Broad-scale informed consent: A survey of the CTSA landscape.

ABSTRACT:

Introduction

Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule's strict regulatory definition for "broad consent") may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broad-scale informed consent within the Clinical Translational Science Award (CTSA) Program Network.

Methods

We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consen

SUBMITTER: Chandler R 

PROVIDER: S-EPMC6813518 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature