The U.S. system for protecting people who volunteer to participate in research has been critiqued as inadequate and in need of reform. Main criticisms of the current protection system, which utilizes institutional review boards (IRBs) to make decisions about human subject participation in research, are: (1) IRBs are underfunded and overworked; (2) they focus too narrowly on documenting consent to participate in research while ignoring the processes for helping people reach informed consent; and (3) they unnecessarily delay or impair research by holding full board reviews for minimal-risk research. Chapters 1 through 3 introduce these arguments, convey the basic concepts involving the protection of human subjects involved in research, and review the regulatory history from 1945 through 2003. Chapters 4 through 6 focus on the recommendations concerning the three main topics addressed in this book: (1) enhancing the informed consent process; (2) protecting data confidentiality; and (3) improving review procedures for minimal-risk research. Recommendations for enhancing the informed consent process include the advice to develop detailed guidelines for IRBs and researchers regarding the appropriate consent procedures for different types of populations; conduct research on procedures for obtaining informed consent that will enhance comprehension of benefits, risks, confidentiality, and other key issues; and develop guidelines for when it is acceptable to omit elements of informed consent. Recommendations for improving data confidentiality include the advice to develop state-of-the-art disclosure protection practices and to develop a certification system for ensuring datasets protect against disclosure. Recommendations for improving the review procedures for minimal-risk research include the advice to develop protocols on what qualifies as “research” with “human subjects” and to develop guidelines that allow researchers flexibility in design decisions during the course of their research. Chapter 7 focuses on system-level issues and offers guidance to IRBs. Figures, boxes, footnotes, references, appendixes