Does Consent Bias Research?
Mark A. Rothstein
University of Louisville - Institute for Bioethics, Health Policy, and Law; University of Louisville - Louis D. Brandeis School of Law
Abigail B. Shoben
Ohio State University (OSU) - College of Medicine and Public Health
April 4, 2013
Am.J.Bioethics 13(4), 2013
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.
Number of Pages in PDF File: 11
Keywords: research ethics, informed consent, consent bias, selection bias
JEL Classification: K31, K32Accepted Paper Series
Date posted: April 6, 2013
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