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
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.
