“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76Fed. Reg. 44,512–44,531 (July 26, 2011).
2.
Id., at 44,513.
3.
National Cancer Policy Board of the Institute of Medicine and Division on Earth and Life Studies of the National Research Council, Large-Scale Biomedical Science: Exploring Strategies for Future Research (Washington, D.C.: National Academies Press, 2003): At 1.
4.
Id.
5.
A third “big science” project, not addressed in this paper, is the “1000 Genomes Project” an international effort begun in 2008 to establish the most detailed catalogue in existence of human genetic variation. See The 1000 Genomes Project Consortium, “A Map of Human Genome Variation from Population-Scale Sequencing,”Nature467, no. 7319 (2010): 1061–1073, available at <http://www.nature.com/nature/journal/v467/n7319/full/nature09534.html> (last visited April 8, 2013).
6.
StoneM., “NIH Builds Substantial Human Microbiome Project,”Microbe Magazine, October 2009, available at <microbe-magazine.org> (last visited April 8, 2013).
7.
TurnbaughP. J.LeyR. E.HamadyM.Fraser-LiggettC. M.KnightR.GordonJ. I., “The Human Microbiome Project,”Nature449, no. 7164 (2007): 804–810.
8.
HawkinsA. K.O'DohertyK. C., “‘Who Owns Your Poop?’: Insights Regarding the Intersection of Human Microbiome Research and the ELSI Aspects of Biobanking and Related Studies,”BMC Medical Genomics4, no. 72 (2011), available at <http://www.biomedcentral.com/1755–8794/4/72> (last visited April 8, 2013) (citations omitted).
9.
See Stone, supra note 6.
10.
NIH News, “NIH Human Microbiome Project Defines Normal Bacterial Makeup of the Body,” June 13, 2012, available at <http://www.genome.gov/27549144> (last visited April 8, 2013).
11.
See Stone, supra note 6.
12.
The NIH HMP Working Group, “The NIH Human Microbiome Project,”Genome Research19, no. 12 (2009): 2317–2323.
13.
See Turnbaugh, supra note 7, at 804
14.
see also ProctorL. M., “The Human Microbiome Project in 2011 and Beyond,”Cell Host and Microbe10, no. 4 (2011): 287–291.
15.
See KolataG., “In Good Health? Thank Your 100 Trillion Bacteria,”New York Times, June 13, 2012.
16.
RelmanD. A., “Learning about Who We Are,”Nature486, no. 7402 (June 14, 2012): 194–195, 195.
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19.
McGuireA. L.AchenbaumL. S.WhitneyS. N., “Perspectives on Human Microbiome Research Ethics,”Journal of Empirical Research on Human Research Ethics7, no. 3 (2012): 1–14.
20.
See Relman, supra note 15, at 194.
21.
See Stone, supra note 6
22.
see also Proctor, supra note 13.
23.
The complete dataset is available through a Data Analysis and Coordination Center hosted at the University of Maryland School of Medicine, Baltimore MD <www.hmpdacc.org> (last visited April 8, 2013).
24.
See Proctor, supra note 13.
25.
Id.
26.
Id.
27.
RavelJ., “Vaginal Microbiome of Reproductive-Age Women,”Proceedings of the National Academy of Sciences108 Supp. 1 (May 7, 2010): 4680–4687, available at <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063603/> (last visited April 8, 2013)
28.
GajerP., “The Temporal Dynamics of the Vaginal Microbiota,”Science Translational Medicine4, no. 132ra52 (2012): 1–12.
29.
See Ravel, supra note 25, at 1.
30.
Id. (citations omitted).
31.
Id., at 2.
32.
Id., at 4.
33.
Id.
34.
Id., at 5.
35.
Id., at 5.
36.
See Gajer, supra note 25.
37.
FortenberryJ. D.NelsonD. E.DongQ., “Marker Paper: The Urethral Microbiome of Adolescent Males,”Nature Precedings (2010), available at <http://dx.doi.org/10.1038/npre.2010.5221.1> (last visited April 8, 2013
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Id.
39.
See NelsonD. E.Van Der PolB. J.DongQ.MiD.KatzB. P.SodergrenE.WeinstockG.FortenberryJ. D., “Dynamics of Bacterial Communities of the Coronal Sulcus and Distal Urethra of Adolescent Males,”PLoS One7, no. 5 (2012): e36298.
40.
See Proctor, supra note 13, at 289.
41.
See National Human Genome Research Institute, Informed Consent for Genomics Research, available at <http://www.genome.gov/27026588> (last visited April 8, 2013).
42.
LewisC. M., “The Human Microbiome Project: Lessons from Human Genomics,”Trends in Microbiology20, no. 1 (January 2012): 1–4.
43.
See Relman, supra note 15, at 195.
44.
BoltonD.NivY., “Ghrelin, Helicobacter pylori and Body Mass: Is There an Association?”Israeli Medical Association Journal14, no. 2 (2012): 130–132.
citing FiererN.LauberC. L.ZhouN.McDonaldD.CostelloE. K.KnightR., “Forensic Identification Using Skin Bacterial Communities,”Proceedings of the National Academy of Sciences of the United States of America107 [2010]: 6477–6481.
49.
See HawkinsO'Doherty, supra note 8, at 3;
50.
see also id. (Fierer).
51.
See McGuire, supra note 18, at 7.
52.
See email from Lita Proctor, Coordinator, Human Microbiome Project, NHGRI, to HMP-funded researchers (March 14, 2012), on file with authors.
53.
Id.
54.
Email from Lita Proctor, Coordinator, Human Microbiome Project, National Human Genome Research Institute, December 5, 2012 (on file with the authors). See also SchloissnigS.ArumugamM.SunagawaS.MitrevaM.TapJ.ZhuA., “Genomic Variation Landscape of the Human Gut Microbiome,”Nature493, no. 7430 (2013): 45–50.
55.
76 Fed. Reg. 44,512–44,522.
56.
76 Fed. Reg. 44,523.
57.
See Lewis, supra note 39.
58.
See Informed Consent Elements Tailored to Genomics Research, available at <www.genome.gov/27026589> (last visited April 8, 2013).
59.
76 Fed. Reg. 44,516.
60.
Id.
61.
Id.
62.
Comments of Jack Schwartz on draft of article, October 1, 2012.
63.
Id.
64.
Id.
65.
76 Fed. Reg. 44,525.
66.
76 Fed. Reg. 44,518.
67.
Id.
68.
The likelihood of such group discrimination is discussed in the context of genetic discrimination. See JuengstE. T., “Group Identity and Human Diversity: Keeping Biology Straight from Culture,”American Journal of Human Genetics63, no. 3 (1998): 673–677.
69.
Juengst provides the example of a finding that some particular group carries a relatively greater genetic propensity for alcoholism may be over-interpreted “as universally predictive for the group.” Id., at 673.
70.
He states that “[t]he resulting stigmatization of members of that group could then be used to deny social goods and opportunities to individuals who might be at no great risk of becoming alcoholics – or even to justify coercive and unnecessary medical treatments.” Id.
71.
FosterM. W., “The Role of Community Review in Evaluating the Risks of Human Genetic Variation Research,”American Journal of Human Genetics64, no. 6 (1999): 1719–1727, at 1719.
72.
See HausmanD., “Protecting Groups from Genetic Research,”Bioethics22, no. 3 (2008): 157–165.
73.
See HausmanD. M., “Group Risks, Risks to Groups, and Group Engagement in Genetics Research,”Kennedy Institute of Ethics Journal17, no. 4 (2007): 351–369.
74.
A GWAS is “defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition.” See 71 Fed. Reg. 51,629 (August 30, 2006).
75.
“Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS),” 72Fed. Reg. 49,290 (August 28, 2007).
76.
Id., at 49,292. It is not clear whether this policy would apply to groups that are not identifiable at the start of the research.
77.
76 Fed. Reg. 44,517.
78.
The NIH HMP Working Group, supra note 12.
79.
See McGuire, supra note 18.
80.
See also Proctor, supra note 12 and Aagaard et al., supra note 17.
81.
See Aagaard, supra note 17, at 1014.
82.
See Relman, supra note 15, at 195.
83.
See Lewis, supra note 39, at 2.
84.
45 CFR46.406.
85.
See Gajer, supra note 25.
86.
See Hausman, supra note 65, at 164.
87.
citing JuengstE., “Group Identity and Human Diversity: Keeping Biology Straight from Culture,”American Journal of Human Genetics63, no. 3 [1998]: 673–677.
88.
DavisD. S., “Groups, Communities, and Contested Identities in Genetic Research,”Hastings Center Report30, no. 6 [2000]: 38–45.
