메뉴 건너뛰기




Volumn 14, Issue 5, 2014, Pages 3-8

Fostering IRB Collaboration for Review of International Research

Author keywords

Institutional review board; international research; multinational research; research ethics board; research partnership

Indexed keywords

ETHICS; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL COOPERATION; LEGISLATION AND JURISPRUDENCE; MEDICAL RESEARCH; PROFESSIONAL STANDARD;

EID: 84899627012     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2014.892168     Document Type: Article
Times cited : (18)

References (48)
  • 1
    • 84899648131 scopus 로고    scopus 로고
    • AIDS International Training and Research Program, Available at, (accessed November 30, 2012)
    • AIDS International Training and Research Program. 2012. Dartmouth/MUHAS IRB training collaboration. Available at: http://www.dmsfogarty.org/component/content/article/49- irb (accessed November 30, 2012).
    • (2012) Dartmouth/MUHAS IRB training collaboration
  • 2
    • 27144480342 scopus 로고    scopus 로고
    • Research ethics committees in the UK-The pressure is now on research and development departments
    • Al-Shahi, R. 2005. Research ethics committees in the UK-The pressure is now on research and development departments. Journal of the Royal Society of Medicine 98: 444-447.
    • (2005) Journal of the Royal Society of Medicine , vol.98 , pp. 444-447
    • Al-Shahi, R.1
  • 3
    • 84899629989 scopus 로고    scopus 로고
    • Advance notice of proposed rulemaking: Summary of comments. February 28
    • Available at: Feb Mtg/anprmebartlett.pdf and Feb Mtg/anprmsummaryebartlett.pdf (accessed November 30, 2012)
    • Bartlett, E. 2012. Advance notice of proposed rulemaking: Summary of comments. February 28. Available at: http://www.hhs.gov/ohrp/sachrp/mtgings/2012 Feb Mtg/anprmebartlett.pdf and http://www.hhs.gov/ohrp/sachrp/mtgings/2012 Feb Mtg/anprmsummaryebartlett.pdf (accessed November 30, 2012).
    • (2012)
    • Bartlett, E.1
  • 4
    • 84899633238 scopus 로고    scopus 로고
    • Biomedical Research Alliance of New York, Available at: (accessed November 30, 2012)
    • Biomedical Research Alliance of New York. 2012. BRANY institutional review board services. Available at, (accessed November 30, 2012).
    • (2012) BRANY institutional review board services
  • 5
    • 0036792615 scopus 로고    scopus 로고
    • New governance arrangements for research ethics committees: Is facilitating research achieved at the cost of participants' interest?
    • Cave, E., and S. Holm. 2002. New governance arrangements for research ethics committees: Is facilitating research achieved at the cost of participants' interest? Journal of Medical Ethics 28: 318-321.
    • (2002) Journal of Medical Ethics , vol.28 , pp. 318-321
    • Cave, E.1    Holm, S.2
  • 6
    • 0037007688 scopus 로고    scopus 로고
    • A central institutional review board for multi-institutional trials
    • Christian, M.C., J.L. Goldberg, J. Killen, et al. 2002. A central institutional review board for multi-institutional trials. New England Journal of Medicine 346(18): 1405-1408.
    • (2002) New England Journal of Medicine , vol.346 , Issue.18 , pp. 1405-1408
    • Christian, M.C.1    Goldberg, J.L.2    Killen, J.3
  • 7
    • 84899644792 scopus 로고    scopus 로고
    • Regional workshop: Capacity building for the ethical review committee of health sciences research
    • College of Public Health Sciences and the Ethics Review Committee for Research Involving Human Research Subjects, Health Sciences Group, Chulalongkorn University (ECCU), Available at: (accessed November 30, 2012)
    • College of Public Health Sciences and the Ethics Review Committee for Research Involving Human Research Subjects, Health Sciences Group, Chulalongkorn University (ECCU). 2010. Regional workshop: Capacity building for the ethical review committee of health sciences research. Available at: http://whothailand.healthrepository.org/handle/123456789/603 (accessed November 30, 2012).
    • (2010)
  • 8
    • 0003433351 scopus 로고    scopus 로고
    • International ethical guidelines for biomedical research involving human subjects
    • Council for International Organizations of Medical Sciences, Available at: (accessed November 30, 2012)
    • Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf (accessed November 30, 2012).
    • (2002)
  • 9
    • 84899625658 scopus 로고    scopus 로고
    • Alternative models of IRB review
    • Available at: (accessed November 30, 2012)
    • Davis, A. 2011. Alternative models of IRB review. Available at: http://primr.blogspot.com/2011/12/alternative-models-of-irb-review.html (accessed November 30, 2012).
    • (2011)
    • Davis, A.1
  • 10
    • 20444487609 scopus 로고    scopus 로고
    • Views of US researchers about informed consent in international collaborative research
    • Dawson, L., and N.E. Kass. 2005. Views of US researchers about informed consent in international collaborative research. Social Science & Medicine 61(6): 1211-1222.
    • (2005) Social Science & Medicine , vol.61 , Issue.6 , pp. 1211-1222
    • Dawson, L.1    Kass, N.E.2
  • 11
    • 33745202604 scopus 로고    scopus 로고
    • Partnership as an ethical model for medical research in developing countries: The example of the "Implementation Trial."
    • Dowdy, D.W. 2006. Partnership as an ethical model for medical research in developing countries: The example of the "Implementation Trial." Journal of Medical Ethics 32(6): 357-360.
    • (2006) Journal of Medical Ethics , vol.32 , Issue.6 , pp. 357-360
    • Dowdy, D.W.1
  • 12
    • 80052847587 scopus 로고    scopus 로고
    • Reforming the regulations governing research with human subjects
    • Emanuel, E.J., and J. Menikoff. 2011. Reforming the regulations governing research with human subjects. New England Journal of Medicine 365(12):1145-1150.
    • (2011) New England Journal of Medicine , vol.365 , Issue.12 , pp. 1145-1150
    • Emanuel, E.J.1    Menikoff, J.2
  • 13
    • 4043134573 scopus 로고    scopus 로고
    • Ethics review procedures for research in developing countries: A basic presumption of guilt
    • Gilman, R.H., and H.H. Garcia. 2004. Ethics review procedures for research in developing countries: A basic presumption of guilt. Canadian Medical Association Journal 171(3): 248-249.
    • (2004) Canadian Medical Association Journal , vol.171 , Issue.3 , pp. 248-249
    • Gilman, R.H.1    Garcia, H.H.2
  • 14
    • 60849106348 scopus 로고    scopus 로고
    • Ethical and scientific implications of the globalization of clinical research
    • Glickman, S.W., J.G. McHutchison, E.D. Peterson, et al. 2009. Ethical and scientific implications of the globalization of clinical research. New England Journal of Medicine 360(8): 816-823.
    • (2009) New England Journal of Medicine , vol.360 , Issue.8 , pp. 816-823
    • Glickman, S.W.1    McHutchison, J.G.2    Peterson, E.D.3
  • 15
    • 84855251048 scopus 로고    scopus 로고
    • Partnering to harmonize IRBs for community-engaged research to reduce health disparities
    • Hammatt, Z.H., J. Nishitani, K.C. Heslin, et al. 2011. Partnering to harmonize IRBs for community-engaged research to reduce health disparities. Journal of Health Care for the Poor and Underserved 22(4 SUPPL.): 8-15.
    • (2011) Journal of Health Care for the Poor and Underserved , vol.22 , Issue.4 SUPPL. , pp. 8-15
    • Hammatt, Z.H.1    Nishitani, J.2    Heslin, K.C.3
  • 16
    • 1342287922 scopus 로고    scopus 로고
    • Ethical review of health research: A perspective from developing country researchers
    • Hyder, A. A., S. A. Wali, A. N. Khan, et al. 2004. Ethical review of health research: A perspective from developing country researchers. Journal of Medical Ethics 30: 68-72.
    • (2004) Journal of Medical Ethics , vol.30 , pp. 68-72
    • Hyder, A.A.1    Wali, S.A.2    Khan, A.N.3
  • 17
    • 84864016559 scopus 로고    scopus 로고
    • Mapping African ethical review committee activity onto capacity needs: The MARC initiative and HRWeb's interactive database of RECs in Africa
    • Ijsselmuiden, C., D. Marais, D. Wassenaar, and B. Mokgatla-Moipolai. 2012. Mapping African ethical review committee activity onto capacity needs: The MARC initiative and HRWeb's interactive database of RECs in Africa. Developing World Bioethics 12(2): 74-86.
    • (2012) Developing World Bioethics , vol.12 , Issue.2 , pp. 74-86
    • Ijsselmuiden, C.1    Marais, D.2    Wassenaar, D.3    Mokgatla-Moipolai, B.4
  • 18
    • 84899629571 scopus 로고    scopus 로고
    • Guideline for good clinical practice, E6
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Available at: (accessed November 30, 2012)
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1996. Guideline for good clinical practice, E6. Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html (accessed November 30, 2012).
    • (1996)
  • 19
    • 84899627558 scopus 로고    scopus 로고
    • Innovative solutions for compliance & research management
    • IRBNet, (accessed November 30, 2012)
    • IRBNet. 2012. Innovative solutions for compliance & research management. http//www.irbnet.org (accessed November 30, 2012).
    • (2012)
  • 20
    • 84899647485 scopus 로고    scopus 로고
    • Advancing collaboration
    • IRBshare, (accessed November 30, 2012)
    • IRBshare. 2012. Advancing collaboration. http://www.irbshare.org (accessed November 30, 2012).
    • (2012)
  • 21
    • 33846685968 scopus 로고    scopus 로고
    • The structure and function of research ethics committees in Africa: a case study
    • Kass, N.E., A.A. Hyder, A. Ajuwon, et al. 2007. The structure and function of research ethics committees in Africa: a case study. PLoS Medicine 4(1): e3. doi:10.1371/journal.pmed.0040003
    • (2007) PLoS Medicine , vol.4 , Issue.1
    • Kass, N.E.1    Hyder, A.A.2    Ajuwon, A.3
  • 22
    • 27744569768 scopus 로고    scopus 로고
    • Status of national research bioethics committees in the WHO African region
    • Kirigia, J.M., C. Wambebe, and A. Baba-Moussa. 2005. Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 6: 10-16.
    • (2005) BMC Medical Ethics , vol.6 , pp. 10-16
    • Kirigia, J.M.1    Wambebe, C.2    Baba-Moussa, A.3
  • 23
    • 84864024281 scopus 로고    scopus 로고
    • US IRBs confronting research in the developing world
    • Klitzman, R.L. 2012. US IRBs confronting research in the developing world. Developing World Bioethics 12(2): 63-73.
    • (2012) Developing World Bioethics , vol.12 , Issue.2 , pp. 63-73
    • Klitzman, R.L.1
  • 24
    • 0036292005 scopus 로고    scopus 로고
    • Ethical oversight of public health research: Can rules and IRBs make a difference in developing countries?
    • London, L. 2002. Ethical oversight of public health research: Can rules and IRBs make a difference in developing countries? American Journal of Public Health 92(7): 1079-1084.
    • (2002) American Journal of Public Health , vol.92 , Issue.7 , pp. 1079-1084
    • London, L.1
  • 25
    • 0035279382 scopus 로고    scopus 로고
    • After Helsinki: Unresolved issues in international research
    • Macklin, R. 2001. After Helsinki: Unresolved issues in international research. Kennedy Institute of Ethics Journal 11(1): 17-36.
    • (2001) Kennedy Institute of Ethics Journal , vol.11 , Issue.1 , pp. 17-36
    • Macklin, R.1
  • 26
    • 34247644846 scopus 로고    scopus 로고
    • Debate over institutional review boards continues as alternative options emerge
    • McNeil, C. 2007. Debate over institutional review boards continues as alternative options emerge. Journal of the National Cancer Institute 99(7): 502-503.
    • (2007) Journal of the National Cancer Institute , vol.99 , Issue.7 , pp. 502-503
    • McNeil, C.1
  • 27
    • 4344675041 scopus 로고    scopus 로고
    • Considerations for preparing collaborative international research: A Ugandan experience
    • Musil, C.M., J. Mutabaazi, M. Walusimbi, et al. 2004. Considerations for preparing collaborative international research: A Ugandan experience. Applied Nursing Research 17(3): 195-200.
    • (2004) Applied Nursing Research , vol.17 , Issue.3 , pp. 195-200
    • Musil, C.M.1    Mutabaazi, J.2    Walusimbi, M.3
  • 28
    • 0003732182 scopus 로고    scopus 로고
    • Ethical and policy issues in international research: Clinical trials in developing countries, Vol. 1
    • National Bioethics Advisory Commission, Available at: (accessed November 30, 2012)
    • National Bioethics Advisory Commission. 2001. Ethical and policy issues in international research: Clinical trials in developing countries, Vol. 1. Available at: http://bioethics.georgetown.edu/nbac/human/overvol1.pdf (accessed November 30, 2012).
    • (2001)
  • 29
    • 0003958446 scopus 로고    scopus 로고
    • The ethics of clinical research in developing countries
    • Nuffield Council on Bioethics, Available at: http://www.nuffieldbioethics.org/sites/default/files/files/Clinical%20research%20in%20developing % 20countries % 20Discussion % 20Paper.pdf (accessed November 30, 2012)
    • Nuffield Council on Bioethics. 1999. The ethics of clinical research in developing countries. Available at: http://www.nuffieldbioethics.org/sites/default/files/files/Clinical%20research%20in%20developing % 20countries % 20Discussion % 20Paper.pdf (accessed November 30, 2012).
    • (1999)
  • 30
    • 84875743416 scopus 로고    scopus 로고
    • Philippine Council for Health Research and Development, Available at, (accessed November 30, 2012)
    • Philippine Council for Health Research and Development. 2006. National Ethical Guidelines for Research. Available at: https://webapps.sph.harvard.edu/live/gremap/files/ph_natl_ethical_gdlns.pdf (accessed November 30, 2012).
    • (2006) National Ethical Guidelines for Research
  • 31
    • 84859470621 scopus 로고    scopus 로고
    • Streamlining scientific and ethics review of multi-center health and medical research in Australia: Report to the National Health and Medical Research Council
    • Available at: (accessed May 1, 2013)
    • Pittman, K. 2007. Streamlining scientific and ethics review of multi-center health and medical research in Australia: Report to the National Health and Medical Research Council. Available at: http://www.nhmrc.gov.au/health-ethics/national-approach-single-ethical-review (accessed May 1, 2013).
    • (2007)
    • Pittman, K.1
  • 32
    • 79952764879 scopus 로고    scopus 로고
    • Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership?
    • Ravinetto, R., A. Buvé, T. Halidou, et al. 2011. Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership? Tropical Medicine and International Health 16(4): 527-530.
    • (2011) Tropical Medicine and International Health , vol.16 , Issue.4 , pp. 527-530
    • Ravinetto, R.1    Buvé, A.2    Halidou, T.3
  • 33
    • 84899630596 scopus 로고    scopus 로고
    • The globalization of research ethics committees: Paternalism, ethical imperialism or partnership
    • Available at: (accessed November 30, 2012)
    • Rennie, S. 2011. The globalization of research ethics committees: Paternalism, ethical imperialism or partnership. Available at: http://globalbioethics.blogspot.com/2011/04/globalization-of-research-ethics.html (accessed November 30, 2012).
    • (2011)
    • Rennie, S.1
  • 34
    • 33645229263 scopus 로고    scopus 로고
    • Universal declaration on bioethics and human rights
    • United Nations Educational, Scientific and Cultural Organization, Available at: http://portal.unesco.org/en/ev.php-URL_ID=31058&URL _ DO = DO _ TOPIC & URL _ SECTION = 201. html (accessed November 30, 2012)
    • United Nations Educational, Scientific and Cultural Organization. 2005. Universal declaration on bioethics and human rights. Available at: http://portal.unesco.org/en/ev.php-URL_ID=31058&URL _ DO = DO _ TOPIC & URL _ SECTION = 201. html (accessed November 30, 2012).
    • (2005)
  • 35
    • 80052857705 scopus 로고    scopus 로고
    • Advanced notice of proposed rulemaking: Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay and ambiguity for investigators
    • U.S. Department of Health and Human Services
    • U.S. Department of Health and Human Services. 2011. Advanced notice of proposed rulemaking: Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay and ambiguity for investigators. Federal Register 76: 44512-44531.
    • (2011) Federal Register , vol.76 , pp. 44512-44531
  • 36
    • 41149152920 scopus 로고    scopus 로고
    • Protection of human subjects
    • U.S. Department of Health and Human Services, Title 45, Part 46. Available at: (accessed November 30, 2012)
    • U.S. Department of Health and Human Services. 2012. Protection of human subjects. Code of Federal Regulations,. Title 45, Part 46. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (accessed November 30, 2012).
    • (2012) Code of Federal Regulations
  • 37
    • 51349156582 scopus 로고    scopus 로고
    • Guidance for industry: Using a centralized IRB review process in multicenter clinical trials
    • U.S. Department of Health and Human Services, Food and Drug Administration, Available at: (accessed November 30, 2012)
    • U.S. Department of Health and Human Services, Food and Drug Administration. 2006. Guidance for industry: Using a centralized IRB review process in multicenter clinical trials. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm (accessed November 30, 2012).
    • (2006)
  • 38
    • 41149152920 scopus 로고    scopus 로고
    • Protection of human subjects
    • U.S. Department of Health and Human Services, Food and Drug Administration, Title 21, Part 50. Available at: = 50 (accessed November 30, 2012)
    • U.S. Department of Health and Human Services, Food and Drug Administration. 2012. Protection of human subjects. Code of Federal Regulations,. Title 21, Part 50. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart = 50 (accessed November 30, 2012).
    • (2012) Code of Federal Regulations
  • 39
    • 84899657565 scopus 로고    scopus 로고
    • National Conference on Alternative IRB Models: Optimizing human subject protection
    • U.S. Department of Health and Human Services, Office of Human Research Protections, National Institutes of Health, Association of American Medical Colleges, American Society of Clinical Oncology, and Department of Veteran's Affairs, Available at: https:// (accessed November 30, 2012)
    • U.S. Department of Health and Human Services, Office of Human Research Protections, National Institutes of Health, Association of American Medical Colleges, American Society of Clinical Oncology, and Department of Veteran's Affairs. 2006. National Conference on Alternative IRB Models: Optimizing human subject protection. Available at: https://www.aamc.org/download/75240/data/irbconf06rpt.pdf (accessed November 30, 2012).
    • (2006)
  • 40
    • 84899649748 scopus 로고    scopus 로고
    • Research portfolio online reporting tool (RePORT). Project number 1S07TW008852-01. Enhanced collaborative ethics committee review of research proposals
    • U.S. Department of Health and Human Services, National Institutes of Health, Available at: (accessed November 30, 2012)
    • U.S. Department of Health and Human Services, National Institutes of Health. 2012a. Research portfolio online reporting tool (RePORT). Project number 1S07TW008852-01. Enhanced collaborative ethics committee review of research proposals. Available at: http://projectreporter.nih.gov/project_info_description.cfm?aid=8051319&icde=0 (accessed November 30, 2012).
    • (2012)
  • 41
    • 84899627203 scopus 로고    scopus 로고
    • Research portfolio online reporting tool (RePORT). Project number 1S07TW008850-01. Building a joint international IRB for Moi University and Indiana University
    • U.S. Department of Health and Human Services, National Institutes of Health, Available at: (accessed November 30, 2012)
    • U.S. Department of Health and Human Services, National Institutes of Health. 2012b. Research portfolio online reporting tool (RePORT). Project number 1S07TW008850-01. Building a joint international IRB for Moi University and Indiana University. Available at: http://projectreporter.nih.gov/project_info_description.cfm?aid=8051263 (accessed November 30, 2012).
    • (2012)
  • 42
    • 84899644593 scopus 로고    scopus 로고
    • Alternative models of IRB review (workshop summary report)
    • U.S. National Institutes of Health, Department of Health and Human Services, Office of Human Research Protections, Association of American Medical Colleges, and American Society of Clinical Oncology, Available at: (accessed November 30, 2012)
    • U.S. National Institutes of Health, Department of Health and Human Services, Office of Human Research Protections, Association of American Medical Colleges, and American Society of Clinical Oncology. 2005. Alternative models of IRB review (workshop summary report). Available at: http://www.hhs.gov/ohrp/archive/sachrp/documents/AltModIRB.pdf (accessed November 30, 2012).
    • (2005)
  • 43
    • 84899647315 scopus 로고    scopus 로고
    • Streamlining the IRB process
    • Available at: (accessed November 30, 2012)
    • Vegoe, E. 2012. Streamlining the IRB process. Available at: http://researchumn.com/2012/04/09/streamlining-the-irb-process (accessed November 30, 2012).
    • (2012)
    • Vegoe, E.1
  • 44
    • 84890132189 scopus 로고    scopus 로고
    • From global bioethics to ethical governance of biomedical research collaborations
    • Wahlberg, A., C. Rehmann-Sutter, M. Sleeboom-Faulkner, et al. 2013. From global bioethics to ethical governance of biomedical research collaborations. Social Science & Medicine 98: 293-300.
    • (2013) Social Science & Medicine , vol.98 , pp. 293-300
    • Wahlberg, A.1    Rehmann-Sutter, C.2    Sleeboom-Faulkner, M.3
  • 45
    • 0033089498 scopus 로고    scopus 로고
    • Guidelines for IRB review of international collaborative medical research: A proposal
    • White, M.T. 1999. Guidelines for IRB review of international collaborative medical research: A proposal. Journal of Law, Medicine & Ethics 27(1): 87-94.
    • (1999) Journal of Law, Medicine & Ethics , vol.27 , Issue.1 , pp. 87-94
    • White, M.T.1
  • 46
    • 11144269775 scopus 로고    scopus 로고
    • Regional ethics organizations for protection of human research participants
    • Wood, A., C. Grady, and E.J. Emanuel. 2004. Regional ethics organizations for protection of human research participants. Nature Medicine 10(12): 1283-1288.
    • (2004) Nature Medicine , vol.10 , Issue.12 , pp. 1283-1288
    • Wood, A.1    Grady, C.2    Emanuel, E.J.3
  • 47
    • 0003807380 scopus 로고    scopus 로고
    • Operational guidelines for ethics committees that review biomedical research
    • World Health Organization, Available at: (accessed November 30, 2012)
    • World Health Organization. 2000. Operational guidelines for ethics committees that review biomedical research. Available at: http://www.who.int/tdr/publications/documents/ethics.pdf (accessed November 30, 2012).
    • (2000)
  • 48
    • 0003491133 scopus 로고    scopus 로고
    • Declaration of Helsinki-Ethical principles for medical research involving human subjects
    • World Medical Association, Available at: (accessed November 30, 2012)
    • World Medical Association. 2008. Declaration of Helsinki-Ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/b3 (accessed November 30, 2012).
    • (2008)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.