Institutional review boards purpose and challenges

Chest

Volumn 148, Issue 5, 2015, Pages 1148-1155

  Grady, Christine ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; INFORMED CONSENT; INSTITUTIONAL REVIEW; LAW; PATIENT RIGHT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS; REVIEW; UNITED STATES; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD;

BIOMEDICAL RESEARCH; ETHICS COMMITTEES, RESEARCH; HUMANS; UNITED STATES;

EID: 84946606782     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.15-0706     Document Type: Article

References (71)

1. McCarthy C. The origins and policies that govern institutional review boards. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008: 541-550.
2. US Code of Federal Regulations. Title 45CFR, part 46. http://www. hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed January 5, 2015.
3. US Code of Federal Regulations. Title 21CFR, part 56. http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart556. Accessed January 5, 2015.
4. US Code of Federal Regulations. Title 45CFR.46.101 (h).
5. US Code of Federal Regulations. Title 21 CFR 312.120; guidance for industry and FDA staff FDA acceptance of foreign clinical studies not conducted under an IND frequently asked questions. US Food and Drug Administration website. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf. Accessed April 12, 2015.
6. US Department of Health and Human Services. Office of Human Research Protections (OHRP). International compilation of human subjects standards. US Department of Health and Human Services website. http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html. Accessed March 1, 2015.
7. ICH guidelines: E6. good clinical practice. International Conference on Harmonisation website. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinicalpractice. html. Accessed February 2, 2015.
8. Riis P. Letter from..Denmark. Planning of scientific-ethical committees. BMJ. 1977; 2 (6080): 173-174.
9. 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, DC: Department of Health Education and Welfare; 1979. DHEW Publication OS 78-0012 1978.
10. Bowen A. Models of institutional review board function. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008: 552-559.
11. Office of Human Subjects Protection. Advanced notice of proposed rulemaking (ANPRM) for revision to Common Rule. US Department of Health and Human Services website. http://www. hhs.gov/ohrp/humansubjects/anprm2011page.html. 2011. Accessed February 10, 2015.
12. Emanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects. N Engl J Med. 2011; 365 (12): 1145-1150.
13. Office of Human Research Protections. IRBs and assurances. US Department of Health and Human Services website. http://www. hhs.gov/ohrp/assurances/index.html. Accessed February 2, 2015.
14. Office of Budget: appropriations history by institute/center (1938 to present). National Institutes of Health, Office of Budget website. http://officeofb udget.od.nih.gov/approp-hist.html. Accessed March 3, 2015.
15. Pharmaceutical R&D and the evolving market for prescription drugs. Congressional Budget Office website. http://www.cbo.gov/sites/default/files/cbofiles/ft pdocs/106xx/doc10681/10-26-drugr&d. pdf. 2009. Accessed March 3, 2015.
16. Mascette AM, Bernard GR, Dimichele D, et al. Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's report on optimizing the IRB process. Acad Med. 2012; 87 (12): 1710-1714.
17. Association for the Accreditation of Human Research Protection Programs. 2013 Metrics on Human Research Protection Program Performance. Washington, DC: Association for the Accreditation of Human Research Protection Programs; 2014.
18. Commercial institutional review boards (IRBs). Citizens for Responsible Care and Research website. http://www.circare.org/info/commercialirb.htm. Accessed March 3, 2015.
19. Fost N, Levine RJ. The dysregulation of human subjects research. JAMA. 2007; 298 (18): 2196-2198.
20. Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med. 2001; 134 (2): 152-157.
21. Gunsalus CK, Bruner EM, Burbules NC, et al. Mission creep in the IRB world. Science. 2006; 312 (5779): 1441.
22. Weil C, Rooney L, McNeilly P, Cooper K, Borror K, Andreason P. OHRP compliance oversight letters: an update. IRB. 2010; 32 (2): 1-6.
23. Infectious Diseases Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Clin Infect Dis. 2009; 49 (3): 328-335.
24. Silberman G, Kahn KL. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q. 2011; 89 (4): 599-627.
25. Whitney SN, Alcser K, Schneider C, McCullough LB, McGuire AL, Volk RJ. Principal investigator views of the IRB system. Int J Med Sci. 2008; 5 (2): 68-72.
26. Lemonick M, Goldstein A, Park A. Human guinea pigs. Time. April 22, 2002.
27. Gilbert S. Trials and tribulations. Hastings Cent Rep. 2008; 38 (2): 14-18.
28. McCarthy C. The origins and policies that govern institutional review boards. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008: 550.
29. Cohen IG, Lynch HF, eds. Introduction. H uman Subjects Research Regulation, Perspectives on the Future. Cambridge, MA: MIT Press; 2014: 2.
30. Association of American Medical Colleges. Alternative Models of IRB Review Workshop summary. Washington, DC: Department of Health and Human Services; 2005.
31. Summary of the 2006 National Conference on Alternative IRB Models: optimizing human subject protection. Association of American Medical Colleges website. https://www.aamc.org/download/75240/data/irbconf06rpt.pdf. November 2006. Accessed January 5, 2015.
32. Mascette AM, Bernard GR, Dimichele D, et al. Are central institutional review boards the solution? The National Heart, Lung, and Blood Institute Working Group's report on optimizing the IRB process. Acad Med. 2012; 87 (12): 1710-1714.
33. Federman D, Hanna K, Rodriguez L, eds. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press; 2003.
34. Klitzman R, Appelbaum PS. Research ethics. To protect human subjects, review what was done, not proposed. Science. 2012; 335 (6076): 1576-1577.
35. Wood A, Grady C, Emanuel EJ. Regional ethics organizations for protection of human research participants. Nat Med. 2004; 10 (12): 1283-1288.
36. Kim S, Ubel P, DeVries R. Pruning the regulatory tree. Nature. 2009; 457 (29): 534-535.
37. Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clin Trials. 2013; 10 (4): 560-567.
38. Ledford H. Human-subjects research: trial and error. Nature. 2007; 448 (7153): 530-532.
39. Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med. 2010; 363 (17): 1591-1593.
40. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004; 141 (4): 282-291.
41. Wilfond BS, Magnus D, Antommaria AH, et al. The OHRP and SUPPORT. N Engl J Med. 2013; 368 (25): e36.
42. Fanaroff JM. Ethical support for surfactant, positive pressure, and oxygenation randomized trial (SUPPORT). J Pediatr. 2013; 163 (5): 1498-1499.
43. Speers M. Evaluating the effectiveness of institutional review boards. In: Emanuel E, Grady C, Crouch R, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008: 560-568.
44. Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002; 346 (18): 1405-1408.
45. National Cancer Institute Central IRB Initiative. National Cancer Institute website. https://ncicirb.org/cirb. Accessed March 1, 2015.
46. Graham DG, Spano MS, Manning B. The IRB challenge for practicebased research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007; 20 (2): 181-187.
47. Office of Research and Development. VA central institutional review board (IRB). US Department of Veterans Affairs website. http://www.research.va.gov/programs/pride/cirb. Accessed March 1, 2015.
48. BRANY institutional review board services. Biomedical Research Alliance of New York (BRANY) website. http://www.branyirb.com. Accessed February 3, 2015.
49. Kaufmann P, O'Rourke PP. Central institutional review board review for an academic trial network. Acad Med. 2015; 90(3): 321-323.
50. Transformation solutions: about us. WIRB-Copernicus Group website. http://wcgclinical.com/about-us/transformational-solutions. Accessed March 10, 2015.
51. Why choose Chesapeake IRB? Chesapeake IRB website. https://www.chesapeakeirb.com. Accessed March 10, 2015.
52. Tip sheet 24 relying on an external IRB. Association for the Accreditation of Human Research Protection Programs website. http://www.aahrpp.org/apply/resources/tip-sheets?docSortBy 5 Updated&docFilterBy 5 &docStart 55. Accessed March 10, 2015.
53. http://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Pages/faq.aspx, https://irb.research.chop.edu/irb-relianceagreements, and others.
54. Slutsman J, Hirschfeld S. A federated model of IRB review for multisite studies: a report on the National Children's Study federated IRB initiative. IRB. 2014; 36 (6): 1-6.
55. Request for comments on the draft NIH policy on the use of a single institutional review board for multi-site research. National Institutes of Health website. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-026.html. Published December 3, 2014. Accessed March 2, 2015.
56. Empirical research on ethical issues related to central IRBs and consent for research using clinical records and data (R01). National Institutes of Health website. http://grants.nih.gov/grants/guide/rfafiles/RFA-OD-14-002.html
57. http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-15-002.html. Accessed April 12, 2015.
58. Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS ONE. 2013; 8 (1): e54999.
59. Coleman CH, Bouësseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics. 2008; 9: 6.
60. Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011; 6 (1): 3-19.
61. Lidz CW, Appelbaum PS, Arnold R, et al. How closely do institutional review boards follow the common rule? Acad Med. 2012; 87 (7): 969-974.
62. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004; 291 (4): 476-482.
63. Grady C. Do IRBs protect human research participants? JAMA. 2010; 304 (10): 1122-1123.
64. Presidential Commission for the Study of Bioethical Issues. Further analysis and recommendations: recommendation 5. In: Moral Science: Protecting Participants in Human Subjects Research. http://bioethics.gov/sites/default/files/Moral%20Science%20June%202012. pdf. 2011. Accessed February 10, 2015.
65. Wagner T, Murray C, Goldberg J, Adler J, Abrams J. Costs and benefits of the National Cancer Institute Central Institutional Review Board. J Clin Oncol. 2010; 28 (4): 662-666.
66. Sugarman J, Getz K, Speckman JL, Byrne MM, Gerson J, Emanuel EJ; Consortium to Evaluate Clinical Research Ethics. The cost of institutional review boards in academic medical centers. N Engl J Med. 2005; 352 (17): 1825-1827.
67. Hyman D. Institutional review boards: is this the least worst we can do? Northwestern University Law Review. 2007; 101 (2): 749-774.
68. Taylor P. Introduction to part II-protection of vulnerable populations. In: Cohen G, Lynch H, eds. Human Subjects Research Regulation, Perspectives on the Future. Cambridge, MA: MIT Press; 2014: 63.
69. Presidential Commission for the Study of Bioethical Issues. Recommendation 2. In: Moral Science: Protecting Participants in Human Subjects Research. http://bioethics.gov/sites/default/files/Moral%20 Science%20June%202012.pdf. 2011. Accessed February 10, 2015.
70. US Code of Federal Regulations at 45CFR.46 and 21CFR56.
71. Presidential Commission for the Study of Bioethical Issues. Executive summary. In: Moral Science: Protecting Participants in Human Subjects Research. http://bioethics.gov/sites/default/files/Moral%20 Science%20June%202012.pdf. 2011. Accessed February 10, 2015.