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This guidance document ensures that non-English speaking individuals are provided with research information in a language they understand to enable informed consent, outlining the roles of interpreters
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How to fill out UMDNJ Guidance for Obtaining and Documenting Informed Consent of Research Subjects Who Do Not Speak English

01
Identify the research subjects who do not speak English.
02
Prepare translated consent forms, ensuring accuracy and cultural appropriateness.
03
Engage a qualified interpreter to facilitate communication between the researcher and the subject.
04
Clearly explain the study objectives, procedures, risks, and benefits in a language the subject can understand.
05
Allow the subject to ask questions and provide thorough answers.
06
Obtain verbal consent from the subject, verified by the interpreter, if necessary.
07
Document the consent process, including the use of interpreters, in the study records.

Who needs UMDNJ Guidance for Obtaining and Documenting Informed Consent of Research Subjects Who Do Not Speak English?

01
Researchers conducting studies involving non-English speaking participants.
02
Institutions or organizations involved in clinical trials or research with diverse populations.
03
Ethics committees and review boards ensuring compliance with informed consent regulations.
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The UMDNJ Guidance provides protocols and standards for ensuring that research subjects who do not speak English are given adequate information about the research study in a language they understand, ensuring that their consent is informed and voluntary.
Researchers and faculty conducting studies involving participants who do not speak English are required to adhere to and file the UMDNJ Guidance to document informed consent appropriately.
To fill out the guidance, researchers must provide a clear explanation of the study in both the native language of the participant and in English, ensure proper translation of consent forms, and document the process of obtaining consent using appropriate forms.
The purpose is to ensure ethical research practices by guaranteeing that non-English speaking participants fully understand the research, their involvement, and the potential risks and benefits, thereby protecting their rights and welfare.
The information reported must include participant's understanding of the study, language used for the consent, details of the study explained, any questions asked by the participant, and how those questions were answered, along with signatures of both the participant and the researcher.
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