A survey instrument was used to gather and evaluate data from medical schools and children's hospitals concerning prevailing national practice on the issue of whether pediatric researchers should be required to obtain informed assent from a minor subject, in addition to parental consent, as a precondition to the participation of the minor in the research protocol. Implications are drawn from the survey results.
Get full access to this article
View all access options for this article.
References
1.
McCormick RAProxy consent in the experimentation situation. In: Mappes TA, Zembaty JS, eds. Biomedical ethics. New York: McGraw-Hill , 1981:1159-69.
2.
Ramsey P.The enforcement of morals: nontherapeutic research on children. Hastings Cent Rep1976;6:21-30.
3.
Porcaro ETExperimentation with children: the "pawns" of medical technology. Med Leg News1979;7:6-9, 16.
4.
Holder ARLegal issues in pediatrics and adolescent medicine. New York: John Wiley and Sons, 1977:159-74.
5.
Korsch BMPhysicians, patients, and decisions. Am J Dis Child1974;127:328-32.
6.
Lewis CE, Lewis MA, Ifekwunigue M.Informed consent by children and participation in an influenza vaccine trial . Am J Public Health1978;68:1079-82.
7.
Public Law No. 93-348 (1974).
8.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Report and recommendations: research involving children. 1977. DHEW Pub. No. (OS)77-0004.
9.
Federal Register, January 13, 1978;43:2084-114.
10.
Jonsen ARResearch involving children: recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Pediatrics1978;62:131-6.
11.
Federal Register, July 21, 1978;43:31786-96.
12.
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.Protecting human subjects: the adequacy and uniformity of federal rules and their implementation. Washington, DC: 1981, pp. 74-76.
13.
Federal Register, January 26, 1981;45:8366-92.
14.
Holder ARCan teenagers participate in research without parental consent? IRB1981;3:5-7.
15.
Lamb GA, Lamb GAThe age of consent. Am J Public Health1978 ;68:1071-2.