A/Prof. Wendy Lipworth1, Dr Tereza Hendl,1 Prof Ian Kerridge,1,2 Assistant Professor Tamra Lysaght3, A/Prof Megan Munsie4, Catherine Waldby5, Prof Cameron Stewart6
1Sydney Health Ethics, University Of Sydney, University Of Sydney, Australia, 2Royal North Shore Hospital, Sydney, Australia, 3Centre for Biomedical Ethics, National University of Singapore, Singapore, 4Centre for Stem Cell Systems, University of Melbourne, Melbourne, Australia, 5Research School of Social Sciences, ANU College of Arts and Social Sciences, Canberra, Australia, 6Sydney Law School, University of Sydney, Sydney, Australia
Background and Purpose: Clinical registries are databases that are used to monitor the “real world” outcomes of medical interventions. In recent years, the possibility of collecting registry data has been used to justify the introduction into practice of “unproven” uses of adult stem cells (e.g. to treat various degenerative diseases). While developing registries to gather data on unproven interventions may offer some value, there are signs that many of these registries have not been designed with the public interest in mind or to genuinely advance scientific knowledge. It is crucial, therefore, to find ways of distinguishing between legitimate registries and those that have been designed to serve the commercial interests of operators.
Method: We synthesised information about stem cell registries, examining their stated and implied purposes, methods and governance systems. We compared a well-established, publicly funded stem cell registry (the International Bone Marrow Transplant Registry) with smaller stem cell registries that are being established in the private sector.
Results: There are clear differences in how different registries are justified, managed, used and governed. Many privately funded registries are touted as alternatives—rather than as supplements—to robust clinical trials and are run in ways that are antithetical to the public interest and lack scientific rigour.
Discussion: Bioethicists need to focus on the impact of commercial imperatives on biomedical innovation so that a balance can be struck between promoting innovation and ensuring that that such innovation is beneficent and prudent.
Wendy Lipworth is an Associate Professor of Bioethics at Sydney Health Ethics, University of Sydney. Her research focuses on the ethics of biomedical innovation, with a particular focus on 1) research using collections of tissue and data; access to “unproven” interventions; and 3) the conduct and influence of industry and (financial and non-financial) conflict of interest.