Does Consent Bias Research?

Am.J.Bioethics 13(4), 2013

11 Pages Posted: 6 Apr 2013

See all articles by Mark A. Rothstein

Mark A. Rothstein

University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law

Abigail Shoben

Ohio State University (OSU) - College of Medicine and Public Health

Date Written: April 4, 2013

Abstract

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in “consent bias.” As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research.

Keywords: research ethics, informed consent, consent bias, selection bias

JEL Classification: K31, K32

Suggested Citation

Rothstein, Mark A. and Shoben, Abigail, Does Consent Bias Research? (April 4, 2013). Am.J.Bioethics 13(4), 2013. Available at SSRN: https://ssrn.com/abstract=2244990

Mark A. Rothstein (Contact Author)

University of Louisville - Institute for Bioethics, Health Policy, and Law ( email )

Louisville, KY 40202
United States

HOME PAGE: http://www.louisville.edu/bioethics

University of Louisville - Louis D. Brandeis School of Law ( email )

Wilson W. Wyatt Hall
Louisville, KY 40292
United States

Abigail Shoben

Ohio State University (OSU) - College of Medicine and Public Health ( email )

United States
614-247-8092 (Phone)

HOME PAGE: http://cph.osu.edu/facstaff/biopage?u=ashoben

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