title: Subjects agree to participate in environmental health studies without fully comprehending the associated risk.
abstract: Recent advances in environmental health research have greatly improved our ability to measure and quantify how individuals are exposed. These advances, however, bring bioethical uncertainties and potential risks that individuals should be aware of before consenting to participate. This study assessed how well participants from two environmental health studies comprehended consent form material. After signing the consent form, participants were asked to complete a comprehension assessment tool. The tool measured whether participants could recognize or recall six elements of the consent form they had just reviewed. Additional data were collected to look for differences in comprehension by gender, age, race, and the time spent reading the original consent form. Seventy-three participants completed a comprehension assessment tool. Scores ranged from 1.91 to 6.00 (mean = 4.66); only three people had perfect comprehension scores. Among the least comprehended material were questions on study-related risks. Overall, 53% of participants were not aware of two or more study-related risks. As environmental public health studies pose uncertainties and potential risks, researchers need to do more to assess participants' understanding before assuming that individuals have given their 'informed' consent.
authors.affiliation: Division of Health Studies, US Agency for Toxic Substances and Disease Registry, 4770 Buford Highway NE, MS F-57, Atlanta, GA 30341, USA. RLee3@cdc.gov
authors.forename: Robin
authors.initials: R
authors.lastname: Lee
authors.forename: Samantha
authors.initials: S
authors.lastname: Lampert
authors.forename: Lynn
authors.initials: L
authors.lastname: Wilder
authors.forename: Anne L
authors.initials: AL
authors.lastname: Sowell
mesh_terms: D000328:Adult; D000368:Aged; D002648:Child; D032882:Comprehension; D032962:Consent Forms; D004782:Environmental Health; D032984:Ethics, Research; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D035842:Research Subjects; D018570:Risk Assessment; D012959:Socioeconomic Factors; D055815:Young Adult