State Regulation of Clinical Trials - - BioPharm International

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State Regulation of Clinical Trials


BioPharm International



John Serio
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 notification).1

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.


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