Evaluating the risks of clinical research: direct comparative analysis.

ABSTRACT:

Objectives

Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations.

Methods

This study employed a conceptual and normative analysis, and use of an illustrative example.

Results

SUBMITTER: Rid A 

PROVIDER: S-EPMC4162436 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature