Subjects Agree to Participate in Environmental Health Studies without Fully Comprehending the Associated Risk
Abstract
:1. Background
2. Methods
3. Results
4. Discussion
Acknowledgments
- Agency DisclaimerThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Agency for Toxic Substances and Disease Registry.
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Study | Word Count | Informed Consent Form | Comprehension Assessment Tool |
---|---|---|---|
National Asbestos Health Program | |||
All participants | 1,301 | 7.9 | 5.4 |
Variation in Urinary Creatinine Study | |||
Adult participants | 994 | 7.2 | 4.9 |
Parents of child participants | 1,088 | 7.1 | 5.1 |
Required Consent Form Element | Comprehension Assessment Method | Number of Questions Asked |
---|---|---|
Voluntary participation | Recognition | 3 |
Study methodologya | Recognition | 7 |
Potential risks to the study participant | Recognition | 5/4b |
Confidentially | Recognition | 1 |
Benefits of participation | Recall | 1 |
Study objectives | Recall | 1 |
Total Number of Elements | 18/17b |
NAHP | VUCS | TOTAL | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
All Participants (n = 10) | All Participants (n = 63) | Adult Participants (n = 21) | Parents of Child Participants (n = 42) | (N = 73) | ||||||
N | % | N | % | N | % | N | % | N | % | |
Gender | ||||||||||
Male | 8 | 80 | 22 | 42 | 11 | 52 | 11 | 35 | 30 | 48 |
Female | 2 | 20 | 30 | 58 | 10 | 48 | 20 | 65 | 32 | 52 |
Missing | 0 | 11 | 0 | 11 | 1 | |||||
Age Group | ||||||||||
20–30 | 1 | 10 | 20 | 38 | 20 | 95 | 0 | 0 | 21 | 34 |
31–50 | 1 | 10 | 27 | 52 | 1 | 5 | 26 | 84 | 28 | 45 |
51–76 | 8 | 80 | 5 | 10 | 0 | 0 | 5 | 16 | 13 | 21 |
Missing | 0 | 11 | 0 | 11 | 11 | |||||
Race\Ethnicity | ||||||||||
Non Hispanic White | 6 | 67 | 39 | 78 | 16 | 84 | 23 | 74 | 45 | 76 |
Other | 3 | 33 | 11 | 22 | 3 | 16 | 8 | 26 | 14 | 24 |
Missing | 1 | 13 | 2 | 11 | 14 | |||||
Develops or reviews study protocols or consent forms | ||||||||||
Yes | - | - | 25 | 40 | 5 | 24 | 20 | 49 | - | - |
No | - | - | 37 | 60 | 16 | 76 | 21 | 51 | - | - |
Missing | 1 | 0 | 1 |
Consent Form Element | Total Possible Score | Overall (N = 73) | NAHP (n = 10) | VUCS (n = 63) | P-valuea |
---|---|---|---|---|---|
Overall Comprehension | 6 | 4.66 | 3.72 | 4.81 | 0.01 |
Voluntary participation | 1 | 0.98 | 0.90 | 0.99 | <0.01 |
Study methodology | 1 | 0.84 | 0.70 | 0.86 | 0.01 |
Potential risks to the study participant | 1 | 0.60 | 0.62 | 0.59 | 0.86 |
Confidentiality | 1 | 0.85 | 0.20 | 0.95 | <0.01 |
Benefits of participating | 1 | 0.77 | 0.70 | 0.78 | 0.59 |
Study objectives | 1 | 0.63 | 0.60 | 0.63 | 0.83 |
© 2011 by the authors; licensee MDPI, Basel, Switzerland This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).
Share and Cite
Lee, R.; Lampert, S.; Wilder, L.; Sowell, A.L. Subjects Agree to Participate in Environmental Health Studies without Fully Comprehending the Associated Risk. Int. J. Environ. Res. Public Health 2011, 8, 830-841. https://doi.org/10.3390/ijerph8030830
Lee R, Lampert S, Wilder L, Sowell AL. Subjects Agree to Participate in Environmental Health Studies without Fully Comprehending the Associated Risk. International Journal of Environmental Research and Public Health. 2011; 8(3):830-841. https://doi.org/10.3390/ijerph8030830
Chicago/Turabian StyleLee, Robin, Samantha Lampert, Lynn Wilder, and Anne L. Sowell. 2011. "Subjects Agree to Participate in Environmental Health Studies without Fully Comprehending the Associated Risk" International Journal of Environmental Research and Public Health 8, no. 3: 830-841. https://doi.org/10.3390/ijerph8030830