FDA Issues Guidance on Clinical Investigator Responsibilities

The Food and Drug Administration (FDA) recently issued Guidance for Industry Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects (Guidance) to help investigators satisfy their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations.

The Guidance clarifies that an investigator must provide adequate supervision over tasks that are delegated to employees or other agents. In assessing the adequacy of supervision, the FDA will focus on four major areas: (1) whether delegates were qualified to perform the delegated tasks, (2) whether study staff received adequate training on how to conduct the delegated tasks and were provided with an adequate understanding of the study, (3) whether there was adequate supervision and involvement in the ongoing conduct of the study, and (4) whether there was adequate supervision or oversight of any third parties involved in a study, to the extent such supervision or oversight was reasonably possible.

The Guidance also clarifies an investigator’s obligation to protect the rights, safety and welfare of his or her study subjects, including (1) providing reasonable medical care for study subjects for medical problems arising during participation in the trial that are, or could be, related to the study intervention; (2) providing reasonable access to medical care when specialized care is needed; and (3) adhering to the protocol so that study subjects are not exposed to unreasonable risks.