In November 2021, the National Institutes of Health (NIH) Office of Science Policy (OSP) published a Request for Information (RFI) concerning their Genomic Data Sharing Policy. NIH is seeking public input on potential updates to the original Policy, issued in 2014. Last week, PRIM&R submitted comments welcoming revisions to the policy in the face of evolving technologies and encouraging NIH enhance its public engagement efforts. We provide more detail on our comments below, and we encourage you to submit your own comments to NIH. On our Public Policy webpage you can find out more about why you should comment, and how to do so. Feel free to use or cite our comments in drafting your own response. Comments are due on February 28, 2022.

First, we urge NIH to embrace the revision of the original Genomic Data Sharing Policy as “an opportunity to undertake a more substantive and meaningful process of public engagement” around genomic data sharing, given that the RFI process tends not to be accessible to the lay public or truly reflect engagement of all relevant communities. More specifically, we urge NIH to “consider holding town halls and listening sessions, running PSA campaigns, and conducting public surveys.” This sort of sustained engagement with the public would allow for a bidirectional communication process between NIH and the stakeholders it is ultimately meant to serve. NIH could communicate the value of genomic data sharing to scientific progress and human health and the risks that data sharing inevitably involves, and improve lay understanding of what sorts of tradeoffs (for instance, between privacy protections and utility of data) data sharing may entail.  And, crucially, NIH could use this engagement to better and more systematically understand the public’s desires and concerns regarding data sharing. Currently, participation in genomic databases is not representative of the general population in terms of race and ethnicity, likely contributing to inequitable health outcomes between racial groups. A well-supported public education campaign might help to address these disparities.

Turning to more specific elements within the RFI, PRIM&R urges the agency to do more to review and assess the full range of safeguards available around genomic data sharing. Deidentification of data, as we have written previously, cannot carry the entire burden of protection because “it is no longer possible to guarantee that data will remain permanently deidentified.” As such, we appreciate that NIH discusses other protection mechanisms within this RFI; however, we call on the agency to go a step further and “review and assess its policies around each of these safeguards to determine whether they are adequate to the current genomic data sharing landscape, and if they need to be supplemented by additional approaches.” These other methods, we note, “are not merely supplementary to deidentification; rather, each is an important tool in its own right in the arsenal of genomic data sharing safeguards.”

We also urge NIH to seriously consider methods and policies for sanctioning parties who misuse the data to which they have been granted access. These sanctions might include “fines, suspension of grants, ineligibility for future funds, or, in extreme cases, debarment,” and they would encourage careful and responsible use of data by raising the stakes for not doing so.

We encourage you to submit your own comment to NIH! You are welcome to use some or all of our language or thinking in your response. Comments will be accepted through February 28, 2022.