Abstract

Human subjects research is an annual $10 billion dollar global activity. In May 2012, Harvard Law School hosted a conference on human subjects research . The conference critically examined HSR relative to the proposed American regulatory framework for federally funded research. The conference did not question the need for human subjects research. Rather, it discussed the need to balance the protection of human subjects from possible research risks while not hindering research—an epic, ongoing debate regarding the balance between paternalism and autonomy. This book draws on the analysis and insights of 33 experts in the field of HSR. The authors critically analyse the epic balance in five parts:‘The Regulation of Risk’, ‘The Protection of Vulnerable Populations’, ‘Re-defining the Participant-Researcher Relationship and the Role of IRBs’, ‘Specimens, Data and Privacy’, and ‘Paradigm Shifts in Research Ethics’. Within each part, the authors sketch out their preferr ..