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. 2016 Aug 17;17(14):1595–1605. doi: 10.2217/pgs-2016-0039

Table 2. . Content analysis of consent forms/test requisitions for the eight elements of informed consent and illustrative quotes.

Component of consent Laboratories including this element on consent form, n (%) Sample text
General description
16 (100)
“The DNA test(s) detect small differences (variants) in DNA which can affect the way drugs work and are metabolized in your body and/or detect potential side effects”
Purpose of test
14 (91)
“Pharmacogenomics testing determines how genetic makeup affects my response to medication”
Genetic counseling recommendation
10 (73)
“Genetic counseling is recommended prior to, as well as following genetic testing”
Potential results/meaning of results
11 (73)
“DNA results may: indicate whether or not you have this condition or are at risk for developing this condition. Indicate whether or not you are a carrier for this condition, predict that another family member has or is at risk for developing this condition, predict that another family member is a carrier of this condition”
Description of disease being tested
16 (100)
“Genotyping of CYP2C9, CYP2C19 and VKORC1 for metabolism status to determine proper initial dosage of warfarin to avoid bleeding events and overdose”
Disclosure of results
15 (91)
“Because of the complexity of genetic testing and the important implications of the test results, results will be reported only through a physician, genetic counselor or other identified healthcare provider”
Storage/destruction of sample
16 (100)
“The sample will be destroyed at the end of the testing process or not more than 60 days after the sample was taken…”
Medical risks and benefits 11 (73) “Side effects of having blood drawn are uncommon, but may include dizziness, fainting, soreness, pain, bleeding, bruising and, rarely, infection. Other risks that may be experienced as a result of this testing include: related emotional issues, impact on life – changing decisions, potential genetic discrimination (e.g., in employment and insurance areas) and loss of confidentiality”