The Food and Drug Administration (FDA) has issued new guidelines on obtaining informed consent in clinical trials that will eventually replace the consent guide in use since 1998.
According to the new Informed Consent Information Sheet, the process of obtaining consent goes beyond merely obtaining written consent from the subject to participate in a medical study, according to Regulatory Affairs Professional Society (RAPS).
The FDA explains that the process involves “providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation,” and the process must help the potential subject understand the information. The subject must be given the opportunity to ask questions and to consider whether to participate. Subjects must be allowed to consider the inherent risks in participating in a trial, and whether participation is appropriate for them, according to RAPS. The process may continue even after the document is signed and subjects may need “opportunities to ask questions . . . throughout the clinical investigation.”
Updates to the 1998 guidelines include a section on non-English-speaking clinical trial participants. Information must be given in a language the subject can understand, and must be written in terms the subject can understand. The FDA says about one-third of adults have only basic – or worse – health literacy, while one-half of adults in the U.S. have difficulty understanding numbers and data, RAPS reports.
The draft has a section on patients with impaired capacity to give consent, impairments that can range from minor or temporary to complete impairment. The FDA says forms for impaired participants may need modification or have a process to allow a legal representative to do the enrollment on the subject’s behalf. An extensive section deals with children’s participation in clinical trials, RAPS reports. The FDA wants investigators to obtain the child’s affirmative “assent” that they are willing to participate in the research as well as a parent or guardian’s consent. Sections on reviewing patient records, subjects participating in more than one clinical trial, and study suspension/termination have been added.
Comments on the draft guidance will be accepted until September 15.