FASEB Submits Comments on Draft Genomic Data Sharing Policy
Created by lgreen on 11/21/2013 11:07:39 AM

By Yvette Seger

Earlier this month, the Federation of American Societies for Experimental Biology (FASEB) submitted its comments to the National Institutes of Health (NIH) on its draft Genomic Data Sharing Policy. NIH developed this policy to facilitate genomic research through the sharing of large-scale human and nonhuman genomic data generated from NIH-supported and NIH-conducted research. In its comments, FASEB expressed concern regarding the potential impacts of the policy that could have a chilling effect on genomics research if implemented in its current form. Specifically, it could cause an increase in administrative burdens for investigators and institutions engaged in genomics research and negatively affect genomics research involving human subjects.

FASEB noted that the draft policy is unclear regarding the types of research to be covered and the expectations for data submission and data release are notably vague. Although FASEB recognizes the importance of flexible policies in an area advancing as rapidly genomics research, the policy’s lack of clarity will likely result in confusion upon implementation. Therefore, the inclusion of a workflow diagram to help investigators and institutions navigate and implement the policy as intended was recommended.

FASEB also highlighted the lack of guidance regarding data for which de-identification of samples cannot be guaranteed in perpetuity and proposed a model in which research subjects have substantive legal protections against the misuse of personal data rather than guaranteed data privacy. FASEB raised additional concerns regarding the policy’s lack of exemptions for studies involving “at risk” or vulnerable populations.

In light of these concerns, FASEB recommended that NIH make significant revisions to the draft policy and provide a second opportunity for public comment prior to its implementation.

Click here to read FASEB’s complete response to the draft NIH Genomic Data Sharing Policy.