PEDIATRICS Vol. 62 No. 2 August 1978, pp. 131-136
This Article
Right arrow Full Text (PDF)
Right arrow P3Rs: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when P3Rs are posted
Right arrow Alert me if a correction is posted
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Jonsen, A. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Jonsen, A. R.

Research Involving Children: Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Albert R. Jonsen Ph.D.1

1 Departments of Medicine, Pediatrics, and History of Health Sciences, School of Medicine, University of California, San Francisco

Throughout history, children have been subjects of research. A legendary Persian prince is said to have isolated newborn babies from all human speech in hopes of discovering whether language was natural and spontaneous. Queen Caroline of England recruited children from a foundling hospital in order to test Jenner's vaccination on them before it was applied to her own royal progeny. The modern controversy over research with children and the retarded can be traced to events at Willowbrook State Hospital for the Mentally Retarded where, during the 1950s and 1960s, healthy mentally retarded children were infected with mild hepatitis in order to study the natural history of the disease. That research aroused great public controversy and its merits and faults are debated even today. It initiated a discussion within and without the medical profession over whether any invasion or manipulation of the body or person of a nonconsenting subject could ever be ethically justified, apart from expectation of benefit to that subjct.1

The prevailing codes of ethics governing the use of human subjects for experimentation are curiously ambivalent about children. The progenitor of these codes, The Code of Nuremberg, if taken literally, would exclude children as subjects, for it requires the voluntary consent of the subject "as absolutely essential," without any provision for proxy consent.1 The World Medical Association's Declaration of Helsinki, on the other hand, states that for nontherapeutic research involving legally incompetent subjects, "the consent of the legal guardian should be procured."3(p277) This position has been adopted by the American Medical Association:

Submitted on September 22, 1977
Accepted on March 6, 1978




This article has been cited by other articles:


Home page
 PediatricsHome page
J. L. Blumer
Off-Label Uses of Drugs in Children
Pediatrics, September 1, 1999; 104(3): 598 - 602.
[Full Text]

Home page
 CLIN PEDIATRHome page
M. B. Kapp
Children's Assent for Participation in Pediatric Research Protocols: Assessing National Practice
Clinical Pediatrics, April 1, 1983; 22(4): 275 - 278.
[Abstract] [PDF]