Ethical and policy issues in cluster randomized trials: Rationale and design of a mixed methods research study

Trials

Volumn 10, Issue , 2009, Pages

  Taljaard, Monica ^a,b,c   Weijer, Charles ^c   Grimshaw, Jeremy M ^a,b,c   Brown, Judith Belle ^d   Binik, Ariella ^c   Boruch, Robert ^e   Brehaut, Jamie C ^a,b   Chaudhry, Shazia H ^a,b   Eccles, Martin P ^f   McRae, Andrew ^c,g   Saginur, Raphael ^a,h   Zwarenstein, Merrick ⁱ   Donner, Allan ^c,j  

^a OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^b UNIVERSITY OF OTTAWA   (Canada)

^c UNIVERSITY OF WESTERN ONTARIO   (Canada)

^d WESTERN UNIVERSITY   (Canada)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f NEWCASTLE UNIVERSITY   (United Kingdom)

^g LONDON HEALTH SCIENCES CENTRE   (Canada)

^h UNIVERSITY OF OTTAWA   (Canada)

ⁱ SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^j ROBARTS RESEARCH INSTITUTE   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL STUDY; DOCUMENTATION; HEALTH SURVEY; INTERVENTION STUDY; INTERVIEW; PUBLICATION; QUALITATIVE RESEARCH; QUANTITATIVE STUDY; RANDOMIZATION; RESEARCH ETHICS; SAMPLE SIZE; SYSTEMATIC REVIEW; ETHICS; HEALTH CARE POLICY; HUMAN; INFORMATION PROCESSING; METHODOLOGY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL;

CLINICAL TRIALS DATA MONITORING COMMITTEES; FOCUS GROUPS; GUIDELINES AS TOPIC; HEALTH POLICY; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 68949209179     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-61     Document Type: Article

References (36)

1. Bero LA Grilli R Grimshaw JM Harvey E Oxman AD Thomson MA Getting research findings into practice: Closing the gap between research and practice: An overview of systematic reviews of interventions to promote the implementation of research findings BMJ 1998, 317:465-468. 1113716 9703533
2. Donner A Klar N Design and Analysis of Cluster Randomization Trials in Health Research London: Arnold 2000.
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report: Ethical Principles for the Protection of Human Subjects of Biomedical and Behavioral Research, DHEW Pub. No. (OS) 78-0012 Washington, D.C.: U.S. Government Printing Office 1978.
4. Weijer C Miller PB When are research risks reasonable in relation to anticipated benefits? Nature Medicine 2004, 10:570-573. 10.1038/ nm0604-570 15170195
5. Weijer C Emanuel EJ Protecting communities in biomedical research Science 2000, 289:1142-1144. 10.1126/science.289.5482.1142 10970227
6. Hutton JL Are Distinctive Ethical Principles Required for Cluster Randomized Controlled Trials? Statistics in Medicine 2001, 20:473-488. 10.1002/1097-0258(20010215)20:3<473::AID-SIM805>3.0.CO;2-D 11180314
7. Klar N Donner A Current and Future Challenges in the Design and Analysis of Cluster Randomization Trials Statistics in Medicine 2001, 20:3729-3740. 10.1002/sim.1115 11782029
8. Medical Research Council - Cluster randomised trials - Methodological and ethical considerations http://www.mrc.ac.uk/Utilities/Documentrecord/ index.htm?d=MRC002406
9. Eldridge SM Ashby D Feder GS Informed Patient Consent to Participation in Cluster Randomized Trials an Empirical Exploration of Trials in Primary Care Clinical Trials 2005, 2:91-98. 10.1191/1740774505cn070oa 16279130
10. Edwards SJL Braunholtz DA Lilford RJ Stevens AJ Ethical Issues in the Design and Conduct of Cluster Randomized Controlled Trials British Medical Journal 1999, 318:1407-1409. 1115783 10334756
11. Glanz K Rimer BK Lerman C Ethical Issues in the Design and Conduct of Community-Based Intervention Studies Ethics and Epidemiology New York: Oxford University Press Coughlin S, Beauchamp T 1996:156-173.
12. COMMIT Research Group Community Intervention Trial for Smoking Cessation (COMMIT): Summary of design and intervention J Natl Cancer Inst 1991, 83(22):1620-8. 10.1093/jnci/83.22.1620 1749015
13. Donner A Klar N Pitfalls of and Controversies in Cluster Randomization Trials American Journal of Public Health 2004, 94(3):416-422. 1448267 14998805 10.2105/AJPH.94.3.416
14. Goldstein M Lavori P Coleman R Advani A Hoffman BB Improving Adherence to Guidelines for Hypertension Drug Prescribing Cluster-Randomized Controlled Trial of General versus Patient-Specific Recommendations Am J Manag Care 2005, 11:667-685.
15. West JP Jatz J Khatry SK LeClerq SC Pradhan EK Shrestha SR Connor PB Dali SM Christian P Pokhrel RP Sommer A Double blind, cluster randomised trial of low dose supplementation with vitamin A or β carotene on mortality related to pregnancy in Nepal BMJ 1999, 318:570-575. 27760 10037634
16. World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects http://www.wma.net/e/ policy/b3.htm
17. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects http://www.cioms.ch/frame_guidelines_nov_2002.htm
18. International Conference of Harmonization Guideline for Good Clinical Practice http://www.ich.org/LOB/media/MEDIA482.pdf
19. CIOMS International Guidelines for Ethical Review of Epidemiological Studies http://www.cioms.ch/frame_1991_texts_of_guidelines.htm
20. Canada Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans http://pre.ethics.gc.ca/english/policystatement/ policystatement.cfm
21. Medical Research Council Guidelines for Good Clinical Practice in Clinical Trials http://www.mrc.ac.uk/Utilities/Documentrecord/ index.htm?d=MRC002416
22. Department of Health And Human Services - Protection Of Human Subjects http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
23. Chaney E Rabuck LG Uman J Mittman DC Simons C Simon BF Ritchie M Cody M Rubenstein LV Human subjects protection issues in QUERI implementation research QUERI series Implementation Science 2008, 3:10. 2276514 18279507 10.1186/1748-5908-3-10
24. 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 Services Research 2005, 40(1):279-290. 1361137 15663713 10.1111/j.1475-6773.2005.00353.x
25. Dillman DA Smyth JD Christian LM Internet, mail, and mixed-mode surveys: the Tailored Design Method Hoboken: Wiley 2009.
26. Crabtree BF Miller WL Doing Qualitative Research Newbury Park: Sage 1999.
27. Mack N Woodsong C MacQueen KM Guest G Namey E Qualitative Research Methods: A Data Collector's Field Guide Research Triangle Park, North Carolina: Family Health International 2005.
28. National Council on Ethics in Human Research http://www.ncehr-cnerh.org/ english/home.php;
29. National Patient Safety Agency http://www.nres.npsa.nhs.uk/rec-community/
30. United States Department of Health and HumanServices http://www.hhs.gov/ ohrp/
31. Marshall C Rossman G Designing Qualitative Research Newbury Park: Sage 1989.
32. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Institutional Review Boards Report and Recommendations Washington, D.C.: DHEW Publication no. (OS) 78-0008 1978.
33. The Interagency Advisory Panel on Research Ethics(PRE) http://www.pre.ethics.gc.ca/eng/index/
34. The President's Council on Bioethics http://www.bioethics.gov
35. Developing a Framework for Social Science Research Ethics http://www.york.ac.uk/res/ref/index.htm
36. Foy R Eccles M Grimshaw J Why does primary care need more implementation research? Family Practice 2001, 18(4):353-355. 10.1093/fampra/18.4.353 11477039