Research ethics. Rethinking research ethics: the case of postmarketing trials

Science. 2012 May 4;336(6081):544-5. doi: 10.1126/science.1216086.

Abstract

Phase IV studies are often criticized for poor scientific standards. Yet they provide an important resource for addressing evidence shortfalls in drug safety, comparative effectiveness, and real-world utility. Current research ethics policies, and contemplated revisions to them, do not provide an adequate framework for preventing social harms that result from poor post-marketing research practice. Rather than focus exclusively on the welfare and interests of human volunteers, research policies and ethics should also safeguard the integrity of the research enterprise as a system for producing reliable medical evidence. We close by briefly describing how an integrity framework might be implemented for phase IV studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials, Phase IV as Topic / ethics*
  • Clinical Trials, Phase IV as Topic / legislation & jurisprudence
  • Clinical Trials, Phase IV as Topic / standards
  • Drug Industry
  • Ethics Committees, Research
  • Ethics, Research*
  • Humans
  • Informed Consent
  • Marketing
  • Public Policy
  • Research Subjects
  • United States