The First Amendment Right to Speak About the Human Genome

Area of Science:

• Bioethics
• Constitutional Law
• Genetics

Background:

• Current laws may restrict sharing genetic test results from research settings.
• The Clinical Laboratory Improvement Amendments of 1988 (CLIA) govern laboratory standards.
• Research participants may request their genetic test results.

Purpose of the Study:

• To explore potential First Amendment violations by laws restricting genetic test result communication.
• To determine if investigators have a right to return results from non-CLIA-certified labs to willing participants.
• To assess if bioethical debates adequately consider First Amendment implications.

Main Methods:

• Survey of state and federal laws impacting genetic test result communication.
• Analysis of historical use of speech restrictions in human research protection.
• Tracing the evolution of First Amendment doctrine in research bioethics.
• Application of textual and constitutional legal analysis.

Main Results:

• CLIA regulations, when interpreted correctly, do not mandate certification for returning results.
• Potential First Amendment issues arise from interpretations that ban returning results from non-CLIA-certified labs.
• Existing laws may unduly restrict the communication of genetic information.

Conclusions:

• Investigators may possess a First Amendment right to share genetic test results with research participants.
• Construing CLIA's research exception to ban result return may infringe upon constitutional rights.
• Further consideration of First Amendment principles is needed in bioethics and policy regarding genetic research.