Nursing Outlook
Volume 58, Issue 4 , Pages 181-187 , July 2010

Changes in the institutional review board submission process for multicenter research over 6 years

References 

  1. Enfield KB, Truwit JD. The purpose, composition, and function of an institutional review board: balancing priorities. Respir Care. 2008;53:1330–1336
  2. Shaw S, Boynton PM, Greenhalgh T. Research governance: where did it come from, what does it mean?. J R Soc Med. 2005;98:496–502
  3. Beardsmore CS, Westaway JA. The shifting sands of research ethics and governance: effect on research in paediatrics. Arch Dis Child. 2007;92:80–81
  4. Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol. 2006;59:784–790
  5. Greene SM, Geiger AM, Harris EL, Altschuler A, Nekhlyudov L, Barton MB, et al. Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes. Ann Epidemiol. 2006;16:275–278
  6. Office for Human Research Protections (OHRP) Database. Registration of an Institutional Review Board. Available at: http://www.hhs.gov/ohrp/assurances/. Accessed June 19, 2009.
  7. Standards for Privacy of Individually Identifiable Health Information. Final Rule, 45 CFR parts 160 and 164. (Vol. Final Rule, 45 CFR parts 160 and 164.) Available at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/. Accessed June 29, 2009.
  8. Larson E, Bratts T, Zwanziger J, Stone P. A survey of IRB process in 68 U.S. hospitals. J Nurs Sch. 2004;36:260–264
  9. Stone PW, Mooney-Kane C, Larson EL, Horan T, Glance LG, Zwanziger J, et al. Nurse working conditions and patient safety outcomes. Med Care. 2007;45:571–578
  10. Stone PW, Dick A, Pogorzelska M, Horan TC, Furuya EY, Larson E. Staffing and structure of infection prevention and control programs. Am J Infect Control. 2009;27:351–357
  11. Angell E, Sutton AJ, Windridge K, Dixon-Woods M. Consistency in decision making by research ethics committees: a controlled comparison. J Med Ethics. 2006;32:662–664
  12. Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res. 2006;41:214–230
  13. Gold JL, Dewa CS. Institutional review boards and multisite studies in health services research: is there a better way?. Health Serv Res. 2005;40:291–307
  14. Wolf LE, Walden JF, Lo B. Human subjects issues and IRB review in practice-based research. Ann Fam Med. 2005;3:S30–S37
  15. Sugarman J, Getz K, Speckman JL, Byrne M, Gerson J, Emanuel EJ. The cost of institutional review boards in academic medical centers. N Engl J Med. 2005;352:1825–1827
  16. Dickler HB, Korn D. The costs of institutional review boards. N Engl J Med. 2005;353:315–317
  17. Speckman JL, Byrne M, Gerson J, Getz K, Wangsmo G, Muse CT, et al. Determining the costs of Institutional Review Boards. IRB. 2007;29:7–13
  18. Byrne M, Speckman J, Getz K, Sugerman J. Variability in the costs of institutional review board oversight. Acad Med. 2006;81:708–712
  19. Columbia University Human Research Protection Program (HRPP). Home Page. Available at: http://www.cumc.columbia.edu/dept/irb/index.html. Accessed June 19, 2009.
  20. Dixon-Woods M, Ashcroft RE. Regulation and the social licence for medical research. Med Health Care Philos. 2008;11:381–391
  21. Edwards SJ, Kirchin S, Huxtable R. Research ethics committees and paternalism. J Med Ethics. 2004;30:88–91
  22. Garrard E, Dawson A. What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics. J Med Ethics. 2005;31:419–423
  23. Graham DG, Spano MS, Manning B. The IRB challenge for practice-based research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007;20:181–187
  24. Edwards SJ, Stone T, Swift T. Differences between research ethics committees. Int J Technol Assess Health Care. 2007;23:17–23
  25. Wainwright P, Saunders J. What are local issues? The problem of the local review of research. J Med Ethics. 2004;30:313–317
  26. Samanta A, Samanta J. Research governance: panacea or problem?. Clin Med. 2005;5:235–239
  27. Citizens for Responsible Care and Research (CIRCARE). Ethical Codes and Guidelines for the Protection of Human Subjects in Research. Available at http://www.circare.org/info1.htm. Accessed June 19, 2009.
  28. Huang DT, Hadian M. Bench-to-bedside review: human subjects research—are more standards needed?. Crit Care. 2006;10:244
  29. Byerly WG. Working with the institutional review board. Am J Health Syst Pharm. 2009;66:176–184
  30. Pech C, Cob N, Cejka JT. Understanding institutional review boards: practical guidance to the IRB review process. Nutr Clin Pract. 2007;22:618–628
  31. Schwenzer KJ. Practical tips for working effectively with your institutional review board. Respir Care. 2008;53:1354–1361
  32. Sims JM. An introduction to institutional review boards. Dimens Crit Care Nurs. 2008;27:223–225

PII: S0029-6554(10)00245-9

doi: 10.1016/j.outlook.2010.04.003

Nursing Outlook
Volume 58, Issue 4 , Pages 181-187 , July 2010