{"id":30731,"date":"2024-02-29T13:28:09","date_gmt":"2024-02-29T13:28:09","guid":{"rendered":"https:\/\/www.enago.com\/academy\/tw\/?p=30731"},"modified":"2024-02-29T13:28:09","modified_gmt":"2024-02-29T13:28:09","slug":"informed-consent-in-clinical-research","status":"publish","type":"post","link":"https:\/\/www.enago.com\/academy\/tw\/informed-consent-in-clinical-research\/","title":{"rendered":"\u5f9e\u6b77\u53f2\u8108\u7d61\u548c\u6cd5\u5f8b\u6846\u67b6\u770b\u77e5\u60c5\u540c\u610f\u5728\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u5be6\u8e10"},"content":{"rendered":"<p>\u77e5\u60c5\u540c\u610f\u662f\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u4e00\u500b\u95dc\u9375\u7684\u502b\u7406\u6982\u5ff5\uff0c\u78ba\u4fdd\u500b\u9ad4\u5177\u6709\u81ea\u4e3b\u6b0a\uff0c\u80fd\u5920\u660e\u667a\u5730\u9078\u64c7\u662f\u5426\u53c3\u8207\u7814\u7a76\u3002\u5176\u91cd\u8981\u6027\u4e0d\u53ef\u4f4e\u4f30\uff0c\u56e0\u70ba\u5b83\u5728\u4fdd\u8b77\u7814\u7a76\u53c3\u8207\u8005\u7684\u6b0a\u5229\u548c\u798f\u7949\u65b9\u9762\u767c\u63ee\u8457\u91cd\u8981\u4f5c\u7528\u3002\u9019\u4e00\u502b\u7406\u539f\u5247\u8981\u6c42\u5728\u4ed6\u5011\u81ea\u9858\u540c\u610f\u53c3\u8207\u4e4b\u524d\uff0c\u500b\u9ad4\u5fc5\u9808\u7372\u5f97\u95dc\u65bc\u7814\u7a76\u76ee\u7684\u3001\u76f8\u95dc\u98a8\u96aa\u3001\u6f5b\u5728\u6536\u76ca\u548c\u53ef\u7528\u66ff\u4ee3\u65b9\u6848\u7684\u5168\u9762\u8cc7\u8a0a\u3002\u77e5\u60c5\u540c\u610f\u6709\u52a9\u65bc\u4fc3\u9032\u900f\u660e\u5ea6\u3001\u57f9\u990a\u4fe1\u4efb\uff0c\u4e26\u7dad\u8b77\u7814\u7a76\u4eba\u54e1\u548c\u53c3\u8207\u8005\u4e4b\u9593\u7684\u5c0a\u91cd\uff0c\u5f9e\u800c\u4fc3\u9032\u502b\u7406\u7814\u7a76\u5be6\u8e10\u3002\u901a\u904e\u8ce6\u4e88\u500b\u9ad4\u505a\u51fa\u7406\u6027\u6c7a\u7b56\u7684\u80fd\u529b\uff0c\u77e5\u60c5\u540c\u610f\u7dad\u8b77\u4e86\u4e00\u9805\u57fa\u672c\u7684\u502b\u7406\u539f\u5247\uff0c\u52a0\u5f37\u4e86\u81e8\u5e8a\u7814\u7a76\u7684\u5b8c\u6574\u6027\uff0c\u6700\u7d42\u4f7f\u7814\u7a76\u4eba\u54e1\u548c\u81ea\u9858\u53c3\u8207\u7684\u4eba\u54e1\u90fd\u53d7\u76ca\u3002<\/p>\n<div 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noreferrer\">\u5716\u65af\u57fa\u6885\u6bd2\u7814\u7a76<\/a>\u662f\u502b\u7406\u4e0d\u7aef\u7684\u60b2\u5287\u6027\u4f8b\u5b50\u3002\u5728\u56db\u5341\u5e74\u7684\u6642\u9593\u88e1\uff0c\u7814\u7a76\u4eba\u54e1\u96b1\u779e\u4e86\u5c0d\u6885\u6bd2\u611f\u67d3\u7684\u975e\u6d32\u88d4\u7f8e\u570b\u7537\u6027\u7684\u6cbb\u7642\u548c\u8cc7\u8a0a\uff0c\u5c0e\u81f4\u56b4\u91cd\u50b7\u5bb3\u3002\u9019\u4e00\u919c\u805e\u5f37\u8abf\u4e86\u77e5\u60c5\u540c\u610f\u7684\u91cd\u8981\u6027\uff0c\u4ee5\u53ca\u4fdd\u8b77\u53c3\u8207\u8005\u6b0a\u5229\u548c\u798f\u7949\u7684\u8cac\u4efb\u3002<\/p>\n<p>\u800c\u5176\u4ed6\u4e00\u4e9b\u502b\u7406\u6e96\u5247\uff0c\u5982<a href=\"https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/\" target=\"_blank\" rel=\"noopener, nofollow noopener noreferrer\">\u8d6b\u723e\u8f9b\u57fa\u5ba3\u8a00<\/a>\uff081964\u5e74\uff09\u548c<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/belmont-report\/index.html\" target=\"_blank\" rel=\"noopener, nofollow noopener noreferrer\">\u8c9d\u723e\u8499\u7279\u5831\u544a<\/a>\uff081979\u5e74\uff09\uff0c\u9032\u4e00\u6b65\u978f\u56fa\u4e86\u9019\u4e9b\u539f\u5247\uff0c\u5f37\u8abf\u4e86\u5c0d\u500b\u4eba\u7684\u5c0a\u91cd\u3001\u5229\u76ca\u548c\u6b63\u7fa9\u3002\u9019\u4e9b\u6a94\u70ba\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u77e5\u60c5\u540c\u610f\u63d0\u4f9b\u4e86\u502b\u7406\u57fa\u790e\uff0c\u4e26\u7e7c\u7e8c\u6307\u5c0e\u7814\u7a76\u4eba\u54e1\u9032\u884c\u502b\u7406\u548c\u8ca0\u8cac\u4efb\u7684\u7814\u7a76\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F%E8%83%8C%E5%BE%8C%E7%9A%84%E5%80%AB%E7%90%86%E5%8E%9F%E5%89%87\"><\/span>\u77e5\u60c5\u540c\u610f\u80cc\u5f8c\u7684\u502b\u7406\u539f\u5247<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u77e5\u60c5\u540c\u610f\u7d2e\u6839\u4e8e\u5e7e\u9805\u57fa\u672c\u502b\u7406\u539f\u5247\uff0c\u9019\u4e9b\u539f\u5247\u512a\u5148\u8003\u616e\u4e86\u7814\u7a76\u53c3\u8207\u8005\u7684\u6b0a\u5229\u3001\u81ea\u4e3b\u6b0a\u548c\u798f\u7949\u3002<\/p>\n<ol>\n<li>\u5f37\u8abf\u60a3\u8005\u5728\u91ab\u7642\u6289\u64c7\u4e0a\u7684\u77e5\u60c5\u6c7a\u7b56\u6b0a\uff1a\u9019\u4e00\u539f\u5247\u627f\u8a8d\u500b\u9ad4\u4f5c\u70ba\u81ea\u4e3b\u6c7a\u7b56\u8005\uff0c\u6709\u6b0a\u9078\u64c7\u662f\u5426\u53c3\u8207\u7814\u7a76\u3002\u5b83\u8457\u91cd\u63d0\u4f9b\u500b\u9ad4\u6240\u9700\u7684\u6240\u6709\u8cc7\u8a0a\uff0c\u4f7f\u5176\u80fd\u5920\u660e\u667a\u5730\u9078\u64c7\u662f\u5426\u53c3\u8207\u7814\u7a76\u3002<\/li>\n<li>\u5e73\u8861\u63d0\u4f9b\u5229\u76ca\u548c\u907f\u514d\u50b7\u5bb3\u7684\u8cac\u4efb\uff1a\u7814\u7a76\u4eba\u54e1\u6709\u9053\u5fb7\u8cac\u4efb\u5c07\u5c0d\u53c3\u8207\u8005\u7684\u6f5b\u5728\u98a8\u96aa\u6700\u5c0f\u5316\uff0c\u4e26\u6700\u5927\u5316\u5176\u7814\u7a76\u7684\u6f5b\u5728\u6536\u76ca\u3002\u9019\u4e00\u539f\u5247\u78ba\u4fdd\u7814\u7a76\u5728\u502b\u7406\u4e0a\u8ca0\u8cac\u4efb\u5730\u9032\u884c\uff0c\u529b\u6c42\u5728\u63a8\u9032\u79d1\u5b78\u77e5\u8b58\u7684\u540c\u6642\u4e0d\u9020\u6210\u50b7\u5bb3\u3002<\/li>\n<li>\u78ba\u4fdd\u8cc7\u8a0a\u7372\u53d6\u548c\u6c7a\u7b56\u904e\u7a0b\u7684\u516c\u5e73\u548c\u516c\u6b63\uff1a\u7814\u7a76\u4e2d\u7684\u516c\u6b63\u8981\u6c42\uff0c\u7121\u8ad6\u500b\u9ad4\u7684\u80cc\u666f\u6216\u60c5\u6cc1\u5982\u4f55\uff0c\u90fd\u6709\u5e73\u7b49\u7372\u53d6\u7814\u7a76\u6a5f\u6703\u8cc7\u8a0a\u7684\u6b0a\u5229\u3002\u5b83\u65e8\u5728\u9632\u6b62\u525d\u524a\u548c\u6b67\u8996\uff0c\u78ba\u4fdd\u7814\u7a76\u7684\u76ca\u8655\u5f97\u5230\u516c\u5e73\u5206\u914d\u3002<\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"%E6%B3%95%E5%BE%8B%E6%A1%86%E6%9E%B6%E8%88%87%E8%A6%8F%E5%AE%9A%E7%AE%A1%E7%90%86%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F\"><\/span>\u6cd5\u5f8b\u6846\u67b6\u8207\u898f\u5b9a\u7ba1\u7406\u77e5\u60c5\u540c\u610f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u77e5\u60c5\u540c\u610f\u4e0d\u50c5\u53d7\u5230\u502b\u7406\u539f\u5247\u7684\u6307\u5c0e\uff0c\u9084\u53d7\u5230\u4e00\u9805\u5168\u9762\u7684\u6cd5\u5f8b\u6846\u67b6\u7684\u76e3\u7ba1\uff0c\u4ee5\u78ba\u4fdd\u4fdd\u8b77\u53c3\u8207\u8005\u7684\u6b0a\u5229\u548c\u96b1\u79c1\u3002<\/p>\n<p>\u5728\u7f8e\u570b\uff0c\u4e00\u9805\u91cd\u8981\u7684\u6cd5\u5f8b\u6846\u67b6\u662f<a href=\"https:\/\/www.hhs.gov\/hipaa\/index.html\" target=\"_blank\" rel=\"noopener, nofollow noopener noreferrer\">\u300a\u5065\u5eb7\u4fdd\u96aa\u53ef\u651c\u5e36\u6027\u8207\u8cac\u4efb\u6cd5\u300b\uff08HIPAA\uff09<\/a>\u3002HIPAA\u898f\u5b9a\u4e86\u500b\u9ad4\u5065\u5eb7\u8cc7\u8a0a\u7684\u96b1\u79c1\u548c\u5b89\u5168\uff0c\u5f37\u8abf\u4e86\u53c3\u8207\u8005\u91ab\u7642\u8a18\u9304\u548c\u5728\u7814\u7a76\u4e2d\u6536\u96c6\u7684\u8cc7\u6599\u7684\u6a5f\u5bc6\u6027\u3002\u6b64\u5916\uff0c\u806f\u90a6\u6cd5\u898f\u5982<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/common-rule\/index.html\" target=\"_blank\" rel=\"noopener, nofollow noopener noreferrer\">\u300a\u901a\u7528\u898f\u5247\u300b\uff08Common Rule\uff09<\/a>\u70ba\u6d89\u53ca\u4eba\u9ad4\u7814\u7a76\u7684\u77e5\u60c5\u540c\u610f\u63d0\u4f9b\u4e86\u5177\u9ad4\u8981\u6c42\u3002\u9019\u4e00\u6cd5\u5f8b\u6846\u67b6\u70ba\u7372\u53d6\u77e5\u60c5\u540c\u610f\u3001\u89e3\u6c7a\u5229\u76ca\u885d\u7a81\u548c\u4fdd\u8b77\u8106\u5f31\u4eba\u7fa4\u5236\u5b9a\u4e86\u6a19\u6e96\uff0c\u52a0\u5f37\u4e86\u77e5\u60c5\u540c\u610f\u80cc\u5f8c\u7684\u502b\u7406\u539f\u5247\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5404\u500b\u5dde\u53ef\u80fd\u6703\u6709\u95dc\u65bc\u77e5\u60c5\u540c\u610f\u548c\u7814\u7a76\u502b\u7406\u7684\u6cd5\u5f8b\uff0c\u589e\u52a0\u4e86\u53e6\u4e00\u5c64\u6cd5\u5f8b\u8003\u616e\u56e0\u7d20\u3002\u9019\u4e9b\u6cd5\u5f8b\u65e8\u5728\u88dc\u5145\u806f\u90a6\u6cd5\u898f\uff0c\u4e26\u78ba\u4fdd\u7814\u7a76\u5be6\u8e10\u8207\u6bcf\u500b\u5dde\u5167\u53c3\u8207\u8005\u7684\u5177\u9ad4\u9700\u6c42\u548c\u6b0a\u5229\u4e00\u81f4\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F%E4%B8%8D%E8%B6%B3%E7%9A%84%E6%B3%95%E5%BE%8B%E5%BE%8C%E6%9E%9C\"><\/span>\u77e5\u60c5\u540c\u610f\u4e0d\u8db3\u7684\u6cd5\u5f8b\u5f8c\u679c<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u7814\u7a76\u4e2d\u7684\u77e5\u60c5\u540c\u610f\u4e0d\u8db3\u6216\u7f3a\u5931\u53ef\u80fd\u6703\u5c0e\u81f4\u91cd\u5927\u7684\u6cd5\u5f8b\u5f8c\u679c\u3002\u7576\u7814\u7a76\u4eba\u54e1\u672a\u80fd\u7372\u5f97\u6709\u6548\u7684\u77e5\u60c5\u540c\u610f\u6642\uff0c\u4ed6\u5011\u53ef\u80fd\u9762\u81e8\u6f5b\u5728\u7684\u6cd5\u5f8b\u8a34\u8a1f\u548c\u7d93\u6fdf\u8655\u7f70\u3002\u9019\u7a2e\u9055\u53cd\u502b\u7406\u548c\u6cd5\u5f8b\u6a19\u6e96\u7684\u884c\u70ba\u53ef\u80fd\u6703\u5c0e\u81f4\u7814\u7a76\u6a5f\u69cb\u6216\u500b\u5225\u7814\u7a76\u8005\u7684\u8072\u8b7d\u53d7\u640d\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5982\u679c\u6c92\u6709\u9075\u5faa\u9069\u7576\u7684\u77e5\u60c5\u540c\u610f\u7a0b\u5f0f\uff0c\u7814\u7a76\u7d50\u679c\u53ef\u80fd\u6703\u88ab\u7121\u6548\u5316\u3002\u9019\u4e0d\u50c5\u6d6a\u8cbb\u4e86\u5bf6\u8cb4\u7684\u8cc7\u6e90\uff0c\u9084\u524a\u5f31\u4e86\u79d1\u5b78\u754c\u5c0d\u7814\u7a76\u7d50\u679c\u5b8c\u6574\u6027\u7684\u4fe1\u4efb\u3002\u9084\u53ef\u80fd\u5c0e\u81f4\u5728\u76e3\u7ba1\u63d0\u4ea4\u6216\u51fa\u7248\u7269\u4e2d\u6392\u9664\u8cc7\u6599\uff0c\u5f9e\u800c\u5ef6\u8aa4\u6f5b\u5728\u6cbb\u7642\u548c\u7642\u6cd5\u7684\u958b\u767c\u3002<\/p>\n<p>\u5be6\u8cea\u4e0a\uff0c\u77e5\u60c5\u540c\u610f\u4e0d\u8db3\u6216\u7f3a\u5931\u7684\u6cd5\u5f8b\u5f8c\u679c\u662f\u591a\u65b9\u9762\u7684\uff0c\u6db5\u84cb\u4e86\u500b\u4eba\u3001\u6a5f\u69cb\u548c\u66f4\u5ee3\u6cdb\u7684\u793e\u6703\u5f71\u97ff\u3002\u7814\u7a76\u4eba\u54e1\u5fc5\u9808\u7406\u89e3\u9019\u4e9b\u5f8c\u679c\u7684\u56b4\u91cd\u6027\uff0c\u4e26\u5207\u5be6\u9075\u5b88\u502b\u7406\u548c\u6cd5\u5f8b\u8981\u6c42\uff0c\u4ee5\u7dad\u8b77\u81e8\u5e8a\u7814\u7a76\u5be6\u8e10\u7684\u4fe1\u4efb\u548c\u53ef\u4fe1\u5ea6\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%9C%89%E6%95%88%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F%E7%9A%84%E9%97%9C%E9%8D%B5%E8%A6%81%E7%B4%A0\"><\/span>\u6709\u6548\u77e5\u60c5\u540c\u610f\u7684\u95dc\u9375\u8981\u7d20<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6709\u6548\u7684\u77e5\u60c5\u540c\u610f\u5efa\u7acb\u5728\u5e7e\u500b\u95dc\u9375\u8981\u7d20\u4e4b\u4e0a\uff0c\u78ba\u4fdd\u7814\u7a76\u53c3\u8207\u8005\u5145\u5206\u7406\u89e3\u7814\u7a76\u7684\u6027\u8cea\u3001\u4ed6\u5011\u7684\u6b0a\u5229\u4ee5\u53ca\u6f5b\u5728\u7684\u98a8\u96aa\u548c\u597d\u8655\u3002\u4ee5\u4e0b\u662f\u5c0d\u7814\u7a76\u4eba\u54e1\u589e\u5f37\u77e5\u60c5\u540c\u610f\u5be6\u8e10\u7684\u57fa\u672c\u5efa\u8b70\uff1a<\/p>\n<ol>\n<li><strong>\u6e05\u6670\u6e9d\u901a<\/strong>\uff1a\u5728\u5411\u53c3\u8207\u8005\u89e3\u91cb\u7814\u7a76\u6642\u4f7f\u7528\u7c21\u660e\u627c\u8981\u7684\u8a9e\u8a00\uff0c\u907f\u514d\u4f7f\u7528\u5c08\u696d\u8853\u8a9e\u3002\u78ba\u4fdd\u53c3\u8207\u8005\u6709\u6a5f\u6703\u63d0\u554f\u4e26\u5c0b\u6c42\u6f84\u6e05\u3002<\/li>\n<li><strong>\u5168\u9762\u8cc7\u8a0a<\/strong>\uff1a\u63d0\u4f9b\u95dc\u65bc\u7814\u7a76\u7684\u8a73\u7d30\u8cc7\u8a0a\uff0c\u5305\u62ec\u5176\u76ee\u7684\u3001\u7a0b\u5f0f\u3001\u6f5b\u5728\u98a8\u96aa\u3001\u6536\u76ca\u548c\u66ff\u4ee3\u65b9\u6848\u3002<\/li>\n<li><strong>\u8a73\u7d30\u8a18\u9304<\/strong>\uff1a\u78ba\u4fdd\u5168\u9762\u800c\u8a73\u7d30\u5730\u8a18\u9304\u8a0e\u8ad6\u3001\u63d0\u51fa\u7684\u554f\u984c\u4ee5\u53ca\u63d0\u4f9b\u7d66\u53c3\u8207\u8005\u7684\u4efb\u4f55\u984d\u5916\u8cc7\u8a0a\u3002<\/li>\n<li><strong>\u6301\u7e8c\u6e9d\u901a<\/strong>\uff1a\u5728\u6574\u500b\u7814\u7a76\u904e\u7a0b\u4e2d\u4fdd\u6301\u6e9d\u901a\u7684\u901a\u66a2\uff0c\u5141\u8a31\u53c3\u8207\u8005\u8868\u9054\u7591\u616e\u6216\u96a8\u6642\u64a4\u56de\u540c\u610f\u3002<\/li>\n<li><strong>\u5c0a\u91cd\u96b1\u79c1<\/strong>\uff1a\u901a\u904e\u4f7f\u7528\u5b89\u5168\u7684\u8cc7\u6599\u5b58\u5132\u548c\u50b3\u8f38\u65b9\u6cd5\u4f86\u4fdd\u8b77\u53c3\u8207\u8005\u7684\u96b1\u79c1\u3002<\/li>\n<li><strong>\u5f31\u52e2\u7fa4\u9ad4<\/strong>\uff1a\u7279\u5225\u6ce8\u610f\u5f9e\u5f31\u52e2\u7fa4\u9ad4\uff0c\u5982\u672a\u6210\u5e74\u4eba\u6216\u80fd\u529b\u53d7\u640d\u8005\uff0c\u7372\u5f97\u77e5\u60c5\u540c\u610f\uff0c\u78ba\u4fdd\u4ed6\u5011\u7684\u6b0a\u5229\u53d7\u5230\u4fdd\u8b77\u3002<\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F%E5%AF%A6%E8%B8%90%E4%B8%AD%E7%9A%84%E6%8C%91%E6%88%B0%E8%88%87%E8%A7%A3%E6%B1%BA%E6%96%B9%E6%A1%88\"><\/span>\u77e5\u60c5\u540c\u610f\u5be6\u8e10\u4e2d\u7684\u6311\u6230\u8207\u89e3\u6c7a\u65b9\u6848<span 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