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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 andprincipal investigator. At the same time, however, the very nature of research requires thatresearch data be shared. This may seem like a dichotomy, but it really is not. Rather, there is abalance 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. Forinstance, negotiators are aware that they must protect the researchers academic freedom andright to publish the results of his/her research. At the same time, rights to inventions in countriesother than the U.S. can be destroyed if publication occurs prior to the submission of a patentapplication. Indeed U.S. invention rights can be destroyed if a public disclosure of the inventionoccurs 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 andinterests with provisions that preserve the institutions and researchers academic freedom.

Once the award is made and the project is underway, universities and other nonprot institutionsusually retain ownership of patentable inventions discovered in the conduct of sponsoredprojects, 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 thebusiness of disseminating the results of research for the public good. The balancing of thoseinterests can be delicate and is best addressed by educating researchers on intellectual propertyrights and the effects publications and public disclosures on obtaining a patent. Since universitiesdo not control researcher disclosures or publications, the responsibility for evaluating whether todisclose/share data properly falls under the purview of the researcher.

In recent years, there has been substantial controversy over the perception that institutions andindividual researchers are too closely tied to corporate research sponsors. That perception resultsfrom the view that institutions and researchers are placing themselves in conicts of interest by

limiting access to research results and data to the companies paying for the research. This meansthat the public good is sacriced for the benet of private interests. A corollary to this perceptionis that researchers are in competition with each other for corporate funding and refuse to sharetheir 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 projectterms and conditions do not create the perception that the institution and/or the researchers aretoo closely tied to the sponsors interests or are acting exclusively in the sponsors interests.

The federal government has expressed concern about this perception and those situations inwhich 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 onObtaining and Disseminating Biomedical Research Resources;

Report of the National Institutes of Health (NIH) Working Group on ResearchTools; and

Final NIH Statement on Sharing Research Data

NIH has created an entire webpage dedicated to policies and guidance related to data sharing.

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Although it is not possible to discuss all of these resources in this tutorial, the basic thrust is thatNIH 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 datasharing plan in which they indicate how the data resulting from the project, if funded, will bedisseminated and shared with others.

The National Science Foundation (NSF) has also addressed this issue. In 1989, NSF issuedImportant Notice 106. The rst two sections of that Important Notice are directly relevant to thisdiscussion.

Section 1, Open Scientic and Engineering Communication, states in part "It(NSF) expects investigators to share with other researchers, at no more thanincremental cost and within a reasonable time, the primary data, samples, physicalcollections, and other supporting materials created or gathered in the course of theresearch."

Section 2, Policies for Openness, recognizes the importance of commercializingthe results of research, but the retention of intellectual property rights, "...does notreduce the responsibility of researchers and institutions to make research results andsupporting materials openly accessible."

These examples from NIH and NSF clearly address the institutions and researchers need tobalance their rights and responsibilities associated with controlling access to and sharing researchdata. The difculty lies in nding the appropriate balance that best ts each situation.