Genetics and Ethics

5.

Governance and Regulation

5.1.

National Laws and Policies

5.1.1.

Genetic Information Nondiscrimination Act

5.1.1.1.

Scope and Limitations

5.1.1.2.

Enforcement and Compliance

5.1.1.3.

Gaps in Protection

5.1.2.

Data Protection Regulations

5.1.2.1.

General Data Protection Regulation

5.1.2.2.

Health Insurance Portability and Accountability Act

5.1.2.3.

National Variations

5.1.3.

National Bioethics Advisory Bodies

5.1.3.1.

Structure and Function

5.1.3.2.

Role in Policy Development

5.1.3.3.

Advisory vs. Regulatory Functions

5.1.4.

Research Regulations

5.1.5.

Clinical Practice Guidelines

5.2.

International Frameworks and Guidelines

5.2.1.

UNESCO Declarations on the Human Genome

5.2.1.1.

Universal Declaration on the Human Genome and Human Rights

5.2.1.2.

Implementation Challenges

5.2.1.3.

Enforcement Mechanisms

5.2.2.

Council of Europe's Oviedo Convention

5.2.2.1.

5.2.2.2.

Ratification and Enforcement

5.2.2.3.

Additional Protocols

5.2.3.

World Health Organization Recommendations

5.2.3.1.

Global Standards

5.2.3.2.

Capacity Building

5.2.3.3.

Technical Guidance

5.2.4.

International Summit on Human Gene Editing

5.3.

Oversight of Research and Clinical Practice

5.3.1.

Institutional Review Boards

5.3.1.1.

Review Processes

5.3.1.2.

Ethical Safeguards

5.3.1.3.

Continuing Review

5.3.2.

Embryo Research Oversight Committees

5.3.2.1.

Regulation of Embryo Research

5.3.2.2.

Ethical Review Criteria

5.3.2.3.

Time Limits and Restrictions

5.3.3.

Regulation of Clinical Laboratories

5.3.3.1.

Clinical Laboratory Improvement Amendments

5.3.3.2.

Quality Assurance and Accreditation

5.3.3.3.

Proficiency Testing

5.3.4.

Gene Therapy Oversight

5.3.5.

Clinical Trial Regulations

5.4.

Intellectual Property and Patenting

5.4.1.

Patenting Genes and DNA Sequences

5.4.1.1.

Legal Precedents

5.4.1.2.

Ethical Debates

5.4.1.3.

Myriad Genetics Case

5.4.2.

Patenting Life Forms and Genetically Modified Organisms

5.4.2.1.

Scope and Limitations

5.4.2.2.

Impact on Innovation

5.4.2.3.

Chakrabarty Case

5.4.3.

Impact on Research and Access to Technology

5.4.3.1.

Barriers to Research

5.4.3.2.

Access to Diagnostic Tests and Therapies

5.4.3.3.

Licensing Practices

5.4.4.

Traditional Knowledge and Biopiracy

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6. Social and Cultural Context