Month: November 2016

The What and How of Data Sharing

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In a recent BMJ article, Milton Packer highlights the value of data sharing using iconic scientific figures: Copernicus, whose heliocentric theory of the universe was built using others’ data; his rival, Brahe, who hoarded data for fear of confirming Copernicus’ theory; and Kepler, whose famous laws of planetary motion depended on data sharing.  The National Institutes of Health (NIH) has long been a leader in data sharing, and there is a clear clamor for more and better data sharing by NIH and other federal agencies. There is little doubt that sharing biomedical research and health-related data plays a key role in advancing knowledge of human health and well-being. But data sharing is not without cost, and data shared in ways that are not useful to the research enterprise can waste, rather than maximize, resources. This is why we need help from you, the research community, to help us shape our data sharing strategies for the future.

Consistent with federal initiatives promoting open data and open science, NIH continues to be committed to ensuring that, to the maximum extent possible, the results of federally-funded scientific research are made publicly to support reuse, reproducibility and discovery. In order to move forward with ongoing commitments to the data sharing enterprise, we are considering priorities for data management and sharing and how to expand upon existing data sharing policies, such as our 2003 Data Sharing Policy. However, we recognize that many factors must be considered when determining what, when, and how data should be managed and shared including, for example, the purpose for sharing, supporting data re-use and reproducibility, maturity of the science, the infrastructure uniqueness of the data, and ethical considerations.

Today we are publishing a Request for Information (RFI) related to strategies for data management, sharing, and citation.  Through this RFI, we are seeking stakeholder feedback on considerations pertaining to what types of data should be shared, the costs and benefits of sharing different types of data, and standards for citation of data and software. Your feedback will help us to prioritize our thinking in data sharing stewardship and be considered as we move forward in developing new NIH policies in this area.

We need to hear from data users, data generators, and data scientists. By assisting us in this request for information, you can help ensure that NIH has the most robust set of information on hand when making future decisions in this important arena.  I encourage all interested stakeholders to review the RFI and provide us with their thoughts.  Comments on the RFI will be accepted until December 29, 2016.

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The Institutional DURC Policy – One Year Later: An Invitation for Stakeholder Input

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Maximizing the benefits of life sciences research while minimizing the potential risks associated with conducting that research is an important and ongoing topic of conversation within the science policy community. For example, developing lifesaving treatments for infectious diseases often requires working directly with infectious pathogens. This presents inherent risks to lab workers, which can be managed with proper biocontainment and safety practices. Scientific information can also pose risks if communicating the research involves findings that could be misused for nefarious purposes.

All research has some “dual use” potential, but so-called dual use research of concern (DURC) is legitimate research with the greatest potential for generating information that could be misused and result in significant harmful consequences. Recognizing the need for oversight of DURC, the U.S. government issued two policies aimed at managing risks associated with this small universe of research. One policy, issued in 2012 focuses on the responsibilities of federal funding agencies to identify DURC and manage risks accordingly. The other, and the focus of this blog, was issued in 2014 and focuses on the responsibilities of research institutions. Together, these complementary policies establish a system of shared responsibility for DURC oversight among federal funding agencies, institutions, and researchers.

Prior to the institutional DURC Policy’s 2015 implementation date, the U.S. government held a workshop to engage stakeholders and address questions. Now, just over a year later, the U.S. Government is interested in learning more about how researchers and institutions are implementing the Policy. What are the challenges being encountered? Are there best practices for identifying DURC or managing risks? To help answer these and other questions, the National Science Advisory Board for Biosecurity (NSABB) is being asked to help the U.S. Government further solicit feedback by hosting a series of regional stakeholder meetings. These meetings will focus on how institutions are implementing the DURC policy and what challenges they are facing.

The NSABB will discuss this new task at its next full Board meeting, a teleconference on November 4th, 2016 from 12:00 pm – 3:00 pm ET. This teleconference is open to the public and time will be reserved on the agenda for public comments. If you can’t participate on Nov. 4th, there will be additional opportunities to engage the NSABB to discuss the institutional DURC policy in the coming months. Additionally, we invite interested stakeholders to submit comments to the NSABB at any time by emailing [email protected].

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