Generating Evidence For Artificial Intelligence Based Medical Devices

Generating evidence for artificial intelligence-based medical devices

WHO Expert Committee on Biological Standardization

The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.

IRB, Human Research Protections, and Data Ethics for Researchers

In the realm of academic research, ensuring ethical standards and compliance with human research protections poses a significant challenge for researchers and investigators. Navigating the complex landscape of institutional review boards (IRB), data ethics, and privacy regulations can often be daunting, especially for new investigators and doctoral students. The consequences of overlooking these critical aspects not only risk the integrity of research findings but also jeopardize the well-being and rights of human subjects involved in studies. IRB, Human Research Protections, and Data Ethics for Researchers emerges as a vital solution to address these challenges comprehensively. With over a decade of experience, Dr. Robin Throne of the University of the Cumberlands edited this book to serve as a guide for researchers, principal investigators, and research supervisors alike. By offering practical guidance and insights into navigating IRB policies, upholding human research protections, and ensuring data ethics compliance, this publication equips readers with the essential knowledge needed to conduct ethical research with integrity and rigor.