Human gene therapy: ethics and public policy.

Area of Science:

• Biomedical Ethics
• Gene Therapy
• Genetic Engineering

Background:

• The Recombinant DNA Advisory Committee (RAC) developed a "Points to Consider" document to evaluate genetic intervention protocols.
• Public surveys reveal limited knowledge of genetic engineering but acceptance of somatic-cell gene therapy for treating diseases.
• International policy statements affirm the ethical legitimacy of somatic-cell gene therapy for disease cure.

Purpose of the Study:

• To report on the initiation of the first human gene transfer/therapy clinical protocols.
• To highlight the established review process for genetic interventions.
• To advocate for a formal public ethical assessment of germ-line genetic intervention.

Main Methods:

• Extensive review process by the Recombinant DNA Advisory Committee (RAC) and its Human Gene Therapy Subcommittee.
• Development and application of the "Points to Consider" document for protocol evaluation.
• Analysis of public attitude surveys and international policy statements regarding gene therapy.

Main Results:

• Three human gene transfer/therapy clinical protocols have commenced.
• The RAC's review framework has been established and applied.
• A societal consensus supports somatic-cell gene therapy, while germ-line intervention requires further ethical deliberation.

Conclusions:

• The initiation of human gene therapy trials marks a significant advancement.
• The ethical debate surrounding gene therapy has matured, particularly for somatic-cell applications.
• A formal public discourse on the ethics of germ-line genetic intervention is now warranted.