title: Standard of care, institutional obligations, and distributive justice.
abstract: The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine two types of institutional contexts: (1) public research agencies - agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care.
authors.forename: Douglas
authors.initials: D
authors.lastname: MacKay
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000941:ethics; D001838:Bolivia; D004338:Drug Combinations; D004991:Ethics, Institutional; D032984:Ethics, Research; D005233:Fatty Alcohols / Q000008:administration & dosage / Q000191:economics; D006801:Humans; D007391:International Cooperation; D010715:Phosphatidylglycerols / Q000008:administration & dosage / Q000191:economics; D017149:Private Sector; D011506:Proteins / Q000008:administration & dosage / Q000191:economics; D017150:Public Sector; D011663:Pulmonary Surfactants / Q000008:administration & dosage / Q000191:economics; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000941:ethics*; D012108:Research Personnel / Q000191:economics / Q000941:ethics; D012109:Research Support as Topic; D012935:Social Justice; D012941:Social Responsibility; D059039:Standard of Care / Q000941:ethics*; D014481:United States
chemical_list: D004338:Drug Combinations; D005233:Fatty Alcohols; D010715:Phosphatidylglycerols; D011506:Proteins; D011663:Pulmonary Surfactants; C502722:lucinactant
keywords: distributive justice; institutional obligations; standard of care