{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,3,31]],"date-time":"2022-03-31T02:13:15Z","timestamp":1648692795226},"reference-count":48,"publisher":"Cambridge University Press (CUP)","issue":"4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":3288,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2012,1,1]],"date-time":"2012-01-01T00:00:00Z","timestamp":1325376000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2012]]},"abstract":"<jats:p>A number of unique problems plague human research protection efforts at United States (US) State and Territorial Departments of Health (DOHs). The first problem is related to the number of Institutional Review Boards (IRBs) operated by and Federalwide Assurances (FWAs) held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and regulations at DOHs. Parsing public health activities into research or practice (1) can be vexing and (2) likely produces variability in (a) how individual DOHs make the determination between research and practice and (b) the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board (IRB) officials might misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences.<\/jats:p>","DOI":"10.1111\/j.1748-720x.2012.00727.x","type":"journal-article","created":{"date-parts":[[2015,10,13]],"date-time":"2015-10-13T10:27:31Z","timestamp":1444732051000},"page":"997-1007","update-policy":"http:\/\/dx.doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB"],"prefix":"10.1017","volume":"40","author":[{"given":"David","family":"Perlman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500017721_bib26","unstructured":"26. See supra note 2."},{"key":"S1073110500017721_bib10","volume-title":"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research","year":"1979"},{"key":"S1073110500017721_bib4","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.20.2701"},{"key":"S1073110500017721_bib29","unstructured":"29. CSTE, supra note 1; Hodge, Jr. , supra note 1."},{"key":"S1073110500017721_bib22","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-7435(02)00061-0"},{"key":"S1073110500017721_bib33","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-141-4-200408170-00008"},{"key":"S1073110500017721_bib8","unstructured":"8. 21 CFR \u00a7 50 at 45 FR \u00a7 36390 (May 30, 1980); 21 CFR \u00a7 54 at 3 FR \u00a7 5250 (February 2, 1998); 21 CFR \u00a7 56 at 46 FR \u00a7 8975 (January 27, 1981)."},{"key":"S1073110500017721_bib14","unstructured":"14. 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. , \u2018To Protect and Serve: Public Health Law Research to Guide Human Research Protections Reforms at US Departments of Health."},{"key":"S1073110500017721_bib28","unstructured":"28. CSTE, supra note 1; CDC, supra note 16; Hodge, Jr. , supra note 1; Perlman, , supra note 1."},{"key":"S1073110500017721_bib47","unstructured":"47. See supra note 5."},{"key":"S1073110500017721_bib48","unstructured":"48. See supra note 42."},{"key":"S1073110500017721_bib23","unstructured":"23. See supra note 3."},{"key":"S1073110500017721_bib18","unstructured":"18. Gawande, A. , \u201cAlifesaving checklist,\u201d 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)."},{"key":"S1073110500017721_bib41","unstructured":"41. See supra note 13."},{"key":"S1073110500017721_bib1","volume-title":"Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Decisions","author":"Hodge","year":"2004"},{"key":"S1073110500017721_bib39","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200504283521723"},{"key":"S1073110500017721_bib27","unstructured":"27. 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 \u201cintent\u201d 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 \u201cgame the system\u201d 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."},{"key":"S1073110500017721_bib32","unstructured":"32. Amoroso, and Middaugh, , supra note 16; Perlman, , supra note 1."},{"key":"S1073110500017721_bib17","unstructured":"17. See supra notes 2 and 16."},{"key":"S1073110500017721_bib30","unstructured":"30. Personal communications from David Perlman, former NJ DOH Human Research Ethics Program Director and Sean Philpott, former NY DOH IRB member to author."},{"key":"S1073110500017721_bib9","unstructured":"9. Department of Health, Education, and Welfare (DHEW), National Research Act of 1974, Title II, Public Law 93\u2013348, 1974."},{"key":"S1073110500017721_bib25","unstructured":"25. Personal communication from Matthew Weinberg, former NJ DOH IRB member to author."},{"key":"S1073110500017721_bib43","unstructured":"43. Section 4.1.15 \u201cHuman Research Subjects Protection\u201d of the NIH Grant Policy (http:\/\/grants.nih.gov\/grants\/policy\/nihgps_2010\/nihgps_ch4.htm) states: \u201cCosts 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.\u201d"},{"key":"S1073110500017721_bib24","unstructured":"24. Personal communication from Daniel Lefkowitz, New Jersey FACE Director to author."},{"key":"S1073110500017721_bib11","unstructured":"11. 1962 Kefauver-Harris amendments to the 1938 Food, Drug, and Cosmetic Act (Public Law 87\u2013781; 76 Stat. 788\u201389)."},{"key":"S1073110500017721_bib3","first-page":"3","article-title":"\u201cSpeaking Truth to Power: Another Reason Why Bioethics Needs a Code of Ethics,\u201d","volume":"11","author":"Perlman","year":"2008","journal-title":"ASBH Exchange"},{"key":"S1073110500017721_bib42","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1353\/ken.2002.0021","article-title":"\u2018IOM Report on the System for Protecting Human Research Participants,\u2019","volume":"12","author":"Emanuel","year":"2002","journal-title":"Kennedy Institute of Ethics Journal"},{"key":"S1073110500017721_bib44","unstructured":"44. See OHRP policy guidance memo, available at <http:\/\/www.hhs.gov\/ohrp\/policy\/local.html> (last visited December 6, 2012)."},{"key":"S1073110500017721_bib16","volume-title":"Distinguishing Public Health Research and Public Health Nonresearch","year":"2010"},{"key":"S1073110500017721_bib37","unstructured":"37. See supra note 3."},{"key":"S1073110500017721_bib2","unstructured":"2. CSTE, id."},{"key":"S1073110500017721_bib6","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-720X.2011.00558.x"},{"key":"S1073110500017721_bib36","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-720X.2002.tb00408.x"},{"key":"S1073110500017721_bib31","unstructured":"31. See supra note 16."},{"key":"S1073110500017721_bib5","unstructured":"5. See <http:\/\/www.hhs.gov\/ohrp\/humansubjects\/anprm-2011page.html> (last visited December 6, 2012)."},{"key":"S1073110500017721_bib7","doi-asserted-by":"publisher","DOI":"10.1002\/j.1477-8696.1991.tb05696.x"},{"key":"S1073110500017721_bib19","unstructured":"19. See supra note 7."},{"key":"S1073110500017721_bib12","volume-title":"Ethical and Policy Issues in Research Involving Human Participants","author":"Schwartz","year":"2001"},{"key":"S1073110500017721_bib21","doi-asserted-by":"publisher","DOI":"10.1177\/174701611100700402"},{"key":"S1073110500017721_bib20","doi-asserted-by":"publisher","DOI":"10.1353\/hcr.2006.0054"},{"key":"S1073110500017721_bib15","unstructured":"15. See supra note 2."},{"key":"S1073110500017721_bib13","volume-title":"\u201cPreliminary Analysis of the Research Ethics Infrastructure at US and Territorial Departments of Health for Making the Distinction between Public Health Research and Practice,\u201d","author":"Perlman","year":"2011"},{"key":"S1073110500017721_bib45","unstructured":"45. The author wishes to acknowledge the second anonymous peer reviewer for suggesting this additional disadvantage."},{"key":"S1073110500017721_bib38","doi-asserted-by":"publisher","DOI":"10.2307\/3528045"},{"key":"S1073110500017721_bib40","unstructured":"40. See supra notes 3 and 25."},{"key":"S1073110500017721_bib46","unstructured":"46. 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)."},{"key":"S1073110500017721_bib35","unstructured":"35. Perlman, , supra note 1."},{"key":"S1073110500017721_bib34","unstructured":"34. 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