A scoping review of empirical research relating to quality and effectiveness of research ethics review

PLoS ONE

Volumn 10, Issue 7, 2015, Pages

  Nicholls, Stuart G ^a   Hayes, Tavis P ^b   Brehaut, Jamie C ^a,b   McDonald, Michael ^c   Weijer, Charles ^d   Saginur, Raphael ^b   Fergusson, Dean ^a,b  

^a UNIVERSITY OF OTTAWA   (Canada)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d WESTERN UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ABSTRACT REPORT; CLINICAL EFFECTIVENESS; CONCEPTUAL FRAMEWORK; CONSENSUS; CONTROLLED CLINICAL TRIAL (TOPIC); DATA EXTRACTION; EMPIRICAL RESEARCH; EUROPE; MEDICAL LITERATURE; METHODOLOGY; NORTH AMERICA; OUTCOME ASSESSMENT; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; REVIEW; SYSTEMATIC REVIEW; COST BENEFIT ANALYSIS; CROSS-SECTIONAL STUDY; HUMAN; PROCEDURES;

COST-BENEFIT ANALYSIS; CROSS-SECTIONAL STUDIES; EMPIRICAL RESEARCH; ETHICS, RESEARCH; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84941985628     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0133639     Document Type: Review

References (74)

1. Heimer CA, Petty J. Bureaucratic Ethics: IRBs and the Legal Regulation of Human Subjects Research. Annual Review of Law and Social Science. 2010;6(1):601-26.
2. Joffe S. Revolution or reform in human subjects research oversight. J Law Med Ethics. 2012; Winter:: 922-9.
3. Jamrozik K. Research ethics paperwork: what is the plot we seem to have lost? Br Med J. 2004;329:236-7.
4. Schrag Z. The case against ethics review in the social sciences. Res Ethics. 2012;7(4):120-31.
5. De Vries R, De Bruin DA, Goodgame A. Ethics review of social, behavioral, and economic research: where should we go from here? Ethics & Behaviour. 2004;14(4):351-68. Epub 2006/04/22.
6. Wynn LL. Ethnographers' Experiences of Institutional Ethics Oversight: Results from a Quantitative and Qualitative Survey. J Policy Hist. 2011;23(01):94-114.
7. Beagan B, McDonald M. Evidence-based practice of research ethics review? Health Law Rev. 2005:62-8. PMID: 16459416
8. McDonald M, Cox S. Moving Toward Evidence-Based Human Participant Protection. J Acad Ethics. 2009;7(1-2):1-16.
9. Association for the Accreditation of Human Research Protection Programs Inc. AAHRPP Accreditation Standards. 2009.
10. Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, et al. Oversight of human participants research: Identifying problems to evalute reform proposals. Ann Intern Med. 2004;141:282-91. PMID: 15313744
11. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701-11. PMID: 10819955
12. Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6(1):3-19. Epub 2011/04/05. doi: 10. 1525/jer.2011.6.1.3 PMID: 21460582
13. Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. 2005;8:19-31.
14. Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implement Sci. 2010;5:69. Epub 2010/09/22. doi: 10.1186/1748-5908-5-69 PMID: 20854677
15. Sandelowski M. Whatever happended to qualitative description? Res Nurs Health. 2000;23:334-40. PMID: 10940958
16. Strauss AL. Qualitative analysis for social scientists: Cambridge University Press; 1996.
17. Valdez-Martinez E, Turnbull B, Garduño-Espinosa J, Porter JDH. Descriptive ethics: a qualitative study of local research ethics committees in Mexico. Dev World Bioeth. 2006;6(2):95-105. PMID: 16594973
18. Klitzman R. The ethics police?: IRBs' views concerning their power. PLoS One. 2011;6(12).
19. Klitzman R. "Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest. PLoS One. 2011;6(7):e22796. Epub 2011/08/11. doi: 10.1371/journal. pone.0022796 PMID: 21829516
20. Klitzman R. US IRBs confronting research in the developing world. Dev World Bioeth. 2012;12(2):63-73. doi: 10.1111/j.1471-8847.2012.00324.x PMID: 22515423
21. Angell E, Sutton AJ, Windridge K, Dixon-Woods M. Consistency in decision making by research ethics committees: a controlled comparison. J Med Ethics. 2006;32(11):662-4. Epub 2006/11/01. PMID: 17074825
22. Byrne MM, Speckman JL, Getz KA, Sugarman J. Variability in the costs of Institutional Review Board oversight. Acad Med. 2006;81:708-12. PMID: 16868423
23. Dal-Ré R, Espada J, Ortega R. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. J Med Ethics. 1999;25:268-73. PMID: 10390685
24. Feldman JA, Rebholz CM. Anonymous self-evaluation of performance by ethics board members: a pilot study. J Empir Res Hum Res Ethics. 2009;4(1):63-9. Epub 2009/04/23. doi: 10.1525/jer.2009.4.1. 63 PMID: 19382879
25. Fitzgerald MH, Phillips PA. Centralized and non-centralized ethics review: a five nation study. Account Res. 2006;13(1):47-74. Epub 2006/06/15. PMID: 16770859
26. Geisser ME, Alschuler KN, Hutchinson R. A Delphi study to establish important easpects of ethics review. J Empir Res Hum Res Ethics. 2011;6(1):21-4. doi: 10.1525/jer.2011.6.1.21 PMID: 21460583
27. Maskell NA. Variations in experience in obtaining local ethical approval for participation in a multi-centre study. QJM. 2003;96(4):305-7. PMID: 12651975
28. Norton K, Wilson DM. Continuing ethics review practices by Canadian research ethics boards. IRB. 2008;30(3):10-4. PMID: 18814440
29. Silberman G, Kahn KL. Burdens on research imposed by Institutional Review Boards: The state of the evidence and its implications for regulatory reform. Milbank Q. 2011;89(4):599-627. doi: 10.1111/j. 1468-0009.2011.00644.x PMID: 22188349
30. Sleem H, Abdelhai RA, Al-Abdallat I, Al-Naif M, Gabr HM, Kehil ET, et al. Development of an accessible self-assessment tool for research ethics committees in developing countries. J Empir Res Hum Res Ethics. 2010;5(3):85-96; quiz 7-8. Epub 2010/09/14. doi: 10.1525/jer.2010.5.3.85 PMID: 20831423
31. Taylor HA, Chaisson L, Sugarman J. Enhancing communication among data monitoring committees and institutional review boards. Clin Trials. 2008;5:277-82. doi: 10.1177/1740774508091262 PMID: 18559418
32. Tsan MF, Smith K, Gao B. Assessing the quality of human research protection programs: the experience at the Department of Veterans Affairs. IRB. 2010;32(4):16-9. Epub 2010/09/22. PMID: 20853799
33. Tsan M-F, Nguyen Y, Brooks R. Using quality indicators to assess human research protection programs at the Department of Veterans Affairs. IRB. 2013;35(1):10-4. PMID: 23424821
34. Wagner TH, Cruz AME, Chadwick GL. Economies of Scale in Institutional Review Boards. Med care. 2004;42(8):817-23. PMID: 15258484
35. Reeser JC, Austin DM, Jaros LM, Mukesh BN, McCarty CA. Investigating Perceived Institutional Review Board Quality and Function Using the IRB Researcher Assessment Tool. J Empir Res Hum Res Ethics. 2008;3(1):25-34. Epub 2009/04/24. doi: 10.1525/jer.2008.3.1.25 PMID: 19385780
36. Keith-Spiegel P, Koocher GP, Tabachnick B. What scientists want from their research ethics committee. J Empir Res Hum Res Ethics. 2006;1(1):67-82. doi: 10.1525/jer.2006.1.1.67 PMID: 19385866
37. Wu MH, Liao CH, Chiu WT, Lin CY, Yang CM. Can we accredit hospital ethics? A tentative proposal. J Med Ethics. 2011;37(8):493-7. Epub 2011/06/04. doi: 10.1136/jme.2010.038836 PMID: 21636607
38. Denham MJ, Foster A, Tyrrell DAJ. Work of a district ethical committee. Br Med J. 1979;2:1042-5. PMID: 519278
39. Allen PA, Waters WE. Development of an ethical committee and its effect on research design. Lancet. 1982:1233-6.
40. Davies H, Wells F, Czarkowski M. Standards for research ethics committees: purpose, problems and the possibilities of other approaches. J Med Ethics. 2009;35(6):382-3. Epub 2009/06/02. doi: 10.1136/jme.2008.027722 PMID: 19482984
41. Allen P, Waters WE. Attitudes to research ethical committees. J Med Ethics. 1983;9:61-5. PMID: 6876098
42. Banos JE, Lucena MI, Seres E, Bosch F. Reflections on running training workshops for research ethics committee members in Spain between 2001 and 2008. Croat Med J. 2010;51(6):552-9. Epub 2010/12/17. PMID: 21162168
43. Carline JD, O'Sullivan PS, Gruppen LD, Richardson-Nassif K. Crafting successful relationships with the IRB. Acad Med. 2007;82(10 Suppl):S57-S60. PMID: 17895692
44. Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, et al. Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Clin Trials. 2013;10:257-68. doi: 10.1177/1740774513475530 PMID: 23539109
45. Lynöe N, Sandlund M, Jacobsson L. Research ethics committees: a comparative study of assessment of ethical dilemmas. Scand J Public Health. 1999;27(2):152-9. PMID: 10421726
46. Mosconi P, Colombo C, Labianca R, Apolone G. Oncologists' opinions about research ethics committees in Italy: an update, 2004. European Journal of Cancer Prevention. 2006;15:91-4. PMID: 16374238
47. Sarpel U, Hopkins MA, More F, Yavner S, Pusic M, Nick MW, et al. Medical students as human subjects in educational research. Med Educ Online. 2013;18:1-6. Epub 2013/02/28.
48. Berry J. Local research ethics committees can audit ethical standards in research. J Med Ethics. 1997;23:379-81. PMID: 9451608
49. Howe A, Delaney S, Romero J, Tinsley A, Vicary P. Public involvement in health research: a case study of one NHS project over 5 years. Prim Health Care Res Dev. 2009;11(01):17.
50. Karunaratne AS, Myles PS, Ago MJ, Komesaroff PA. Communication deficiencies in research and monitoring by ethics committees. Intern Med J. 2006;36(2):86-91. Epub 2006/02/14. PMID: 16472262
51. Kent G. The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs. J Med Ethics. 1997;23:186-90. PMID: 9220334
52. McGrath MM, Fullilove RE, Kaufman MR, Wallace R, Fullilove MT. The limits of collaboration: a qualitative study of community ethical review of environmental health research. Am J Public Health. 2009;99(8):1510-4. Epub 2009/06/23. doi: 10.2105/AJPH.2008.149310 PMID: 19542033
53. Nelson K, Garcia RE, Brown J, Mangione CM, Louis TA, Keeler E, et al. Do patient consent procedures affect participation rates in health services research? Med care. 2012;40:283-8.
54. Skrutkowski M, Weijer C, Shapiro S, Fuks A, Langleben A, Freedman B. Monitoring informed consent in an oncology study posing serious risks to subjects. IRB. 1998;20(6):1-6. PMID: 11657586
55. Simek J, Zamykalova L, Mesanyova M. Ethics Committee or Community? Examining the identity of Czech Ethics Committees in the period of transition. J Med Ethics. 2010;36(9):548-52. Epub 2010/08/03. doi: 10.1136/jme.2009.034298 PMID: 20675735
56. Foster CG, Marshall T, Moodie P. The annual reports of Local Research Ethics Committees. J Med Ethics. 1995;21:214-9. PMID: 7473640
57. Driscoll A, Currey J, Worrall-Carter L, Stewart S. Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency. J Clin Nurs. 2008;17(16):2212-20. Epub 2008/08/19. doi: 10. 1111/j.1365-2702.2007.02219.x PMID: 18705740
58. Lidz CW, Appelbaum PS, Arnold R, Candilis P, Gardner W, Myers S, et al. How closely do institutional review boards follow the common rule? Acad Med. 2012;87(7):969-74. Epub 2012/05/25. doi: 10. 1097/ACM.0b013e3182575e2e PMID: 22622205
59. Larson E, Bratts T, Zwanziger J, Stone P. A survey of IRB process in 68 U. S. hospitals. J Nurs Scholarsh. 2004;36(3):260-4. PMID: 15495496
60. Allen HJ. Genetic protocols review by Institutional Review Boards at National Cancer Institute-designated cancer centers. Genet Test. 1998;2(4):329-36. PMID: 10464612
61. Borovecki A, ten Have H, Orešković S. Ethics and the structures of health care in the European countries in transition: hospital ethics committees in Croatia. Br Med J. 2005;331:227-30.
62. Brahme R, Mehendale S. Profile and role of the members of ethics committees in hospitals and research organisations in Pune, India. Indian J Med Ethics. 2009;6(2):78-84. PMID: 19517650
63. Wichman A, Kalyan DN, Abbott LJ, Wesley R, Sandler AL. Protecting human subjects in the NIH's Intramural Research Program: a draft instrument to evaluate convened meetings of its IRBs. IRB. 2006;28(3):7-10. Epub 2006/10/14. PMID: 17036438
64. Kass N, Dawson L, Loyo-Berrios NI. Ethical oversight of research in developing countries. IRB. 2003;25(2):1-10. PMID: 12833901
65. Ateudjieu J, Williams J, Hirtle M, Baume C, Ikingura J, Niare A, et al. Training needs assessment in research ethics evaluation among research ethics committee members in three African countries: Cameroon, Mali and Tanzania. Dev World Bioeth. 2010;10(2):88-98. Epub 2009/11/17. doi: 10.1111/j. 1471-8847.2009.00266.x PMID: 19912281
66. de Jong JP, Ter Riet G, Willems DL. Two prognostic indicators of the publication rate of clinical studies were available during ethical review. J Clin Epidemiol. 2010;63(12):1342-50. Epub 2010/06/19. doi: 10.1016/j.jclinepi.2010.01.018 PMID: 20558034
67. McKenzie JE, Herbison GP, Roth P, Paul C. Obstacles to researching the researchers: a case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials. Trials. 2010;11:28. Epub 2010/03/23. doi: 10.1186/1745-6215-11-28 PMID: 20302671
68. McDonald M, Pullman D, Anderson J, Preto N, Sampson H. Research ethics in 2020: strengths, weaknesses, opportunities, and threats. Health Law Rev. 2011;19(3):36-55.
69. Bruni RA, Laupacis A, Martin DK. Public engagement in setting priorities in health care. CMAJ. 2008;179(1):15-8. Epub 2008/07/02. doi: 10.1503/cmaj.071656 PMID: 18591516
70. Redman BK. Review of measurement instruments in clinical and research ethics, 1999-2003. J Med Ethics. 2006;32(3):153-6. Epub 2006/03/02. PMID: 16507659
71. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001;4:99-108. PMID: 11359540
72. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of Informed Consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001;93:139-47. PMID: 11208884
73. Kassam-Adams N, Newman E. The reactions to research participation questionnaires for children and for parents (RRPQ-C and RRPQ-P). Gen Hosp Psychiatry. 2002;24:336-42. PMID: 12220800
74. Anderson JA, Sawatzky-Girling B, McDonald M, Pullman D, Saginur R, Sampson HA, et al. Research ethics broadly writ: beyond REB review. Health Law Rev. 2011;19(3):12-24.