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Ethical Considerations in the Interpretation and Communication of Clinical Trial Results

¹ Department of Medicine, University of Texas Health Center at Tyler, Tyler, Texas

Correspondence and requests for reprints should be addressed to David Coultas, M.D., Department of Medicine, The University of Texas Health Center at Tyler, 11937 U.S. Highway 271, Tyler, TX 75708-3154. E-mail: david.coultas{at}uthct.edu

ABSTRACT

The ethical interpretation and communication of research results is essential to ensure the validity, timeliness, and accessibility of new knowledge for patients, physicians, and regulatory agencies. Failure to adhere to ethical principles may cause adverse outcomes for patients because of overestimation of benefit, underestimation of harm, and lack of timely awareness of benefit or harm. Although fabrication, falsification, and plagiarism are the traditional criteria for research misconduct, other more subtle behaviors may cause greater threats to public safety and trust in the research enterprise. Growing awareness of research misconduct has led to a number of initiatives worldwide during the past decade in an attempt to control the problem at various stages of the research process through the funding agencies, research institutions, and editorial oversight. The objective of this article is to raise awareness among the pulmonary research community of the broad range of ethical issues that arise during manuscript preparation, review, publication, and dissemination of research results, and efforts that are in progress to minimize misconduct.

Key Words: ethics • research misconduct • clinical trial • bias • publications • data interpretation