Research on Emerging Biotechnologies

Abstract

Abstract This chapter explores ethical and policy issues common to research on emerging biotechnologies, focusing in particular on two broad categories: gene addition and gene editing research and stem cell–based intervention and regenerative medicine research. The issues addressed include the relationship between science and ethics in trial design, informed consent, and the therapeutic misconception in early-stage research with patient-subjects; treatment versus enhancement; questions of cost, access, and justice; and governance challenges. The chapter considers some ethical questions that only novel biotechnologies may raise, such as germline effects and enhancement, but the primary focus is on key research ethics issues common to most contemporary human research and how these issues manifest in all the novel biotechnologies considered herein. The chapter concludes with observations calculated to assist researchers, clinicians, and the public in understanding and discussing both the potential and the realities involved in rapidly developing areas of biotechnology research, in order to achieve a reasonable balance between fostering research progress and ensuring the safety and effectiveness of new biotechnological treatments.