Case Studies in Biomedical Research Ethics.

Case Studies in Biomedical Research Ethics

Timothy F. Murphy. Cambridge, MA: MIT Press, 2004.

The human research subject protection enterprise has become extremely complex. Institutional review boards (IRBs) and researchers face increasing regulatory complexity. At the same time, an ever-growing number of technologies and therapies offer potentially great promise, but also present greater potential risk to research participants. At times the effort to adhere to regulatory requirements seems to relegate basic ethical considerations to second place.

Timothy Murphy has prepared a useful work, Case Studies in Biomedical Research Ethics, to facilitate contemplation and discussion of some of these basic ethical considerations. It is organized into nine chapters addressing the range of topics involved in biomedical research, from oversight and study design, through informed consent, to authorship and publication. Of particular interest to contemporary research ethical discussions are the two chapters on embryos, fetuses, and children and genetic research. Each chapter begins with a brief introduction of the subject--none is greater than eight pages in length. The introduction is followed by a variety of case studies to further explore the topic. Most cases are only one page in length, with two to three study questions. Each case study has at least one reference. Altogether there are 149 case studies.

One could choose to read only the introductory section of each chapter and this would form a nice primer on current biomedical research ethics. Additionally, the cases would fit well into education for IRB members or researchers, and could be easily used in formal undergraduate or graduate courses on research ethics.

The case studies represent a wide variety of topics. Some are important historical cases, eg, the Tuskegee syphilis study, Pasteur's rabies vaccine study, Milgram's study of obedience to authority in which subjects were deceived regarding the study's purpose. Others are contemporary cases, including two high-profile examples involving the death of research subjects which led to at least temporary closure of research programs at the sponsoring universities--the death of Jesse Gelsinger in a gene therapy study, and the death of a healthy volunteer exposed to inhaled hexamethonium in a lung physiology study. However, not all the case studies represent true cases. Rather, some present general ethical questions not linked to any specific case, eg, the issue of consent in subjects lacking mental capacity, or the concept that the biotechnology industry should focus more research efforts on biotechnology which will benefit the poor.

Overall, I found this to be an interesting text which will be useful in a variety of educational settings.

I am not young enough to know everything.
--Oscar Wilde

Kenneth E. Olive, MD, FACP 

Chair, ETSU/Veterans Administration

Medical IRB

East Tennessee State University 

Johnson City, TN