This book is divided into three PART 1: Landmark Documents, contains materials that have in some way influenced policy development related to research with human subjects PART 2: Selected major policies, presents important policies relating to this research. These include policies that address general issues arising in the context of research with human subjects, as well as those addressing particular subject populations and research settings. PART 3: Selected Bibliography, provides citations to resources that are intended to amplify understanding of policies for human subjects research and, perhaps more importantly, address gaps where policy guidance is lacking.