Fall 2016: Gene Editing

Science & Engineering

Brave New Technology: Brave New Babies

Eileen Smith Ewing

A column from the 2016–2017 Chair of the Section of Science & Technology Law.

Biotechnology

U.S. Regulatory Challenges for Gene Editing

Regulation of somatic gene editing in the United States generally involves review and approval from the NIH Recombinant DNA Advisory Committee, an institutional review board, and the FDA. In contrast, germline gene editing, though not prohibited by federal law, raises ethical and legal issues that may be addressed by embryonic research laws and policy.

Biotechnology

Legal Risks and Liabilities of Human Gene Editing

Human gene editing may create unintended adverse effects, resulting in potential liability to a variety of parties under a diverse range of causes of action, including malpractice, products liability, and wrongful birth/life.

Science & Engineering

Science in the World of Gene Editing and Gene Therapy

An introduction to the history and science of gene editing and gene therapy, with a focus on CRISPR technology and its application to somatic and embryonic gene modification.

Ethics

The Evolving Ethics Challenge in Genomic Science

Assessing the risks of genetic manipulation requires careful, evidence-based analysis of ethical, legal, and social implications, without letting our human-centrism blind us to the benefits of gene editing technology.

Ethics

CRISPR Lit the Fire: Ethics Must Drive Regulation of Germline Engineering

Regulation of germline engineering must first address the potential inheritable risks. Even where the benefits seemingly outweigh the risks, consideration should be given to other factors such as availability of treatment (both geographically and financially) and how far we are willing to shift the baseline of health.

Government

The Regulation of Gene Editing in the United Kingdom

The U.K. regulatory framework for somatic and embryonic gene editing, which operates to protect patients from unregulated, untested treatments and ensures that both researchers and clinics are licensed and regularly inspected, serves as a blueprint for other countries.