Adjustments to the Consent Process Based on the Needs of the Person; Non-English Speakers, Low Literacy, Physical and Sensory Disabilities

As with all consent discussions, sufficient time should be allowed for explaining each section of the consent and for the potential subject to ask questions. Working with an interpreter to explain complex topics such as randomization, placebo control, dosing schedules and invasive/noninvasive procedures may require additional time and/or subsequent discussions.  It is the investigator's responsibility to judge the subject's comprehension of the consent information including the understanding that participation is voluntary and that the subject has the right to withdraw at any time during the study. If the investigator doubts the subject's consent comprehension, they should not enroll the subject in the study unless the IRB has prospectively approved a decision making capacity assessment and surrogate consent process. A subject's autonomy must not be jeopardized due to a perceived language barrier.

Preferred Method of Obtaining Informed Consent 

If the investigator anticipates a substantial portion of eligible subjects to be non-English-speaking people, translated consent forms in the common languages should be prepared in advance.  In Orange County, it may be reasonable to anticipate certain languages such as Spanish and Vietnamese. 

Alternative Short Form Method of Obtaining Informed Consent 

The alternative "short form" method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking subject in a study for which no consent form in the subject's language has been prepared. 

IMPORTANT NOTE:  The IRB must formally approve the use of short forms prior to enrolling a subject via the short form process.

• Use of the short form consent process must be prospectively reviewed and approved by the IRB.
• Only those study team members who are approved by the IRB to obtain informed consent from research participants may obtain short form consent.
• All versions of the short form and California Experimental Subject’s Bill of Rights are available on the HRP Toolkit page.
• Additional translations may be requested by contacting the HRP at IRB@research.uci.edu.

Procedures for the Alternative Short Form Consent Method

1. If IRB approved, the investigator consents non-English speaking subjects using the translated short form and approved English consent document. 
2. The subject will read the short form consent in their chosen language.
3. An interpreter, in the presence of the Principal Investigator or delegated Co-Investigator will orally translate the English version of the IRB-approved consent document and will facilitate the question and answer phase of the informed consent process between the potential subject and the researcher.
4. A copy of the Experimental Subject’s Bill of Rights should also be provided to all research subjects considering participation in a medical experiment, per California Health & Safety Code. 
5. A witness will be present during the oral presentation of the English version of the IRB-approved consent document.
   • Note: The witness must be an adult, fluent in both languages, who in general is not a member of the study team. The interpreter may serve as the witness. For any exceptions, see HRP-090 Informed Consent Process for Research. 
     
6. The following signatures will be obtained on the short form consent and the English version of the IRB-approved consent:
   • The subject will sign and date the short form consent; and
   • The witness will sign and date both the short form consent and the English informed consent document.
   • The researcher obtaining consent will sign and date the English informed consent document.
7. A copy of the English informed consent document and the short form consent will be given to the subject.
8. Once the subject has consented and eligibility is confirmed, the English version of the IRB-approved consent form must be translated into the subject’s language by a professional or certified translator and provided to the subject within one month from the date that eligibility is confirmed.
9. For additional information on the consent process, review the Informed Consent Process and the August 2023 Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors.

Translation Requirements

Preparing Translated Consent Materials

The English version consent and study materials submitted to the IRB should be written at the 8th grade level or lower. In general, translations are prepared after IRB review and approval of the English version.

Translation Expectations

Greater than minimal risk studies: a professional or certified translation of the consent/assent form(s) and recruitment material(s) is required for studies that pose more than minimal risk to subjects (i.e., studies that require full committee review), unless the IRB has granted a waiver of documentation of informed consent.

For a professional translation the Principal Investigator must provide the qualifications of the individual who translated the informed consent documents and recruitment materials. Include any credentials, certifications, education, native language fluency, etc. For a certified translation, a copy of the certification from the translator or translation service should be attached to the translation of any informed consent documents and recruitment materials.

Minimal risk studies: Studies that are eligible for expedited review also require translation of the consent/assent forms; however, certified translation is not required. The IRB will accept documents translated by an individual fluent (i.e., can speak, read and write) in a given language. The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents. As noted above, include any credentials, certifications, education, native language fluency, etc.

Differences between an interpretation and a translation: For purposes of research informed consent, an interpretation is a verbal exchange between two parties and the person serving as interpreter is fluent (can speak, read and write) in English and the language of the subject. A translation is the process of translating a written document (e.g., consent form) from one language into another, assuring the language of the translated document has the same meaning as the written document in the first language.

The following documents should be translated before enrolling non-English speaking subjects on a study:

The IRB-approved English informed consent/assent document(s)

California Subject's Bill of Rights (when applicable). Several translations are available on the on the HRP Toolkit page.

Authorization for the Use of Personal Health Information for Research (when applicable). Translations are available in Spanish & Vietnamese on the HRP Toolkit page.

Self-Certification of Surrogate Decision Makers for Participation in Research (when applicable). A translation is available in Spanish on the HRP Toolkit page.

Cost of Translation

The cost of translating written consents is the investigator's responsibility. These costs may be quite high, particularly for large studies where multiple translations are needed and/or studies with relatively complex consent information that may require additional time by a skilled professional. Investigators should include the costs of written translations as well as medical interpreter services on grants and contracts. Industry sponsors are often willing to pay the costs of translating consent forms.