As a physician who 20 years ago teetered on the life path bifurcation between bench-top biomedical research with a Ph.D. and hands-on clinical work with an M.D., I was intrigued to read this book. The editors represent the research experience from the perspective of APA (Harold Pincus and Sandy Ferris) and from within the university setting (Jeffrey Lieberman). The diverse and highly credentialed chapter authors take on virtually all of the concerns that have recently appeared in major mental health newsletters and journals.
The introduction focuses the reader on some specifics in medical research ethics around which discussion and opinion continue to evolve, most notably human experimentation by Nazi scientists, the Tuskegee Syphilis Study, and radiation research by the U.S. Department of Energy conducted during the Cold War. Although one conclusion is that the regulations promulgated by the federal government through the Department of Health and Human Services in 1991 (45 C.F.R., Part 46) offer some substantial protections, a more chilling conclusion is that complete protections for many groups of patients—most notably those with mental illness—are by no means guaranteed.
The editors’ stated intention to provide a reasoned starting place to illuminate the fundamental principles of ethical investigation is handily fulfilled. Each of the 12 chapters addresses one specific area of interest and is replete with references and other resource materials. The writing is dense with references, the style pragmatic, and the topics presented more in a basic educational manner than as ideas up for debate. Throughout, the approach is sensible and even-handed, drawing more from an academic perspective and credible literature than from anecdotal data.
Some sections will appeal primarily to administrators (namely, chapters 5, “Surrogate Decision-Making and Advance Directives With Cognitively Impaired Research Subjects,” and 10, “Administrative Issues and Informed Consent”) and researchers (chapter 2, “Issues in Clinical Research Design”). I found the sections dealing with quality care in the context of clinical research (chapter 3), how to inform subjects about risks and benefits (chapter 6), substance abuse research (chapter 8), and family concerns (chapter 9) most useful and readily applicable.
In general, this is a serious volume that compacts a huge amount of information into a quite readable space. I suspect that separate chapters may be used consultationally, on an as-needed basis, rather than being read straight through. In summary, this collection provides a quintessentially comprehensive and inarguably definitive summary of current themes in the ethics of research with human subjects.
