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Increasing Value And Reducing Waste In Biomedical Research Regulations And Management, Rustam Salman, Elaine Beller, Jonathan Kagan, Elina Hemminki, Robert Phillips, Julian Savulescu, Malcolm Macleod, Janet Wisely, Iain Chalmers

Elaine Beller

After identifi cation of an important research question and selection of an appropriate study design, waste can arise from the regulation, governance, and management of biomedical research. Obtaining regulatory and governance approval has become increasingly burdensome and disproportionate to the conceivable risks to research participants. Regulation and governance involve interventions that are assumed to be justifi ed in the interests of patients and the public, but they can actually compromise these interests. Ineffi cient management of the procedural conduct of research is wasteful, especially if it results in poor recruitment and retention of participants in well designed studies addressing important …