Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Sep;41(5):35-40.
doi: 10.1002/eahr.500031.

Randomization Among: The Other Randomization

Deborah R Barnbaum  1
Affiliations

Randomization Among: The Other Randomization

Deborah R Barnbaum. Ethics Hum Res. 2019 Sep.

Abstract

A valid informed consent process for a randomized controlled trial requires the disclosure to potential participants that they will be randomized to receive the study intervention or a control intervention. This is a case of randomization within a trial, a type of randomization that has received significant attention in research ethics. When institutions recruit large numbers of research participants for multisite clinical trials, a different, hidden form of randomization may occur: randomization among clinical trials. If it is essential to disclose to potential participants randomization within a clinical trial, then it may be the case that randomization among clinical trials recruiting individuals from the same cohort of eligible participants should also be disclosed. This article examines how randomization among clinical trials might take place and the ethical issues such randomization raises about informed consent to research participation.

Keywords: clinical equipoise; human subjects research; informed consent; randomization; randomized clinical trials.

PubMed Disclaimer

References

REFERENCES

    1. Binik, A., and M. Sheehan, “Randomization Should Be Disclosed to Potential Research Subjects,” American Journal of Bioethics 13, no. 13 (2013): 35-71.; Lantos, J. D., and C. Feudtner, “SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies,” Hastings Center Report 45, no. 45 (2015): 30-39.; Silverman, H. J., and D. Dreyfuss, “Were There ‘Additional Foreseeable Risks’ in the SUPPORT Study?,” Hastings Center Report 45, no. 45 (2015): 21-29.; Rabin, R. C., “Trial by Fire: Critics Demand That a Huge Sepsis Study Be Stopped,” New York Times, September 24, 2018.
    1. Wendler, D., “Must Research Participants Understand Randomization?,” American Journal of Bioethics 9, no. 9 (2009): 3-8.
    1. Jaeb Center for Health Research, DRCR.net., https://public.jaeb.org/drcrnet.
    1. A survey of the ways in which physicians’ preferences may affect enrollment can be found in Joffe, S., and R. D. Truog, “Equipoise and Randomization,” in Emanuel, E. J., et al., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008), 245-60.
    1. For an opposing view, see Wendler, “Must Research Participants Understand Randomization?”

LinkOut - more resources