ETHICAL PRINCIPLES IN PEDIATRIC CLINICAL TRIALS

12/9/99


Click here to start


Table of Contents

ETHICAL PRINCIPLES IN PEDIATRIC CLINICAL TRIALS

ETHICAL PRINCIPLES IN PEDIATRIC CLINICAL TRIALS

ETHICAL PRINCIPLES

ROLES OF IRB

RECRUITMENT OF PARTICIPANTS

RECRUITMENT OF PARTICIPANTS

CONSENT

INFORMING THE CHILD AND ASSENT

RISK, DISTRESS, BENEFIT

MINIMIZING RISK

MINIMIZING DISTRESS

MINIMIZING DISTRESS

BENEFIT

DHHS BENEFIT/RISK CATEGORIES

NON-THERAPEUTIC RESEARCH

NON-THERAPEUTIC RESEARCH

OPTIMIZING BENEFIT IN NON-THERAPEUTIC RESEARCH

OPTIMIZING BENEFIT IN NON-THERAPEUTIC RESEARCH

STUDIES OF HEALTHY SUBJECTS

STUDIES OF HEALTHY SUBJECTS

STUDIES OF HEALTHY SUBJECTS

SUMMARY

Author: Janssen End Users