2021 Articles
Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process
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 long-form translation in the subject’s native language is not available. However, the abbreviated short form does not adequately inform the subject of the study’s purpose and potential risks. United States Department of Health and Human Services (HHS) leaders should amend federal guidance to provide specific details on obtaining proper informed consent when there is a language barrier. The code of federal regulations should also establish a standard for quality translation services and interpreters. This paper will review current federal regulations and draft policy, analyze literature describing hospital experiences, and discuss non-compliance areas. This author recommends an amendment to federal policy, which is important because it helps ensure the rights of study participants under the principle of justice.
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Files
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Mistretta_2022_Amending Federal Regulations to Counteract Language Barriers in the Informed.pdf application/pdf 271 KB Download File
Also Published In
- Title
- Voices in Bioethics
- DOI
- https://doi.org/10.52214/vib.v8i.8815
More About This Work
- Academic Units
- Bioethics
- Published Here
- August 29, 2022
Notes
Research Ethics, Language Barriers, Clinical Trials, Informed Consent