Transcript An Attorney General`s Perspective on Pain Management Issues

Subjects with Absent or
Questionable Capacity:
Doing Research in a
Legal Fog
Jack Schwartz
Director of Health Policy
Maryland AG’s Office
[email protected]
Topics

Children as research subjects

Research generally




Research of specific kinds


Parental consent/child assent
Emancipated minors?
Mature minors?
Child’s consent authorized?
Adults


Questionable capacity
Incapacitated
Children
as
research subjects
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
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
Consent authority by status?

A minor who




“has the same capacity as an adult to
consent to medical treatment”
Issue: What kind of research  “medical
treatment”?


is married or
the parent of a child
Evidence-based possibility of direct medical
benefit (AG view; no court decision)
Issue: fit with federal regs’ “legal age”?
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
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?
Adults
with
questionable or
impaired capacity
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
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
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