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In February 2017, a significant report was released, outlining the potential path for clinical trials of heritable genome editing. Led by bioethicist Alta Charo and approved by National Academies of Science president Ralph Cicerone, the report concluded that while some trials could be allowed to proceed, strict conditions would be necessary.
The report emphasized that "enrichment," or the creation of designer babies, should not be permitted in clinical trials at this time. The focus is on alleviating a vast range of illnesses, such as diabetes, sickle-cell anemia, Alzheimer's, autism, muscular dystrophy, hemophilia, cancer, and even H.I.V., using cutting-edge human genetic engineering.
However, the risks of edits to DNA in reproductive cells, or "germline" editing, differ fundamentally from "somatic" edits inside a living organism. The changes would be permanent and passed to all descendants, making the stakes significantly higher.
The report's recommendations are primarily shaped by ethical, scientific, and regulatory frameworks developed by international bodies like the World Health Organization (WHO). These standards prioritize robust ethical oversight, rigorous review and approval by research ethics committees, transparency, and governance mechanisms at various levels to ensure responsible conduct of such trials.
The WHO has established an Expert Advisory Committee to ensure clinical studies are reviewed and approved by appropriate ethics committees before being registered. They also aim to develop assessment mechanisms to identify trials with potential ethical concerns, create and maintain international standards for clinical trials registry concerning human genome editing, and promote transparency and ethical oversight.
Enforcement of these standards depends on national regulatory agencies and institutional review boards following international guidelines. There is no single global enforcement agency, but the WHO’s framework aims to influence member states to adopt harmonized policies. Enforcement relies on national regulatory bodies approving and overseeing clinical trials, institutional ethics committees conducting prior ethical review, global registries for transparency on clinical trials, and ongoing monitoring and reporting requirements.
Despite these standards, heritable genome editing clinical trials remain rare and highly regulated due to ethical concerns over germline modification. The focus is on governance rather than widespread clinical application, given the profound ethical and social implications.
Recent developments in the field have sparked ethical debates. In September 2018, researchers from an American biotech company announced the preliminary results of the first-ever clinical trial to edit the genes of a living person using a CRISPR-like technique. The embryos in the study were destroyed after a few days, as required by federal law.
In December 2018, Chinese scientist He Jiankui announced the birth of the world's first "designer babies" equipped with genes tailored to make them resistant to HIV, sparking an immediate backlash from biologists around the world. This incident underscores the need for strict adherence to the established global standards.
As the global ethical reckoning on human gene editing continues, leading CRISPR scientists have called for a global moratorium on clinical trials of heritable genome editing. The WHO, U.S. National Academy of Sciences, China's Academy of Sciences, and other scientific authorities are currently assembling international committees to weigh the future of human gene editing.
In summary, the global standards for clinical trials of heritable genome editing are established through WHO-led international ethical and governance frameworks, enforced primarily by national regulatory and ethics bodies, with a strong emphasis on transparency, rigorous review, and ethical safeguards. The ongoing debates and developments in the field underscore the importance of these standards in ensuring responsible and ethical conduct in human gene editing research.
- The global community is actively engaged in discussions about social justice with regards to the potential for clinical trials of heritable genome editing.
- A significant magazine article discussed a report released in February 2017, emphasizing the need for strict conditions for such trials due to ethical, scientific, and regulatory considerations.
- The Non-profit World Health Organization (WHO) plays a crucial role in shaping recommendations for human genome editing clinical trials.
- The WHO's focus is on establishing assessment mechanisms, international standards for clinical trials registry, and promoting transparency and ethical oversight.
- Science, particularly environmental science and medical-health-wellness, plays a vital role in understanding the implications of heritable genome editing.
- Fossil fuels and climate change, topics in science and finance, are areas where addressing ethical concerns is necessary for responsible development.
- Aside from science, culture, art, and lifestyle also impact the discourse on genome editing, reflecting societal values and attitudes.
- Business and technology sectors must consider the ethical implications of heritable genome editing, ensuring that investments in this field align with societal values.
- The education-and-self-development sector has a crucial role in understanding and informing about the potential risks and benefits of heritable genome editing.
- The sports industry, like casino-and-gambling, should be aware of the ethical implications and be transparent in engaging with technology like CRISPR, which has sparked debates in the field.
- Lastly, the weather, an aspect of the environment, must also be taken into account as it could potentially impact the outcomes of heritable genome editing clinical trials.