Use of altered informed consent in pragmatic clinical research

Clin Trials. 2015 Oct;12(5):494-502. doi: 10.1177/1740774515597688. Epub 2015 Sep 15.


There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests.

Keywords: Common Rule; Informed consent; bioethics; clinical trial; cluster-randomized trial; institutional review board; practical clinical trial; pragmatic clinical research.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / ethics*
  • Biomedical Research / legislation & jurisprudence*
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / standards
  • Ethics Committees, Research
  • Human Experimentation / ethics
  • Human Experimentation / legislation & jurisprudence
  • Human Experimentation / standards
  • Humans
  • Informed Consent / ethics*
  • Informed Consent / legislation & jurisprudence*
  • Research Design / legislation & jurisprudence
  • Research Design / standards*
  • United States