Abstract

ALTERNATIVE METHODS TO THE PHYSICAL PROCESS OF OBTAINING INFORMED CONSENT FOR CLINICAL TRIALS DURING PUBLIC HEALTH EMERGENCY

Veer J. Patel* and Dasharath M. Patel

ABSTRACT

A systematic review of literature was performed to analyze the background and new alternative methods to obtain informed consent for clinical trials in emergency settings. A review of the WHO guidance document and federal guideline on conducting clinical trials of medicinal products during public health emergency was performed and out of the various literature search done, a total of seven literature texts were selected for inclusion. The new recommended methodologies by the federal agency for obtaining informed consent from trial participants were studied and expressed in an overview pattern. This review article emphasizes on the recent changes that can be adopted as an alternative to physical communication for informed consent and the effective and non-contact methodologies in obtaining an informed consent from human subjects of clinical trials during public health emergency.

Keywords: Informed consent, human subject, trial participant, clinical trial, public health emergency.