Regulatory Issues for Clinical Trials in Humans

Abstract

Clinical trials in humans are research studies designed to evaluate two or more treatments in human participants. Major concerns in any clinical trial are the protection of study participants’ safety and rights and ensuring the accuracy and validity of the data being collected. To ensure that these concerns are adequately addressed in a study, the funding institutions, the institutions where the research actually takes place, and federal and state regulatory agencies have developed regulations and guidelines for conducting human research. In the United States, each of the granting federal departments and agencies has its own regulations and guidelines for conducting human research that must be followed. If a new drug/device is being tested or an approved drug/device is being tested for a new indication, then the study must be conducted under the rules and regulations of the US Food and Drug Administration (FDA). In cases where there is both a federal funding institution and a new drug/device being tested, the regulations of both the funding department or agency and the FDA must be followed. These regulations for the FDA (1) and the various federal departments and agencies can be found in the Code of Federal Regulations (CFR). A listing of the appropriate CFR for the various federal departments and agencies can be found in the instructions for federalwide assurance from the Office for Human Research Protections, Department of Health and Human Services (2). Although many clinical trials in the United States are funded by federal departments and agencies, many are funded by the pharmaceutical industry. These industry studies will almost always comply with FDA regulations and the International Conference on Harmonisation guidelines that have been adopted by the FDA. In this article, some of the more pertinent regulatory issues that an investigator must