Patient Consent for Testing
You have requested to be evaluated by a healthcare provider for DNA genotyping and analysis (the “Test”). The purpose of the Test is to obtain additional information that may inform your healthcare provider’s medical management of your condition. This document describes the potential risks, benefits, and limitations of the Test. If you have any questions or need additional information, please consult a healthcare provider before signing. You are not required to have the Test. If you decide to authorize the Test if it is ordered, please sign and date where indicated at the end of this document.
If you proceed with the Test, it is important that you review the test results and reference information with your treating healthcare provider. Medications or dosing should not be changed outside of the direction and monitoring of a licensed provider, or changed solely based on the test results or reference information.
Purpose & Process
Subject to a healthcare provider order, Tempus (or its licensed, third-party contractor) will perform sequencing and analysis of certain regions of your DNA, and Tempus will report Test results to you and the healthcare provider designated by you. Depending on your DNA, the Test may indicate whether you have one or more genetic variants that may be associated with the metabolism of certain therapeutic products. Tempus will obtain a saliva or buccal swab sample and may also obtain information related to your health from you (for example, as part of your test request or through the TempusPro app) or your electronic health record. Genetic material, such as DNA, will be obtained from your sample, stored, and analyzed.
Your identifiable data is subject to legal requirements regarding its use, protection, and confidentiality. Tempus may also use your samples and health information for the following purposes in accordance with applicable law:
- Tempus may use and disclose the Test results and your other health data as described in its notice of privacy practices (NPP).
- In order to improve the quality of our testing, Tempus may retain genetic material (e.g., DNA or RNA) extracted from your saliva or buccal swab for an indefinite period of time following the testing and use leftover materials for internal purposes, including quality assurance and test validation, which may include further genetic analysis.
- Tempus may also remove direct identifiers from these materials and/or information about your health from the sources described above, and use the de-identified information and materials for research purposes, including future research related to diagnosis, testing and therapies. Tempus’ NPP includes information about how de-identified genetic analysis and other health data may be commercially used and shared in or out of the United States with life science companies or others. Third parties receiving de-identified data or genetic material are prohibited from using it to re-identify you.
- Tempus may contact you from time to time about potential opportunities to participate in research projects.
Risks, Benefits, & Limitations
Tempus’ Test report does not provide any medical diagnosis and does not make any specific treatment recommendations; instead, it provides information for your provider to review. There is no guarantee that the Test will yield clinically relevant information, inform your provider’s clinical decision-making or otherwise lead to any particular or beneficial outcome for you.
Knowledge about the effects and meaning of genetic information is constantly changing. This Test does not examine every possible variant that may exist, and the technology also may not identify all variants related to your condition or treatment, because there is a possibility of testing errors and because some biological factors may limit the accuracy of results. Tempus is under no ongoing obligation to update, revisit or later re-evaluate the results of the Test after those results have been made available through the test report described above.
To learn more about genetic testing, you may want to speak with a genetic counselor before and/or after testing. If you want to talk to a genetic counselor, you can ask your provider to refer you to one.
By signing below, you certify that you are at least 18 years old, and you acknowledge that you have read (or have had read to you) and understand the information provided above; you understand that the Test is voluntary and you may choose not to have any Test; and you consent to the genetic testing and to the other matters listed, including collection, use, retention, maintenance, and disclosure of your health information, genetic materials, and the results of any DNA analysis. If law requires you to consent to these terms but you have been unable to sign, provision of your materials to Tempus indicates your consent. Revisions to this form are void. If you are signing on behalf of the patient, you further certify that you have legal authority to consent on behalf of the patient and that the patient is at least 18 years old.