Ethical Issues in Multicenter/Multisite Studies

  • Sana Loue
  • Earl C. Pike


Ethical Issue Technology Transfer Agency Representative Research Partnership Agency Staff 


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  1. Barry, M. (1988). Ethical considerations of human investigation in developing countries: The AIDS dilemma. New England Journal of Medicine, 319, 1081–1083.CrossRefGoogle Scholar
  2. Burman, W.P., Breese, S., Weiss, N., Bock, J., Bernardo, A., & Tuberculosis Trial Consortium. (2003). The effects of a local review on informed consent documents from a multicenter clinical trials consortium. Controlled Clinical Trials, 24, 245–255.PubMedCrossRefGoogle Scholar
  3. Califf, R.M., Morse, M.A., Wittes, J., Goodman, S.N., Nelson, D.K., DeMets, D.L., Iafrate, R.P., Sugarman, J. (2003). Toward protecting the safety of participants in clinical trials. Controlled Clinical Trials, 24, 256–271.PubMedCrossRefGoogle Scholar
  4. Council for International Organizations of Medical Sciences. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: Author.Google Scholar
  5. Council for International Organizations of Medical Sciences. (2005). International Guidelines for Ethical Review of Epidemiological Studies. Geneva, Switzerland: Author.Google Scholar
  6. Emanuel, E.J. (2004). Ending concerns about undue inducement. Journal of Law, Medicine, & Ethics, 32, 100–105.CrossRefGoogle Scholar
  7. Gold, J.L., & Dewa, C.S. (2005). Institutional review boards and multisite studies in health services research: Is there a better way? HSR: Health Services Research, 40(1), 291–307.CrossRefPubMedGoogle Scholar
  8. Hewson, S.A., Weston, J., & Hannah, M.E. (2002). Crossing international boundaries: Implications for the Term Breech Trial data Coordinating Centre. Controlled Clinical Trials, 23, 67–73.PubMedCrossRefGoogle Scholar
  9. Levine, R.J. (1988). Ethics and Regulation of Clinical Research. New Haven, Connecticut: Yale University Press.Google Scholar
  10. Loue, S., Okello, D., & Kawuma, M. (1996). Research bioethics in the Ugandan context: A program summary. Journal of Law, Medicine, & Ethics, 24, 47–53.CrossRefGoogle Scholar
  11. Marshall, P.A. (1992). Research ethics in applied anthropology. IRB: A Review of Human Subjects Research, 14, 1–5.Google Scholar
  12. McWilliams, R.J., Hoover-Fong, A., Hamosh, S., Beck, S., Beaty, T., & Cutting, G. (2003). Problematic variation in local institutional review of a multicenter genetic epidemiology study. Journal of the American Medical Association, 290(3), 360–366.PubMedCrossRefGoogle Scholar
  13. Middle, C., Johnson, A., Petty, T., Sims, L., Macfarlane, A. (1995). Ethics approval for a national postal survey: Recent experience. British Medical Journal, 311, 659–660.PubMedGoogle Scholar
  14. National Consensus Conference on Bioethics and Health Research in Uganda. (1997). Uganda’s Guidelines for the Conduct of Health Research Involving Human Subjects in Uganda. Kampala, Uganda: Author.Google Scholar
  15. Silverman, H., Hull, S.C., & Sugarman, J. (2001). Variability among institutional review boards’ decisions within the context of a multicenter trial. Critical Care Medicine, 29(2), 235–241.PubMedCrossRefGoogle Scholar
  16. Treloar, C. & Graham, I.D. (2003). Multidisciplinary cross-national studies: A commen-tary on issues of collaboration, methodology, analysis, and publication. Qualitative Health Research, 13(7), 924–932.PubMedCrossRefGoogle Scholar
  17. Van Raak, L., Hilton, A., Kessles, F., & Lodder, J. (2002). Implementing the AGASIS trial, an international multicenter acute intervention trial in stroke. Controlled Clinical Trials, 23, 74–79.PubMedCrossRefGoogle Scholar
  18. Weinberger, M., Oddone, E.Z., Henderson, W.G., Smith, D.M., Huey, J., Giobbie-Hurder, A., et al. (2001). Multisite randomized controlled trials in health services research: Scientific challenges and operational issues. Medical Care, 39, 627–634.PubMedCrossRefGoogle Scholar
  19. 45 Code of Federal Regulations 46 (2006).Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Sana Loue
    • 1
  • Earl C. Pike
    • 2
  1. 1.Case Western Reserve UniversityCleveland
  2. 2.AIDS Taskforce of Greater ClevelandCleveland

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