Legal issues in human clinical investigation: a primer for physicians

Human clinical investigation plays a central role in contemporary nuclear cardiology. It is a complex expensive endeavor triggering multiple responsibilities not otherwise encountered by physicians in clinical practice. Clinical investigators, drug and device manufacturers, hospitals and universities, governmental agencies, research subjects, patient advocacy groups, and investors all have a legitimate interest in the conduct and the outcome of clinical research. Past abuses of research subjects in many countries including those unknowingly exposed to radioactive isotopes have raised ethical concerns that are now addressed by overlapping laws, regulations, guidelines, and institutional policies that have evolved to guide the research enterprise. The policies underlying this legal and regulatory structure include protection of research subjects, protection of the integrity of research design and research data, and protection of the public and private purse. Knowledge of these laws and regulations is essential for physicians participating in clinical investigations to protect their professional and personal interests. This article reviews legal issues relevant to physicians conducting human clinical trials in the United States.