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Children in Research: Informed Consent and Critical Factors Affecting Mothers

Pamela K. Pletsch, Ph.D., R.N.

University of Wisconsin-Milwaukee

Patricia E. Stevens, Ph.D., R.N., F.A.A.N.

University of Wisconsin-Milwaukee, pstevens{at}uwm.edu

Thirty-three mothers whose ill children had been enrolled in clinical trials were interviewed about their experiences giving informed consent. The qualitative data from mothers of children with cancer and mothers of children with diabetes were compared and contrasted using narrative analysis techniques. Results suggest four critical factors that differentiated and defined their informed consent experiences: immediacy of the threat to the life of the child, trajectory of illness-related events, opportunities for autonomy, and expertise of mothers in managing their child’s illness and in negotiating the health care system. Implications for practice and research with families whose ill children are enrolled in clinical research are discussed.

Journal of Family Nursing, Vol. 7, No. 1, 50-70 (2001)
DOI: 10.1177/107484070100700104
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