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Genome Editing Criteria Outlined in New Report

By Kenny Walter | February 15, 2017

A new report highlights the need to move forward with genome editing, while also ensuring there is strict oversight.

Genome editing to treat or prevent diseases or disabilities could become a reality, despite some ethical concerns.

A new report has highlighted the need for clinical trials for genome editing of the human germline by adding, removing or replacing DNA base pairs in gametes or early embryos— but only for serious conditions under strict oversight.

The joint report from the National Academy of Sciences and the National Academy of Medicine outlines several criteria that should be met before allowing genome editing clinical trials to move forward.

According to the report, these editing tools could one day be used on human embryos, eggs and sperm to remove the genes that can cause inherited diseases.

The report recommends a set of overarching principals to be used by any nation in governing human genome editing research or applications, including providing a benefit and preventing harm to those affected, transparency, due care, responsible science, respect for persons, fairness and transnational cooperation.

While genome editing is not new, more powerful, precise and less costly genome editing tools like CRISPR/Cas9, have paved the way for a bevy of new research opportunities and potential clinical applications—both heritable and non-heritable—to address a wide range of human health issues.

While the report warns of the ethical issues involving this type of science, it also states that genome editing deserves some serious consideration.

Human genome editing is widely used in basic research, but is in the early stages of developments and trials for clinical applications that involve non-heritable cells.

This type of therapy affects only the patient and not any offspring.

However, there is significant public concern over the prospect of using the same techniques for “enhancement” of human traits and capacities such as physical strength or even for uses that are not currently possible, including improving intelligence.

The report recommends that genome editing for enhancement should not currently be allowed and that public input and discussion should be solicited before allowing clinical trials for somatic genome editing for any purpose other than treating or preventing disease or disability.

“Human genome editing holds tremendous promise for understanding, treating, or preventing many devastating genetic diseases, and for improving treatment of many other illnesses,” Alta Charo, co-chair of the study committee and Sheldon B. Lubar Distinguished Chair and Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin-Madison, said in a statement.

“However, genome editing to enhance traits or abilities beyond ordinary health raises concerns about whether the benefits can outweigh the risks, and about fairness if available only to some people,” she added.

Germline genome editing has become contentious because genetic changes would be inherited by the next generation and many view it as crossing an “ethically inviolable” line, according to the report.

There are concerns including spiritual objections to interfering with human reproduction to speculation about effects on social attitude toward people with disabilities to possible risks to the health and safety of future children.

However, germline genome editing could provide parents who are carriers of genetic diseases with their best or most acceptable option for having genetically related children who are born free of these diseases.

“Genome editing research is very much an international endeavor, and all nations should ensure that any potential clinical applications reflect societal values and be subject to appropriate oversight and regulation,” committee co-chair Richard Hynes, Howard Hughes Medical Institute Investigator and Daniel K. Ludwig Professor for Cancer Research, Massachusetts Institute of Technology, said in a statement. “These overarching principles and the responsibilities that flow from them should be reflected in each nation’s scientific community and regulatory processes.”

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