FDA Issues Guidance Regarding Participant Withdrawal From Research Studies
The FDA recently issued guidance regarding participant withdrawal from human subjects research studies. The guidance, intended for clinical investigators, sponsors, and institutional review boards, articulates the FDA's already longstanding policy that data accrued from a study participant prior to that participant's withdrawal should remain part of the study data. The FDA, in formulating this guidance, cited its concern that to permit otherwise, i.e. to allow for the deletion of a withdrawn participant's data, would undermine the scientific validity and ethical integrity of human subjects research studies.
This FDA guidance, available here, does not establish legally enforceable responsibilities. Rather, the guidance represents the FDA's current thinking regarding participant withdrawal and its effect on human subjects research.
The U.S. Office for Human Research Protections recently issued similar guidance regarding participant withdrawal, available here, and is currently soliciting public comment regarding this guidance.
