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Are Changes to the Common Rule Necessary to Address Evolving Areas of Research?

A Case Study Focusing on the Human Microbiome Project

Published online by Cambridge University Press:  01 January 2021

Extract

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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References

“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Fed. Reg. 44,512–44,531 (July 26, 2011).Google Scholar
Id., at 44,513.Google Scholar
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.Google Scholar
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,” Nature 467, no. 7319 (2010): 10611073, available at <http://www.nature.com/nature/journal/v467/n7319/full/nature09534.html> (last visited April 8, 2013).CrossRef+(last+visited+April+8,+2013).>Google Scholar
Stone, M., “NIH Builds Substantial Human Microbiome Project,” Microbe Magazine, October 2009, available at <microbe-magazine.org> (last visited April 8, 2013).CrossRef+(last+visited+April+8,+2013).>Google Scholar
Turnbaugh, P. J. Ley, R. E. Hamady, M. Fraser-Liggett, C. M. Knight, R. Gordon, J. I., “The Human Microbiome Project,” Nature 449, no. 7164 (2007): 804810.CrossRefGoogle Scholar
Hawkins, A. K. O'Doherty, K. C., “‘Who Owns Your Poop?’: Insights Regarding the Intersection of Human Microbiome Research and the ELSI Aspects of Biobanking and Related Studies,” BMC Medical Genomics 4, no. 72 (2011), available at <http://www.biomedcentral.com/1755–8794/4/72> (last visited April 8, 2013) (citations omitted).CrossRefGoogle Scholar
See Stone, , supra note 6.Google Scholar
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).+(last+visited+April+8,+2013).>Google Scholar
See Stone, , supra note 6.Google Scholar
The NIH HMP Working Group, “The NIH Human Microbiome Project,” Genome Research 19, no. 12 (2009): 23172323.CrossRefGoogle Scholar
See Turnbaugh, et al., supra note 7, at 804 see also Proctor, L. M., “The Human Microbiome Project in 2011 and Beyond,” Cell Host and Microbe 10, no. 4 (2011): 287291.Google Scholar
See Kolata, G., “In Good Health? Thank Your 100 Trillion Bacteria,” New York Times, June 13, 2012.Google Scholar
Relman, D. A., “Learning about Who We Are,” Nature 486, no. 7402 (June 14, 2012): 194195, 195.CrossRefGoogle Scholar
See NIH Human Microbiome Project – Core Microbiome Sampling Protocol A, February 28, 2011, available at <http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000228.v3.p1> (last visited April 8, 2013).+(last+visited+April+8,+2013).>Google Scholar
Aagaard, K. et al., “The Human Microbiome Project Strategy for Comprehensive Sampling of the Human Microbiome and Why It Matters,” FASEB Journal 27, no. 3 (March 2013): 10121022.CrossRefGoogle Scholar
McGuire, A. L. Achenbaum, L. S. Whitney, S. N., “Perspectives on Human Microbiome Research Ethics,” Journal of Empirical Research on Human Research Ethics 7, no. 3 (2012): 114.CrossRefGoogle Scholar
See Relman, , supra note 15, at 194.Google Scholar
See Stone, , supra note 6; see also Proctor, , supra note 13.Google Scholar
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).+(last+visited+April+8,+2013).>Google Scholar
See Proctor, , supra note 13.Google Scholar
Ravel, J. et al., “Vaginal Microbiome of Reproductive-Age Women,” Proceedings of the National Academy of Sciences 108 Supp. 1 (May 7, 2010): 46804687, available at <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063603/> (last visited April 8, 2013); Gajer, P. et al., “The Temporal Dynamics of the Vaginal Microbiota,” Science Translational Medicine 4, no. 132ra52 (2012): 1–12.CrossRefGoogle Scholar
See Ravel, et al., supra note 25, at 1.Google Scholar
Id. (citations omitted).Google Scholar
Id., at 2.Google Scholar
Id., at 4.Google Scholar
Id., at 5.Google Scholar
Id., at 5.Google Scholar
See Gajer, et al., supra note 25.Google Scholar
Fortenberry, J. D. Nelson, D. E. Dong, Q., “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, 2013CrossRef+(last+visited+April+8,+2013>Google Scholar
See Nelson, D. E. Van Der Pol, B. J. Dong, Q. Mi, D. Katz, B. P. Sodergren, E. Weinstock, G. Fortenberry, J. D., “Dynamics of Bacterial Communities of the Coronal Sulcus and Distal Urethra of Adolescent Males,” PLoS One 7, no. 5 (2012): e36298.CrossRefGoogle Scholar
See Proctor, , supra note 13, at 289.Google Scholar
See National Human Genome Research Institute”, Informed Consent for Genomics Research, available at <http://www.genome.gov/27026588> (last visited April 8, 2013).+(last+visited+April+8,+2013).>Google Scholar
Lewis, C. M. et al., “The Human Microbiome Project: Lessons from Human Genomics,” Trends in Microbiology 20, no. 1 (January 2012): 14.CrossRefGoogle Scholar
See Relman, , supra note 15, at 195.Google Scholar
Bolton, D. Niv, Y., “Ghrelin, Helicobacter pylori and Body Mass: Is There an Association?” Israeli Medical Association Journal 14, no. 2 (2012): 130132.Google Scholar
McAuliffe, K., “How Your Cat Is Making You Crazy,” The Atlantic, March 2012, available at <http://www.theatlantic.com/magazine/archive/2012/03/how-your-cat-is-making-you-crazy/308873/> (last visited April 8, 2013).+(last+visited+April+8,+2013).>Google Scholar
See McGuire, et al., supra note 18, at 7. citing Fierer, N. Lauber, C. L. Zhou, N. McDonald, D. Costello, E. K. Knight, R., “Forensic Identification Using Skin Bacterial Communities,” Proceedings of the National Academy of Sciences of the United States of America 107 [2010]: 64776481.Google Scholar
See Hawkins, O’Doherty, , supra note 8, at 3; see also id. (Fierer, et al.).Google Scholar
See McGuire, et al., supra note 18, at 7.Google Scholar
See email from Lita Proctor, Coordinator, Human Microbiome Project”, NHGRI, to HMP-funded researchers (March 14, 2012), on file with authors.Google Scholar
Email from Lita Proctor, Coordinator, Human Microbiome Project, National Human Genome Research Institute, December 5, 2012 (on file with the authors). See also Schloissnig, S. Arumugam, M. Sunagawa, S. Mitreva, M. Tap, J. Zhu, A., “Genomic Variation Landscape of the Human Gut Microbiome,” Nature 493, no. 7430 (2013): 4550.CrossRefGoogle Scholar
76 Fed. Reg. 44,512–44,522.Google Scholar
76 Fed. Reg. 44,523.Google Scholar
See Lewis, et al., supra note 39.Google Scholar
See Informed Consent Elements Tailored to Genomics Research, available at <www.genome.gov/27026589> (last visited April 8, 2013).+(last+visited+April+8,+2013).>Google Scholar
76 Fed. Reg. 44,516.Google Scholar
Comments of Jack Schwartz on draft of article, October 1, 2012.Google Scholar
76 Fed. Reg. 44,525.Google Scholar
76 Fed. Reg. 44,518.Google Scholar
The likelihood of such group discrimination is discussed in the context of genetic discrimination. See Juengst, E. T., “Group Identity and Human Diversity: Keeping Biology Straight from Culture,” American Journal of Human Genetics 63, no. 3 (1998): 673677. 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. 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.CrossRefGoogle Scholar
Foster, M. W. et al., “The Role of Community Review in Evaluating the Risks of Human Genetic Variation Research,” American Journal of Human Genetics 64, no. 6 (1999): 17191727, at 1719.CrossRefGoogle Scholar
See Hausman, D., “Protecting Groups from Genetic Research,” Bioethics 22, no. 3 (2008): 157165.CrossRefGoogle Scholar
See Hausman, D. M., “Group Risks, Risks to Groups, and Group Engagement in Genetics Research,” Kennedy Institute of Ethics Journal 17, no. 4 (2007): 351369.CrossRefGoogle Scholar
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).Google Scholar
“Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS),” 72 Fed. Reg. 49,290 (August 28, 2007).Google Scholar
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.Google Scholar
76 Fed. Reg. 44,517.Google Scholar
The NIH HMP Working Group, supra note 12.Google Scholar
See McGuire, et al., supra note 18. See also Proctor, , supra note 12 and Aagaard et al., supra note 17.Google Scholar
See Aagaard, et al., supra note 17, at 1014.Google Scholar
See Relman, , supra note 15, at 195.Google Scholar
See Lewis, et al., supra note 39, at 2.Google Scholar
45 CFR 46.406.Google Scholar
See Gajer, et al., supra note 25.Google Scholar
See Hausman, , supra note 65, at 164. citing Juengst, E., “Group Identity and Human Diversity: Keeping Biology Straight from Culture,” American Journal of Human Genetics 63, no. 3 [1998]: 673677. Davis, D. S., “Groups, Communities, and Contested Identities in Genetic Research,” Hastings Center Report 30, no. 6 [2000]: 38–45.Google Scholar