Data

Abstract

This question (to share or to not share data) was the topic of the Changing Face Hof Epidemiology symposium at the 2008 Annual Meeting of the Society for Epidemiological Research. The 2 presenters, Daniel Levy and Graham Colditz, offered their perspectives based on years of experience as principal investigators for the Framing ham Study and the Nurses' Health Study, respectively. Both studies are unique for the richness of the data collected, for the duration of follow-up, and for the myriad hypotheses still to be tested using their data; both are supported by the National Institutes of Health (NIH) and are costly. The approaches taken for data sharing, as described by Levy and Colditz, differed. For the Framingham study, there has long been data sharing via public use data sets whereas the Nurses' Health Study has required the submission of a proposal for review by the Principal Investigator and subsequently by the study's Advisory Committee. Levy was firm in calling for open access to data collected with public funds, as long as confidentiality and privacy of data are maintained. Colditz spoke to the realities of data sharing-the need for infrastructure, the varied approaches to data sharing issues by Institutional Review Boards, and the competing interests of study investigators and their students with those seeking data access. In this commentary, I broaden the discussion to issues that inevitably come as we enter the era of data sharing: (1) the definition of the data that are to be shared; (2) the need to develop a culture of data sharing in epidemiology; (3) the consequences of data sharing for epidemiology (as fewer new population studies are supported); and (4) the implica tions of data sharing for students and researchers. First, regarding the rhetorical question posed in the title of this commentary-yes, share. Regardless of whether epidemiologists want to share data, the era of data sharing has arrived. One historical landmark was the Amendment, a 1-sentence amend ment inserted into the 1998 appropriations bill. The Shelby Amendment led to changes in the Office of Management and Budget's Circular AI 10 governing research such that data collected with federal funds and cited in a regulation have to be made available if requested under the Freedom of Information Act. The Shelby Amendment was prompted by the reliance of the Environmental Protection Agency on data from the Harvard Six Cities Study and the American Cancer Society's Cancer Prevention Study II in setting the 1997 National Ambient Air Quality Standard for particulate matter. Industrial stakehold ers argued that the data should be available for analysis by affected parties because of the