By ordering this test, the provider represents a licensed medical professional authorized to order genetic testing and acknowledges the parent or guardian have been supplied information regarding genetic testing. The parent or guardian has consented testing. I confirm that this is medically necessary for the diagnosis or detection of a disease, illness, impairment, syndrome or disorder, and that these results will be used in the medical management and treatment decisions for this patient. I have offered counseling to patient and family regarding the process required for sequencing and genetic analysis.
Provider’s signature: ________________________________________ Date: ____________
By signing I confirm that I understand the limitations of a genetic test and its possible results. The American College of Medical Genetics (ACMG) recommends that secondary findings on 56 genes (most likely unrelated to the diagnosis) to be reported. The provider has explained to me the sequencing process prior to the test and the further need for counseling. The final report should be complemented with discussions with my doctor regarding possible genetic findings and potential health implications. By signing this consent I acknowledge that my samples may be used for research and /or education in anonymized fashion. I would like to proceed with testing.
Parent or guardian signature: _________________________________ Date: ____________
Below is a much longer option for Informed consent used in US but the short form above may be sufficient in China.
Please read this form carefully. You are being offered a blood test that looks at your genetic material. We hope this blood test will help us having a better understanding of your medical condition. This consent form will try to explain the risks and benefits of doing the test.
Identification of the molecular basis of the disorder on your family.
You will be asked to provide blood sample and DNA will be extracted and sequenced. The sequence of each family member (on Trios) will be compared to look for differences or similarities that could explain the disorder that runs in the family.
This test looks for genetic changes associated with your disease. It may find changes or variants in one or more genes that cause or contribute to your condition. However it is also possible that this test will not find any changes that would explain your signs and symptoms. It does not mean that you do not have a genetic disease.
Results will be released to the ordering clinician and NOT to the patient/family directly. The results will be part of your medical records.
If incidental findings are thought to be medically important they may be reported to your healthcare provider. Your provider will talk to you about how these findings may change your risk for disease and/or medical care. Therefore, post-test genetic counseling or clinical genetics consultation is highly recommended.
You may learn medical information about yourself that you did not expect. Learning that you are at risk for a disease other than your initial condition, and which may or may not be preventable or treatable, could lead to emotional or psychological distress.
This a list of genes to be reported recommended by the American College of Medical Genetics. The list includes
56 genes well-recognized and known to have a strong link of causation. The conditions were chosen if preventative measures and treatments exist. It includes cancer predisposition risk, later-onset cardiac syndromes, and connective tissue syndromes.
By signing this consent, I acknowledge that my samples may be used for research and /or education in anonymized fashion.
By signing this form I confirm that I understand the limitations of a genetic test and its possible results and consequences and I would like to proceed with testing.
Patient’s signature: ____________________________________ Date: ____________