Author(s): Eric Kodish, M.D.
Background and Module Content
Efforts to improve the health of children depend on clinical investigations that use children as research subjects. Children are a vulnerable population, however, and so are accorded special protection from research risks. Researchers in pediatrics may encounter conflicts between protecting the children who are vulnerable research subjects and developing generalizable knowledge to benefit children as a class. Furthermore, there are many pitfalls for the researcher in carrying out the communication with both parents and children that is required for responsible decision-making about participation by children or adolescents in experiments.
There is a long-standing moral and legal tradition that supports parents as the primary decision-makers for their minor children, including the right to make proxy decisions for children about participation in research. Parental decision-making is a critical factor in the study of pediatric research ethics, even though it is recognized that parents, as well as health researchers, may have interests that conflict with the best interests of the child.
Today, the legitimate role of the child in decisions about research participation is recognized. The ethical concept of assent provides a framework to assist investigators and parents with efforts to incorporate the views of children who are recruited as research subjects. Assent is analogous to consent where the subject has a reduced capacity to understand the matter to which they are assenting.
This course covers the key issues that arise when research is conducted with children as subjects.
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Method and Scenarios
Distribution of scenarios to the students and faculty.
Panel discussion based on those scenarios and questions and any others that students or faculty wish to add.
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Reading (recommended for discussion of scenarios)
- Understanding of key ethical principles that arise in research with children as subjects and how these principles are appropriately exercised in such matters.
- Increased ability to discuss these ethical issues and to prevent misunderstandings.
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Bibliography (for further reading)
- Gaylin, W. and Macklin, R. Who Speaks for the Child? The Problems of Proxy Consent (New York: Plenum Press, 1982).
- Grodin, M. and Glantz, L., eds. Children as Research Subjects: Science, Ethics, and Law (New Yorks: Oxford University Press, 1994).
- King, N. M. P. and Cross, A. W. "Children as Decision Makers: Guidelines for Pediatricians." Journal of Pediatrics (1989) 115: 10-16.
- Levine, R. J. Ethics and Regulation of Clinical Research (New Haven and London: Yale University Press, 1988).
- Kodish, E., Pentz, R., Noll, R., Ruccione, K., Buckley, J., Lange, B. "Informed Consent in the Childrens Cancer Group: Results of Preliminary Research" Cancer(1998) 82: 2467-80.
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Relevant Web Resources
- Questions and Answers about the NIH Policy and Guidelines on the Inclusion of Children as Participant in Research Involving Human Subjects, March 1999.
- The NIH has developed the following Questions and Answers to facilitate implementation of the Policy on the Inclusion of Children in Research Involving Human Subjects. These Q's and A's are prepared to provide guidance to NIH staff, advisory groups, and the extramural community as they consider the policy and associated issues.
- Ethical and Policy Issues in Research Involving Human Participants
- National Bioethics Advisory Commission Recommendations and Commissioned Papers. See especially "Privacy and Confidentiality: As Related to Human Research in Social and Behavioral Science", by Joan E. Sieber, explanation of Subparts B, C, and D of 45 CFR 46.
- NIH Bioethics Web Site
- Extensive information.