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Balancing Data Control with Data Sharing As seen in the previous section, access to research data is controlled by the

institution and principal investigator. At the same time, however, the very nature of research requires that research data be shared. This may seem like a dichotomy, but it really is not. Rather, there is a balance between control and access that generally falls within the purview of the researcher. This need for balance can also frequently be found in the negotiation of sponsored projects. For instance, negotiators are aware that they must protect the researcher’s academic freedom and right to publish the results of his/her research. At the same time, rights to inventions in countries other than the U.S. can be destroyed if publication occurs prior to the submission of a patent application. Indeed U.S. invention rights can be destroyed if a public disclosure of the invention occurs more than a year before the submission of a U.S. patent application. Therefore, negotiators and researchers must balance the need to protect intellectual property rights and interests with provisions that preserve the institution’s and researcher’s academic freedom. Once the award is made and the project is underway, universities and other nonprofit institutions usually retain ownership of patentable inventions discovered in the conduct of sponsored projects, so they have an interest in ensuring that public disclosure of relevant research data is not made prematurely. While universities have an interest in intellectual property, they are in the business of disseminating the results of research for the public good. The balancing of those interests can be delicate and is best addressed by educating researchers on intellectual property rights and the effects publications and public disclosures on obtaining a patent. Since universities do not control researcher disclosures or publications, the responsibility for evaluating whether to disclose/share data properly falls under the purview of the researcher. In recent years, there has been substantial controversy over the perception that institutions and individual researchers are too closely tied to corporate research sponsors. That perception results from the view that institutions and researchers are placing themselves in conflicts of interest by limiting access to research results and data to the companies paying for the research. This means that the public good is sacrificed for the benefit of private interests. A corollary to this perception is that researchers are in competition with each other for corporate funding and refuse to share their data with competitor researchers or even other researchers within their own departments. Institutions need to be aware of such situations and exercise due care that sponsored project terms and conditions do not create the perception that the institution and/or the researchers are too closely tied to the sponsor’s interests or are acting exclusively in the sponsor’s interests. The federal government has expressed concern about this perception and those situations in which researchers may have acted inappropriately. As a result, federal agencies have taken steps to intervene in order to encourage and/or require researchers to share research data. As examples, NIH has published the following documents: • Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources; • Report of the National Institutes of Health (NIH) Working Group on Research Tools; and • Final NIH Statement on Sharing Research Data NIH has created an entire webpage dedicated to policies and guidance related to data sharing.

Although it is not possible to discuss all of these resources in this tutorial, the basic thrust is that NIH grantees shall, to the greatest extent and as freely as possible, share data and the results of their research, subject to legitimate intellectual property rights. In addition, for large proposals (exceeding budget requests in excess of $500,000 in any year), applicants must submit a data sharing plan in which they indicate how the data resulting from the project, if funded, will be disseminated and shared with others. The National Science Foundation (NSF) has also addressed this issue. In 1989, NSF issued Important Notice 106. The first two sections of that Important Notice are directly relevant to this discussion. • Section 1, Open Scientific and Engineering Communication, states in part "It (NSF) expects investigators to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections, and other supporting materials created or gathered in the course of the research." • Section 2, Policies for Openness, recognizes the importance of commercializing the results of research, but the retention of intellectual property rights, "...does not reduce the responsibility of researchers and institutions to make research results and supporting materials openly accessible." These examples from NIH and NSF clearly address the institution’s and researcher’s need to balance their rights and responsibilities associated with controlling access to and sharing research data. The difficulty lies in finding the appropriate balance that best fits each situation.