I. Glenn Cohen and Holly F. Lynch (eds.): Human subjects research regulation: perspectives on the… image

Theoretical Medicine and Bioethics, September 26, 2014
Lydia Stewart Ferreira (Visiting Scholar)


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Human Subjects Research (HSR) is an annual $10 billion dollar global activity. While there is consensus that HSR is necessary, a number of egregious historical examples point to the need to regulate this form of research. The American government recently proposed changes to update its existing regulatory framework for federally funded HSR. The proposed federal regulatory changes were met with intense public and private interest. In May of 2012, the Petrie Flom Center hosted a conference at Harvard University to discuss HSR and the American government’s proposed changes. Academic experts discussed the need to balance the protection of human subjects from possible research risks while not hindering research. At the heart of the discussion was the epic, ongoing debate regarding the balance paternalism and individual autonomy.

This book is based on the conference proceedings. The book includes chapters on the regulation of risk, the protection of vulnerable populations, re-defining the participant-researcher relationship, the role of IRBs, the issue of specimens, data and privacy, as well as discussing paradigm shifts in research ethics. According to I. Glenn Cohen, Faculty Director of the Petrie Flom Center, the proposed federal regulatory changes started the conversation and this book aims to continue the discussion.

bioethics biotechnology health law policy holly fernandez lynch human subjects research i. glenn cohen