Christiane Druml, Bioethics
e-mail: christiane [dot] drumlrud [dot] lbg [dot] ac [dot] at
website: UNESCO Chair on Bioethics
Rare diseases research poses various ethical and societal issues that will be thoroughly investigated by the LBI-RUD Bioethics research group under the leadership of Christiane Druml. We will conduct a dedicated research program on ethical, legal, social and political aspects of rare diseases in Austria and beyond. The full integration of ethics research into the LBI-RUD research program follows the principles of “Responsible Research and Innovation” (RRI), as put forward by the European Commission to ensure that ethical and societal issues become an integral part of research and innovation processes.
Ethical aspects of rare diseases research include adequate informed consent procedures, protection of vulnerable patient groups like children, ressource allocation, data sharing, and others. Moving beyond ethics Christiane Druml and Paul Just as part of the LBI-RUD Bioethics research group will investigate broader social and political issues of rare diseases including economic aspects, or the role of patient advocacy groups.
Challenges of rare diseases
Due to the low number of cases, the rights and expectations of rare disease patients may be undermined as research and available treatment options focus on more common diseases such as atherosclerosis or diabetes. This problem is further aggravated by exceptionally high prices for the relatively few rare disease drugs. We will develop a qualitative framework that helps to detect and overcome structural discrimination of rare disease patients in health economics and comparative effectiveness research.
Secure data sharing constitutes another challenge of rare disease research, which often involves genetic approaches, and may require sharing of patient data with other research institutes located in different national and regulatory contexts. Furthermore, the merits of data sharing may conflict with privacy concerns and competitive reasons. We seek to enrich the ethical debate with empirical findings and patients’ interests by conducting qualitative social scientific research in order to establish state-of-the-art, integrative approaches for rare diseases research.
Handbook on ethical, legal and societal aspects (ELSA) of rare diseases
We will develop guidelines and publish a handbook that provides concrete and practical guidance for people, who are directly or indirectly affected by rare or undiagnosed diseases such as patients or family members, clinicians, researchers, policy makers and regulators, as well as the public in Austria and beyond. Following RRI principles we will engage with a broad public by organizing public events, and will provide a platform for rare diseases in Austria in close collaboration with patients’ organizations like Pro Rare, EURORDIS, Orphanet and others.
Photo Credit - Josephinum