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Ethics review of multisite studies: the difficult case of community-based Indigenous health research

David M Studdert, Tamara M Vu, Sarah S Fox, Ian P Anderson, Jill E Keeffe and Hugh R Taylor
Med J Aust 2010; 192 (5): 275-280.
  • David M Studdert1
  • Tamara M Vu1
  • Sarah S Fox2,3
  • Ian P Anderson1
  • Jill E Keeffe2,3,4
  • Hugh R Taylor1,4

  • 1 Melbourne School of Population Health, University of Melbourne, Melbourne, VIC.
  • 2 Centre for Eye Research Australia, Melbourne, VIC.
  • 3 Royal Victorian Eye and Ear Hospital, Melbourne, VIC.
  • 4 Vision Cooperative Research Centre, Sydney, NSW.

Correspondence: d.studdert@unimelb.edu.au

Acknowledgements: 

Michelle Mello provided helpful comments on an earlier draft of the manuscript.

Competing interests:

None identified.

  • 1. Weeramanthri T, Currie BJ. Isn’t one institutional ethics committee’s approval enough? Med J Aust 1994; 161: 398-399.
  • 2. Banscott Health Consulting. Report of the review of access to unapproved therapeutic goods. Canberra: Therapeutic Goods Administration, 2005. http://www.tga.gov.au/consult/2005/cltrialrevrep.pdf (accessed Jun 2009).
  • 3. Jamrozik K, Kolybaba M. Are ethics committees retarding the improvement of health services in Australia? Med J Aust 1999; 170: 26-28. <MJA full text>
  • 4. Gold JL, Dewa CS. Institutional review boards and multisite studies in health services research: is there a better way? Health Serv Res 2005; 40: 291-308.
  • 5. Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi institutional trials. N Engl J Med 2002; 346: 1405-1408.
  • 6. Dziak K, Anderson R, Sevick MA, et al. Variations among institutional review board reviews in a multisite health services research study. Health Serv Res 2005; 40: 279-290.
  • 7. Vick CC, Finan KR, Kiefe C, et al. Variation in institutional review processes for a multisite observational study. Am J Surg 2005; 190: 805-809.
  • 8. 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: 214-231.
  • 9. Larson E, Bratts T, Zwanziger J, Stone P. A survey of IRB process in 68 US hospitals. J Nurs Scholarsh 2004; 36: 260-265.
  • 10. Dyrbye LN, Thomas MR, Mechaber AJ, et al. Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions. Acad Med 2007; 82: 654-660.
  • 11. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards’ decisions within the context of a multicenter trial. Crit Care Med 2001; 29: 235-241.
  • 12. Burman W, Breese P, Weis S, et al. The effects of a local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials 2003; 24: 245-255.
  • 13. McWilliams R, Hoover-Fong J, Hamosh A, et al. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003; 290: 360-366.
  • 14. Al-Shahi Salman R, Brock TM, Dennis MS, et al. Research governance impediments to clinical trials: a retrospective survey. J R Soc Med 2007; 100: 101-104.
  • 15. Ah-See KW, Mackenzie J, Thakker NS, Maran AGD. Local research ethics committee approval for a national study in Scotland. J R Coll Surg Edinb 1998; 43: 303-305.
  • 16. Middle C, Johnson A, Petty T, et al. Ethics approval for a national postal survey: recent experience. BMJ 1995; 311: 659-660.
  • 17. Jenkin R, Bennett J, Frommer M, Madronio C. A streamlined national approach to scientific and ethics review of multi-centre health and medical research in Australia: issues and options, 2006. http://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/hrecs/A_streamlined_national_approach_to%20scientific_and_ethics_reviewvof%20multi-centre_health_and_medical_research_in_Australia.pdf (accessed Jan 2010).
  • 18. National Health and Medical Research Council. Harmonisation of Multi-centre Ethical Review (HoMER) enabling system: proposed national approach for the adoption of a single ethical and scientific review for multi-centre health and medical human research. Canberra: NHMRC, 2008. http://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/homer/consultation/homer-consultation-complete.pdf (accessed Jan 2010).
  • 19. National Health and Medical Research Council. Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander research. Canberra: NHMRC, 2003. http://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/human/conduct/guidelines/e52.pdf (accessed Jan 2010).
  • 20. Anderson I. Ethics and health research in Aboriginal communities. In: Daly J, editor. Ethical intersections: health research, methods and researcher responsibility. Sydney: Allen and Unwin, 1996.
  • 21. Griew RM, McAulley D. Review of the interim guidelines on ethical matters in Aboriginal and Torres Strait Islander health: background paper. Canberra: Australian Health Ethics Committee, 2001.
  • 22. Anderson I, Griew R, McAullay D. Ethics guidelines, health research and Indigenous Australians. N Z Bioeth J 2003; 4: 20-29.
  • 23. Humphery K. The development of the National Health and Medical Research Council guidelines on ethical matters in Aboriginal and Torres Strait Islander health research: a brief documentary and oral history. Melbourne: VicHealth Koori Health Research and Community Development Unit, University of Melbourne, 2003. (Discussion Paper No. 8.)
  • 24. National Indigenous Eye Health Survey Team. National Indigenous Eye Health Survey: full report. Melbourne: University of Melbourne, 2009. http://www.cera.org.au/publications/reports/091012%20NIEHS %20Final%20Report%20V2_0d.pdf (accessed Jan 2010).
  • 25. Central Office for Research Ethics Committees. Governance arrangements for NHS research ethics committees. London: COREC, 2001. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727 (accessed Jun 2009).
  • 26. Dunn NR, Arscott A, Mann RD. Costs of seeking ethics approval before and after the introduction of multicenter research ethics committees. J Roy Soc Med 2000; 93: 511-512.
  • 27. Tully J, Ninis N, Booy R, Viner R. The new system of review by multicenter research ethics committees: Prospective study. BMJ 2000; 320: 1179-1182.
  • 28. Al-Shahi R. Research ethics committees in the UK — the pressure is now on research and development departments. J Roy Soc Med 2005; 98: 444-447.
  • 29. National Health and Medical Research Council. National statement on ethical conduct in human research. Canberra: NHMRC, 2007. http://www.nhmrc.gov.au/publications/synopses/e72syn.htm (accessed Jun 2009).
  • 30. National Health and Medical Research Council. Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics. Canberra: NHMRC, 2005. http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e65.pdf (accessed Jun 2009).
  • 31. Taylor HR, Fox SS. Ethical hurdles in Indigenous research. Aust N Z J Public Health 2008; 32: 489-490.

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