Article ID Journal Published Year Pages File Type
1082670 Journal of Clinical Epidemiology 2012 6 Pages PDF
Abstract

ObjectiveTo present a structured account of ethical problems and possible solutions related to selective publication and incomplete trial registration.Study Design and SettingThe presentation of ethical problems and possible solutions is structured using the tools of conceptual normative analysis.ResultsSelective publication runs contrary to (1) principles of ethical research, such as social value and respect for participants, (2) sound medical decision making and clinical guideline development, (3) appropriate patient information, (4) public trust in clinical research, and (5) just allocation of public resources for clinical research. Reasons against the obligation of complete registration and publication of trials can be divided into (1) protection of private data and (2) commercial interests. Empirical findings indicate that selective publication and incomplete trial registration (1) are frequent, (2) extensively distort patient-relevant outcomes, and (3) affect a large number of patients.ConclusionEmpirical data and normative arguments outweigh their counterarguments and present a clear case in favor of an even more restrictive obligation to register trials. Institutional review boards and better-educated stakeholders might play a crucial role in facilitating unbiased registration and publication of clinical research. For evaluation purposes, the field needs better standards for study protocols.

Related Topics
Health Sciences Medicine and Dentistry Public Health and Health Policy
Authors
,