title: Raising the bar for reproducible science at the U.S. Environmental Protection Agency Office of Research and Development.
abstract: Considerable concern has been raised regarding research reproducibility both within and outside the scientific community. Several factors possibly contribute to a lack of reproducibility, including a failure to adequately employ statistical considerations during study design, bias in sample selection or subject recruitment, errors in developing data inclusion/exclusion criteria, and flawed statistical analysis. To address some of these issues, several publishers have developed checklists that authors must complete. Others have either enhanced statistical expertise on existing editorial boards, or formed distinct statistics editorial boards. Although the U.S. Environmental Protection Agency, Office of Research and Development, already has a strong Quality Assurance Program, an initiative was undertaken to further strengthen statistics consideration and other factors in study design and also to ensure these same factors are evaluated during the review and approval of study protocols. To raise awareness of the importance of statistical issues and provide a forum for robust discussion, a Community of Practice for Statistics was formed in January 2014. In addition, three working groups were established to develop a series of questions or criteria that should be considered when designing or reviewing experimental, observational, or modeling focused research. This article describes the process used to develop these study design guidance documents, their contents, how they are being employed by the Agency's research enterprise, and expected benefits to Agency science. The process and guidance documents presented here may be of utility for any research enterprise interested in enhancing the reproducibility of its science.
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882.
authors: Barbara Jane
authors: BJ
authors: George
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882.
authors: Jon R
authors: JR
authors: Sobus
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882.
authors: Lara P
authors: LP
authors: Phelps
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882.
authors: Brenda
authors: B
authors: Rashleigh
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882.
authors: Jane Ellen
authors: JE
authors: Simmons
authors: *US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory; US Environmental Protection Agency, Office of Research and Development, National Exposure Research Laboratory; US Environmental Protection Agency, Office of Research and Development, Office of the Science Advisor, Research Triangle Park, North Carolina 27711; and US Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Narragansett, Rhode Island 02882 hines.ronald@epa.gov.
authors: Ronald N
authors: RN
authors: Hines
mesh_terms: D015203:Reproducibility of Results; D012106:Research / Q000592:standards*; D014481:United States; D014484:United States Environmental Protection Agency