With the advent of pediatric biomedical technology research in the past few decades, concern for the rights of children as research subjects is increasing. This article offers an orientation for pediatric nurses regarding the historical background of protection of children's rights, ethical principles, ethical issues of consent and risk versus benefit, and nursing implications relating to research involving children.
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References
1.
Silverberg E. , Boring CC, Squires TS: Cancer statistics, 1990. CA40:9-26, 1990
2.
Grodin MA, Alpert JJ: Children as participants in medical research. Pediatr Clin North Am35:1389-1406, 1988
3.
Foley MK: Children with cancer: Ethical dilemmas. Semin Oncol Nurs5:109-113, 1989
4.
Moore IM: Nontherapeutic research using children as subjects. MCN7:285-294, 1982
5.
Doxiadis SA: Children, society, and ethics. Child Abuse Negl13:11-17, 1989
6.
Renshaw DC, Thomasma DC: Child abuse: The role of health care professionals and the state, in Monagle JF, Thomasma DC (eds): Medical Ethics: A Guide for Health Professionals . Rockville, MD, Aspen, 1988, pp 60-61
7.
Levine RJ: Ethics and Regulation of Clinical Research (ed 2). Baltimore, MD, Urban & Schwarzenberg , 1986, pp 235-250
8.
World Medical Association: Declaration of Helsinki, 1964, in Beecher H (ed): Research and the Individual Human Studies. Boston, MA, Little Brown, 1970
9.
Katz J.: Experimentation with Human Beings. New York, NY, Russell Sage Foundation, 1972, pp 9-65, 633, 1007,1010
10.
United States Health, Education, and Welfare Department: Research Involving Children: Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Fed Reg43:2084-2108, 1978
11.
Truman JT: The history of institutional review boards, in Truman JT, van Eys J, Pochedly C (eds): Human Values in Pediatric Hematology/Oncology. New York, NY, Praeger, 1986, pp 23-31
12.
Fry ST: Ethical issues in clinical research. Nurs Clin North Am24:1033-1039, 1989
13.
Childress JF : Who Should Decide? Paternalism in Health Care: New York, NY, Oxford , 1982
14.
McCartney JJ : Research on children: National Commission says "yes, if...." Hastings Cent Rep8:26-31, 1978
15.
Strauman JT , Cotanch PH: Oncology nurse research issues: Over studied populations. Oncol Nurs Forum15:665-668, 1988
16.
Gaylin W.: The competence of children. No longer all or none. Hastings Cent Rep12:33-38, 1982
17.
Loewy EH: Textbook of Medical Ethics. New York, NY, Plenum, 1989, pp 170-172
18.
Piaget J.: The Theory of Stages in Cognitive Development. New York, NY, McGraw-Hill, 1969
19.
Congliana-Shutta NA: Pediatric phase I trials: Ethical issues and nursing considerations. Oncol Nurs Forum13:29-32, 1986
20.
Department of Health, Education, and Welfare : National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Children. DHEW Publication No. 77-0004, 1977, pp 109-113
21.
Verzemnicks IL, Nash D.: Ethical issues related to pediatric care . Nurs Clin North Am19:319-328, 1984
22.
Mahon NE, Yarcheski A.: Ethical concerns in research with adolescents. J Pediatr Nurs3:341-344, 1988
23.
Hofmann AD: The right to consent and confidentiality in adolescent health care: An evolutionary dilemma, in Bandsman EL, Bandsman BB (eds): Bioethics and Human Rights . Boston, MA,Little Brown, 1978, p 187
24.
Sheldon M., Sheldon BB: Adolescent and informed consent, in Mongle JF, Thomasma DC: Medical Ethics: A Guide for Health Professionals. Rockville, MD, Aspen, 1988, pp 90-96
25.
Weithorn LA , Campbell SB: The competence of children and adolescents to make informed treatment decisions. Child Dev53:1589-1598, 1982
26.
Ramsey PA: The enforcement of morals: Nontherapeutic research in children. Inquiry6:21-30, 1976
27.
Ramsey PA: Children as research subjects: A reply. Hastings Cent Rep7:40-42, 1977
28.
McCormick RA : Proxy consent in the experimental situation . Perspect Biol Med18:2-20, 1974 29. McCormick RA: Experimentation in children: Sharing in society. Hastings Cent Rep6:41-46, 1976
29.
American Nurses' AssociationCode for Nurses. Kansas City, MO, ANA, 1976
30.
Department of Health and Human Services: Protection of Human Subjects: Informed Consent. Federal Register , Jan 27, 1981, Part IX
Erickson S. , Hopkins MA: Gray areas: Informed consent in pediatric and comatose adult patients. Heart Lung16:323-326, 1987
33.
Chamorro T. , Applebaum J.: Informed consent: Nursing issues and ethical dilemmas. Oncol Nurs Forum15:803-808, 1988
34.
Monagle JF, Thomasma DC: Hospital ethics committees: Roles, membership, and structure, in Monagle JF, Thomasma DC (eds): Medical Ethics: A Guide for Health Professionals. Rockville, MD, Aspen, 1988, pp 397-417