Issues surrounding protection and assent in pediatric research

Area of Science:

• Pediatric research ethics
• Child protection in clinical studies

Background:

• Physical therapists (PTs) are increasingly involved in research.
• Ethical considerations for research involving children are paramount.
• Understanding child assent is vital for PT researchers.

Purpose of the Study:

• To inform PT researchers about child assent.
• To review the history, regulations, and issues concerning child protection in research.
• To highlight the importance of parental permission and child assent.

Main Methods:

• Review of historical context of child protection in research.
• Analysis of current regulations governing research with minors.
• Discussion of ethical issues specific to obtaining assent from children.

Main Results:

• Knowledge of research history, regulations, and child protection issues is essential for ethical conduct.
• PTs must be aware of the spectrum of risks in research, even if typically low.
• Child assent ensures that capable children understand and can choose to participate in studies.

Conclusions:

• Ethical research requires understanding child assent, parental permission, and relevant regulations.
• PTs need to be aware of the nuances of obtaining assent from children.
• Involvement in research advances the physical therapy profession and evidence-based practice.