1. ADOLESCENTS and IRBs 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.
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?