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As a rule, a pediatric subject is legally unable to provide informed consent. Therefore pediatric study participants are dependent on their parent(s)/legal guardian to assume responsibility for their participation in clinical studies. Fully informed consent should be obtained from the legal guardian in accordance with regional laws or regulations. All participants should be informed to the fullest extent possible about the study in language and terms they are able to understand. Where appropriate, participants should assent to enroll in a study (age of assent to be determined by IRB's/IEC's or be consistent with local legal requirements). Participants of appropriate intellectual maturity should personally sign and date either a separately designed, written assent form or the written informed consent. In all cases, participants should be made aware of their rights to decline to participate or to withdraw from the study at any time. Attention should be paid to signs of undue distress in patients who are unable to clearly articulate their distress. Although a participant's wish to withdraw from a study must be respected, there may be circumstances in therapeutic studies for serious or life-threatening diseases in which, in the opinion of the investigator and parent(s)/legal guardian, the welfare of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this situation, continued parental (legal guardian) consent should be sufficient to allow participation in the study. Emancipated or mature minors (defined by local laws) may be capable of giving autonomous consent.
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