pdf version of the entryThe Ethics of Clinical Researchhttp://plato.stanford.edu/archives/fall2012/entries/clinical-research/from the Fa l l 2 0 1 2 E d i t i o n of theStanford Encyclopediaof PhilosophyEdward N. Zalta Uri Nodelman Colin Allen John PerryPrincipal Editor Senior Editor Associate Editor Faculty SponsorEditorial Boardhttp://plato.stanford.edu/board.htmlLibrary of Congress Catalog DataISSN: 1095-5054Notice: This PDF version was distributed by request to mem-bers of the Friends of the SEP Society and by courtesy to SEPcontent contributors. It is solely for their fair use. Unauthorizeddistribution is prohibited. To learn how to joi n the Friends of theSEP Society and obtain authorized PDF versions of SEP entries,please visit https://leibniz.stanford.edu/friends/ .Stanford Encyclopedia of PhilosophyCopyrightc 2012 by the publisherThe Metaphysics Research LabCenter for the Study of Language and InformationStanford University, Stanford, CA 94305The Ethics of Clinical ResearchCopyrightc 2012 by the authorDavid WendlerAll rights reserved.Copyright policy: https://leibniz.stanford.edu/friends/info/copyright/The Ethics of Clinical ResearchFirst published Fri Jan 30, 2009; substantive revision Thu Sep 20, 2012Clinical research attempts to address a relatively straightforward, andextremely important challenge: how do we determine whether a newmedical intervention represents an advance over current methods, whetherthe new intervention would avoid harms currently incurred, whether itwould save lives currently lost? Clinicians may one day be able to answerthese questions by relying on computer models, thereby avoiding relianceon clinical research and the ethical concerns it raises. Until that day,clinical researchers begin by testing potential new medical interventionsin the laboratory, and often in animals. While these methods can providevaluable information and, in the case of animal research, raise importantethical issues of their own, potential new interventions eventually must betested in humans. Potential new interventions which work miracles in testtubes and rats, often leave humans untouched, or worse off.The human tests of a new medical intervention typically pose some,possibly serious Risks to subjects, no matter how many laboratory andanimal tests have preceded them. These studies thus provide a clearexample of what the central ethical concern raised by clinical research:the possibility of exploitation. Put generally, the process of exposingsubjects to risks in order to collect data introduces the possibility ofexploiting subjects for the benefit of future patients. The present entryfocuses on this concern, and canvasses the most prominent attempts toaddress it. The present entry largely ignores the range of interesting andimportant ethical issues that arise in the course of conducting clinicalresearch: How should it be reviewed? Who may conduct it? What mustpotential subjects understand to give valid consent? May it be conductedin countries that will not be able to afford the intervention being tested?Do investigators have any obligations to treat unrelated medical1conditions they uncover in the course of their research?One might attempt to address the potential exploitation of researchsubjects by locating the evaluation of potential new interventions, andtheir attendant risks, within the clinical setting, offering experimentalinterventions to patients who want to try them. This approach, which hasthe virtue of evaluating new interventions in the process of trying to helpindividual patients, poses enormous scientific and practical problems. Onthe practical side, who would be willing to manufacture a newintervention without knowing whether it works? What dose should beused? How often should the new drug be taken? More importantly, thisapproach might not yield reliable information as to whether the newtreatment is useful or harmful until hundreds, perhaps thousands of peoplehave received it. Clinical research is designed to address these concernsby systematically exposing a small number of individuals, including verysick ones, to potential new treatments.Many of our actions, driving a car,smoking a cigarette, flushing our waste down the drain, expose others torisk of harm. Nonetheless, there has been surprisingly little philosophicalanalysis of the conditions under which it is acceptable to do this(Hayenhjelm and Wolff 2012). Therefore, in addition to being of value inits own right, evaluation of the ethics of clinical research provides anopportunity to consider one of the more fundamental concerns in moraltheory: when is it acceptable to expose some individuals to risks of harmfor the potential benefit of others?1. What is Clinical Research?2. Early Clinical Research3. Abuses and Guidelines4. Clinical Research and Clinical Care5. A Libertarian Analysis6. Contract Theory7. Minimal RisksThe Ethics of Clinical Research2 Stanford Encyclopedia of Philosophy8. Goals and Interests9. Industry Sponsored ResearchBibliographyAcademic ToolsOther Internet ResourcesRelated Entries1. What is Clinical Research?Human subjects research is research which involves humans, as opposedto animals, atoms, or asteroids, as the subjects of study. A study toevaluate whether humans prefer 100 dollars or a 1% chance of 10,000dollars constitutes human subjects research. Clinical research refers to thesubset of human subjects research which focuses on improving humanhealth and well-being. To focus on the issues that have featured mostprominently in debates over the ethics of clinical research, we shall limitthe discussion to research designed to improve human health and well-being by identifying better methods to treat, cure or prevent illness. Thisfocus on treating, curing and preventing illness is intended to bracket themore recent question of whether research on enhancements qualifies asclinical research. Such research has the potential to improve well-being,allowing us to live longer and better, without identifying methods toaddress illness.We shall also bracket the question of whether quality improvement andquality assurance projects qualify as clinical research.