Article
Issues Related to Children Participating in Clinical Research

https://doi.org/10.1016/j.pedn.2007.02.004Get rights and content

Research involving children is necessary to bridge the gap created by years of applying the findings of adult clinical trials to children. Given the mandate from the National Institutes of Health to include children in clinical trials, pediatric nurses will undoubtedly be asked to assist with pediatric research projects. Nurses working with children must consider the unique legal and ethical issues surrounding children as study participants. The purpose of this article is to examine issues related to children participating in clinical research. A review of pertinent literature is summarized, and practical approaches to the recommendations are discussed.

Section snippets

Historical Overview of Children in Research

Children are a vulnerable population because of their limited developmental capabilities and reliance on adults for protection. During the 18th and 19th centuries, children, often viewed as property of adults, were recruited as research subjects to observe the effects of infectious diseases such as syphilis, gonorrhea, tuberculosis, and yellow fever on humans. Later, researchers recruited children into trials that tested vaccines. Procedures protecting children from such exploitation were not

Legal and Ethical Issues

For research with children to be approved, federal codes require informed parental permission and, in some cases, voluntary assent from the child. If research is determined by the IRB to have greater than minimal risk, additional safeguards must be initiated (Meaux & Bell, 2001). The (Food and Drug Administration, 1991a, Food and Drug Administration, 1991b), the U.S. Department of Health and Human Resources (USDHHS), Public Health Service (1991), and the NIH (1998) outline four categories of

Parent Permission and Child Assent

Within the legal structure of the levels identified for review by the IRB are complex ethical issues concerning children's participation in clinical trials. Obtaining parental permission and assent from the child requires careful navigation by the pediatric researcher. By signing the informed consent, parents give the researcher permission to approach the child about participating in the research (Broome, Richards, & Hall, 2001). It should be noted that the USDHHS allows for a waiver of

Risk Versus Benefit of Participation

In addition to ethical issues, parental permission, and obtaining assent from the child, IRBs have raised concerns regarding the assessment of the risk versus benefit of the proposed research. Application of federal risk and benefit ratios by IRBs nationwide is variable and sometimes contradicted by available data on the risk and regulations themselves (Shah, Whittle, Wilfond, Gensler, & Wendler, 2004). Therefore, IRBs need guidelines for applying federal risk and benefit categories as well as

Recruitment Issues

Over the years, researchers have employed several recruitment techniques in an effort to bolster participation in pediatric clinical trials. Mass advertisements, mailings, and posters have not been found to be particularly successful methods for recruiting children due to their impersonal nature. Some recruitment success has been achieved with media interviews and press conferences that describe the study and introduce the investigative team to the public. An effective method to recruit

Retention Issues

Perhaps the single most important factor for retention of children in research studies is to allow for flexible scheduling with minimal disruption to the child's daily routine such as school, extracurricular activities, sports, or time with friends (Pletsch & Stevens, 2001). Scheduling a child's participation in research can be extremely difficult, especially if there are a number of siblings in the family. Many pediatric researchers have, at times, made home visits to accommodate busy

Payment for Pediatric Research Participation

Payment of research subjects has long been a controversial topic among research policymakers and investigators. Providing incentives maximizes participation and minimizes attrition over the duration of the study (Rice & Broome, 2004). Provision of payment, or remuneration, to research subjects has become a common recruitment and retention strategy among researchers despite lingering ethical concerns. Payment to pediatric research participants becomes particularly problematic because of the

Conclusions

Although federal mandates regarding inclusion of children in research have been in place for about a decade, a tremendous gap in pediatric research continues. For pediatric clinical researchers to have successful trials, they must familiarize themselves with the ethical issues regarding children and strictly adhere to federal guidelines. These include obtaining parental permission, as well as determining when it is appropriate to seek a child's assent for participation.

Investigators must employ

Acknowledgments

This project was supported by Grant # R15 NR08106-01 from the National Institute of Nursing Research at the NIH awarded to Dr. Burkhart.

The authors gratefully acknowledge the constructive feedback from Dr. Lynne Hall, Associate Dean for Research and Scholarship in the College of Nursing at the University of Kentucky, and the insights on inclusion of children in research from Ms. Ada Sue Selwitz, Development Director, Office of Sponsored Programs, and Dr. Lori Shook, Associate Professor of

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