Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated,Independent Public Health IRB

Council of State and Territorial Epidemiologists (CSTE), Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Decisions (Atlanta, GA: CSTE, 2004); Hodge J. Jr. , “An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 125–141; Perlman D. J. , “Public Health Practice vs. Research: Implications for Preparedness and Disaster Research Review By Institutional Review Boards At State Health Departments,” Disaster Medicine and Public Health Preparedness 2, no. 3 (2008): 185–191.

CSTE, id.

Perlman D. J. , “Speaking Truth to Power: Another Reason Why Bioethics Needs a Code of Ethics,” ASBH Exchange 11, no. 3(2008): 3, 10; Perlman D. J. , “The Independence Principle in Bioethics,” Penn Center Guide to Bioethics (New York: Springer, 2008): 21–34.

Emanuel E. J. Wendler D. , and Grady C. , “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–11.

See <http://www.hhs.gov/ohrp/humansubjects/anprm-2011page.html> (last visited December 6, 2012).

Burris S. C. and Anderson E. D. , “Making the Case for Laws That Improve Health: The Work of the Public Health Law Research National Program Office,” Journal of Law, Medicine & Ethics 39, Supplement 1 (2010): 15–20.

45 CFR § 46 at 56 FR § 28003 (June 18, 1991.)

21 CFR § 50 at 45 FR § 36390 (May 30, 1980); 21 CFR § 54 at 3 FR § 5250 (February 2, 1998); 21 CFR § 56 at 46 FR § 8975 (January 27, 1981).

Department of Health, Education, and Welfare (DHEW), National Research Act of 1974, Title II, Public Law 93–348, 1974.

The 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 of Research (Washington, D.C.: DHEW, 1979).

1962 Kefauver-Harris amendments to the 1938 Food, Drug, and Cosmetic Act (Public Law 87–781; 76 Stat. 788–89).

Schwartz J. , “Oversight of Human Subject Research: The Role of the States,” Ethical and Policy Issues in Research Involving Human Participants, volume II, (Bethesda, MD: National Bioethics Advisory Commission, 2001): At 359–378.

Perlman , supra note 1; Perlman D. J. , “Preliminary Analysis of the Research Ethics Infrastructure at US and Territorial Departments of Health for Making the Distinction between Public Health Research and Practice,” poster presentation at the American Public Health Association 2011 Meeting, Washington, D.C., October 31, 2011.

Research to fill these gaps remains one of the goals of the author, especially because searching DOH websites for mention of CDC and/or CSTE and checking publicly available data does not constitute an entirely valid or exhaustive way to determine if either the DOH is aware of these resources or what the IRBs without FWAs and/or IRBs do to protect subjects. A complete research agenda for filling in these gaps in evidence is outlined in the following unpublished 2012 manuscript: Perlman D.J. , 'To Protect and Serve: Public Health Law Research to Guide Human Research Protections Reforms at US Departments of Health.

See supra note 2.

Centers for Disease Control and Prevention (CDC), Distinguishing Public Health Research and Public Health Nonresearch (Atlanta, GA: CDC, 2010), available at <http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf> (last visited December 6, 2012). The 2010 policy supercedes the 1999 policy: CDC, Guidelines for Defining Public Health Research and Public Health Non-Research (Atlanta, GA: CDC, 1999).

See supra notes 2 and 16.

Gawande A. , “Alifesaving checklist,” New York Times (December 30, 2007), available at <http://www.nytimes.com/2007/12/30/opinion/30gawande.html?_r=1&ref=opinion&oref=slogin> (last visited December 6, 2012).

See supra note 7.

Baily M. A. , “Special Report: The Ethics of using QI Methods to Improve Health Care Quality and Safety,” Hastings Center Report 36, no. 4 (2006): S1–S40; Baily M. A. , “Harming Through Protection?” New Engl. J. Med. 358, no. 8 (2008): 768–9; Candib L. M. , “How Turning a QI Project Into ‘Research’ Almost Sank a Great Program,” The Hastings Center Report 37, no. 1 (2007): 26–30; Lynn J. , “The Ethics Of Using Quality Improvement Methods In Health Care,” Annals of Internal Mediane 146, no. 9 (2007): 666–673.

Schrag Z. M. , “The Case Against Ethics Review in the Social Sciences,” Research Ethics 7, no. 4 (2011): 120–131.

Amoroso P. J. and Middaugh J. P. , “Research vs. Public Health: When Does a Study Require IRB Review?” Preventive Medicine 36, no. 2 (2003): 250–253; CSTE, supra note 1; CDC, supra note 16; Hodge Jr. , supra note 1; Perlman , supra note 1.

See supra note 3.

Personal communication from Daniel Lefkowitz, New Jersey FACE Director to author.

Personal communication from Matthew Weinberg, former NJ DOH IRB member to author.

See supra note 2.

See supra note 16. It should be noted that the 1999 CDC policy relied heavily on the regulatory definition of research found at 45 CFR Part 46 and put the onus on the “intent” of both the activity and the investigator. Without additional criteria, the CDC's guidance created a loophole whereby investigators wishing to avoid IRB review could “game the system” by not intending their activity to meet the definition of research. The 2010 CDC policy changes this onus and puts it (rightly) on public health officials to make the determination of what constitutes research or practice. The 2010 policy, while providing several examples, still does not provide precise, determinative criteria for making such a determination. The 1999 CDC policy seemed more philosophical in nature and therefore could be adapted to agencies or institutions beyond CDC. In contrast, the 2010 policy tightens its requirements and guidance to apply only to CDC and its stakeholders.

CSTE, supra note 1; CDC, supra note 16; Hodge Jr. , supra note 1; Perlman , supra note 1.

CSTE, supra note 1; Hodge Jr. , supra note 1.

Personal communications from David Perlman, former NJ DOH Human Research Ethics Program Director and Sean Philpott, former NY DOH IRB member to author.

See supra note 16.

Amoroso and Middaugh , supra note 16; Perlman , supra note 1.

Emanuel E. J. Wood A. , and Fleischman A. , “Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals,” Annals of Internal Medicine 141, no. 4 (2004): 282–291.

See <http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm> (last visited December 16, 2012).

Perlman , supra note 1.

Barnes M. and Florencio P. S. , “Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts,” Journal of Law, Medicine & Ethics 30, no. 3 (2002): 390–402; Levinsky N.G. , “Nonfinancial Conflicts of Interest in Research,” New Engl. J. Med. 347, no. 10 (2002):759–761.

See supra note 3.

Baylis F. , “Heroes in Bioethics,” Hastings Center Report 30, no. 3(2000): 34–39; Baylis F. , “The Olivieri Debacle: Where Were the Heroes of Bioethics,” Journal of Medical Ethics 30 (2004): 44–49; Freedman B. , “Bringing Codes to Newcastle,” in Hoffmaster B. , eds., Clinical Ethics: Theory and Practice (Clifton, NJ: Humana Press, 1989): 125–139; American Society for Bioethics and Humanities, “Proposed Code of Professional Responsibilities of Health Care Ethics Consultants,” available at <http://www.asbh.org/about/content/committees.html> (last visited December 6, 2012).

Sugarman J. Getz K. Speckman J. L. Byrne M. M. Gerson J. , and Emanuel E. J. , “The Cost of Institutional Review Boards In Academic Medical Centers,” New Engl. J. Med. 352, no. 17 (2005): 1825–1827

See supra notes 3 and 25.

See supra note 13.

Emanuel E.J. Wood A. Fleischman A. , supra note 33; Association for the Accreditation of Human Research Protection Programs, “Accreditation Standards,” (2009), available at <http://www.aahrpp.org/Documents/D000230.PDF> (last visited December 6, 2012); Beauchamp T. L. , ‘IOM Report on the System for Protecting Human Research Participants,’ Kennedy Institute of Ethics Journal 12, no. 4, (2002): 389–90.

Section 4.1.15 “Human Research Subjects Protection” of the NIH Grant Policy (http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch4.htm) states: “Costs associated with IRB review of human research protocols are not allowable as direct charges to NIH-funded research unless such costs are not covered by the organization's F&A rate.”

See OHRP policy guidance memo, available at <http://www.hhs.gov/ohrp/policy/local.html> (last visited December 6, 2012).

The author wishes to acknowledge the second anonymous peer reviewer for suggesting this additional disadvantage.

See ANPRM, Question 28, available at <http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm> (last visited December 6, 2012).

See supra note 5.

See supra note 42.