The Cambridge Handbook of Health Research Regulation

The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

This multi-disciplinary Handbook examines human health research and its regulation. It uses real world examples - research using patient data, tissue and other human materials - to explore current challenges in delivering good medical research for the public good. Practical recommendations for real-world situations are a key feature of the book.The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.