Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses.

ABSTRACT:

Background

Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., "miscellaneous clinical studies", have no legally mandated timelines for institutional review boards' (IRB) decisions.

Goal

To evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients).

Methods

Descriptive and comparative statistics. Protocol 1 is a prospective, multicenter, cross-sectional screening study of a symptomatic pediatric population at risk for Fabry disease involving genetic testing (NCT02152189

SUBMITTER: Kastner B 

PROVIDER: S-EPMC4537221 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature