Increasing value and reducing waste in biomedical research regulation and management
Al-Shahi Salman R., Beller E., Kagan J., Hemminki E., Phillips RS., Savulescu J., Macleod M., Wisely J., Chalmers I.
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 questions. These sources of waste can be minimised if the following four recommendations are addressed. First, regulators should use their infl uence to reduce other causes of waste and ineffi ciency 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 effi ciency of recruitment, retention, data monitoring, and data sharing in research through use of research designs known to reduce ineffi ciencies, and further research should be done to learn how effi ciency 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.