Informed Consent for Genetic Sequencing & Analysis
Last Updated: December 2025
Please review this form carefully. By submitting your biological sample (saliva or blood) to Hampton Genetics Ltd, you are providing your explicit consent for genetic testing and analysis as described below. If you do not agree to these terms, please do not activate your kit or return your sample.
This Informed Consent explains:
- What Hampton Genetics does and how our Whole Exome Sequencing (WES) technology works.
- The difference between our Screening (Hampton A) and Diagnostic (Hampton B) services.
- The potential benefits, risks, and limitations of genetic testing.
- How we protect your privacy and how to withdraw consent.
Key Terms
- Hampton Genetics: Refers to Hampton Genetics Ltd ("we," "us," or "our").
- NGS (Next Generation Sequencing): The "Gold Standard" technology we use to read your DNA.
- Whole Exome Sequencing (WES): Our specific method that targets the protein-coding regions (exons) of your genome, where most known disease-causing variants occur.
- Variant: A change in your DNA sequence compared to a reference genome. Variants can be "Benign" (harmless), "Pathogenic" (disease-causing), or "VUS" (Variant of Unknown Significance).
- VUS (Variant of Unknown Significance): A genetic change where the impact on health is not yet fully understood by science. We use AI to predict the potential impact of these variants.
1. What is Hampton Genetics?
Hampton Genetics provides advanced genetic insights using clinical-grade DNA sequencing. Depending on the service you selected:
- Hampton A (Screening): Designed for healthy individuals or couples planning a family. It screens for carrier status of recessive genetic conditions and provides nutraceutical health insights.
- Hampton B (Diagnostic): Designed for adults or children with suspected undiagnosed genetic conditions. This service aims to identify the genetic cause of symptoms and provide actionable reports for your physician.
2. How the Process Works
Unlike services that only analyze uploaded data, Hampton Genetics performs the sequencing process from start to finish:
- Sample Collection: You provide a saliva or blood sample using our at-home kit or via a partner clinic.
- Sequencing: We process your sample using Next Generation Sequencing (NGS) to read approximately 20,000 genes (the Whole Exome).
- AI Analysis: Our proprietary AI algorithms analyze the data to identify variants and predict the clinical significance of Variants of Unknown Significance (VUS) based on DNA structure and disease prevalence.
- Reporting: A Clinical Report is generated outlining our findings.
3. What will I learn? (Results)
Your report may include:
- Positive Result: A genetic variant was found that is known to be associated with a specific disease or condition.
- Carrier Status: You carry one copy of a gene variant for a recessive condition. You typically do not have symptoms, but there is a risk of passing it to children.
- Negative Result: No significant genetic variants were found relative to the conditions tested. Note: This does not rule out all genetic diseases.
- VUS Findings: Variants were found where the medical impact is unclear. Our AI provides a prediction of risk, but these are not definitive diagnoses.
4. Risks and Limitations
- Emotional Impact: You may learn information about your health or your family's health that is upsetting or anxiety-provoking. This information cannot be "unlearned."
- Family Implications: Because you share DNA with blood relatives, your results may imply genetic risks for them as well.
- VUS Uncertainty: Science is always evolving. A "Variant of Unknown Significance" may be reclassified as benign or pathogenic in the future as new research emerges.
- Not a Substitute for Medical Care: While Hampton B is a diagnostic tool, all results should be reviewed by a qualified healthcare professional before making medical decisions.
5. Privacy and Data Access
Your privacy is a priority. Your sample and data are de-identified (separated from your name) during analysis. Access is limited to:
- Laboratory Personnel: To process the physical sample.
- Clinical Team & Genetic Counselors: To interpret results and generate your report.
- You: Via your secure portal.
We do not sell your individual data to third parties. For full details, please review our Privacy Policy.
6. Withdrawal of Consent
Participation is voluntary. You may withdraw consent at any time before your report is generated by contacting support. Upon withdrawal, we will destroy your biological sample and delete your genetic data, subject to legal retention requirements for clinical laboratories.
Acknowledgment and Consent
By proceeding with the Hampton Genetics service, I acknowledge that:
- I have read and understood the benefits, risks, and limitations of Whole Exome Sequencing.
- I understand that Hampton Genetics uses AI to predict the impact of uncertain variants (VUS) and that these predictions are not 100% definitive.
- I am at least 18 years of age (or I am the parent/guardian consenting for a minor).
- I consent to the processing of my biological sample and the generation of genetic data as described above.
[ ] I CONSENT to the analysis of my genetic sample.
