Children's and Their Parents' Views on Facing Research Risks for the Benefit of Others

Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bldg 10, Room 1C118, Bethesda, MD 20892, USA.
JAMA Pediatrics (Impact Factor: 5.73). 02/2008; 162(1):9-14. DOI: 10.1001/archpediatrics.2007.3
Source: PubMed


To assess children's and parents' attitudes regarding pediatric research that poses minimal risk or a minor increase over minimal risk and does not offer the potential to benefit the child clinically.
Separate in-person interviews with children and their parents.
Clinics where the children were receiving clinical care or participating in clinical research for asthma or cancer.
Children aged 7 to 14 years and their parents or legal guardians.
In-person interviews.
Respondents' willingness to enroll the child in nonbeneficial research and charitable activities that posed the same risks.
Overall, 81 child-parent pairs were interviewed. For a hypothetical study that would not benefit the child and posed a risk of headache, 71% of the children were willing to participate, and 72% of the parents would allow their children to participate. For a hypothetical study that would not benefit the child and posed a very small chance of a broken leg, 43% of the children and 24% of the parents endorsed the child's participation. Overall, respondents were equally willing to have the child help others by participating in nonbeneficial research or by participating in a charitable activity.
Most respondents were willing to have the child participate in some nonbeneficial research, and most did not consider nonbeneficial pediatric research to be more problematic than charitable activities for children. These findings provide empirical data to support the acceptability of exposing children to some research risks for the benefit of others.

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Available from: Tammara Jenkins, May 26, 2015
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    • "Researchers involved in such studies will reach the point where the parents' original consent needs to be complemented by the children's assent, and later, entirely replaced when children can give proper consent. Studies also show that children want to be involved in decisions about research (Wendler & Jenkins, 2008). Other studies show that balancing the formal rights and wishes of parents with the child's increasing rights may prove a challenging issue unless there are prior appropriately developed strategies (Swartling, Helgesson, Hansson, & Ludvigsson, 2009). "
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    ABSTRACT: There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children's own views. This study explored children's views (N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in general a positive attitude to pediatric research and emphasized trust in researchers. The children stressed the importance to receive information and to be involved in decisions. The children also reported feeling concerned about blood sampling and disease risk. Researchers involved in long-term pediatric research need to address these issues to promote involvement and decrease worry. © The Author(s) 2014.
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    • "Absolute upper limits of risks for research participants are irreversible impairments and death. Standard limits for research with incompetent patients are no more than ”minimal risk,“ ”minor increase of minimal risk“ and ”direct prospective benefit,“ 42,43 terms which are under discussion. "
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    • "However, it remains still open the question whether or not it is acceptable to expose children to some research risks for the benefit of others. The results of the survey conducted by Wendler and Jenkins [30] support the acceptability of such an exposure. According to Westra et al [31] the absolute limit of minimal risks and minimal burdens stipulated by the EU recommendations may prohibit important appropriate research. "
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