The OMB Information Quality Guidelines require that "influential" scientific, financial, or statistical information in official Government documents must be based on studies that can be substantially reproduced if the original or supporting data were to be independently reanalyzed using the same methods. "Influential" when used in the phrase "influential scientific, financial, or statistical information" means that the NIH can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions, or will have important consequences for specific health practices, technologies, substances, products, or firms." NIH is committed to applying rigorous scientific standards to ensure the accuracy, reliability, and reproducibility of research results.
The reproducibility standard applies to analytic results and not necessarily to the original and supporting data used to produce the analytic results. To facilitate the replication of scientific and other influential information by qualified third parties, NIH continues to encourage the sharing of original data and methods where practicable. After publication, the research data, any unique reagents, and any supporting data that form the basis of any research communication should be made available promptly and completely to any person who seeks further information.
Since the influence and implications of NIH-disseminated information cannot always be fully anticipated, all NIH scientific reports are expected to state clearly how analytic results are generated -- the specific data used, various assumptions, specific analytic methods, statistical procedures, sources of error -- making the analysis sufficiently transparent so as to be capable of being reproduced. NIH advocates the archiving of data where feasible to facilitate the reproducibility of influential information. Exceptions may be necessary to maintain the confidentiality of clinical data or if unique materials were developed or obtained under agreements that preclude their dissemination. Investigators should retain research data long enough to allow replication of study results -- in general, 5 to 7 years. In situations where public access to underlying data is not practicable, NIH shall apply especially rigorous robustness checks to analytic results and document what checks were undertaken.
Examples of the types of information disseminated by NIH that have the potential of being considered influential and that fall within the scope of the OMB Guidelines include:
NIH Consensus Statements
NIH Research Reports
NIH Recommendations about Health Practice or Medical Treatment
NIH Funding for Research Areas of Interest
For scientific and technical documents, the scientific community recognizes peer review as the primary means of quality control. NIH routinely seeks input from qualified peer reviewers of influential materials for propriety, accuracy, completeness, and quality (including objectivity, utility, and integrity) prior to dissemination. Although concerted efforts are made to ensure that influential information be subjected to rigorous peer review and reproducibility specifications, standard operating procedures may be temporarily disrupted under urgent situations, such as when an imminent threat to public health or homeland security is identified.
With respect to health, safety, and environmental information, NIH does not have a mandate to conduct formal risk assessments, which are the purview of the appropriate Federal, State, and local health regulatory and research agencies (see Section V.2.iv). NIH makes every effort to ensure that the presentation and dissemination of information about environmental health is comprehensive, informative, and understandable, and that scientific conclusions are based on: (1) The best available science and supporting studies, particularly peer-reviewed studies, conducted in accordance with sound and objective scientific practices; and (2) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).