Abstract

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Highlights

  • As English is the predominant language of research protocols in the United States, non-English speaking subjects face language barriers during clinical trial enrollment

  • Federal regulation 45 C.F.R. 46 requires that a research subject receive information about a clinical trial “in language understandable to the subject or the legally authorized representative." A researcher may enroll a subject using short-form consent when a longform translation in the subject’s native language is not available

  • Law requires that a research subject should receive information about a clinical trial “in language understandable to the subject or the legally authorized representative.”[1]. This law states that a researcher may enroll a subject using a “short-form” consent when a “long-form” translation in the subject’s native language is not available.[2]

Read more

Summary

Short Form and Noncompliance

Vagueness in the federal regulations has caused disparate interpretation among institutions, leading to noncompliance.[12] Each institution has its own interpretation of 45 CFR 46, known as the Common Rule, which protects vulnerable research subjects and provides research teams with a short-form template.[13] As noted above, the regulations do not require a translator, nor do they specify the translator’s specific role or qualifications.[14] HHS has not made it clear whether the witness may be a member of the study team or related to the patient, or whether the witness providing interpretation must be independent. It should recommend cultural competency programs for investigators at the institutional level

Limitations
Support
Findings
CONCLUSION
Full Text

Published Version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.