Abstract

Ethical Challenges in Translating ATMPs for Orthopedic Disorders into Clinical Trials and Society

Sophie Niemansburg, PhD Student, University Medical Center Utrecht

ATMPs are likely to change the field of orthopedics considerably. The debate about the ethical issues of translating these innovative interventions from bench to bedside is developing. However, no empirical studies have systematically described the attitudes, opinions, and experiences of professionals in the field of orthopedic RM concerning these challenges. By means of in-depth qualitative interviews this study aimed to identify the attitudes, opinions and expectations of biomedical professionals, mainly basic scientists and surgeons, in the area of Regenerative Medicine for musculoskeletal disorders on the ethical issues of translating these into (early) clinical studies and society. Four ethical themes on the issues of the translation into clinical studies emerged from the interview data; the risks to study participants; the appropriate selection of study participants; setting relevant goal(s) for measuring outcome; and the need for evidence-based medicine and scientific integrity, which is considered challenging in orthopedics. Furthermore, three themes of societal impacts emerged: the counteraction of ageing, prevention of disease, and social justice. The overall attitude toward the development of ATMPs in the orthopedic field was positive. However, efforts should be taken to adequately address the ethical and scientific issues in the translation of RM interventions into clinical research and society. This is required to prevent unnecessary risks to study participants, to prevent exposure of future patients to useless clinical applications, as well as to prevent this young field from developing a negative reputation. Furthermore, we recommend to include surgeons in an early stage of the technology development as they are aware of the societal impacts and, in response, can co-shape the technology.