Protecting Data, Promoting Access: Improving Our Toolbox

You may recall from one of my previous blogs that there are policy challenges in balancing the sharing of valuable research data with the protection of the participants whose data is being shared. The NIH Office of Science Policy is taking a leading role in ensuring that genomic data is shared in a responsible way.

Under the NIH Genomic Data Sharing Policy, institutions must indicate the appropriate use of genomic data, including any limitations on the distribution and use of that data.  In order to assist institutions in recognizing potential data use limitations (DUL), NIH created several resources for investigators.  These include Points to Consider in Developing Effective Data Use Limitation Statements as well as a set of Standard Data Use Limitations.  However, even with these resources, there is still the possibility for multiple interpretations which may cause time delays and additional costs when trying to share genomic data.

This raises some interesting questions: could time delays and cost burdens be reduced if the conditions of potential data use and sharing were clearly communicated at the time the data is generated? What are the variations in the designation of data conditions, and what does that landscape look like, domestically and internationally? To begin to address these questions, OSP staff collaborated with members of the Global Alliance for Genomics and Health to a set of “Consent Codes” that could be used to assign genomic datasets to standardized data use groups in order to allow a consistent interpretation for the appropriate secondary use of vital genomic data.  As described in a recent article in PLOS Genetics, the consent codes should help in avoiding the introduction of unnecessary new restrictions on data use, while at the same time facilitating research with the greatest amount of data available.

The issue of genomic data sharing highlights the importance of international collaboration as well as the delicate balance between the broad sharing of valuable research and ensuring the protection of participants.  OSP will continue to develop resources on genomic data sharing while evaluating the existing policy landscape to ensure that researchers have appropriate access to data while simultaneously making sure that the data is not inadvertently or deliberately misused.

Posted by Dr. Carrie D. Wolinetz, May 2, 2016

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