Ethical Issues in Pediatric Research: Antimuscarinics to control the medical and psychosocial complications of drooling

5/21/01


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Table of Contents

Ethical Issues in Pediatric Research: Antimuscarinics to control the medical and psychosocial complications of drooling

Ethical considerations in human subjects research

Pediatric Risk Categories in 45 CFR 46

Some concerns about studies related to studies of antimuscarinics in children with swallowing dysfunction

Overview

Pediatric care decisions include parental convenience/reassurance

Limitations to parental assessments

Antimuscarinics are routinely used in children with swallowing dysfunction without the benefits of clinical trials

IRB evaluation

Should IRBs limit enrollment decisions to children living with their parents?

Conclusion

Author: DHHS