Patient Informed Consent
How will my samples be used?
Your samples will be used to test for genetic markers. These genetic markers form the Genecept™ Assay, which provides information to clinicians that can be used to inform treatment decisions based on an individual patient’s genetic profile. The results of the specific DNA test ordered may: a) predict your ability to absorb, distribute, metabolize and/or eliminate medications properly; b) identify whether or not you are at increased risk of having an adverse drug reaction or therapeutic failure to standard dosages of a particular drug or class of drugs; c) indirectly reveal non-paternity; and/or d) be indeterminate due to technical limitations (even with comprehensive testing results, there is not an easy way for clinicians to determine which genetic variations are most important and/or relevant for therapeutic strategies).
What are the risks of this genetic testing?
The DNA test result reported back to the clinician is specific only for the genes described above. It will not detect all variants possible within these genes. Although genetic variant analysis usually yields precise information, several sources of error are possible. These include, but are not limited to, clinical misinterpretation of the gene, sample misidentification, and sample contamination. While DNA testing is highly accurate and widely accepted, as in all testing, there is a possibility of delay or error.
What are my rights?
Your clinician has ordered this testing for you. However, allowing your samples to be tested is completely voluntary and you have the absolute right not to agree to have your DNA sampled. You may also direct, per Section 1 of the form accompanying the kit, that your sample not be used for future research. Your decision will not affect your right to treatment in any way. You may refuse testing without any consequences to your treatment. Once you agree to the testing, you may withdraw from the testing at any time until your results are received by your clinician. Your test results will be released to the clinician who ordered the test. Additional genetic counseling may be warranted or desired, either before signing this form, after testing, or after going over the test results with your clinician.
Statement of Consent and Release
I hereby certify that the information provided is true and accurate. I understand that the Genecept™ Assay is a set of genes that are being tested for variation. This variation can be used to help inform my clinician(s) as to the medication options that they decide will help treat the condition(s) for which I am currently seeking their care.
The significance of this test has been explained to me.
I acknowledge that I have been informed that Genomind, Inc. (CLIA No. 39D2088097) has validated the Genecept™ Assay consistent with the Clinical Laboratory Improvement Amendments (CLIA) standards for high-complexity testing but the assay has not been approved by the Food and Drug Administration (FDA). Genomind will adhere to the Genetic Information Nondiscrimination Act (GINA) of 2008 which prohibits discrimination in health coverage and employment based on genetic information.
The DNA test results are not intended to be used as the only tool for patient management decisions. I understand that prescription drug regimens should never be altered without consulting a clinician.
I consent to the collection of specimens from myself or any listed minor or other dependent for the purpose of DNA testing by Genomind, its agents or contractors. I also authorize Genomind, its agents or contractors to provide testing information to my insurance carrier as necessary to validate services and receive payment. I understand that Genomind and its representatives are not responsible for any medical or other decisions made based on the results of the DNA test ordered by my clinician. I hereby release and hold harmless Genomind, Inc., its employees, contractors, successors, and assigns from any liability arising from such decisions, including from any course of treatment chosen using the test results. If I choose to share my genetic, or other personal information with third parties – whether intentionally or inadvertently – I agree to hold harmless Genomind, its employees, contractors, successors, and assignees from any and all liability arising from such disclosure or use of my genetic or other personal data. I agree that I have the authority, under the laws of the state or jurisdiction in which I reside, to provide this consent and release.