Purpose/Objectives: To describe newly enrolled clinical trial subjects' knowledge and understanding of the oncology clinical trials in which they were participating.
Design: Descriptive, correlational.
Setting: The oncology center of a small community hospital in New England.
Sample: 8 patients who consented to enroll in oncology clinical trials.
Methods: The Quality of Informed Consent questionnaire was sent to 17 potential participants who recently had consented to participate in oncology clinical trials.
Main Research Variables: Knowledge of the basic elements of informed consent and participants' understanding of the clinical trials in which they were enrolled.
Findings: Scores on the Quality of Informed Consent questionnaire indicated that participants had a good overall understanding of the basic elements of informed consent as well as the clinical trials in which they were enrolled. However, half of the sample failed to understand that clinical trial treatment is not standard treatment and may involve additional risk when compared with standard treatment.
Conclusions: The results of this investigation provide valuable feedback regarding participants' understanding of the informed consent process. The Quality of Informed Consent questionnaire may be a useful tool for monitoring the quality of the informed consent process and contributing to patients' understanding of clinical trials and the research process.
Implications for Nursing: The Quality of Informed Consent questionnaire may provide valuable feedback regarding clinical trial participants' understanding of clinical trials and the research process. Individual responses to questions on the questionnaire may be used to aid personalized patient education and validation of the informed consent throughout trial enrollment. Future research efforts need to focus on the development of reliable tools to measure participants' understanding of informed consent and nursing interventions that improve the informed consent process as well as enhance patients' understanding of the research process.
Aaronson, N.K., Visser-Pol, E., Leenhouts, G.H., Muller, M.J., van der Schot, A.C., van Dam, F.S., et al. (1996). Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology, 14, 984-996.
Appelbaum, P.S., Roth, L.H., Lidz, C.W., Benson, P., & Winslade, W. (1987). False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report, 17(2), 20-24.
Berry, D.L., Dodd, M.J., Hinds, P.S., & Ferrell, B.R. (1996). Informed consent: Process and clinical issues. Oncology Nursing Forum, 23, 507-512.
Daugherty, C.K. (1999). Impact of therapeutic research on informed consent and the ethics of clinical trials: A medical oncology perspective. Journal of Clinical Oncology, 17, 1601-1617.
Daugherty, C.K., Kiolbasa, T.A., Siegler, M., & Ratain, M.J. (1997). Informed consent (IC) in clinical research: A study of cancer patient (pt) understanding of consent forms and alternatives of care in phase I clinical trials [Abstract 188]. Proceedings of the American Society of Clinical Oncology, 16. Retrieved May 2, 2005, from http://www.asco.org/ac/1,1003,_12-002640-00_18-0030-00_19-0010500,00.asp
Erlen, J.A. (2000). Clinical research: What do patients understand? Orthopedic Nursing, 19(2), 95-99.
Hubbard, S.M. (1982). Cancer treatment research: The role of the nurse in clinical trials of cancer therapy. Nursing Clinics of North America, 17, 763-783.
Joffe, S., Cook, E.F., Cleary, P.O., Clark, J.W., & Weeks, J.C. (2001a). Quality of informed consent: A new measure of understanding among research subjects. Journal of the National Cancer Institute, 93, 139-147.
Joffe, S., Cook, E.F., Cleary, P.O., Clark, J.W., & Weeks, J.C. (2001b). Quality of informed consent in cancer clinical trials: A cross-sectional study. Lancet, 358, 1772-1777.
Koski, G. (2000). Risks, benefits, and conflicts of interest in human research: Ethical evolution in the changing world of science. Journal of Law, Medicine, and Ethics, 28, 330-331.
Meade, C.D. (1999). Improving understanding of the informed consent process and document. Seminars in Oncology Nursing, 15, 124-137.
National Cancer Institute. (1998). Simplification of informed consent documents. Retrieved May 12, 2005, from http://www.cancer.gov
Rosse, P.A., & Krebs, L.U. (1999). The nurse's role in the informed consent process. Seminars in Oncology Nursing, 15, 116-123.
Sadler, G.R., Lantz, J.M., Fullerton, J.T., & Dault, Y. (1999). Nurses' unique roles in randomized clinical trials. Journal of Professional Nursing, 15, 106-115.
Schaeffer, M.H., Krantz, D.S., Wichman, A., Masur, H., Reed, E., & Vinicky, J.K. (1996). The impact of disease severity on the informed consent process in clinical research. American Journal of Medicine, 100, 261-268.
Sharp, S.M. (2001). Improving the process of obtaining informed consent. Applied Clinical Trials, January, 1-5.
U.S. Department of Health and Human Services. (2004). Code of federal regulations: Title 21, section 50.25: Elements of informed consent. Washington, DC: U.S. Government Printing Office.
Yoder, L.H., O'Rourke, T.J., Etnyre, A., Spears, D.T., & Brown, T.D. (1997). Expectations and experiences of patients with cancer participating in phase I clinical trials. Oncology Nursing Forum, 24, 891-896.