Research participant safety and systems factors in general clinical research centers

IRB Ethics and Human Research

Volumn 28, Issue 6, 2006, Pages 8-14

  Murff, Harvey J ^a,b   Pichert, James W ^a,b   Byrne, Daniel W ^b   Hedstrom, Christa ^b   Black, Margo ^b   Churchill, Larry ^b   Speroff, Ted ^a,b  

^a DEPARTMENT OF VETERANS AFFAIRS   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; FEMALE; HEALTH PERSONNEL ATTITUDE; HUMAN; NURSING STAFF; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PSYCHOLOGICAL ASPECT; SAFETY; STATISTICS; UNITED STATES;

ACADEMIES AND INSTITUTES; ADULT; ATTITUDE OF HEALTH PERSONNEL; FEMALE; HUMANS; NURSING STAFF, HOSPITAL; SAFETY MANAGEMENT; UNITED STATES;

EID: 33747296804     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Kohn LT. To Err is Human. Washington, DC: National Academy Press, 2000;
2. Weingart SN, Wilson RM, Gibberd RW, et al. Epidemiology of medical error. BMJ 2000;320(7237):774-777.
3. Leape LL. Error in medicine. JAMA 1994;272(23):1851-1857;
4. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA 1995;274(1):35-43;
5. Reason J. Managing the Risks of Organizational Accidents. Aldershot: Ashgate, 1997.
6. Nolan TW. Understanding medical systems. Annals of Internal Medicine 1998;128(4):293-298.
7. Perrow C. Normal Accidents. Princeton, NJ: Princeton University Press, 1999; See ref. 2, Reason 1997.
8. Plesk P. Innovative thinking for the improvement of medical systems. Annals of Internal Medicine 1999;131:438-444;
9. Nolan TW. System changes to improve patient safety. BMJ 2000;320(7237):771-773.
10. Steinbrook R. Improving protection for research subjects. NEJM 2002;346(18):1425-1430;
11. Steinbrook R. Protecting research subjects - the crisis at Johns Hopkins. NEJM 2002;346(9):716-720;
12. Kahn JP, Mastroianni AC. Moving from compliance to conscience: Why we can and should improve on the ethics of clinical research. Archives of Internal Medicine 2001;161(7):925-928.
13. Murff HJ, Byrne DW, Harris PA, et al. "Near-miss" reporting system development and implications for human subjects protection. In: Henriksen K, Battles JB, Marks ES, Lewin DI, eds. Advances in Patient Safety: From Research to Implementation. Vol. 3 Implementation Issues. Rockville, MD: AHRQ Publication No. 05-0021-3, Agency for Healthcare Research and Quality, 2005.
14. See ref. 6, Steinbrook 2002.
15. Cassel C, Stock MC, Wood AJ, et al. Report of Johns Hopkins University External Review Committee, August 8, 2001.
16. van Stuijvenberg M, Suur MH, de Vos S, et al. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Archives of Disease in Childhood 1998;79(2):120-125;
17. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 2001;358(9295):1772-1777;
18. Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Controlled Clinical Trials 1981;2(4):287-303;
19. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. Journal of Clinical Oncology 1995;13(5):1062-1072;
20. Daugherty CK, Banik DM, Janish L, et al. Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB: A Review of Human Subjects Research 2000;22(3):6-14;
21. Bergler JH, Pennington AC, Metcalfe M, et al. Informed consent: How much does the patient understand? Clinical Pharmacology and Therapeutics 1980;27(4):435-440;
22. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 2004;292(13):1593-1601.
23. For an analysis of nurses' perceptions and behaviors regarding informed consent, see Murff HJ, Pichert JW, Byrne DW, et al. General clinical research center staff nurse perceptions and behaviors regarding informed consent: Results of a national survey. IRB: Ethics & Human Research 2006 28(4):8-12.
24. Federman D, Hanna KE, Rodriguez LL, eds. Committee on Assessing the System for Protecting Human Research Participants. Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press, 1003.
25. Wendler D. Can we ensure that all research subjects give valid consent? Archives of Internal Medicine 2004;164(20):2201-2204.
26. See ref. 10, Flory et al. 2004.
27. See ref. 2, Leape et al. 1995.
28. Needleman J, Buerhaus P, Mattke S, et al. Nurse-staffing levels and the quality of care in hospitals. NEJM 2002;346(22):1715-1722;
29. Aiken LH, Clarke SP, Sloane DM, et al. Hospital nurse staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA 2002;288(16):1987-1993.
30. See ref. 16, Aiken et al. 2002
31. Weeks WB, Bagian JP. Developing a culture of safety in the Veterans Health Administration. Effective Clinical Practice 2000;3(6):270-276;
32. Pizzi LT, Goldfarb NI, Nash DB. Promoting a culture of safety. In: Shojania KG, Duncan BW, McDonald KM, Wachter RM, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices: Agency for Healthcare Research and Quality, 2001.
33. Leape LL, Woods DD, Hatlie MJ, et al. Promoting patient safety by preventing medical error. JAMA 1998;280(16):1444-1447.
34. See ref. 6, Kahn and Masttoianni 2001.
35. National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants. Bethesda, MD: NBAC, 2001.
36. Office of Inspector General. Institutional Review Boards: A Time for Reform. Washington, DC: Department of Health and Human Services, 1998.
37. Committee on Assessing the System for Protecting Human Research Subjects. Institute of Medicine. Preserving Public Trust: Accreditation and Human Research Participant Protection Program. Washington, DC: National Academies Press, 2001.
38. See ref. 12, Federman et al. 2003.
39. Burman WJ, Reves RR, Cohn DL, et al. Breaking the camel's back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medicine 2001;134(2):152-157.
40. Bramstedt KA. Research subject advocates: To whom are they loyal? Clinical and Investigative Medicine 2003;26(2):64-69;
41. Neill KM. Research subject advocate: A new protector of research participants. Accountability in Research 2003;10(3):159-174.