AI for Biomedical Research Volume 2 Quality, Impact, and Implementation
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AI for Biomedical Research Volume 2
Quality, Impact, and Implementation
Molly Klote
Artificial intelligence is transforming every aspect of research practice. Researchers face a fragmented landscape of tools, evolving ethical requirements, emerging regulations (notably the EU AI Act), and rapidly shifting best practices. The second of two volumes, this book provides a comprehensive treatment of artificial intelligence across the complete research lifecycle—from initial ideation through analysis, quality assurance, dissemination, and long-term impact.
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.
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 lead office for the policy called "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. Prior to the VHA, she served for 30 years in the Army, with her final assignment working for the Army Surgeon General overseeing all US Army Human Research policy and compliance. Additionally, Dr. Klote has directed two major research programs, served as an Institutional Official, and chaired three Institutional Review Boards. She is currently President of Klote Medical Research Advisors, LLC.
| Publication Date: | 31 March 2027 |
| Publisher: | CRC Press |
| Imprint: | CRC Press |
| ISBN-13: | 9781041323433 |
| Format: | Paperback softback |
| Page Count: | 416 |