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The book Innovation in Medical Technology: Ethical Issues and Challenges is not the sort of reading one does for pure and simple enjoyment. The text is not jargon-filled, nor is it packed with difficult, multisyllabic words that make it impossible to read. It is not what one would call easy reading, though. As is mentioned in the Preface (p. x), it is "written for those interested in studying the ethical, legal, and social policy aspects of biomedical science, medical practice, and their regulation." The authors also suggest that that the most appreciative audience of such a book would be those with "familiarity with the guidelines, regulations, and laws that govern medical research and ... practice." Such recommendations for the audience seems fair and reasonable, as the subject material is surely not for everyone.
This book is a follow-up of sorts to a forum held in Washington, D.C. in 2003 by the Lasker Foundation. The forum was to investigate how unproven, new technologies are used, as well as discussion of ethical issues therein. The distinction between innovation and research in medical practice, and ethical considerations that are inherent in both, were discussed at great length at this forum. Participants reviewed fictional (but possible) case studies in preparation for their discussion. The case studies are also included in the book, and provide a good framework for the book's discussion as well. Using new technology or discoveries, or using an old piece of equipment in a new way, or an existing drug for something other than it was originally tested for, are considered innovations. There is no overseer like the FDA, there are no Institutional Review Boards (IRBs) and there is no strict structure or strictly-written guidelines for innovations such as this. On the other hand is research -- hypothesis-based, rigidly-tested, overseen by IRBs and other rules and regulators. The book discusses the similarities and differences of these two methods of introducing new and innovative ideas and technology into medicine, and the ethical concerns and considerations of each.
Following a description of the difference between innovation and research in medical practice, this book first provides a history of human research and human research ethics. It is rather frightening to read about research conducted with apparent disregard for ethical concerns, indeed for the patients at all, including fairly recent times (through the 1970s). The famous Tuskegee syphilis study, for example, was from 1932 to 1972. After the history are the chapters including case studies and questions for discussion. These chapters include discussion of off-label drug use, surgery, assisted reproduction and neuroimaging.
Ethical concerns and considerations of human subjects -- never forgetting that subjects are indeed human --are worthy concerns of innovation and research. As reminders of this, as well as for details referenced in the historical chapter, Eaton and Kennedy include as appendices the Nuremburg Code, the Declaration of Helsinki and the Department of Health and Human Services (DHHS) Regulations for the Protection of Human Subjects.
Case studies are used as a way to provide thoughtful situations to stimulate reflection and discussion. While the cases are fictional, they certainly have a basis in reality, and are examples of cutting-edge topics, very relevant in society today. The discussion points that follow the cases are very thought-provoking and would certainly be good conversation-starters for a forum such as that the Lasker Foundation hosted, or at a medical innovations or ethics conference. Just because we have the technology to do something, does that mean we should? Or must? Does the ability to do it make it ethically sound? Another point that is mentioned is another that is very real in our modern society, especially in the U.S.A., and that is the legal, malpractice concern.
The forum and the book include recommendations for the future of medical innovation and research, and that is one of the later chapters. One of the identified concerns is that medical innovation does not provide hard data like research does. Also, the concern for a lack of protective measures that are part of formal research, but are not a part of medical innovations (outside of research). The model recommended by Eaton and Kennedy, is the Massachusetts General Hospital's Innovative Diagnostics and Therapeutics Committee. This committee reviews new technology for determination of its deployability (necessity, safety etc).
The authors recognize that it is through solid, painstaking and careful research that data and conclusive scientific results are disseminated. But it may be through imagination that the idea for a research study came about in the first place, as doctors suggest the innovative off-label use of a drug, or a new technique for helping infertile couples conceive. They indicate that, while innovation and research are different and distinct, there is a undeniable relationship between them that is possibly symbiotic. The two are probably both necessary for advancements.
© 2008 Margaret Riley
Margaret Riley, M.S., R.N. -- has been a Critical Care nurse in a highly acute ICU in the Denver Metro Area since graduation from nursing school. She continues to work occasionally in that setting, but now works full-time as a faculty member at her Alma Mater.
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