Consent Forms and Procedures

Obtaining the informed consent of a participant is a prerequisite for enrollment in a clinical trial. In the United States, federal regulations provide the framework for establishing informed consent with additional protections for persons considered vulnerable due to incarceration, illiteracy, or other condition. Investigators are tasked with providing sufficient information about the research to satisfy the ethical and regulatory requirements while communicating it in a manner that maximizes the participant’s ability to make an informed decision regarding study enrollment. There are clinical trial design features that are essential to include in the consent form with care to describe topics such as randomization, allocation ratio, and masking in a manner understood by the lay public. The informed consent discussion should continue throughout the course of the trial as informally reaffirming the participant’s willingness to continue participation and reconsenting them when there are significant changes to the study protocol are important considerations for providing truly informed consent.