A tiered-layered-staged model for informed consent in personal genome testing

Area of Science:

• Genomics and Personalized Medicine
• Bioethics
• Consumer Health Information

Background:

• Commercial personal genome testing (PGT) offers broad, simultaneous disease risk assessment directly to consumers.
• The volume and complexity of PGT information challenge traditional informed consent processes.
• Current guidelines for informed consent in PGT are lacking.

Purpose of the Study:

• To address the ethical challenges in informed consent for direct-to-consumer PGT.
• To propose a novel model for informed consent in the context of PGT.
• To enhance consumer understanding and autonomy in PGT.

Main Methods:

• Development of a tiered-layered-staged informed consent model.
• Categorization of diseases based on ethical, personal, or societal implications (tiered).
• Progressive information delivery through layers and stages, including updates.

Main Results:

• The proposed model offers consumer choice through disease categories.
• Information is presented in layers, starting with essential details and offering more upon request.
• Consent is a process, accommodating ongoing scientific advancements and result updates.

Conclusions:

• A tiered-layered-staged model can improve informed consent for PGT consumers.
• This approach addresses ethical issues related to information provision in direct-to-consumer genetic testing.
• Focusing on the consumer perspective is key to successful PGT informed consent.