Ethical issues of cutting edge biotechnology: Embedded interdisciplinary risk benefit evaluation of first-in-human trials in synthetic biology and nanomedicine
Synthetic biology and nanotechnology are currently some of the most widely discussed examples of so-called “cutting edge biotechnology”. A very promising branch of research in nanotechnology and synthetic biology involves the translation of these technologies into new medical applications, which has the potential to improve human health significantly. Advances in synthetic biology and the nanosciences that address chronic but non-fatal diseases have now reached the preclinical testing stage. First-in-human (FIH) trials are the next important step before these applications can enter the clinic. However, the specific ethical issues that are raised by early phase trials involving synthetic biology and nanomedicine necessitate a reassessment of the traditional ethical framework of clinical research.
The objective of this research project is to generate in-depth understanding of various ethical issues related to FIH trials of cutting edge biotechnology by undertaking comprehensive, interdisciplinary empirical research. The ethical evaluation will take into account the perspectives of various stakeholders including ethicists, technology experts, and the technology-manufacturing industry, as well as patients and healthy volunteers in their role as potential trial participants. The focus will be on elaborating the risks and benefits of the research, which plays a crucial role in the process of ethical approval by research ethics committees (RECs).
A scheme for the ethical evaluation of early phase clinical research involving cutting edge biotechnology will be developed as a result of the analysis of the empirical data. This scheme is designed to assist researchers who plan FIH studies, funding agencies and REC members who evaluate them, patients who make decisions to participate or not in these trials, and finally, policy makers that have to decide whether and how to regulate such trials.