Does Consent Bias Research?

Type Journal Article Author Mark A. Rothstein Author Abigail B. Shoben URL http://dx.doi.org/10.1080/15265161.2013.767955 Volume 13 Issue 4 Pages 27-37 Publication The American Journal of Bioethics ISSN 1526-5161 Date April 1, 2013 Extra 00027 PMID: 23514393 DOI 10.1080/15265161.2013.767955 Accessed 2016-02-10 01:39:32 Library Catalog Taylor and Francis+NEJM 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.