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ADOLESCENTS and IRBs

ADOLESCENTS and IRBs. Christopher V. Chambers, M.D. Department of Family and Community Medicine Jefferson Medical College Thomas Jefferson University. Adolescents Participation in Research. Consent for medical care What does CFR say? Controversies for IRBs.

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ADOLESCENTS and IRBs

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  1. ADOLESCENTSandIRBs Christopher V. Chambers, M.D. Department of Family and Community Medicine Jefferson Medical College Thomas Jefferson University

  2. Adolescents Participation in Research Consent for medical care What does CFR say? Controversies for IRBs

  3. AGE OF CONSENT (Pennsylvania) 18 or over Graduate of High School Married Pregnant (or previous pregnancy) Exceptions

  4. EMANCIPATED MINOR Living apart from parents with or without consent and Self-supporting and Managing own financial affairs. or 2. Married. or 3. In Armed Services.

  5. MATURE MINOR DOCTRINE 1. 15 years of age or over. 2. Able to give informed consent. 3. The proposed treatment is for the minor’s benefit (and not another’s). 4. The proposed treatment is necessary according to the best professional judgment. 5. The treatment does not involve high-risk procedures.

  6. 45 CFR 46 46.408(a) Solicit assent of children when, in judgment of IRB, children are capable of providing assent.

  7. 45 CFR 46 46.408(c) If the IRB determines that a protocol is designed for a condition for which parental permission is not a reasonable requirement, it may waive requirement for parental permission, provided an appropriate mechanism for protecting the child is substituted.

  8. ISSUES for IRBs Child assent ages 7-17. Appropriate form? Payment? Coersive or appropriate? Assent or consent for mature adolescents?

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