Genomics, Ethics, and Compliance
Genomics offers unprecedented opportunity to personalize medical care. Pharmacogenomics may help identify the best treatments for patients. These advances raise new ethical issues to consider. These issues also interface with the critically important issu
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Genomics, Ethics, and Compliance Sara W. Faulks and Steven R. Feldman
Abstract Genomics offers unprecedented opportunity to personalize medical care. Pharmacogenomics may help identify the best treatments for patients. These advances raise new ethical issues to consider. These issues also interface with the critically important issue of patient adherence and compliance to treatment. This chapter begins with a review of the history of ethics and especially its relationship to research in medicine, and this is followed by a discussion of genomics and the ethical issues it elucidates, as well as compliance in medicine and the associated ethical implications. The chapter is concluded with a commentary regarding this rather contemporary movement of pharmacogenomics, which embodies both ethics and compliance and is pertinent to the field of dermatology. Keywords Adherence • Compliance • Pharmacogenomics • Ethics • Genomics
History of Ethics in Research This first section is a brief look at the history underlying the ethics that guide research today. It is important to understand from where ethical principles were birthed and why these basic principles are crucial before one can fully apply them in research and practice (Table 7.1) [1–6].
The Nuremberg Code Ubiquitously considered in the field of research medicine to be one of, if not the most significant document in the foundation of objective ethical principles, the Nuremberg Code is a landmark document that arose in 1947 from a dark history.
S.W. Faulks, BS • S.R. Feldman, MD, PhD (*) Department of Dermatology, Wake Forest Baptist Medical Center, 4618 Country Club Road, Winston-Salem, NC 27104, USA e-mail: [email protected] © Springer International Publishing Switzerland 2016 R.A. Norman (ed.), Personalized, Evolutionary, and Ecological Dermatology, DOI 10.1007/978-3-319-41088-3_7
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Table 7.1 Historical documents and major contributions to ethics Document The Nuremberg Code, 1947 Geneva Declaration, 1948 Declaration of Helsinki, 1964
Belmont Report, 1979 CIOMS, 1993
Major contributions Cornerstone of objective ethical principles; establishes informed consent and the right to withdraw A revised and more contemporary Hippocratic Oath; a pledge that the physician’s first priority is to give his or her life to serve humanity Ever-evolving document, loosens the previously very strict principles of informed consent and right to withdraw, differentiates between research with a direct therapeutic benefit versus an indirect and more generalized scientific benefit Details respect for persons, beneficence, and justice, and their respective associations with informed consent, assessment of risks and benefits, and selection of subjects Particularly focuses on maintaining ethical standards in research in less developed countries and ensuring informed consent is adequately obtained given cultural differences
During World War Two, concentration camp prisoners were subjected to atrocities against their will, those atrocities including
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