Whether to suggest enrollment of pediatric oncology patients with advanced or refractory disease into a Phase I clinical trial may present a significant ethical dilemma for health care professionals. Phase I trials are experimental and unpredictable by nature, yet health care professionals must ensure the trial's therapeutic intent as well as address the many vulnerabilities of the child with terminal cancer. After reviewing the role and phases of clinical research in pediatric oncology, this article discusses ethical considerations in Phase I clinical trials according to The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research and discusses specific applications of these key ethical principles.
Ackerman, T.F. (1995). Phase I pediatric oncology trials. Journal of Pediatric Oncology Nursing, 12, 143-145.
2.
Bourret, J.A. (1997). Primer: Bioethics for oncology practitioners. Highlights in Oncology Practice, 15. Retrieved January 11, 2008, from http://www.meniscus.com/web/publications/hl/Art2_151.html
3.
Carlson, C., Reilly, M., & Hitchens, A. (2005). An innovative approach to the care of patients on Phase I and Phase II clinical trials: The role of the experimental therapeutics nurse. Journal of Pediatric Oncology Nursing, 22, 353-364.
4.
Chang, A. (2004). Nurses' perceptions of Phase I clinical trials in pediatric oncology: A review of the literature. Journal of Pediatric Oncology Nursing, 21, 343-349.
5.
Chang, A. (2008). An exploratory survey of nurses' perceptions of Phase I clinical trials in pediatric oncology. Journal of Pediatric Oncology Nursing, 25, 14-23.
6.
Cogliano-Shutta, N.A. (1986). Pediatric Phase I clinical trials: Ethical issues and nursing considerations. Oncology Nursing Forum, 13, 29-32.
7.
Craig, C. (1998). Clinical trials. In M. J. Hockenberry-Eaton (Ed.), Essentials of pediatric oncology nursing: A core curriculum (pp.77-78). Glenview, IL: Association of Pediatric Oncology Nurses.
8.
Deatrick, J.A., Angst, D.B., & Moore, C. (2002). Parents' view of their children's participation in Phase I oncology clinical trials. Journal of Pediatric Oncology Nursing, 19, 114-121.
9.
Furman, W.L., Pratt, C.B., Rivera, G.K., Krischer, J.P., Kamen, B.A., & Vietti, T.J. (1989). Mortality in pediatric Phase I clinical trials . Journal of the National Cancer Institute, 81, 1193-1194.
10.
Hazelton, J. (1991). The role of the nurse in Phase I clinical trials . Journal of Pediatric Oncology Nursing, 8, 43-45.
11.
Hinds, P.S., Oakes, L., Furman, W., Foppiano, P., Olson, M.S., Quargnenti, A., et al. (1997). Decision making by parents and health care professionals when considering continued care for pediatric patients with cancer. Oncology Nursing Forum, 24, 1523-1528.
12.
Ratain, M.J., Collyer, D., Kamen, B.A., Eisenhauer, E., Lawrence, T.S., Runowicz, C., et al. (1997). Critical role of Phase I clinical trials in cancer treatment. Journal of Clinical Oncology, 15, 853-859.
13.
Reaman, G.H. (2004). Pediatric cancer research from past successes through collaboration to future transdisciplinary research. Journal of Pediatric Oncology Nursing, 21, 123-127.
14.
Ries, L. A. G., Eisner, M. P., Kosary, C. L., Hankey, B. F., Miller, B. A., Clegg, L., et al. (Eds.). (2004). SEER cancer statistics review, 1975-2001 . Bethesda, MD: National Cancer Institute. Retrieved January 12, 2008, from http://seer.cancer.gov/csr/1975_2001/
15.
Shah, S., Weitman, S., Langevin, A.M., Bernstein, M., Furman, W., & Pratt, C. (1998). Phase I therapy trials in children with cancer . Journal of Pediatric Hematology/Oncology, 20, 431-438.
16.
Spilker, B. (1991). Guide to clinical trials. Philadelphia: Lippincott-Raven.
17.
Ulrich, C.M., Grady, C., & Wendler, D. (2004). Palliative care: A supportive adjunct to pediatric Phase I clinical trials for anticancer agents? Pediatrics , 114, 852-855.
18.
U.S. Department of Health, Education, and Welfare: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979, April). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved January 3, 2008, from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
19.
U.S. Department of Health and Human Services: Food and Drug Administration. (2003). Report to Congress: Patient access to new therapeutic agents for pediatric cancer. Retrieved January 19, 2008, from http://www.fda.gov/cder/pediatric/BPCA-ReportDec2003.doc
20.
Zimmerman, J.F. (1997). The Belmont report: An ethical framework for protecting research subjects. The Monitor. Retrieved January 3, 2008 from http://www.impactcg.com/docs/BelmontReport.pdf
