Moving from 'fully' to 'appropriately' informed consent in genomics: The PROMICE framework

Area of Science:

• Genomic medicine
• Bioethics
• Informed Consent

Background:

• Genomic sequencing (GS) presents unique challenges to traditional informed consent models.
• Complexity and broad results of GS make full understanding difficult.
• Rapid genomic testing (RGS) in neonatal intensive care units exacerbates consent challenges due to time and emotional distress.

Purpose of the Study:

• To propose a new ethical framework for informed consent in genomic medicine.
• To assess the ethical appropriateness of different informed consent models.
• To establish 'appropriately-informed consent' as the standard for genomic medicine.

Main Methods:

• Development of the PROmoting Morally Important Consent Ends (PROMICE) framework.
• Analysis of informed consent goals: autonomy, well-being, and trust.
• Application of the PROMICE framework to two case studies: tiered GS consent and RGS in neonates.

Main Results:

• The PROMICE framework provides a basis for evaluating informed consent models.
• Tiered and layered consent models can be ethically appropriate for GS.
• Consent for RGS in critically ill newborns requires careful ethical consideration.

Conclusions:

• Informed consent is crucial for promoting autonomy, well-being, and trust in medicine.
• 'Appropriately-informed consent' is the correct ethical standard for genomic medicine and research.
• Existing consent models may need adaptation to meet the ethical demands of genomic technologies.