1. The study involved semi-structured, in-person interviews with 17 users of controlled-access data (data users) and 3 members of committees that oversee the release of such data. The interviews were transcribed, coded, and analyzed using inductive, Grounded Theory methods (Strauss 1987). Interview subjects were chosen from publicly available lists of scientists who have accessed controlled data, and from lists of published journal articles in which controlled-access datasets have been used. Interviewees included scientists from the United States, the United Kingdom, and China. This project was reviewed by the University of Wisconsin IRB and determined to be exempt from the requirements of the federal Common Rule (DHHS 2005).
2. The relevant regulations are the federal Common Rule, 45 CFR §46 (2005), and the comparable FDA regulations, 29 CFR §§ 50 and 56 (2009).
3. A genotype is an ordered catalog or map of the particular DNA variants a person possesses. For a large project, each person’s genotype would typically consist of data from about 500,000 to 1 million genetic markers spread relatively evenly across a person’s entire genome. “Whole-exome” sequence refers to sequence representing all of the protein coding regions in a person’s genome. Only a few percent of the human genome encodes proteins.
4. A “marker” is any place where the DNA varies between people. This variation can be a single nucleotide polymorphism (SNP), a site in the genome where some people have a particular nucleotide (one of the four chemical building blocks of DNA), such as guanine, and other people have a different nucleotide, such as cytosine. Other types of markers involve different numbers of repeated motifs that people may have at a particular site, or insertions or deletions of sequence.
5. Because both types of repositories are institutions, both will be subject to the same general business law, such as employment, labor, and tax law.
6. Cases such as Moore v. Regents, 973 P. 2d 479 (CA 1990), Greenberg v. Miami Children’s Hospital, 264 F. Supp. 2d 1064 (S.D. FL 2003), and Washington v. Catalona, 490 F. 3d 667 (CA 8, 2007) may cause some to doubt that courts will treat extracorporeal tissue as property of the persons from whom it was derived, but there is no doubt that courts have treated the tissue as researchers’ or research institutions’ personal property.
7. Importantly, this means that the Genetic Information Nondiscrimination Act of 2008, Public Law No. 110–233, 122 Stat. 881, does not apply to all of the individual-level information in dbGaP. Employment or health insurance discrimination could occur based on the nongenetic information in the repository.
We thank Christopher Peterson, Eric Jackson, Kristine Rømer Thomsen, Christine Parsons, and Katie Young for helpful comments on earlier versions of this manuscript. Our research has been supported by grants from the TrygFonden Charitable Foundation to Kringelbach and from the National Institute of Mental Health and National Institute on Drug Abuse to Berridge.