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.

Download full-text


Available from: Tammara Jenkins, May 26, 2015
  • Source
    • "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). "
    [Show abstract] [Hide abstract]
    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.
    Journal of Empirical Research on Human Research Ethics 08/2014; 9(4). DOI:10.1177/1556264614544456 · 1.25 Impact Factor
  • Source
    • "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. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because the former are interventional in nature and may have unknown and perhaps severe somatic risks, whereas naturalistic studies seem not to intervene but only to observe, and therefore are assumed to have fewer or almost no risks. However, there are also ethical implications in naturalistic trials, although their weight is differently accentuated, more with potential, more with potential psychological burdens of the observational procedures and more with potential physical risks in interventional trials. This will be elaborated with examples of placebo-controlled trials and of incidental findings in screenings, of marketing influences on observational studies, and of psychological burdens by survey interviews. The ethical implications will be analyzed within a more general framework. Finally, recommendations will be offered.
    Dialogues in clinical neuroscience 06/2011; 13(2):173-82.
  • Source
    • "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. "
    [Show abstract] [Hide abstract]
    ABSTRACT: The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the quality of research into medicines for children but without subjecting the paediatric population to unnecessary clinical trial. This article addresses ethical and legal issues arising from the regulation and makes recommendations for the framework conditions facilitating the development of clinical research with children.
    Italian Journal of Pediatrics 02/2011; 37(1):12. DOI:10.1186/1824-7288-37-12 · 1.52 Impact Factor
Show more