General clinical research center staff nurse perceptions and behaviors regarding informed consent: Results of a national survey

IRB Ethics and Human Research

Volumn 28, Issue 4, 2006, Pages 8-12

  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

BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; COMPREHENSION; EMPIRICAL APPROACH; ETHICS; HEALTH PERSONNEL ATTITUDE; HUMAN; HUMAN EXPERIMENT; INFORMATION PROCESSING; INFORMED CONSENT; NURSE ADMINISTRATOR; NURSE ATTITUDE; NURSING STAFF; PATIENT ADVOCACY; PERSUASIVE COMMUNICATION; PSYCHOLOGICAL ASPECT; QUESTIONNAIRE; RESEARCH SUBJECT; REVIEW; STANDARD; UNITED STATES; UNIVERSITY HOSPITAL;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

ACADEMIC MEDICAL CENTERS; ATTITUDE OF HEALTH PERSONNEL; CLINICAL TRIALS; COERCION; COMPREHENSION; DATA COLLECTION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; NURSE ADMINISTRATORS; NURSE'S ROLE; NURSING STAFF; PATIENT ADVOCACY; QUESTIONNAIRES; RESEARCH SUBJECTS; UNITED STATES;

EID: 33748493387     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (31)

1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283(20):2701-2711;
2. Beauchamp TL, Childress JF, eds. Principles of Biomedical Ethics. 5th ed. New York: Oxford University Press, 2001;
3. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2000;284(23):3043-3045.
4. 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;
5. Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Controlled Clinical Trials 1981;2(4):287-303;
6. 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;
7. 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;
8. 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.
9. National Center for Research Resources. General Clinical Research Centers. http://www.ncrr.nih.gov/clinical/cr_gcrc.asp.
10. Murff HJ, Pichert JW, Byrne DW, Hedstrom C, Black M, Speroff T. Research participant safety and systems factors in general clinical research centers. IRB: Ethics & Human Research, forthcoming.
11. Wendler D. Can we ensure that all research subjects give valid consent? Archives of Internal Medicine 2004;164(20):2201-2204.
12. Kodish ED, Pentz RD, Noll RB, et al. Informed consent in the Children's Cancer Group: Results of preliminary research. Cancer 1998;82(12):2467-2481.
13. See ref. 5, Wendler 2.004.
14. Verheggen FW, Jonkers R, Kok G. Patients' perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Education and Counseling 1996;29(2):137-153,
15. see ref. 6, Kodish et al. 1998;
16. see ref. 2, Joffe et al. 2001;
17. van Stuijvenberg et al. 1998.
18. Waggoner WC, Mayo DM. Who understands? A survey of 25 words or phrases commonly used in proposed clinical research consent forms. IRB: A Review of Human Subjects Research 1995;17(1):6-9;
19. Young DR, Hooker DT, Freeberg FE. Informed consent documents: Increasing comprehension by reducing reading level. IRB: A Review of Human Subjects Research 1990;12(3):1-5;
20. Hochhauser M. Can patients understand their consent forms? Benders Health Care Law Monthly 1997:8-10;
21. 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;
22. See ref. 2, Bergler et al. 1980.
23. Cassileth BR, Zupkis RV, Sutton-Smith K, et al. Informed consent-why are its goals imperfectly realized? NEJM 1980;302(16):896-900;
24. Dodd MJ, Mood DW. chemotherapy: Helping patients to know the drugs they are receiving and their possible side effects. Cancer Nursing 1981;4(4):311-318;
25. see ref. 2, Joffe et al. 2001;
26. Bergler et al. 1980.
27. See ref. 2, Joffe et al. 2001.
28. See ref. 9, Young et al. 1990;
29. see ref. 10, Dodd et al. 1980.
30. See ref. 1, Beauchamp 2001.
31. Levinsky NG. Nonfinancial conflicts of interest in research. NEJM 2002;347(10):759-761.