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Volumn 12, Issue , 2011, Pages

When is informed consent required in cluster randomized trials in health research?

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLUSTER ANALYSIS; HEALTH PRACTITIONER; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; QUESTIONNAIRE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; STUDY DESIGN; ETHICS; METHODOLOGY;

EID: 80052601465     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-202     Document Type: Article
Times cited : (84)

References (37)
  • 2
    • 0033594688 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of cluster randomised controlled trials
    • 1115783, 10334756
    • Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999, 318(7195):1407-9. 1115783, 10334756.
    • (1999) BMJ , vol.318 , Issue.7195 , pp. 1407-1409
    • Edwards, S.J.1    Braunholtz, D.A.2    Lilford, R.J.3    Stevens, A.J.4
  • 4
    • 14744306281 scopus 로고    scopus 로고
    • London UK, date accessed: July 24, 2011, U.K. Medical Research Council
    • U.K. Medical Research Council Cluster Randomized Trials: Methodological and Ethical Considerations 2002, London UK, date accessed: July 24, 2011, U.K. Medical Research Council., http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=8241&dDocName=MRC002406&allowInterrupt=1
    • (2002) Cluster Randomized Trials: Methodological and Ethical Considerations
  • 5
    • 18344367627 scopus 로고    scopus 로고
    • Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care
    • 10.1191/1740774505cn070oa, 16279130
    • Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care. Clin Trials 2005, 2(2):91-8. 10.1191/1740774505cn070oa, 16279130.
    • (2005) Clin Trials , vol.2 , Issue.2 , pp. 91-98
    • Eldridge, S.M.1    Ashby, D.2    Feder, G.S.3
  • 6
    • 80053337587 scopus 로고    scopus 로고
    • Factors associated with reporting of patient consent in healthcare cluster randomized trials
    • University of Western Ontario, Department of Epidemiology and Biostatistics, London ON
    • McRae AD. Factors associated with reporting of patient consent in healthcare cluster randomized trials. Ethical Challenges in Cluster Randomized Trials. PhD Thesis 2011, University of Western Ontario, Department of Epidemiology and Biostatistics, London ON.
    • (2011) Ethical Challenges in Cluster Randomized Trials. PhD Thesis
    • McRae, A.D.1
  • 10
    • 0010062732 scopus 로고
    • Three theories of informed consent: philosophical foundations and policy implications
    • Washington: US Government Printing Office
    • Veatch RM. Three theories of informed consent: philosophical foundations and policy implications. The Belmont Report. Appendix (Volume 2) 1979, 26:1-66. Washington: US Government Printing Office.
    • (1979) The Belmont Report. Appendix (Volume 2) , vol.26 , pp. 1-66
    • Veatch, R.M.1
  • 11
    • 0016538817 scopus 로고
    • A moral theory of informed consent
    • Freedman B. A moral theory of informed consent. Hastings Cent Rep 1975, 5:(4):32-9.
    • (1975) Hastings Cent Rep , vol.5 , Issue.4 , pp. 32-9
    • Freedman, B.1
  • 12
    • 0003823374 scopus 로고    scopus 로고
    • Washington USA, date accessed July 24, 2011, Department of Health and Human Services
    • Department of Health and Human Services Protection of Human Subjects 2005, Washington USA, date accessed July 24, 2011, Department of Health and Human Services., http://ohsr.od.nih.gov/guidelines/45cfr46.html
    • (2005) Protection of Human Subjects
  • 13
    • 84937030792 scopus 로고    scopus 로고
    • Ottawa Canada, date accessed: July 24, 2011, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council
    • , . Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans 2010, Ottawa Canada, date accessed: July 24, 2011, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council., http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf
    • (2010) Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans
  • 14
    • 0003491133 scopus 로고    scopus 로고
    • Ferney-Voltaire France, date accessed: July 24, 2011, World Medical Association
    • World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 2008, Ferney-Voltaire France, date accessed: July 24, 2011, World Medical Association., http://www.wma.net/en/30publications/10policies/b3/index.html
    • (2008) Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
  • 15
    • 0003433351 scopus 로고    scopus 로고
    • Geneva Switzerland, date accessed: July 24, 2011, Council of International Organizations of Medical Science
    • Council of International Organizations of Medical Science International Ethical Guidelines for Biomedical Research Involving Human Subjects 2002, Geneva Switzerland, date accessed: July 24, 2011, Council of International Organizations of Medical Science., http://www.cioms.ch/publications/layout_guide2002.pdf
    • (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • 16
    • 0035866022 scopus 로고    scopus 로고
    • Are distinctive ethical principles required for cluster randomized controlled trials?
    • 10.1002/1097-0258(20010215)20:3<473::AID-SIM805>3.0.CO;2-D, 11180314
    • Hutton JL. Are distinctive ethical principles required for cluster randomized controlled trials?. Stat Med 2001, 20(3):473-88. 10.1002/1097-0258(20010215)20:3<473::AID-SIM805>3.0.CO;2-D, 11180314.
    • (2001) Stat Med , vol.20 , Issue.3 , pp. 473-488
    • Hutton, J.L.1
  • 17
    • 0033867561 scopus 로고    scopus 로고
    • Indoor residual spraying with alphacypermethrin controls malaria in Pakistan: a community-randomized trial
    • 10.1046/j.1365-3156.2000.00581.x, 10964269
    • Rowland M, Mahmood P, Iqbal J, Carneiro A, Chavasse D. Indoor residual spraying with alphacypermethrin controls malaria in Pakistan: a community-randomized trial. Trop Med Int Health 2000, 5(7):472-81. 10.1046/j.1365-3156.2000.00581.x, 10964269.
    • (2000) Trop Med Int Health , vol.5 , Issue.7 , pp. 472-481
    • Rowland, M.1    Mahmood, P.2    Iqbal, J.3    Carneiro, A.4    Chavasse, D.5
  • 18
    • 34250621200 scopus 로고    scopus 로고
    • Canberra Australia, date accessed: July 24, 2011, National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors' Committee
    • , . National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors' Committee National Statement on Ethical Conduct in Human Research 2007, Canberra Australia, date accessed: July 24, 2011, National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors' Committee., http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
    • (2007) National Statement on Ethical Conduct in Human Research
  • 19
    • 0003823374 scopus 로고    scopus 로고
    • Washington USA, date accessed July 24, 2011, Department of Health and Human Services
    • Department of Health and Human Services Protection of Human Subjects. 46.116(d) 2005, Washington USA, date accessed July 24, 2011, Department of Health and Human Services., http://ohsr.od.nih.gov/guidelines/45cfr46.html
    • (2005) Protection of Human Subjects. 46.116(d)
  • 20
    • 0003823374 scopus 로고    scopus 로고
    • Washington USA, date accessed July 24, 2011, Department of Health and Human Services
    • Department of Health and Human Services Protection of Human Subjects. 46.102(i) 2005, Washington USA, date accessed July 24, 2011, Department of Health and Human Services., http://ohsr.od.nih.gov/guidelines/45cfr46.html
    • (2005) Protection of Human Subjects. 46.102(i)
  • 21
    • 0027569844 scopus 로고
    • In loco parentis: minimal risk as an ethical threshold for research upon children
    • 10.2307/3562813, 8307741
    • Freedman B, Fuks A, Weijer C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Cent Rep 1993, 23(2):13-9. 10.2307/3562813, 8307741.
    • (1993) Hastings Cent Rep , vol.23 , Issue.2 , pp. 13-19
    • Freedman, B.1    Fuks, A.2    Weijer, C.3
  • 23
    • 0003568396 scopus 로고    scopus 로고
    • Rockville, MD: National Bioethics Advisory Commission, National Bioethics Advisory Commission
    • National Bioethics Advisory Commission Research Involving Human Biological Materials: Ethical Issues and Policy Guidance: 1999, Rockville, MD: National Bioethics Advisory Commission, National Bioethics Advisory Commission.
    • (1999) Research Involving Human Biological Materials: Ethical Issues and Policy Guidance:
  • 25
    • 60349122668 scopus 로고    scopus 로고
    • Ethical issues in implementation research: a discussion of the problems in achieving informed consent
    • Hutton JL, Eccles MP, Grimshaw JM. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implementation Sci 2008, 3:52.
    • (2008) Implementation Sci , vol.3 , pp. 52
    • Hutton, J.L.1    Eccles, M.P.2    Grimshaw, J.M.3
  • 26
    • 0030966539 scopus 로고    scopus 로고
    • Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?
    • 10.1016/S0895-4356(96)00422-2, 9179102
    • Winkens RA, Knottnerus JA, Kester AD, Grol RP, Pop P. Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?. J Clin Epidemiol 1997, 50(4):435-9. 10.1016/S0895-4356(96)00422-2, 9179102.
    • (1997) J Clin Epidemiol , vol.50 , Issue.4 , pp. 435-439
    • Winkens, R.A.1    Knottnerus, J.A.2    Kester, A.D.3    Grol, R.P.4    Pop, P.5
  • 27
    • 0141639672 scopus 로고    scopus 로고
    • Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals
    • 10.1136/bmj.327.7418.785, 214092, 14525877
    • Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ 2003, 327(7418):785-9. 10.1136/bmj.327.7418.785, 214092, 14525877.
    • (2003) BMJ , vol.327 , Issue.7418 , pp. 785-789
    • Puffer, S.1    Torgerson, D.2    Watson, J.3
  • 28
    • 1442354585 scopus 로고    scopus 로고
    • Pitfalls of and controversies in cluster randomization trials
    • 10.2105/AJPH.94.3.416, 1448267, 14998805
    • Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004, 94(3):416-22. 10.2105/AJPH.94.3.416, 1448267, 14998805.
    • (2004) Am J Public Health , vol.94 , Issue.3 , pp. 416-422
    • Donner, A.1    Klar, N.2
  • 29
    • 33644994477 scopus 로고    scopus 로고
    • Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial
    • 10.1016/S0140-6736(06)68381-5, 2367116, 16546539
    • Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet 2006, 367(9514):910-8. 10.1016/S0140-6736(06)68381-5, 2367116, 16546539.
    • (2006) Lancet , vol.367 , Issue.9514 , pp. 910-918
    • Mullany, L.C.1    Darmstadt, G.L.2    Khatry, S.K.3    Katz, J.4    LeClerq, S.C.5    Shrestha, S.6    Adhikari, R.7    Tielsch, J.M.8
  • 30
    • 0033125035 scopus 로고    scopus 로고
    • Informed consent in school health research: why, how and making it easy
    • 10.1111/j.1746-1561.1999.tb06378.x, 10363220
    • Ross JG, Sundberg EC, Flint KH. Informed consent in school health research: why, how and making it easy. J Sch Health 1999, 69(5):171-6. 10.1111/j.1746-1561.1999.tb06378.x, 10363220.
    • (1999) J Sch Health , vol.69 , Issue.5 , pp. 171-176
    • Ross, J.G.1    Sundberg, E.C.2    Flint, K.H.3
  • 31
    • 33645110837 scopus 로고    scopus 로고
    • Passive consent for clinical research in the age of HIPAA
    • Littenberg B, Maclean CD. Passive consent for clinical research in the age of HIPAA. J Gen Int Med 2006, 21(3):207-11.
    • (2006) J Gen Int Med , vol.21 , Issue.3 , pp. 207-211
    • Littenberg, B.1    Maclean, C.D.2
  • 32
    • 13644266883 scopus 로고    scopus 로고
    • Variations among institutional review board reviews in a multisite health services research study
    • 1361137, 15663713
    • Dziak K, Anderson R, Sevick MA, Weisman CS, Levine DW, Scholle SH. Variations among institutional review board reviews in a multisite health services research study. Health Serv Res 2005, 40:(1):279-90. 1361137, 15663713.
    • (2005) Health Serv Res , vol.40 , Issue.1 , pp. 279-90
    • Dziak, K.1    Anderson, R.2    Sevick, M.A.3    Weisman, C.S.4    Levine, D.W.5    Scholle, S.H.6
  • 33
    • 80053324227 scopus 로고    scopus 로고
    • Chicago USA, date accessed July 24, 2011, American Medical Association
    • American Medical Association AMA's Code of Medical Ethics Chicago USA, date accessed July 24, 2011, American Medical Association., http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml
    • AMA's Code of Medical Ethics
  • 34
    • 80053323964 scopus 로고    scopus 로고
    • Ottawa Canada, date accessed July 24, 2011, Royal College of Physicians and Surgeons of Canada
    • Royal College of Physicians and Surgeons of Canada Using the Framework of Continuing Professional Development Activities 2006, Ottawa Canada, date accessed July 24, 2011, Royal College of Physicians and Surgeons of Canada., http://www.rcpsc.edu/opa/moc-program/2006framework_e.pdf
    • (2006) Using the Framework of Continuing Professional Development Activities
  • 35
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • 10.1056/NEJM198707163170304, 3600702
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987, 317(3):141-5. 10.1056/NEJM198707163170304, 3600702.
    • (1987) N Engl J Med , vol.317 , Issue.3 , pp. 141-145
    • Freedman, B.1
  • 37
    • 34447321819 scopus 로고    scopus 로고
    • Participation in biomedical research is an imperfect moral duty: a response to John Harris
    • 10.1136/jme.2006.017384, 2598131, 17601870
    • Shapshay S, Pimple KD. Participation in biomedical research is an imperfect moral duty: a response to John Harris. J Med Ethics 2007, 33(7):414-7. 10.1136/jme.2006.017384, 2598131, 17601870.
    • (2007) J Med Ethics , vol.33 , Issue.7 , pp. 414-417
    • Shapshay, S.1    Pimple, K.D.2


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