Journal of Free Speech Law: "The NIH's Genomic Data Sharing Policy and the First Amendment," by Prof. Adam Candeub

An article from the Information as Medicine symposium.

Here's the Abstract; the full article is here:

Genome-wide association studies (GWAS) use DNA statistical analy­ses to examine the relationship between genotypic differences and phenotypic traits. Revolutionizing genetics, these studies have discovered more than 50,000 associations of genome-wide significance between genetic variants and common diseases and traits. GWAS also have transformed the study of physical anthropology, establishing the relatedness of modern and proto-humans and other primates as well as modern humans' ancient migration patterns.

The NIH's 2014 Genomic Data Sharing Policy (GDSP) governs collecting, storing, and accessing the databases upon which most GWAS research in this country relies. Many data repositories refuse access to those who pursue what the NIH categorizes as "stigmatizing" or "sensitive" research.

The GDSP does not comply with the Administrative Procedure Act (APA). The policy's "sensitive" and "stigmatizing" standard lacks any statutory basis and is perforce arbitrary and capricious.

And even assuming that the GDSP is consistent with administrative law, the policy is best viewed as a condition to obtain a government benefit or as a viewpoint-based restriction of generally available government information. So characterized, the GDSP violates the First Amendment.