The International Commission on the Clinical use of Heritable Human Genome Editing has proposed the following set of strict preclinical and clinical criteria that would need to be fulfilled before considering heritable human genome editing as safe and effective:
1. Rigorous assessment of the safety and efficacy of the genome editing technology in preclinical studies using appropriate animal models.
2. Demonstration of precise and specific genome editing with minimal off-target effects.
3. Comprehensive evaluation of potential unintended consequences of genome editing, such as the induction of mutations or genetic abnormalities.
4. Consideration of the ethical, social, and cultural implications of heritable human genome editing, including potential risks and benefits to individuals and society.
5. Informed consent and participation of all individuals involved in the process, including parents, donors, and any resulting offspring.
6. Commitment to transparency and open communication with the public and regulatory authorities throughout the research and development process.
7. Adherence to national and international guidelines and regulations governing human research, including those related to genetic manipulation and human reproduction.
8. Continuous monitoring and evaluation of the long-term effects of heritable human genome editing on individuals and future generations.
These criteria are intended to ensure that any clinical applications of heritable human genome editing are conducted with the highest standards of safety, ethics, and social responsibility.
what are the International Commission on the Clinical use of Heritble Human Genome Editing proposed set of strict preclinical and clinical criteria that would need to be fulfilled before considering heritable human genome editing as safe and effective.
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