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.
Highlights
Their decision to participate may not be based on the inherent risks and benefits of study participation. While this issue has been widely documented among specific subpopulations such as the elderly, substance abusers, the mentally challenged, or participants in clinical trials [6,7,8,9,10,11,12,13] To our knowledge, no studies have measured comprehension of consent material provided to the broader population involved in general environmental public health research
Comprehension of consent form material was measured among study participants from two environmental health studies conducted by the U.S Agency for Toxic Substances and Disease Registry (ATSDR)
These two studies were selected to measure comprehension of consent form material because they were conducted by the same team of scientist at ATSDR and because both studies were implemented during a similar time period
Summary
Biomonitoring and genetic research are two tools environmental health scientists are using more frequently as advances in these fields improve our ability to understand environmental influences on individuals and communities These tools are revolutionary resources, there are new bioethical uncertainties, interpretative challenges, and potential risks that individuals who agree to participate in these studies should know [1,2,3,4]. While obtaining information consent is ethically necessary a number of studies have found that participants have limited comprehension of the consent form materials they are given Their decision to participate may not be based on the inherent risks and benefits of study participation. The study ascertained whether certain demographic factors (i.e., gender, age, race) or the amount of time spent reviewing the form were associated with the ability to recognize or recall specific information
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