHECHENGXUGENGXINSHIXUEXIZUIXINKECHENG。

    LILAIZHIYAOSHENGWULUNLIZIXUNWEIYUANHUIFUZETIGONGNEIBUSHENGWULUNLIZIXUNFUWU,BANGZHULILAIZHIYAODEYUANGONGSHIBIEHEJIEJUEYOUGUANLILAIYANJIUSHIYANSHIYANFAHUODONGDESHENGWULUNLIWENTI。GAIWEIYUANHUIKEJIUJUTISHENGWULUNLIWENTITIGONGZIXUN,JIESHILILAIZHIYAODESHENGWULUNLILICHANGYIJIRUHEJIANGQIYINGYONGYUGONGZUOCHANGSUO,BINGCUJINYOUGUANJIASHEQINGKUANGHELISHIQINGKUANGDETAOLUN。

    礼来制药生物伦理网络

    SHENGWULUNLIXIANGMUZUIJINTUICHULELILAIZHIYAOSHENGWULUNLIWANGLUO(XIACHENG “BEN”)。TASHIYIGEFEIZHENGSHIXUNIZHIYUANSHEQU,YOUYOUYIJILEISHENGWULUNLIZHISHIHEJINENGDELILAIZHIYAOYUANGONGZUCHENG。CANYUZHEIYISHEQU,JIYOUJIHUIJIESHOUPEIXUN,CANJIAXIANGGUANJIANGZUO、YANTAOHUI、ANLITAOLUNYIJIYOUSHENGWULUNLIXIANGMUZHUBANDEQITAHUODONG。

    生物伦理专家团队(BEST)以及生物伦理专家发展项目

    SHENGWULUNLIZHUANJIATUANDUISHILILAIZHIYAOSHENGWULUNLIWANGLUOZHONGDEYIGEXIAOQUN,CHENGYUANZHUYAOSHIYONGYOUSHENGWULUNLIZHUANYEZHISHIHEJINENG、CHIXUCHENGNUOZAIZHEIYILINGYUFAZHANDELILAIZHIYAOYUANGONG。TAMENTONGGUOCANYUSHENGWULUNLIHUODONGHEXIANGMUWEISHENGWULUNLIXIANGMUTIGONGZHICHI。

    SHENGWULUNLIZHUANJIAFAZHANXIANGMUSHIYIGEWEIQILIUGEYUEDENEIBUTIYANSHIPEIXUNXIANGMU,ZHIZAIBANGZHULILAIZHIYAODEYUANGONGSHIBIEHEXIANGYINGYUQIZAIGONGSIHEZHIYAOXINGYEDEZHINENGJIAOSEMINGQUEXIANGGUANDESHENGWULUNLIWENTI。LIUGEYUEGUOHOU,SHENGWULUNLIZHUANJIAKENENGCHENGWEISHENGWULUNLIZHUANJIATUANDUIDECHENGYUAN,BINGCHIXUKAIZHANYOUGUANZISHENZHINENGLINGYUDESHENGWULUNLIXIANGMU。

    人体生物医学研究生物伦理框架

    2010NIAN,WEILEXIANGYANJIURENYUANTIGONGXIANGGUANZHIDAOYUANZEHESHIYONGGONGJU,LILAIZHIYAOZHUANMENKAIFALEYIGESHENGWULUNLIKUANGJIA,YONGYUMIAOSHUHEPINGGUSHEJIRENLEISHOUSHIZHEYANJIUDEKAIFA、KAIZHANYIJIYANJIUJIEGUOFENXIYUPILUDELUNLIDAODE。GAIKUANGJIANANGKUOLEQUANQIUGONGRENDEXIANGGUANZHIYINHEXUESHUWENXIANZHONGGUIDINGDELUNLIDAODEYUANZE,BAOKUODANBUXIANYU:《BEIERMENGBAOGAO》(The Belmont Report)、《HEERXINJIXUANYAN》(The Declaration of Helsinki)、《GUOJIYIXUEKEXUEZUZHILISHIHUI(CIOMS)GUOJILUNLIZHINAN》YIJI《GUOJIXIEDIAOHUIYIYAOPINLINCHUANGSHIYANZHILIANGGUANLIGUIFAN》。

    礼来制药生物伦理立场

    LILAIZHIYAOSHENGWULUNLIXIANGMUYUANZISHANGSHUKUANGJIA,ZHIZAIZHENDUIBAOKUOXIALIEGEXIANGZAINEIDEXIANGGUANJIXINXINGZHUTIQUELISHENGWULUNLILICHANG:

  • 科学出版物和报告的署名权
  • I 期临床试验的对照选择:安慰剂对照的使用
  • II 期临床试验的对照选择:阳性对照的使用
  • 研究性药物的同情性用药
  • 研究性药物的持续获取
  • 人类生物样本
  • 跨国临床研究
  • 小儿医学和器械临床发展
  • 科学出版物和报告
  • 干细胞研究
  • 在临床试验中保护研究课题的权利

    WOMENDESHENGWULUNLIKUANGJIASHILILAIZHIYAOYINGYONGYUQUANQIULINCHUANGSHIYANXINGWEIDEQUANQIUTONGYIBIAOZHUNDEYIJU。CHULEZUNSHOUYANJIUSUOZAIGUOJIADEFALVFAGUIWAI,WOMENDESHIJIANJUNZUNXUN《MEIGUOYIYAOYANJIUYUZHIZAOSHANGXIEHUILINCHUANGSHIYANXINGWEIZHUNZE》。

    LILAIZHIYAOSHIYIJIAFUWUYUQUANQIURENQUNYILIAOXUQIUDEQUANQIUXINGGONGSI。ZAIQUANQIUGEDIXUANZEKAIZHANLINCHUANGSHIYANDEDIDIANSHI,LILAIZHIYAOKAOLVDESHIYANJIUSHEJIDEJIBINGDEDANGDILIUXINGCHENGDU,YIJIKAOLVZHONGDEXIANGGUANJIGOUDEYIXUEYANJIUNENGLI。

    CIWAI,LILAIZHIYAOHAIYUDANGDILUNLIWEIYUANHUIHEWEISHENGDANGJUHEZUO,QUEBAOZAIGEDIKAIZHANSUOTIYIDEYANJIUJUYOUKEXUEHELUNLIYIJU。YUCIYOUGUANDEJUEDINGYINGKAOLVYIXIAYINSU:

  • 研究参与者的风险和收益
  • 研究推动重要科学进步的潜力
  • 研究与当地卫生需求的相关性
  • 在所在国进行药品注册的目的
  • ZAIKAOLVSHANGSHUYINSUDEGUOCHENGZHONG,LILAIZHIYAOZUIZHONGSHIGETIYANJIUCANYUZHEDEANQUANXINGHEJIANKANG。ZONGHEKAOLV,ZHEIYIWAIBUHENEIBUZHINANKEBANGZHUYANJIURENYUANHUOQUYOUGUANLUNLIWENTIDESHENSISHULVDE、YOUGENJUDE、SHIZHONGRUYIDEJIANYI,CILEIWENTIWANGWANGSHEJILINCHUANGSHIYANDESHEJI、JIHUAHESHISHIYIJIYANJIUJIEGUODEJISHIPILU。

    知情同意书

    ZHIQINGTONGYISHULIUCHENGSHIBAOHUYANJIUCANYUZHEDEYIGEGUANJIANFANGMIAN,ZHUANWEIZUNZHONGGETIDEZIZHUQUANQIEBAOHUGETIDEXUANZEZIYOUERSHEJI。XIWANGCANYULILAIZHIYAOFAQIDELINCHUANGYANJIUDEMEIYIHUANZHEHUOZHIYUANZHEJUNHUISHOUDAOGUANYUYANJIUMUDE、FANGFA、KENENGDEFENGXIANHEHAOCHUDEKOUTOUHESHUMIANTONGZHI,QIEZHIXIZIJISUISHIKEYINRENHELIYOUZIYOUTUICHULINCHUANGYANJIU。

    ZHIYUANCANYUMOUXIANGYANJIUDEJUEDINGBIXUSHIGERENXUANZE,BUDESHOUDAOBUDANGYINGXIANGDEZUOYOU,LIRUKENENGSHUOFUMOURENTONGYICHENGDANHELIFENGXIANZHIWAIDEFENGXIAN。WEIBANGZHUQUEBAOZHEIYIDIAN,LILAIZHIYAOZHIDINGLEYIXIANGZHENGCE,JIXIANJINFUKUANHUOQITAJIANGLIDECHENGNUOBUDEDADAOZUYIDUIMOUQIANZAISHOUSHIZHEDEJUEDINGCHANSHENGBUDANGYINGXIANG。RUGUOGETITONGYICANYUMOUXIANGYANJIU,NEIMEBIXUZAIXIEYISHANGQIANZIBINGTUOSHANBAOGUANGAIXIEYI。RUGUOMOUGETI(BAOKUOERTONG)WEINENGTIGONGZHIQINGTONGYISHU,NEIMEKEYIYAOQIUDAIBIAOGAIGETIDEHEFASHOUQUANDAIBIAOTIGONGTONGYISHU,QIANTISHIYANJIUCANYUZHEYUANYICANYULINCHUANGYANJIU。

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