title: Increasing value and reducing waste in biomedical research regulation and management.
abstract: After identification 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 justified in the interests of patients and the public, but they can actually compromise these interests. Inefficient 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 questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their influence to reduce other causes of waste and inefficiency in research. Second, regulators and policy makers should work with researchers, patients, and health professionals to streamline and harmonise the laws, regulations, guidelines, and processes that govern whether and how research can be done, and ensure that they are proportionate to the plausible risks associated with the research. Third, researchers and research managers should increase the efficiency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce inefficiencies, and further research should be done to learn how efficiency can be increased. Finally, everyone, particularly those responsible for health-care systems, should promote integration of research into everyday clinical practice. Regulators and researchers should monitor adherence to each of these recommendations and publish metrics.
authors.affiliation: Division of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK. Electronic address: rustam.al-shahi@ed.ac.uk.
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
authors.affiliation: Centre for Research in Evidence-Based Practice, Bond University, Robina, QLD, Australia.
authors.forename: Elaine
authors.initials: E
authors.lastname: Beller
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kagan
authors.affiliation: National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Elina
authors.initials: E
authors.lastname: Hemminki
authors.affiliation: Centre for Reviews and Dissemination, University of York, York, UK.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Phillips
authors.affiliation: Oxford Centre for Neuroethics, University of Oxford, Oxford, UK.
authors.forename: Julian
authors.initials: J
authors.lastname: Savulescu
authors.affiliation: Division of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Macleod
authors.affiliation: Health Research Authority, London, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Wisely
authors.affiliation: James Lind Initiative, Oxford, UK.
authors.forename: Iain
authors.initials: I
authors.lastname: Chalmers
mesh_terms: D001675:Bioethics; D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D012107:Research Design / Q000592:standards