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Balancing recruitment and protection: children as research subjects
Insights
Federal guidelines require including children in clinical research, creating ethical challenges for researchers. This article reviews protections, consent issues, and capacity factors to balance recruitment with protecting children's rights.
Area of Science:
- Pediatric Research Ethics
- Clinical Trial Recruitment
- Vulnerable Populations in Research
Background:
- Federal guidelines since 1994 mandate the inclusion of children in clinical research.
- This mandate presents an ethical dilemma for researchers balancing access with protection.
- Nurse-researchers must understand informed consent and assent issues specific to pediatric populations.
Purpose of the Study:
- To review historical exploitation of children in research.
- To examine laws and federal regulations governing informed consent and assent for minors.
- To explore research on factors influencing children's capacity for consent/assent.
Main Methods:
- Literature review of ethical guidelines and regulations.
- Analysis of historical cases of child exploitation in research.
- Synthesis of research on children's cognitive and developmental capacity for assent/consent.
Main Results:
- Instances of child exploitation in research have occurred.
- Specific laws and regulations exist to protect children in clinical trials.
- Children's capacity to consent/assent varies based on developmental factors.
Conclusions:
- Recommendations are provided to balance child recruitment with ethical protections.
- Ensuring informed consent and assent is crucial for ethical pediatric research.
- Protecting the rights of children as human subjects is paramount.
Abstract:
Since 1994, federal guidelines for research in the United States have called for the inclusion of special populations, among them, children, in clinical research (National Institutes of Health, 1998). While the guidelines are intended to assure the fair distribution of research benefits to children, this federal mandate has created an ethical dilemma for researchers. Health professionals involved in research with children are called on to balance improving access and recruitment of children for clinical trials with the need to protect this very vulnerable population. Given this balancing act, it is important for nurse-researchers to be familiar with the issues of informed consent and assent with children. Our article reviews instances of exploitation of children in research, laws and federal regulations on informed consent and assent designed to protect children, and research on factors that affect children's capacity to consent/assent. We conclude with recommendations to assure a proper balance between the need to recruit children into clinical trials and the need to protect their rights as human subjects.