UK Office of Research Integrity

IRB Application: Informed Consent/Assent Process

Section 2
FORM H.   Non-English Speaking Subjects or Subjects from a Foreign Culture

If you are recruiting non-English speaking subjects, the consent document needs to be in the subject’s native language.  Use the model consent provided in Section 2, Form C of the applicable IRB application as a guide for developing the consent document.

If you are recruiting subjects from a foreign culture, or subjects for whom English is a second-language, you may be required to develop a plan for evaluating the level of English comprehension, and the threshold for providing a translation, or explain why an evaluation would not be necessary.

If you are recruiting non-English speaking subjects, and/or subjects from a foreign culture, include contact information for someone who can act as a cultural consultant for your study. The person should be familiar with the culture of the subject population and/or be able to verify that translated documents (if applicable) are the equivalent of the English version of documents submitted. The consultant should be able to provide comments/suggestions for the IRB regarding consent procedures and appropriateness of the research for the culture. The consultant should not have any direct involvement with the study. Please note: The Office of Research Integrity does not have resources to compensate consultants; consultants are asked to provide such services on a voluntary basis by donating their time. Any consultant identified by an investigator should be made aware of this when agreeing to provide services. Please contact staff in the Office of Research Integrity for additional guidance, if needed.

If you do not know someone who would be willing to act as your cultural consultant, the Office of Research Integrity will try to find someone to fill this role (this may delay the approval process for your protocol). Please include the name, address, telephone number, and email of the person who will act as the cultural consultant for your study.

If you are proposing research which involves non-English speaking subjects, or subjects from a foreign culture (i.e., international research), please mark the appropriate selection(s) in the General Information Sheet [Section 1, Form A].

UK Healthcare Policies

Please note the following UK Healthcare Policy/Procedure documents which may provide useful information for you:

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