Table 1.
Length and Complexity Comparison for Standard and Concise Consent Forms
| Format A Standard |
Format B Concise |
Reduction | |||
|---|---|---|---|---|---|
| VRC 306 | VRC 307 | VRC 306 | VRC 307 | percentage | |
| Total Pages (when in 10 pt font) | 10 | 10 | 5 | 5 | 50 |
| Total Word Count | 5134 | 4912 | 1790 | 1916 | 63 |
| Words: Intro, Purpose, *Study Vaccines | 920 | 721 | 249 | 240 | 70 |
| Words: Procedures and Monitoring/What Happens in the Study | 925 | 973 | 372 | 477 | 55 |
| Words: Genetic Tests/HLA/Stored Samples | 981 | 981 | 166 | 165 | 83 |
| Words: Study Risks/Birth Control | 1271 | 1191 | 535 | 507 | 58 |
| Words: Study Benefits/Alternatives | 65 | 88 | 83 | 100 | (13) |
| Words: Costs and Compensation | 166 | 169 | 57 | 67 | 60 |
| Words: Reasons for Removal from Study | 199 | 194 | 68 | 65 | 66 |
| Words: Conflict of Interest/Other Information | 607 | 595 | 260 | 295 | 54 |
| Flesch-Kincaid Reading Grade Level | 10.1 | 10.2 | 9.5 | 9.2 | <1 grade |
| *Example of standard and concise text selected from VRC 306 regarding the DNA Vaccine | |||||
|
Standard: Vaccines are substances used to try to create resistance (or immunity) to a disease and to prevent an infection. You cannot get an avian flu infection from either study vaccine because neither of the study vaccines contain avian influenza virus that can cause avian flu infection or disease. The investigators will then see if the body creates resistance or immunity to an influenza protein called “hemagglutinin 5”. This is also called H5 or H5 protein. In this consent the two vaccines will be called “DNA H5 Vaccine” and “Inactivated H5N1 Vaccine”. The hope is that an immune response to H5 protein may protect against avian influenza virus infection. It is not known if the study vaccines work to protect against avian influenza. DNA H5 Vaccine: Most vaccines are made of proteins and injected into a muscle. Proteins are natural substances that the body uses as building blocks. DNA serves as nature’s code (instructions) for protein production in the body. A new kind of vaccine being tested in this study is made from the DNA that is the code for an influenza H5 protein. It is made from just one small part of the code for avian influenza H5 virus protein. In this study, the DNA will be injected into a muscle. It will instruct the body to make a small amount of the H5 protein, which is based on the protein from the avian influenza virus. The dose of the DNA H5 vaccine in this study has been tested in 15 people in an earlier study. Smaller doses of the DNA H5 vaccine have been tested in 58 people… |
Simplified: Although vaccines are used to boost the immune system to prevent infection, we do not know if either of the two experimental study vaccines will prevent bird flu. However, you cannot get bird flu from the study vaccines. One study vaccine is made from DNA that will cause your body to make a protein called H5. The same dose of the vaccine used in this study (4 mg.) was tested in 15 people, and a lower dose was tested in 58 people… |
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Word counts and reading levels were obtained using Microsoft Word 2007®. The percent reduction in size or score was calculated using the mean of the two standard documents and mean of the two simplified documents. Parentheses indicate a percentage increase.