Ethical issues posed by cluster randomized trials in health research

Springer Science and Business Media LLC - 2011
Charles Weijer1, Jeremy Grimshaw2, Monica Taljaard2, Ariella Binik1, Robert F. Boruch3, Jamie Brehaut2, Allan Donner4, Martin Eccles5, Antonio Gallo1, Andrew McRae4, Raphael Saginur6, Merrick Zwarenstein7
1Rotman Institute of Philosophy, Department of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada
2Ottawa Hospital Research Institute, Clinical Epidemiology Program, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada
3Graduate School of Education and Statistics Department, Wharton School, University of Pennsylvania, 3700 Walnut Street, Philadelphia, PA, 19104, USA
4Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, N6A 5C1, Canada
5Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne NE2 4AX, UK
6Department of Medicine, University of Ottawa and Ottawa Hospital, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada
7Centre for Health Services Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada

Tóm tắt

Từ khóa


Tài liệu tham khảo

Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. 2000, London: Arnold

The COMMIT Group: Community intervention trial for smoking cessation (COMMIT): I. Cohort results from a four-year community intervention. Am J Public Health. 1995, 85 (2): 183-92.

Lewin S, Dick J, Zwarenstein M, Lombard CJ: Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa. Bull World Health Organ. 2005, 83 (4): 250-9.

Kennedy A, Robinson A, Hann M, Thompson D, Wilkin D: A cluster-randomised controlled trial of a patient-centred guidebook for patients with ulcerative colitis: effect on knowledge, anxiety, and quality of life. Health Soc Care Community. 2003, 11 (1): 64-72. 10.1046/j.1365-2524.2003.00399.x.

Halloran ME, Longini IM, Struchiner CJ: Design and interpretation of vaccine field studies. Epidemiol Rev. 1999, 21 (1): 73-88.

Campbell MJ, Donner A, Klar N: Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007, 26 (1): 2-19. 10.1002/sim.2731.

Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. Br Med J. 2004, 328 (7441): 702-8. 10.1136/bmj.328.7441.702.

Taljaard M, Weijer C, Grimshaw J, Belle Brown J, Binik A, Boruch R, Brehaut JC, Chaudhry S, Eccles MP, McRae A, Saginur R, Zwarenstein M, Donner A: Study protocol: Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials. 2009, 10: 61-10.1186/1745-6215-10-61.

Eccles M, Steen N, Grimshaw J, Thomas L, McNamee P, Soutter J, Wilsdon J, Matowe L, Needham G, Gilbert F, Bond S: Effect of audit and feedback, and reminder messages on primary-care radiology referrals: a randomised trial. Lancet. 2001, 357 (9266): 1406-9. 10.1016/S0140-6736(00)04564-5.

Hutton JL, Eccles MP, Grimshaw JM: Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci. 2008, 3: 52-10.1186/1748-5908-3-52.

Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C: An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006, 355 (26): 2725-32. 10.1056/NEJMoa061115.

Wenzel RP, Edmond MB: Team-based prevention of catheter-related infections. N Engl J Med. 2006, 355 (26): 2781-3. 10.1056/NEJMe068230.

45 Code of Federal Regulations 46.101(b)(4). date accessed: April 19, 2011, http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=26deb50e7f77001a876fde96d3a2b8e3&rgn=div5&view=text&node=45:1.0.1.1.25&idno=45 ;

Miller FG, Emanuel EJ: Quality-improvement research and informed consent. N Engl J Med. 2008, 358 (8): 765-7. 10.1056/NEJMp0800136.

Kass N, Pronovost PJ, Sugarman J, Goeschel CA, Lubomski LH: Controversy and quality improvement: lingering questions about ethics, oversight, and patient safety research. Jt Comm J Qual Patient Saf. 2008, 34 (6): 349-53.

Levine RJ: Ethics and Regulation of Clinical Research. 1988, New Haven: Yale University Press

Weijer C, Lanata CF, Plowe CV: Ethical considerations in the conduct of vaccine trials in developing countries. New Generation Vaccines. Edited by: Levine MM, Dougan G, Good MF, Liu MA, Nabel GJ, Nataro JP, Rappuoli R. 2010, New York: Informa Health Care, Inc, 59-65. 4

Weijer C, Miller PB: When are research risks reasonable in relation to anticipated benefits?. Nat Med. 2004, 10 (6): 570-3. 10.1038/nm0604-570.

Freedman B: Equipoise and the ethics of clinical research. N Engl J Med. 1987, 317 (3): 141-5. 10.1056/NEJM198707163170304.

Fuks A, Weijer C, Freedman B, Shapiro S, Skrutkowska M, Riaz A: A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. J Clin Epidemiol. 1998, 51 (2): 69-79. 10.1016/S0895-4356(97)00240-0.

Caldwell P, Murphy S, Butow P, Craig J: Clinical trials in children. Lancet. 2004, 364 (9436): 803-11. 10.1016/S0140-6736(04)16942-0.

Dresser R: Wanted: single, white male for research. Hastings Cent Rep. 1992, 22 (1): 24-9. 10.2307/3562720.

Childress JF: Compensating injured research subjects: the moral argument. Hastings Cent Rep. 1976, 6 (6): 21-7. 10.2307/3561144.

Weijer C, Emanuel EJ: Protecting communities in biomedical research. Science. 2000, 289 (5482): 1142-4. 10.1126/science.289.5482.1142.

Ross LF, Loup A, Nelson RM, Botkin JR, Kost R, Smith GR, Gehlert S: The challenges of collaboration for academic and community partners in a research partnership: points to consider. J Empir Res Hum Res Ethics. 2010, 5 (1): 19-31. 10.1525/jer.2010.5.1.19.

Baily MA: Harming through protection?. N Engl J Med. 2008, 358 (8): 768-9. 10.1056/NEJMp0800372.

Siegel MD, Alfano SL: The ethics of quality improvement research. Crit Care Med. 2009, 37 (2): 791-2. 10.1097/CCM.0b013e318194c4d6.

Savel RH, Goldstein EB, Gropper MA: Critical care checklists, the Keystone Project, and the Office for Human Research Protections: A case for streamlining the approval process in quality-improvement research. Crit Care Med. 2009, 37 (2): 725-8. 10.1097/CCM.0b013e31819541f8.

Baily MA, Bottrell M, Lynn J, Jennings B: The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep. 2006, 36 (4): S1-S39. 10.1353/hcr.2006.0054.

45 Code of Federal Regulations 46.102(f). date accessed: April 19 2011, http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=26deb50e7f77001a876fde96d3a2b8e3&rgn=div5&view=text&node=45:1.0.1.1.25&idno=45 ;

Mann H, Reyes M: Identifying the human research subject in cluster randomized controlled trials. IRB. 2008, 30 (5): 14-8.

Edwards SJL, Braunholtz DA, Lilford RJ, Stevens AJ: Ethical issues in the design and conduct of cluster randomised controlled trials. Br Med J. 1999, 318 (7195): 1407-9.

Medical Research Council: Cluster Randomised Trials: Methodological and Ethical Considerations. date accessed: April 19, 2011, http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002406 ;

45 Code of Federal Regulations 46.116(d). date accessed: April 19 2011, http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=26deb50e7f77001a876fde96d3a2b8e3&rgn=div5&view=text&node=45:1.0.1.1.25&idno=45 ;

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.

Glanz K, Rimer BK, Lerman C: Ethical issues in the design and conduct of community-based intervention studies. Ethics and Epidemiology. Edited by: Coughlin SS, Beauchamp TL. 1996, Oxford: Oxford University Press, 156-77.

Herrera MG, Nestel P, el Amin A, Fawzi WW, Mohamed KA, Weld L: Vitamin A supplementation and child survival. Lancet. 1992, 340 (8814): 267-71. 10.1016/0140-6736(92)92357-L.

Ghana VAST Study Team: Vitamin A supplementation in northern Ghana: effects on clinic attendances, hospital admissions, and child mortality. Lancet. 1993, 342 (8862): 7-12. 10.1016/0140-6736(93)91879-Q.

Klar N, Donner A: Ethical challenges posed by cluster randomization. Wiley Encyclopedia of Clinical Trials. 2007, 1-5.

Slutsky AS, Lavery JV: Data safety and monitoring boards. N Engl J Med. 2004, 350 (11): 1143-7. 10.1056/NEJMsb033476.

Miller PB, Weijer C: Fiduciary obligations in clinical research. J Law Med Ethics. 2006, 34 (2): 424-40. 10.1111/j.1748-720X.2006.00049.x.

Hearnshaw H: Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. Br Med J. 2004, 328 (7432): 140-1. 10.1136/bmj.328.7432.140.

Kopelman LM: Children as research subjects: a dilemma. J Med Philos. 2000, 25 (6): 745-64.

Althabe F, Buekens P, Bergel E, Belizan JM, Campbell MK, Moss N, Hartwell T, Wright LL: A behavioral intervention to improve obstetrical care. N Engl J Med. 2008, 358 (18): 1929-39. 10.1056/NEJMsa071456.

Hickman M, McDonald T, Judd A, Nichols T, Hope V, Skidmore S, Parry JV: Increasing the uptake of hepatitis C virus testing among injecting drug users in specialist drug treatment and prison settings using dried blood spots for diagnostic testing: a cluster randomized controlled trial. J Viral Hepat. 2008, 15 (4): 250-4. 10.1111/j.1365-2893.2007.00937.x.

Kipping RR, Jago R, Lawlor DA: Diet outcomes of a pilot school-based randomised controlled obesity prevention study with 9-10 year olds in England. Prev Med. 2010, 51 (1): 56-62. 10.1016/j.ypmed.2010.04.011.

de Smet AM, Kluytmans JA, Cooper BS, Mascini EM, Benus RF, van der Werf TS, van der Hoeven JG, Pickkers P, Bogaers-Hofman D, van der Meer NJ, Bernards AT, Kuijper EJ, Joore JC, Leverstein-van Hall MA, Bindels AJ, Jansz AR, Wesselink RM, de Jongh BM, Dennesen PJ, van Asselt GJ, te Velde LF, Frenay IH, Kaasjager K, Bosch FH, van Iterson M, Thijsen SF, Kluge GH, Pauw W, de Vries JW, Kaan JA, Arends JP, Aarts LP, Sturm PD, Harinck HI, Voss A, Uijtendaal EV, Blok HE, Thieme Groen ES, Pouw ME, Kalkman CJ, Bonten MJ: Decontamination of the digestive tract and oropharynx in ICU patients. N Engl J Med. 2009, 360 (1): 20-31. 10.1056/NEJMoa0800394.

Bolton P, Bass J, Neugebauer R, Verdeli H, Clougherty KF, Wickramaratne P, Speelman L, Ndogoni L, Weissman M: Group interpersonal psychotherapy for depression in rural Uganda. JAMA. 2003, 289 (23): 3117-24. 10.1001/jama.289.23.3117.

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.

Marshall P, Rotimi C: Ethical challenges in community-based research. American Journal of Medical Science. 2001, 322 (5): 241-5. 10.1097/00000441-200111000-00001.

Thông tin
Thông tin xuất bản

Springer Science and Business Media LLC

Thông tin tác giả