In this section
Consent of non-English speaking subjects
Ensuring that prospective subjects understand a research study – the purpose, the risks and benefits, what will happen to them, etc., can be challenging in the best of circumstances, particularly with complex and high risk studies. When a potential subject does not speak English, this creates an even greater challenge of obtaining truly informed consent.
Federal regulations from the US Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), and the US Food and Drug Administration (FDA) state that informed consent, "shall be in a language understandable to the subject or representative." A non-English speaking subject is one unable to verbally comprehend the spoken English language or read and comprehend documents written in English.
Per Children's policy, Federal regulations, and guidance from OHRP, there are two methods by which to obtain and document a subject's informed consent to participate in a research study.
- Preferred method: the preferred method is to provide consent forms written in a language understandable to the subject or the subjects legally authorized representative.
- Short form method: this method should only be used for the occasional and unexpected enrollment of a non-English speaking subject when no prospectively IRB approved translated consent documents in the appropriate language are available. The investigator may use oral translation of an IRB approved study summary (the IRB approved English informed consent document may be used as the summary) to explain the study to obtain consent, and an IRB approved "short form" to document consent (if one is available in the appropriate language).
Reminders for both methods
The IRB must approve the enrollment of non-English speaking subjects. Investigators must specify on the IRBNet registration page and in the study summary/new study application if non-English speaking subjects will be included. Investigators should provide a description of how the investigator and study team will communicate with non-English speaking subjects. Because informed consent is an ongoing process, investigators should provide a description of how non-English speaking subjects' questions and concerns as well as their continued agreement to participate in the research will be assessed.
Use a qualified interpreter (one with training and understanding regarding medical terminology), fluent in both English and the subject's language, to present the study summary/full consent document to the subject and facilitate discussion, questions and answers.
The interpreter should not be a family member of the subject.
For assistance with obtaining an interpreter contact, Children's Language Services at 414-266-3336.
It is the investigator's responsibility to judge subjects' comprehension of the consent information, including whether participation is voluntary and the right to withdraw at any time.
- If there is any doubt about a subject's comprehension due to a language barrier, that subject should not be enrolled.
- Per OHRP, it is the responsibility of the IRB to determine which procedure (preferred method or short form method) to obtain and document the consent of non-English speaking subjects is appropriate. In some circumstances, the IRB may not approve the use of the short form.
- For example, the IRB may feel the study is too complex, or it may determine that non-English enrollments are expected and thus may require fully translated material.
Preferred method processWhen planning research, investigators should consider the potential for non-English speaking subjects that may be a part of the population being studied. If enrollment of non-English speaking subjects is anticipated, certified full translations of all recruitment material, patient information, and informed consent documents should be incorporated into the budget and study design.
- The IRB must first approve all other aspects of the study, except for translated material, with no further modifications required.
- This prevents having to re-translate documents if there are modifications required to the English versions
- Include all materials, in addition to the informed consent documents, that will be translated and provided to non-English speaking subjects (such as patient brochures, information sheets, advertisements, patient diaries or data collection tools, surveys, etc.)
- Investigator then submits, via an amendment, the translated documents for IRB review and approval.
- Investigator must include a certification of translation
- Two way, or "back" translation is not required
- IRB Coordinators may expedite approval of the translated documents
- If this is an amendment being done because a short form was previously approved (and therefore non-English enrollments are no longer unexpected) and fully translated documents are being submitted, the most current IRB approved English versions of the consent documents should be used for the translation and the amendment should indicate which versions were translated
- Consent should be obtained using the IRB approved translated documents which the subject or subject's legally authorized representative is able to read and comprehend, and a translator should be available to assist with questions and discussion.
- Consent is documented by having the subject or the subject's legally authorized representative sign the IRB approved translated consent document.
- A copy of the translated, signed consent form is given to the subject/subjects legally authorized representative.
Short form method processThe short form essentially states that the elements of informed consent have been presented orally to the potential subject or the subject's legally authorized representative and the subject agrees to participate in the study. There are templates available in several languages with accompanying certifications.
The IRB must approve the written summary of what is to be said to the subject and the short form before consent is obtained and the subject enrolled. The investigator may use the IRB approved English version of the informed consent document as the study summary.
- When a potential non-English speaking subject is identified, the investigator should submit an amendment requesting use of the short form for a particular subject.
- An amendment form requesting use of a short form for a particular subject
- Typically this should be requested via an amendment after there is an unexpected, identified subject for which no fully translated consent documents are available at the time of enrollment. If this is being requested before a potential non-English speaking subject is identified, these requests must provide sufficient rationale for why the IRB should approve use of this method prior to identification of a specific non-English speaking subject. These requests will be assessed case by case.
- Include the short form template with study title, investigator's name and contact information included
- Reference the effective date of the IRB approved English consent form that will be used as the summary
- There must be a witness to the translation and consent discussion done through an interpreter.
- This witness must be fluent in both English and the subject's language
- The witness must be present for the entire discussion, not just the signature
- Per OHRP, the interpreter may serve as the witness. This reduces the burden of finding another party who is not family of the subject and fluent in both languages to witness the discussion.
- Consent is documented with signature on IRB approved informed consent documents:
- Subject or subjects legally authorized representative signs the short form
- Person obtaining informed consent signs the IRB approved English consent document (summary)
- Witness signs both the short form and the IRB approved English consent document (summary)
- A copy of the signed summary and short form is given to the subject or subject's legally authorized representative.
Short form templates and certificates of translation