Genetic Testing Consent Form

The Genetic Testing Consent Form provides comprehensive informed consent documentation for patients undergoing clinical genetic or genomic testing. This template addresses the unique ethical and legal considerations inherent in genetic testing, including the scope of testing (single-gene, multi-gene panel, whole-exome, or whole-genome sequencing), the types of results that may be returned (positive, negative, variant of uncertain significance), and the possibility of incidental or secondary findings unrelated to the primary indication. The form explains concepts such as analytical validity, clinical validity, and clinical utility in patient-accessible language.

The consent covers critical aspects specific to genetic medicine including the implications of test results for biological relatives, the potential for genetic discrimination (with reference to GINA protections and state-specific genetic privacy laws), the limitations of negative results in the context of residual risk, and the distinction between diagnostic and predictive testing. Patients are given the option to elect or decline categories of secondary findings consistent with ACMG recommendations for reporting of secondary findings in clinical exome and genome sequencing.

Data privacy sections detail how genetic specimens and sequence data will be stored, whether de-identified data may be contributed to research databases or variant repositories (e.g., ClinVar, gnomAD), and the patient's rights regarding biobanking and future reanalysis. Pre-test and post-test genetic counseling acknowledgments are captured, along with dual signatures from the patient and ordering provider, creating a complete audit trail that satisfies CAP/CLIA laboratory requirements and institutional policies for genomic medicine.