Journal of General Internal Medicine

, Volume 31, Issue 12, pp 1511–1518

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

  • James H. Flory
  • Alvin I. Mushlin
  • Zachary I. Goodman
Review Paper

DOI: 10.1007/s11606-016-3780-5

Cite this article as:
Flory, J.H., Mushlin, A.I. & Goodman, Z.I. J GEN INTERN MED (2016) 31: 1511. doi:10.1007/s11606-016-3780-5

Abstract

Background

Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions—for example, emergency research—are widely accepted.

Methods

The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs.

Results

We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent.

Conclusion

Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems.

Key Words

Informed consent Randomized controlled trials Bioethics Clinical research Learning health care system 

Copyright information

© Society of General Internal Medicine 2016

Authors and Affiliations

  • James H. Flory
    • 1
  • Alvin I. Mushlin
    • 1
  • Zachary I. Goodman
    • 1
  1. 1.Department of Healthcare Policy and ResearchWeill Cornell Medical CollegeNew YorkUSA