Clinical research studies conducted in the US are regulated by the Food and Drug Administration (FDA) and by the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)). Throughout the research process, there are legal and ethical implications that researchers and doctors, clinical trial sponsors, and drug development companies must be aware of to successfully bring drugs and medical devices to the consumer market. Each ethical and legal requirement is important to the drug development process, but it is the study participants knowledge, voluntary acceptance or ‘informed consent’, and study participation that can ultimately lead to advancements in medical knowledge and improvements to aspects of social welfare.
The FDA requires that any principal investigator who conducts clinical research involving human subjects, obtain informed consent of the subject or in studies where minors and/or incapacitated subjects are participating, consent of their legal representative. Although the FDA does not require a specific type of document to obtain consent, the FDA does require that subjects be provided with fourteen basic elements as part of the consent process. While the FDA does not maintain final authority of an informed consent form (ICF), the agency does defer to the ethical judgement and determination of the Institutional Review Board (IRB) to review a clinical research study and to ensure that the purpose of the research and the documents utilized for the research, collectively ensure the research is ethical.
This presentation will provide a review of the fourteen basic elements of informed consent, the role of the IRB, and the role a paralegal may play in evaluating the ICF elements from the clinical research study sponsor perspective.