title: Does consent bias research?
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.
authors.affiliation: University of Louisville School of Medicine, 501 East Broadway #310, Louisville, KY 40202, USA. mark.rothstein@louisville.edu
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rothstein
authors.forename: Abigail B
authors.initials: AB
authors.lastname: Shoben
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics*; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D001782:Blood Donors / Q000523:psychology / Q000706:statistics & numerical data; D028663:Ethical Theory; D032984:Ethics, Research; D015444:Exercise; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D016017:Odds Ratio; D018579:Patient Selection; D026684:Personal Autonomy; D011640:Public Policy / Q000639:trends; D012107:Research Design; D035842:Research Subjects / Q000523:psychology; D015983:Selection Bias; D012945:Social Values; D014481:United States