Healthcare Genetic Consent Form

HEALTHCARE GENETIC CONSENT FORM

Patient Name:    Date of Birth:    Medical Record #:

Patient Information

Insurance Information

Medical History (Relevant to Genetic Testing)

Genetic Test Information and Consent

Test/Procedure to be performed:

Purpose: The purpose of this genetic test is to identify genetic variants that may explain a medical condition, inform clinical management, or provide information for reproductive decision-making. Results may be diagnostic, predictive, or of uncertain significance. Testing may not detect all genetic alterations.

Risks and Limitations: I understand that genetic testing may reveal information with psychological, familial, or insurance implications. Test results may be inconclusive or identify variants of uncertain clinical significance. There is a possibility of incidental findings unrelated to the reason for testing. No test can guarantee a particular clinical outcome.

Alternatives: I have had the opportunity to discuss alternatives to this test with my clinician, including no testing, other tests, or referral to genetic counseling.

I have been offered or received genetic counseling regarding the nature, benefits, risks, and limitations of this testing.

I understand that, while efforts will be made to protect my privacy, genetic information may be included in my medical record and could be disclosed as required by law or permitted by this authorization.

I understand there is no guarantee that testing will provide a definitive answer or prevent future medical problems.

Results, Incidental Findings, and Disclosure

Result disclosure: I authorize the laboratory and my clinician to release test results to me and to other treating clinicians involved in my care. I understand that results may include incidental findings that have health implications beyond the original reason for testing.

I consent to be informed of medically actionable incidental findings.

I do NOT wish to be informed of incidental findings (except those required by law to be reported).

Specimen Handling, Storage, and Research Use

Specimen storage: I authorize the laboratory to retain my specimen and DNA material for a period necessary for test validation and quality control. Stored samples may be used for future clinical testing or method development unless I decline below.

I consent to de-identified use of my specimen or data for future research.

I do NOT consent to research use of my specimen or data.

Authorization, Duration, and Revocation

Authorization: By signing below I authorize the performance of the genetic test described above and the release of results to the persons and entities described in this form. I understand that I may revoke this authorization in writing at any time, except to the extent that action has already been taken in reliance on it. Revocation does not affect actions taken prior to receipt of the revocation.

Legal Notices and Certifications

I understand that genetic information may affect family members and that my clinician may recommend notifying at-risk relatives. I understand that laws governing genetic discrimination vary and that genetic information may affect eligibility for certain life or disability insurance products. I have had the opportunity to ask questions and to have them answered to my satisfaction.

I certify that I have read and understand the information in this consent form (or that it has been read to me), that my questions have been answered, and that I voluntarily consent to the genetic testing described above.

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