CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each (...) stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

The philosopher Henry Richardson's short book is a defense of a position on a neglected topic in medical research ethics. Clinical research ethics has been a longstanding area of study, dating back to the aftermath of the Nazi death-camp doctors and the Tuskegee syphilis study. Most ethical regulations and institutions have developed in response to those past abuses, including the stress on obtaining informed consent from the subject. Richardson points out that that these ethical regulations do not address one of (...) the key dilemmas faced by medical researchers -- whether or not they have obligations towards subjects who need care not directly related to the purpose of the study, termed 'ancillary care obligation'. (shrink)

:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues (...) about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)