Measuring the process and quality of informed consent for clinical research: Development and testing

Oncology Nursing Forum

Volumn 38, Issue 4, 2011, Pages 417-422

  Cohn, Elizabeth Gross ^a   Jia, Haomiao ^a   Smith, Winifred Chapman ^b   Erwin, Katherine ^b   Larson, Elaine L ^a  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b MOREHOUSE SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PILOT STUDY; PSYCHOMETRY; REPRODUCIBILITY; STANDARD;

BIOMEDICAL RESEARCH; HUMANS; INFORMED CONSENT; PILOT PROJECTS; PSYCHOMETRICS; REPRODUCIBILITY OF RESULTS;

EID: 79959825698     PISSN: 0190535X     EISSN: 15380688     Source Type: Journal    
DOI: 10.1188/11.ONF.417-422     Document Type: Article

References (33)

1. Albrecht, T.L., Blanchard, C., Ruckdeschel, J.C., Coovert, M., & Strongbow, R. (1999). Strategic physician communication and oncology clinical trials. Journal of Clinical Oncology, 17, 3324-3332. (Pubitemid 29470669)
2. Brown, R.F., Butow, P.N., Butt, D.G., Moore, A.R., & Tattersall, M.H. (2004). Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Social Science and Medicine, 58, 379-390. doi:10.1016/S0277-9536(03)00204-1 (Pubitemid 37353050)
3. Brown, R.F., Butow, P.N., Ellis, P., Boyle, F., & Tattersall, M.H. (2004). Seeking informed consent to cancer clinical trials: Describing current practice. Social Science and Medicine, 58, 2445-2457. doi:10.1016/j.socscimed. 2003.09.007 (Pubitemid 38476982)
4. Buccini, L.D., Caputi, P., Iverson, D., & Jones, C., (2009). Toward a construct definition of informed consent comprehension. Journal of Empirical Research on Human Research Ethics, 17-23.
5. Cohn, E., & Larson, E. (2007). Improving participant comprehension in the informed consent process. Journal of Nursing Scholarship, 39, 273-280. doi:10.1111/j.1547-5069.2007.00180.x
6. Council for International Organizations of Medical Services. (2002). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences.
7. Delany, C. (2008). Making a difference: Incorporating theories of autonomy into models of informed consent. Journal of Medical Ethics, 34, E3. doi:10.1136/jme.2007.023804
8. Dresden, G.M., & Levitt, M.A. (2001). Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Academic Emergency Medicine, 8, 246-252. doi: 0.1111/j.1553-2712.2001.tb01300.x (Pubitemid 32201694)
9. Ferguson, P.R. (2002). Patients' perceptions of information provided in clinical trials. Journal of Medical Ethics, 28, 45-48. doi:10.1136/jme.28.1.45 (Pubitemid 34162899)
10. Flory, J., & Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA, 292, 1593-1601. doi:10.1001/jama.292.13.1593 (Pubitemid 39314966)
11. Foderaro, L.W. (2009, January 28). Study refutes claims on pediatric AIDS drug trials. New York Times, p. A26. Retrieved from http://nytimes.com/2009/01/ 28/nyregion/28foster.html
12. Grossman, S.A., Piantadosi, S., & Cohavey, C. (1994). Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? Journal of Clinical Oncology, 12, 2211-2215. (Pubitemid 24356041)
13. Guarino, P., Lamping, D.L., Elbourne, D., Carpenter, J., & Peduzzi, P. (2006). A brief measure of perceived understanding of informed consent in a clinical trial was validated. Journal of Clinical Epidemiology, 59, 608-614. doi:10.1016/j.jclinepi.2005.11.009
14. Henderson, G.E., Easter, M.M., Zimmer, C., King, N.M., Davis, A.M., Rothschild, B.B., ⋯ Nelson, D.K. (2006). Therapeutic misconception in early phase gene transfer trials. Social Science and Medicine, 62, 239-253. doi:10.1016/j.socscimed.2005.05.022 (Pubitemid 41728121)
15. Jenkins, V.A., Fallowfield, L.J., Souhami, A., & Sawtell, M. (1999). How do doctors explain randomised clinical trials to their patients? European Journal of Cancer, 35, 1187-1193. (Pubitemid 29359177)
16. Joffe, S., Cook, E.F., Cleary, P.D., Clark, J.W., & Weeks, J.C. (2001). Quality of informed consent: A new measure among research subjects. Journal of the National Cancer Institute, 93, 139-147. (Pubitemid 32111992)
17. Katz, J. (2002). The silent world of doctor and patient. Baltimore, MD: Johns Hopkins University Press.
18. Landis, J.R., & Koch, G.G. (1977). The measurement of observer agreement for categorical data. Biometrics, 33, 159-174. (Pubitemid 8054849)
19. Lavori, P.W., Wilt, T.J., & Sugarman, J. (2007). Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clinical Trials, 4, 638-649. doi:10.1177/1740774507085144 (Pubitemid 351567520)
20. Lindegger, G., Milford, C., Slack, C., Quayle, M., Xaba, X., & Vardas, E. (2006). Beyond the checklist: Assessing understanding for HIV vaccine trial participation in South Africa. Journal of Acquired Immune Deficiency Syndromes, 43, 560-566. (Pubitemid 44885623)
21. Makoul, G. (2001). Essential elements of communication in medical encounters: The Kalamazoo consensus statement. Academic Medicine, 76, 390-393. doi:10.1097/00001888-200104000-00021 (Pubitemid 32298942)
22. Miller, C.K., O'Donnell, D.C., Searight, H.R., & Barbarash, R.A. (1996). The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects. Pharmacotherapy, 16, 872-878. (Pubitemid 26322190)
23. National Cancer Institute. (2009). NCI's Clinical Trials Cooperative Group Program. Retrieved from http://www.cancer.gov/cancertopics/factsheet/NCI/ clinical-trials-cooperative-group
24. National Institutes of Health. (2011). About clinicaltrials.gov. Retrieved from http://clinicaltrials.gov/ct2/info/about.
25. National Patient Safety Agency. (2009). Information sheet and consent form guidance (Version 3.5). Retrieved from http://www.nres.npsa.nhs.uk/ applications/guidance/consent-guidance-and-forms/
26. Ness, D.E., Kiesling, S.F., & Lidz, C.W. (2009). Why does informed consent fail? A discourse analytic approach. Journal of American Academy of Psychiatry and the Law, 37, 349-362.
27. Rivera, R., & Borasky, D. (2009). Research ethics training curriculum (2nd ed.). Durham, NC: Family Health International. Santen, S.A.,
28. Rotter, T.S., & Hemphill, R.R. (2008). Patients do not know the level of training of their doctors because doctors do not tell them. Journal of General Internal Medicine, 23, 607-610.
29. Shalala, D. (2000). Protecting research subjects: What must be done. New England Journal of Medicine, 343, 808-810.
30. Stepan, K.A., Gonzalez, A.P., Dorsey, V.S., Frye, D.K., Pyle, N.D., Smith, R.F., ⋯ Cantor, S.B. (2011). Recommendations for enhancing clinical trials education: A review of the literature. Journal of Cancer Education, 26, 64-71.
31. Tomamichel, M., Sessa, C., Herzig, S., de Jong, J., Pagani, O., Willems, Y., & Cavalli, F. (1995). Informed consent for phase 1 studies: Evaluation of quantity and quality of information provided to patients. Annals of Oncology, 6, 363-369.
32. U.S. Department of Health and Human Services. (2005). Protection of human subjects, Title 45 C.F.R. 46. Retrieved from http://www.hhs.gov/ohrp/ humansubjects
33. Woodsong, C., & Karim, Q.A. (2005). A model designed to enhance informed consent: Experiences from the HIV prevention trials network. American Journal of Public Health, 95, 412-419. (Pubitemid 40315114)