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

SUBMITTER: Al-Shahi Salman R 

PROVIDER: S-EPMC3952153 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature