Overcoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues with the Use of the “Short Form”

Abstract

Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

• auditing
• clinical research
• informed consent
• IRB
• quality assurance
• short form