Principles and Obstacles for Sharing Data from Environmental Health Research Workshop Summary (2016) / Chapter Skim
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2 Current Approaches and Weaknesses of Those Approaches
2 Current Approaches and Weaknesses of Those Approaches
Pages 5-28
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After the summary of the presentations, relevant discussions from sessions from throughout the day1 are described. The second part of the chapter summarizes the presentations that described current approaches to the sharing of environmental health data by federal agencies and identified the weaknesses and shortcomings of these approaches.
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"Most of us, when we are doing systematic reviews, are more convinced that something is going on when we see reproducibility as well as replicability." Different Meanings of "Data" During Session 2, Bernard Lo, president and chief executive officer of The Greenwall Foundation, noted that there are a number of different types of data. There are raw data, which come straight from the survey or the experiment.
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When in tthe study process shou uld certain data d be shareed and how?
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The Electronic Freedom of Information Act Amendments of 19964 require agencies to release electronic copies of documents that have been previously requested and 2 The Committee on Strategies for Responsible Sharing of Clinical Trial Data released its final report in January 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk is available at www.nap.edu/catalog/18998.
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The Shelby Amendment was enacted in response to concerns about a desire to reanalyze two studies, the Harvard Six Cities Study (Dockery et al., 1993) and the American Cancer Society Study (Pope et al., 1995)
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. For an agency's rule to be upheld on judicial review, the agency must have placed in the administrative record all of the information that the agency relied upon to reach its decision -- a requirement known as the "Portland Cement doctrine."7 "The E-Government Act makes it a little easier," Verkuil said, "because you can post rules online and you can use regulations.gov to find out what else has been posted by other commenters." Sometimes, however, there can be problems with paperbased comments, Verkuil said.
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Executive Branch Guidance More generally, the executive branch puts forward a variety of policies regarding data sharing. George Gray, director of the Center for Risk Science and Public Health at the Milken Institute School of Public Health at George Washington University, described some of the more relevant policies during his presentation.
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• It also exempts confidential business information or other information that needs to be confidential, but only until the data are published in a journal or cited by an agency in support of its action. One of the things that is interesting about the circular, Gray said, is that rather than applying to research that is done within the federal government, it applies to grants and agreements that are made by the government with institutions of higher education, hospitals, and other nonprofits.
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"Again, this is the exhortation to more data sharing, more openness in the way things are done." • "Scientific research supported by the federal government catalyzes innovative breakthroughs that drive our economy. The results of that research become the grist for new insights and are assets for progress in areas such as health, energy, the environment, agriculture, and national security" (Executive Office of the President, 2013)
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The Limits to Data-Sharing Requirements Given that the federal government requires researchers to share data that have been collected through the use of federal funds, several workshop participants raised the issue of just how far that requirement extends. Does it extend to any research project that has accepted any federal funds for any aspect of the project?
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But I do not know how you go beyond that." Linda Birnbaum, director of NIEHS of NIH, offered as an example a project in which NIEHS funded a small piece of an analysis of some data that had been collected by Norwegian investigators. "It is often unclear to us, even given the Shelby Amendment, whether that data has to be provided upon FOIA or not," she said.
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16 PRINCIPLES AND OBSTACLES FOR SHARING DATA suppose that study in Norway is one of two studies worldwide that have found an effect that the agency is trying to characterize and think about regulating. Is there a different legal standard there?
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U.S. Environmental Protection Agency Goldman spoke about EPA's experience with data sharing under the Information Quality Act (IQA)
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However, EPA ruled that the data needed to be made available pursuant to the Shelby Amendment because of the fact that some federal funding had been made available for doing this systematic review." There were a few other factors as well, Goldman said, such as the fact that the battery manufacturers were suing EPA about the National Ambient Air Quality Standards, and EPA did not want to act until the lawsuit was settled. "But at the end of the day," she said, "EPA prevailed upon Cincinnati Children's Medical Center, and Bruce's hard drive was taken and provided to EPA." Currently, Goldman continued, there is a new request for EPA to release raw data from the Harvard Six Cities Study and the American Cancer Society Study.
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Overall, he said, "Scientific data developed with taxpayer dollars by taxpayer-supported scientists should be shared with data requestors unless there is a strong countervailing interest that can be articulated [and] that supports a decision to withhold data in a manner that prevents data reanalysis." In short, the sharing of data should be the default position, and if it is not feasible to share all of the data -- for instance, because of privacy concerns -- then one should share as many of the data as possible.
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"While they are somewhat popular," he said, "they do not provide particularly strong protections for sensitive, potentially identifying data provided to data analyzers because it is difficult to monitor and it is difficult to enforce specified restrictions on data use. Recognizing these limitations, we found that data use agreements need to clearly state what happens in the case of nonadherence." Lesson four is that secure enclaves can protect the confidentiality of highly sensitive and potentially identifying data sets while providing access for analysis that is maximally useful.
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It collects health and health care data in such surveys as the National Health Interview Study and the National Health and Nutrition Examination Survey, it coordinates and collates data concerning births and deaths in the United States, and so on. "All of that is extremely important," Sondik said, "but if we put it in a safe, it does absolutely no good at all." Thus, the center's prime directive includes not only the collection of data but also the dissemination of the information that it collects.
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"It is interesting. You have two federal statistical agencies taking different strategies." Given the potential effects of reidentification on individuals and the possibility that such risks could keep people from taking part in environmental health studies, Sondik suggested that the effects of disclosure should also be discussed in terms of the ability to carry out research in this area.
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For instance, NIH is developing a mandatory training module on the responsible conduct of research that will be given to NIH-funded trainees, both intramural and extramural, and the various institutes and centers at NIH are developing checklists to ensure the more systematic evaluation of grant applications. Pilot programs are also being run to assess the value of such things as cross-reviewing panels.
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just generally available." These data centers are secure facilities where researchers carry out analyses on the data that are kept there. The centers provide various statistical packages for the researchers to use.
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They want to see data sharing there." Information Concerning Data Collection and Analysis In Session 2, Collman noted that many of the difficulties in reproducing studies are related to the methods used and simply sharing data will do little to help. The scientific papers that describe a study often have relatively short methods sections that are not very detailed, and
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Which ones will we not rely upon? All of those can ultimately have an influence on the end product, especially if the end product is something quantitative, like a national ambient air quality standard or a reference dose in EPA's integrated risk information system." Thus, it is crucial when sharing data to also share how those data were used in coming to a particular conclusion.
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2014. Discussion framework for clinical trial data sharing: Guiding principles, elements, and activities.
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