Abstract

What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board (IRB) members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research.