Equitable selection is a regulatory criterion for IRB approval. While non-English speaking participants should not be routinely excluded from research offering potential benefit, their enrollment requires time, effort, and financial cost typically borne by the researcher.
Participants who have limited or no English proficiency may be enrolled in your research provided you have the resources to communicate effectively with the participants during the recruitment process, while obtaining consent, and for the duration of the study.
Use of the short form process is appropriate when you don’t anticipate encountering non-English speaking individuals. If you expect to enroll more than an incidental number of participants speaking the same non-English language, it is best in most cases to use a translated full form.
Short Form Process for non-English speaking potential participants incidentally encountered:
A short form consent process is an option when not targeting or anticipating non-English speaking individuals and there is not enough time or resources available to translate the English version of the approved consent document into a language the potential participant understands. The process involves a translated short form, verbal process with an interpreter, and attestation from a witness. ORI has provided translated short forms and HIPAA Authorizations in common languages locally encountered. To learn more about this option, see the short form guidance and FAQ.
If you are not recruiting non-English speaking subjects, and the study offers potential benefits, you may request approval to use the short form process for non-English speaking prospective subjects encountered incidentally. Translated short forms and stand-alone HIPAA authorizations templates are available in several languages on this page and in E-IRB. Refer to the short form guidance for implementation requirements.
Translated Documents for recruitment of non-English speaking subjects:
If you are recruiting non-English speaking subjects, the consent document needs to be in the subject’s native language. Use the applicable model consent template provided on the website and in the "All Templates" option on the left-hand menu of your E-IRB application as a guide for developing the consent document. Spanish versions of informed consents and HIPAA authorization documents are available.
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 the 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), you should mark "yes" to the question "Does your research involve Non-English Speaking Subjects or Subjects from a Foreign Culture?" at the end of the Research Description section in your E-IRB application.
