Authors

  1. Section Editor(s): STOKOWSKI, LAURA A. RN, MS

Article Content

The parents of neonates and older children are often approached about entering their child in a clinical trial. This can be a tough decision for some parents, and with the exception of the research team, there are few places to find information on which to base their decision to consent or decline participation. A new Web resource aims to educate parents about what it means to participate in a clinical trial, and support them through the process of consent and beyond.1

 

The Children and Clinical Studies Web site is a joint project of the National Heart, Lung, and Blood Institute and the National Institutes of Health. Conceived by a nurse, the site is easy to navigate and is set up so that parents and other users can get as much or as little information as they need in easily digested pieces. In short video vignettes, research experts, parents, and children themselves discuss common issues such as the following:

 

* Why do research in children?

 

* What is the difference between research and care?

 

* Will my child benefit from the study?

 

* What if I want to say no?

 

* What should I ask before I make my decision?

 

* Will it cost me any money?

 

* Do kids have a say?

 

* What if I want to leave a study?

 

* What happens when the study ends?

 

 

Users can also easily find information about "who's who" on the research team, safety and protections, the rights of families, the effect of clinical studies on families, and the potential benefits of enrolling in a trial. In a diagram of the research team, the family is depicted at the center of the team. The site also offers a video glossary of research terms that may be unfamiliar to parents, such as placebo, masking or blinding, informed consent, assent, protocol, IRB, and randomization. Definitions are clear and easy to understand.

 

A unique focus of the Children in Clinical Studies Web site is on sharing the perspectives of the children themselves. In "What do kids say about being in a study?" users can listen to what children think and feel: what frightens them, what reassures them, how they think research will benefit other children, and how they can have a voice in their study participation. A section of the Web site called "Minority Issues and Questions" encourages minority parents to ask questions, request interpreters, reach out to others, and make sure they understand written documents. A Spanish-language version of the Web site is in development. Parents who enroll their children in long-term studies will find that the Web site is a great resource for them when they think of additional questions down the road.

 

Reference

 

1. National Heart, Lung, and Blood Institute, National Institutes of Health. Children and clinical studies. http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php. Accessed September 16, 2008. [Context Link]