The regulatory framework for conducting clinical trials in the United States is set forth under Title 21 of the Code of Federal
Regulations, which addresses the protection of human subjects, institutional review boards (IRBs), and financial relationships,
as well as other significant regulatory issues in the conduct of clinical trials. While Title 21 sets forth regulations that
need to be complied with, the clinical trial professional must understand that there are specific state laws and regulations
that impact clinical trials (e.g., those related to informed consent, age of consent, legal representatives, and government
Although it is important that clinical trial sponsors and investigators focus on complying with FDA regulations, these FDA
regulations do not preclude states from imposing their own requirements.2 Clinical trial professionals must remember that FDA's informed consent regulation specifies that the states are not preempted
from establishing additional requirements. Failure to comply with state laws and regulations in areas such as informed consent
can expose sponsors and investigators to significant liability risks. Lawyers, who specialize in injury claims caused by medical
treatment, are becoming particularly creative in their attempts to file suits against individuals and companies sponsoring
and conducting clinical trials. Negligence, informed consent, battery, wrongful death, and conflicts of interest are state
law theories utilized by plaintiffs' counsels to allege liability of parties conducting clinical trials.
Most recently, significant verdicts and settlements in favor of clinical trial participants over the last few years have contributed
to the increase in clinical trial lawsuits.3 Various theories of tort liability may be brought on behalf of clinical trial participants, but it is important to understand
that these causes of action typically involve both federal and state law-based claims. Compliance with state informed consent
requirements (e.g., age and legal capacity of the clinical trial subject to consent) will significantly impact the ability
of a plaintiff's counsel to raise these various theories of tort liability.
It is important for the clinical trial professional to understand that cases citing negligence based on a failure to provide
informed consent, or inadequate informed consent, often depend on state interpretation. Failure to comply with state consent
requirements can be used by a plaintiff's counsel to assert negligence-based claims, and in some jurisdictions may be used
as evidence of negligence per se, which exposes the clinical trial professional to increased risks. Failure to adhere to state
law requirements may cause clinical investigators to improperly give consent human subjects. Those who have the legal capacity
to give consent on behalf of minors or incompetent patients, also may not properly obtain it. This increases exposure to lack
of informed consent-based claims.
Traditionally, injured clinical trial subjects have brought claims against pharmaceutical manufacturers based on theories
of products liability, negligence, and other legal causes of action. In recent years, however, an increasing number of cases
have included claims against clinical trial investigators, professionals assisting investigators in conducting trials, and
IRBs of the institutions where the trials are being conducted.
A widely-publicized case that raised awareness of clinical trial liability involved the death of a healthy teenager who had
participated in a gene therapy experiment.4 The estate of the deceased teenager sued the physician, the founder of the sponsor company, the sponsor company, and the
university trustees. The suit was filed in state court and alleged state claims that included wrongful death, intentional
assault and battery, lack of informed consent, intentional and negligent infliction of emotional distress, common law fraud
and misrepresentation, and products liability. Another lawsuit regarding this gene therapy trial subsequently was filed on
behalf of another participant with similar allegations.5 The lawsuit involving the teenager ended in a multimillion dollar settlement; however, had it proceeded to trial, state statutes
and regulations regarding informed consent would have been central to the plaintiff's case.