Decisions about Gain-of-function Research: Who Bears the Burden of Proof?
Harvey Fineberg, Institute of Medicine, Washington
Speech at the Herrenhausen Symposium "Dual Use Research on Microbes: Biosafety, Biosecurity, Responsibility", 10.12.2014
In his talk, Harvey Fineberg describes a recent fundamental shift in US policy on dual use research on microbes. In the summer of 2014 three lapses in biosafety became public and caused the U.S. government to temporarily halt its funding for dual use research on certain kinds of organisms. This decision represents a fundamental shift: In the past, the burden of proof whether research or the publication of research results was too high a risk, lay with the regulating body, i.e. mainly the government. The halting of funding turned this around. Now the researchers and the research institutions have the burden of proof to show that the benefits of going forward with their research outweigh the risks. In his talk, Fineberg lays out the challenges to reaching informed, sensible, acceptable, and appropriate solutions. He emphasizes that the words in which we frame the problems already influence the issues we raise and the answers we might give. Fineberg describes what a discussion about this kind of risk-benefit analysis could look like and who needs to be involved. Fineberg served two consecutive terms as President of the Institute of Medicine of the National Academy of Sciences in the USA (2002-2014). He served as Provost of Harvard University from 1997 to 2001, following thirteen years as Dean of the Harvard School of Public Health. His past research has focused on the process of policy development and implementation, assessment of medical technology, evaluation and use of vaccines, and dissemination of medical innovations. Dr. Fineberg helped found and served as president of the Society for Medical Decision Making and has been a consultant to the World Health Organization.
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