CRISPR AND GERMLINE EDITING CLINICAL TRIALS

Abstract

This paper examines the conditions under which it is ethical to engage in first-in-human germline genome editing (GGE) clinical trials. GGE refers to the editing of the genome of sperm, egg or embryo. The focus is on GGE because it is more ethically controversial as opposed to the editing of the somatic cell genome, because of the heritable genetic changes that GGE makes, and that somatic cell therapy can be regulated using the established ethical norms developed for gene therapy. While there are many articles and reports examining the ethics of GGE in general, they have not specifically examined how the arguments play out during the review process of GGE clinical trials. The examination of how reviewing bodies should review the ethics of GGE is important because no GGE could be used clinically without going through a clinical trial. Focusing on the clinical trial also allows one to distinguish which arguments, especially those concerning safety and efficacy, are concerned with the risk as the technology currently stands, and which arguments go beyond such concerns. The paper is divided into 3 parts. In the first part, CRISPR and how it works will be briefly described. Although there are other methods of making precise genome modifications through the use of Zinc Finger Nuclease (ZFNs) or Transcription activator-like effector nucleases (TALENs), the “low-costs”, “ease in use”, and “efficiency” of CRISPR means that engaging in GGE is more practicable. This is similar to the shift from large mainframe computers to personal computers which democratized computing. Hence, the paper focuses on CRISPR. Part 2 describes the law governing GGE in Singapore. Part 3 proposes a framework to assess whether a proposed GGE clinical trial is ethical, and discusses which actors should be responsible for applying the framework.