Should Participants in Clinical Trials Be Able to Withdraw from Passive Follow-Up?

Abstract

A research participant s right to withdraw from all research procedures is widely accepted, but there can be justifiable limits to a participant s exercise of autonomy to withdraw from some procedures. Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. Subjects refusal to complete follow-up, even through passive medical record review, can cause failure to detect safety signals, inaccurate estimation of efficacy, or lack of acceptance of trial results, which alters the study s benefit-risk ratio. Allowing participant refusal of follow-up data collection therefore creates tension between respect for persons and beneficence. With minimal risk study procedures that can help preserve trial benefit, such as passive data collection, we argue that the importance of upholding the principle of beneficence outweighs individual autonomy concerns. Furthermore, a consent process that prospectively informs participants of mandatory passive follow-up is ethically justified and optimizes the balance between autonomy and beneficence.