For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices.
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References
1.
45 CFR 46. 2017.
2.
C. K.Gunsalus, E. M.Bruner, N. C.Burbules, L.Dash, M.Finkin, J. P.Goldberg, W. T.Greenough, G. A.Miller, and M. G.Pratt, “Mission Creep in the IRB World,”Science312, no. 5779 (2006): 1441.
3.
Centers for Disease Control (CDC), Guidelines for Defining Public Health Research and Public Health Non-research (Atlanta, GA: CDC, 1999).
4.
L. M.Lee and S. B.Thacker, “Public Health Surveillance and Knowing about Health in the Context of Growing Sources of Health Data,”American Journal of Preventive Medicine41, (2011): 636–640, available at <http://dx.doi.org/10.1016/j.amepre.2011.08.015> (last visited March 21, 2019).
5.
See supra note 3.
6.
M. Q.Patton, Utilization-Focused Evaluation: The New Century Text, 3rd ed, (Thousand Oaks, CA: Sage, 1997).
7.
45 CFR 46. 1991.
8.
K.Gebbie, B. D.Goldstein, and D. I.Gregorio, “The National Board of Public Health Examiners: Credentialing Public Health Graduates,”Public Health Report122, no. 4 (2007): 435–440.
9.
K.Bender, J.Kronstadt, R.Wilcox, and T. P.Lee, “Overview of the Public Health Accreditation Board,”Journal of Public Health Management and Practice20, no. 1 (2014): 4-6.
10.
J. C.Thomas, M.Sage, J.Dillenberg, and V. J.Guillory, “A Code of Ethics for Public Health,”American Journal of Public Health92, no. 7 (2002): 1057–1059; L. M. Lee, C. B. Fisher, and B. Jennings, “Revising the American Public Health Association's Public Health Code of Ethics,” American Journal of Public Health 106, no. 7 (2016): 1198-1199.
11.
World Health Organization (WHO), Guidance for Managing Ethical Issues in Infectious Disease Outbreaks (Geneva: WHO, 2016).
12.
World Health Organization (WHO), Guidelines on Ethical Issues in Public Health Surveillance (Geneva: WHO, 2017).
13.
L. M.Lee and L. O.Gostin, “Ethical Collection, Storage, and Use of Public Health Data: A Proposal for National Privacy Protection,”JAMA302, no. 1 (2009): 82-84.
14.
Centers for Disease Control and Prevention (CDC), Distinguishing Public Health Research and Public Health Nonre-search Policy (Atlanta, GA: CDC, 2010).
J. D.Loe, D. A.Winkelman, and C. T.Robertson. “An Assessment of the Human Subjects Protection Review Process for Exempt Research,”Journal of Law, Medicine & Ethics44, no. 3 (2016): 481–91.
