相關主題
商品描述
Artificial intelligence (AI) is transforming every aspect of biomedical research practice. Researchers face a fragmented landscape of tools, evolving ethical requirements, emerging regulations, and rapidly shifting best practices. The first of two volumes, this book provides a comprehensive treatment of AI across the complete research lifecycle, from initial ideation through analysis, quality assurance, dissemination, and long-term impacts.
Key Features
- This book is the only resource covering AI applications across the entire research journey, from initial idea through long-term impact
- It systematically applies four major AI governance frameworks (RUAIH, FUTURE-AI, NIST AI RMF, and GMLP) throughout both volumes, showing researchers how to operationalize abstract principles in daily practice
- It includes detailed analysis of the EU AI Act implementation timeline (February 2025 through August 2027) with specific guidance for research applications. It helps researchers and institutions understand high-risk classifications, research exemptions, and compliance strategies before requirements take effect
- It moves beyond hype and fear to deliver a balanced, practical approach to human-AI collaboration. Each chapter includes "Capabilities and Limitations" analysis, ethical considerations, and implementation strategies that acknowledge both AI's transformative potential and its persistent limitations
- This book features concrete examples demonstrating implementation principles in practice. Each chapter concludes with practical implementation strategies, reflection questions, and guidance applicable to institutions of varying sizes and resources
- Volume 1 explores how AI can improve essential research activities, including designing studies, securing funding, navigating compliance and ethics reviews, recruiting participants, managing operations, collecting data, and analyzing results
- Volume 2 continues the exploration of quality assurance, dissemination, peer review, impact, and the necessary institutional changes to responsibly implement AI capabilities
商品描述(中文翻譯)
人工智慧（AI）正在改變生物醫學研究實務的各個面向。研究人員面對的是由各種工具組成的零散環境、不斷演變的倫理要求、新興法規，以及快速變動的最佳實務。本書為兩冊中的第一冊，完整探討 AI 如何貫穿整個研究生命週期，從最初的構想發展，到分析、品質保證、成果傳播，以及長期影響。
主要特色
• 本書是唯一涵蓋完整研究歷程中 AI 應用的資源，從最初的研究構想一路延伸至長期影響。
• 全書兩冊系統性地套用四大 AI 治理架構（RUAIH、FUTURE-AI、NIST AI RMF 與 GMLP），向研究人員說明如何在日常實務中落實抽象的治理原則。
• 本書詳細分析 EU AI Act 的實施時程（2025 年 2 月至 2027 年 8 月），並針對研究應用提供具體指引。協助研究人員與研究機構在相關要求生效前，了解高風險分類、研究豁免與合規策略。
• 本書超越炒作與恐慌，提供平衡且務實的人機協作方法。每章均包含「能力與限制」分析、倫理考量，以及實作策略，正視 AI 的變革潛力與其持續存在的限制。
• 本書透過具體範例示範如何在實務中落實相關實作原則。每章結尾均提供實務導入策略、反思問題，以及適用於不同規模與資源條件之研究機構的指引。
• 第一冊探討 AI 如何改善重要的研究活動，包括研究設計、取得研究經費、因應合規與倫理審查、招募研究參與者、管理研究作業、蒐集資料，以及分析研究結果。
• 第二冊延續探討品質保證、成果傳播、同儕審查、研究影響，以及負責任地導入 AI 能力所需的組織變革。
作者簡介
Molly Klote, MD, is the former Director of the US Department of Health and Human Services Office for Human Research Protections (OHRP). OHRP is the policy, education, and compliance office that oversees federally funded medical research for 21 federal agencies, 13,000 institutions, and over 6000 institutional review boards in the US and internationally. It is the proponent office for the policy known as "The Common Rule" (45 CFR 46). Before joining OHRP, Dr. Klote spent six years as the research policy, regulatory, and education lead for the Veterans Health Administration, the largest integrated healthcare system in the United States. Prior to the Veterans Health Administration, she served for 30 years in the Army, with her final assignment at the rank of Colonel, working for the Army Surgeon General, overseeing all US Army Human Research policy and compliance. Additionally, Dr. Klote has directed two major research program offices, served as an Institutional Official, chaired three Institutional Review Boards, and led a Research Scientific Review Board. She recently launched her own consulting company, Klote Medical Research Advisors, LLC, to bring her over 36 years of distinguished military and civilian federal experience to those who need to better understand federal research policy. She is the author of Adapting to Change: Federal Policy Dynamics and the Pharmaceutical Industry, CRC Press 2025.
作者簡介(中文翻譯)
Molly Klote 醫學博士曾任美國衛生及公共服務部人類研究保護辦公室（Office for Human Research Protections, OHRP）主任。OHRP 是負責政策、教育與合規事務的辦公室，監督美國及國際間由聯邦政府資助的醫學研究，涵蓋 21 個聯邦機構、13,000 個研究機構，以及超過 6,000 個機構審查委員會（Institutional Review Boards, IRBs）。OHRP 也是被稱為「共同規則」（The Common Rule，45 CFR 46）之政策的主管辦公室。
加入 OHRP 前，Klote 博士曾在美國最大的整合型醫療體系——退伍軍人健康管理局（Veterans Health Administration）擔任研究政策、法規與教育主管，任職六年。在加入退伍軍人健康管理局之前，她曾於美國陸軍服役 30 年，最後以上校軍階擔任美國陸軍軍醫總監辦公室的職務，負責監督全美陸軍的人體研究政策與合規事務。
此外，Klote 博士曾主管兩個大型研究計畫辦公室、擔任機構正式負責人（Institutional Official）、主持三個機構審查委員會（Institutional Review Boards），並領導一個研究科學審查委員會（Research Scientific Review Board）。近期，她成立了自己的顧問公司 Klote Medical Research Advisors, LLC，將超過 36 年來在軍方及聯邦民政體系累積的卓越經驗，帶給需要深入了解聯邦研究政策的人士。
她著有 Adapting to Change: Federal Policy Dynamics and the Pharmaceutical Industry，CRC Press，2025 年出版。
