An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research

32 C.F.R 219 (1991).

Council for International Organizations of Medical Sciences, International Guidelines for Ethical Review of Epidemiological Studies (Geneva, Switzerland: CIOMS, 1991). Reprinted in Law, Medicine & Health Care 19 (1991): 258.

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See NBAC, supra note 12.

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Council of State and Territorial Epidemiologists, Hodge J. G. , Public Health Practice v. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Distinctions (Atlanta, GA: CSTE, 2004) 1–61.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects (Washington, DC: Office of Protection from Research Risks, Department of Health, Education, and Welfare: 1979).

32 C.F.R. 219 (1991).

32 C.F.R 219 (1991).

See CDC, supra note 9.

See NBAC, supra note 12; See Amoroso and Middaugh , supra note 15.

See NBAC, supra note 12.

See IOM, supra note 13.

See NBAC, supra note 12.

See CDC, supra note 9.

See Snider and Stroup , supra note 3.

Massachusetts Department of Health Human Subjects Guidelines, MA Department of Health website, at <http://www.state.ma.us/dph/bhsre/resource_guide/datarequestprotcol.htm> (last visited January 19, 2005).

See CDC, supra note 9.

See id.

See Snider and Stroup , supra note 3

See Buehler and Burris , supra note 5

Casarett D. Karlawish J. , and Sugarman J. , “Determining when Quality Improvement Initiatives Should be Considered Research” JAMA 283 (2000): 2275–2280.

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See Amoroso and Middaugh , supra note 15.

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DeShaney v. Winnebago County Dep't of Soc. Services, 489 U.S. 189 (1989).

Mojica B. , New York Deputy Commissioner of Health, Letter to Donna Knutson, Executive Director, CSTE, (August 25, 1999) On file with author.

See Gostin , supra note 35.

Gostin L. O. , Public Health Law: Power, Duty Restraint (Berkeley, CA: University of California Press; 2000): at 48.

Turning Point Public Health Statute Modernization National Collaborative, Model State Public Health Act. Turning Point website, at<http://www.hss.state.ak.us/dph/deu/turningpoint/publications.htm> (last visited January 19, 2005).

Zucht v. King, 260 U.S. 174 (1922).

Leisy v. Hardin, 135 U.S. 100 (1890).

See v. Seattle, 387 U.S. 541 (1967); Givner v. State, 124 A.2d 764 (Ct. App. Md. 1956).

Francis v. La. St. Livestock Sanitary Bd., 184 So.2d 247 (La. 1st Cir. 1966); Jones v. Ind. Livestock Sanitary Bd., 163 N.E.2d 605(Ind. 1960).

Oklahoma ex rel. Corp. Comm'n v. Texas County Irrigation & Water Res. Ass'n, Inc., 818 P.2d 441 (Okla. 1991).

Highland Farms Dairy, Inc. v. Agnew, 16 F. Supp. 575 (E.D. Va. 1936).

Strandwitz v. Board of Dietetics, 614 N.E.2d 817 (Ct. App. Oh. 1992).

Safe Water Ass'n, Inc. v. Fond Du Lac, 516 N.W.2d 13 (Ct. App. Wis. 1994); Douglas A. and Balog D. A. , note, “Fluoridation of Public Water Systems: Valid Exercise of State Police Power or Constitutional Violation?” Pace Environmental Law Review 14 (1997): At 645.

Adams v. Dept. of Health & Human Resources, 458 So.2d 1295 (La. 1985); State v. Otterholt, 15 N.W.2d 529 (Iowa 1944).

See NBAC, supra note 12.

45 C.F.R. 46.103 (1991).

Burris S. Gable L. Stone L. , and Lazzarini Z. , “The Role of State Law in Protecting Human Subjects of Public Health Research and Practice,” Journal of Law, Medicine, and Ethics 31, no. 4 (2004): 654–662.

45 C.F.R. 46.111(a)(4)-(5) (1991).

45 C.F.R. 46.111(a)(7) (1991).

45 C.F.R. § 46.111(a)(1)-(2) (1991).

45 C.F.R. § 46.111(a)(3) (1991).

45 C.F.R. 46.109(e) (1991); 46.111(a)(6) (1991).

45 C.F.R. 46.111(b) (1991); 45 C.F.R. 46.201 (1991); 45 C.F.R. 46.301(1991); 45 C.F.R. 46.401 (1991).

45 C.F.R. 46.102(d) (1991).

National Institutes of Health (NIH), Guidelines for the Conduct of Researching Involving Human Subjects at the National Institutes of Health, NIH website, at <http://www.nihtraining.com/ohsrsite/guidelines/graybook.html> (last visited January 19, 2005).

45 C.F.R. 46.101(c) (1991).

Office for Human Research Protection, Engaging in Human Subjects Research by Institutions (January 26, 1999), Department of Health and Human Services website, at <http://ohrp.osophs.dhhs.gov/humansubjects/assurance/engage.htm> (last visited January 19, 2005).

See id.

45 C.F.R. 46.102(f) (1991).

See NIH, supra note 60.

45 C.F.R. 46.102(b)(1) (1991).

45 C.F.R. 46.102(b)(2) (1991).

45 C.F.R. 46.102(b)(4) (1991).

45 C.F.R. 46.102(b)(5) (1991).

45 C.F.R. 46.102(b)(6) (1991).

See NBAC, supra note 12.

45 C.F.R. 46.110 (1991).

Office for Human Research Protection, Categories of Research that May Be Reviewed by an Institutional Review Board (IRB) through an Expedited Review Procedure (November 9, 1998), Department of Health and Human Services website, at <http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm> (last visited January 19, 2005).

See Burris , supra note 52.

See id.

Miss. Code Ann. § 41351 (2001).

See Burris , supra note 52.

Whalen v. Roe, 429 U.S. 589 (1977).

Gostin L. O. , “Health Information Privacy,” Cornell Law Review 80 (1995): 451–528.

45 C.F.R. § 164.501 (2003).

45 C.F.R. § 164.514(a)(b) (2002).

45 C.F.R. § 160.103 (2003).

“HIPAA Privacy Rule and Public Health,” Guidance from CDC and the U.S. Department of Health and Human Services, Morbidity and Mortality Weekly Report 52 (Suppl.) (2003): 1–17, 19–20; “Guidelines for protecting health information in research,” U.S. Department of Health and Human Services website, at <http://privacyruleandresearch.nih.gov/pr_02.asp> (last visited January 19, 2005).

45 C.F.R. § 164.508(a)(1) (2002).

45 C.F.R. § 164.501 (2003).

45 C.F.R. § 164.512(a) and (b) (2002).

OCR HIPAA Privacy Guidelines: Research (April 3, 2003), Department of Health and Human Services website, at <http://www.hhs.gov/ocr/hipaa/guidelines/research.rtf> (last visited January 19, 2005).

Rivara F. P. , “Research and Human Subjects,” Archives of Pediatric and Adolescent Medicine 156 (2002): 641–642.

See 45 CFR l64.512(i)(1)(ii) (2002).

See 45 CFR l64.512(i)(1)(iii) (2002).

See 45 CFR 164.514(e) (2002).

42 U.S.C.A. § 242m(d) (1997).

42 U.S.C.A. § 241(d) (1997).

Gostin L. O. Hodge J. G. Jr. , and Valdiserri R. O. , “Informational Privacy and the Public's Health: The Model State Public Health Privacy Act,” American Journal of Public Health 91 (2001): 1388–1392.

See id.

See Turning Point, supra note 40.

See Gostin , supra note 94.

N.Y. Pub. Health Law § 2441(2) (McKinney 2002).

See Snider and Stroup , supra note 3.