1. Subjects with Absent or Questionable Capacity: Doing Research in a Legal Fog Jack Schwartz Director of Health Policy Maryland AG’s Office jschwartz@oag.state.md.us

2. Topics Children as research subjects Research generally Parental consent/child assent Emancipated minors? Mature minors? Research of specific kinds Child’s consent authorized? Adults Questionable capacity Incapacitated

3. Children as research subjects

4. Federal regulations “Children” = not of legal age for consent Consent to what? “Treatments or procedures involved in the research” Legal age determined by state law where research is done

5. Maryland’s legal age Generally: an 18 y/o “is an adult,” has legal capacity for all purposes Generally: < 18 y/o lacks legal capacity for all purposes Generally: < 18 y/o, parent makes decisions For research, generally: < 18 y/o, parental permission, child’s assent Limitation on parental authority per Kennedy Krieger decision

6. Consent authority by status? A minor who is married or the parent of a child “has the same capacity as an adult to consent to medical treatment” Issue: What kind of research  “medical treatment”? Evidence-based possibility of direct medical benefit (AG view; no court decision) Issue: fit with federal regs’ “legal age”?

7. Consent authority by maturity? Some state courts recognize mature minor doctrine in clinical medicine = ability of average person to understand and weigh risks/benefits of treatment No Maryland case; AG’s opinion Same issues as emancipated minors

8. Consent authority by nature of research? Minor authorized “to consent to treatment for or advice about” drug abuse, alcoholism STD’s contraception, pregnancy Issues Research  “treatment”? Research  “advice”? Fit with federal regs?

9. Adults with questionable or impaired capacity

10. Adults with questionable capacity Problem: capacity assessment If capable, no issue different from research generally If incapable, special protections Response No regulatory provisions Therefore, left to self-regulation More attention in institutional practice/policy? Central Maryland Alzheimer’s Association recommendations  Alz Dis & Assoc Dis 2004; 18: 171-75

11. Subjects with identified incapacity Problem: relying on a valid proxy Response Informed consent needed from “legally authorized representative” (45 CFR § 46.116) No regulatory specification about who is a “legally authorized representative” Guardian? DPA for health care? Default health care proxy? OHRP queries Deference re interpretation of state law

12. The uncertainties of current law Problem Tort liability if no legal authority Consent would be invalid; battery or negligence Constructions of health care proxy laws untested Response: specific state law CA and VA statutes, TN regulation No Maryland law Contentious or unaddressed issues Risk limitations Decisionmaking criteria Role of research advance directives