Issues surrounding protection and assent in pediatric research.
OBJECTIVE
This article provides the physical therapist (PT) researcher with valuable information regarding the issues of assent by reviewing the history, regulations, and issues surrounding the protection of children participating in research.


CONCLUSIONS
To conduct ethical research, knowledge about the history, regulations, and issues surrounding the protection of children in research is important. While most of the research done by PTs is non-invasive and low risk, it is still important for a researcher to be aware of the full spectrum of risk involved with research. An important topic for PTs involves the related concepts of parental permission and child assent. Those children, who are capable of understanding a research study, need to know what is involved in the study and have the choice to participate or to decline to participate.
PTs should be encouraged to be involved in research to advance the profession and contribute to evidence-based practice. Due to this, PTs are becoming more involved in the process of obtaining assent from a child, and therefore need to be aware of the unique aspects of this process.
Johnston
Therese E
TE
Shriners Hospitals for Children, Philadelphia, Pennsylvania, USA.
D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002648:Child; D006801:Humans; D007258:Informed Consent; D026761:Physical Therapy Specialty / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*