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Maryland Law and Clinical Research:
Finding a Way Forward
Jack Schwartz
Director of Health Policy
Maryland AG’s Office
Topics
The impact of the Krieger decision Parental authority to allow their kids in research
Evolution and scope of the Maryland statute Evaluation?
Research with incapacitated subjects Improved practice, new law?
Grimes v. Kennedy Krieger: the plaintiffs’ case
Negligence claims Improper abatement methods Failure to warn
Plaintiffs win only if Krieger: Had a legally recognized duty to them Breached that duty By the breach, caused them injury
Krieger’s Pyrrhic victory
Krieger’s argument: no duty owed “Even if what the plaintiffs say were true, they still
lose.” Trial court agrees
grants Krieger’s motion for summary judgment No trial No factual record except plaintiffs’ allegations
Issue on appeal: existence of duty
Court of Appeals reverses trial court Krieger did have a duty of care Sources:
Consent document = contract Nature of “nontherapeutic” research Federal regulations Nuremberg Code
Holding on parental authority
Standard = best interest of the child Court’s view of the Krieger research
Healthy children; no personal benefit Risk of permanent, serious harm
Participation could not be in child’s best interest
Therefore, no parental authority to consent
Step 1: Any therapeutic procedures involved?
Therapeutic = evidence-based possibility of direct medical benefit
Nontherapeutic = done solely to answer the scientific question
Weijer C & Miller PB. When are research risks reasonable in relation to anticipated benefits? Nature Med 2004; 10: 570-73.
If NO Parental authority probably limited to minimal risk
If YES To Step 2
Step 2: Clinical equipoise?
Are therapeutic procedures consistent with competent medical care?
If NO No parental authority Not in child’s best interest to forgo preferable care
If YES To Step 3
Step 3: Potential direct benefits worth the risk?
Are risks of therapeutic procedures justified by prospect of direct benefit?
If NO No parental authority
If YES To Step 4
Step 4: Risk of nontherapeutic procedures minimized?
Are risks of nontherapeutic procedures minimized consistent with sound scientific design?
If NO No parental authority
If YES To Step 5
Step 5: Risk of nontherapeutic procedures justified?
Are risks of nontherapeutic procedures no more than a minor increase over minimal and justified by scientific value?
If NO No parental authority
If YES Parental permission allowed
Applying the analysis: Phase 1 oncology trials
Is test article a therapeutic procedure? By FDA definition, not an efficacy trial But: what if no clinical alternative for hope of
remission? Depending on facts about child, research,
and alternatives: Answer might be “Yes” to all Parental best interest judgment possible
Applying the analysis: prophylactic vaccine trials
Is test article a therapeutic procedure? Therapeutic for healthy subjects? Maybe, depending on risk of future disease
If IRB finds it not a therapeutic procedure: > minimal risk No parental authority
If IRB finds it a therapeutic procedure: Answer might be “Yes” to all Parental best interest judgment possible
Basic information
Bill reference: House Bill 917 of 2002 Passed House 135-1, passed Senate 47-0 Statutory reference: new §§ 13-1601 to 13-
1604, Health-General Article, Maryland Code Effective date: October 1, 2002
Extending federal regulations
All human subject research must comply with HHS or FDA regulations Note: requires compliance with all of 45 CFR Part
46, not just Common Rule Should have no effect on FWA institutions
Allows exemptions/waivers authorized under federal regulations
Issue: Does HB 917 apply to research begun prior to October 1, 2002?
Access to minutes
Roughly comparable to FOIA process Allow inspection within 30 days of request
“Confidential or privileged information” may be redacted
Issue: What is “confidential or privileged”? Issue: Is access granted to minutes created
before October 1, 2002?
Attorney General enforcement
Needed for research outside OHRP jurisdiction
Authority to seek court order for compliance No authority to regulate No appropriation for enforcement unit
respond to complaints only AG will coordinate with, defer to, OHRP
Has the bill made any difference?
AG’s Office would like to find out possibility of questionnaire to IRBs
Previously unreviewed research now sent to IRB?
Effect of provision on minutes? Impact on conduct of meeting? Content of minutes? Number of requests?
Epstein’s Law: If you think the problem is bad now, just wait until we’ve solved it.
Subjects 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 obvious incapacity
Problem: identifying a 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 Contentious or unaddressed issues
Risk limitations Decisionmaking criteria Role of research advance directives