Ethical considerations in research involving human subjects

Abstract

“Ethical issues” may present themselves in two ways: as an incongruity between affirmed values and derivative actions, or as a mistaken set of affirmed values. In consideration of formal statements of values appealed to in research involving human subjects—The Nuremberg Code, The Declaration of Helsinki, The Policies and Guidelines of DHEW, the AMA's “Ethical Guidelines for Clinical Investigation” et al.—current ethical issues in this matter are of the first sort: discontinuity between values affirmed and actions taken. The principal concerns emerge from these formal statements: for the study itself and for the subject(s) of the study. Ethical adequacy of investigations involving human subjects is assessed with reference to a study's design, conduct, and result; none of these is dispensable. Ethical concerns for the subject(s) evolve primarily about valid consent and risk-assessment. (1) Where there is sufficient warrant to test experimental hypotheses, in order to advance medical knowledge and/or meet human medical needs, and (2) where the design, conduct, and result of clinical investigation appropriately forward these intentions, and (3) where human subjects are involved only after valid consent is secured, their protection from possible injury, disability, or death is guarded, and the risk to subjects determined to be both acceptable and proportional to the significance of the study—where these elements are present, the ethical interests of the formal statements conventionally appealed to are served. These ethical interests, in themselves, are appropriate; current issues derive, not so much from mistaken values as from failure to express those well-articulated values in discrete action(s).