Facts
- Kennedy Krieger Institute, Inc. (KKI) conducted a government-sponsored, nontherapeutic research study in Baltimore to compare the effectiveness of differing degrees of lead-paint abatement in older rental homes.
- Homes were placed into treatment groups that included partial abatement rather than complete lead hazard removal; landlords sometimes received public funding to perform the work.
- KKI encouraged and at times required landlords to rent the study homes to families with young children so investigators could measure lead dust levels and the children’s blood-lead levels over time.
- Families signed consent forms and received small payments; plaintiffs alleged the consent materials did not clearly disclose that the study entailed ongoing lead exposure risk and blood testing to measure contamination.
- Plaintiffs alleged KKI knew lead hazards could persist or recur after partial abatement, failed to provide adequate warnings, and delayed notifying parents of elevated environmental and blood-lead measurements.
- Ericka Grimes lived in a study home from birth into early childhood and allegedly experienced steadily increasing blood-lead levels during the study.
- Myron Higgins moved into a partially abated study home and allegedly experienced rising blood-lead levels, with delayed notice to his mother.
- The children and their mothers sued KKI in negligence, claiming injuries associated with elevated blood-lead levels and alleging duties arising from the researcher-subject relationship and consent process.
- Trial courts granted KKI summary judgment, concluding KKI owed no actionable duty and that consent forms did not create contractual or special-relationship obligations.
Issues
- Whether, under Maryland law, a parent or surrogate may consent to a child’s participation in nontherapeutic research that presents risk of injury or damage to health.
- Whether informed-consent agreements in nontherapeutic research may constitute contracts and/or create a special relationship imposing duties of reasonable care on researchers toward subjects.
- Whether human-subject research regulations may supply or inform legally cognizable duties owed by researchers to subjects.
- Whether summary judgment for KKI was proper given the alleged duties, disclosure failures, and resulting injuries.
Decision
- The Court of Appeals of Maryland vacated the summary judgments and remanded for further proceedings.
- The court held that a parent or other surrogate cannot consent to a child’s participation in nontherapeutic research in which there is any risk of injury or damage to the child’s health.
- The court held that, in certain circumstances, informed-consent agreements in nontherapeutic research can constitute contracts.
- The court held that, ordinarily, nontherapeutic researcher-subject relationships create special relationships that can impose duties, the breach of which may support negligence claims.
- The court held that governmental regulations governing human-subject research can create or support duties running from researchers to subjects.
- Applying these holdings to the record viewed favorably to plaintiffs, the court concluded the trial courts erred in granting summary judgment.
Legal Principles
- Nontherapeutic research using children is subject to heightened common-law protection because the research is not designed to provide direct benefit to the child participants.
- Parental or surrogate consent does not validly authorize placing a child into nontherapeutic research that poses risk of injury or harm to health; consent cannot operate as a defense where the law does not permit the risk-imposing intervention.
- Informed-consent documents and the surrounding exchange may, depending on circumstances, form a contract between researchers and participants, supplying enforceable obligations.
- The researcher-subject relationship in nontherapeutic studies can constitute a special relationship giving rise to duties of reasonable care, including duties tied to disclosure, monitoring, and timely warning about known or detected hazards.
- Research regulations may be relevant not only as ethical guidance but as a source of legally cognizable duties supporting tort liability when breached.
Conclusion
The court allowed negligence claims by child research subjects and their families to proceed, holding that Maryland law restricts parental consent for nontherapeutic pediatric research posing health risks and that researcher duties may arise from consent agreements, special relationships, and research regulations, making summary judgment improper on the record presented.