The University of Iowa
Human Subjects Office

Guidance for Principal Investigators and Research Team Members

Manuals

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The IRB provides the following guidance for obtaining consent with a Short Form when the research team encounters a potentially eligible, non-English speaking individual that is interested in participating in a study.
 
Short Forms are available in several languages.  If there is a need for a Short Form in a language not available here, the Principal Investigator is responsible for using the English version as a template to translate the Short Form into any additional needed languages.  Therefore, IRB review and approval of the Short Form is not required.
 
  1. Download a Short Form in the appropriate language from the HSO website.
  2. Enlist a translator who is fluent in both English and the potential subject’s language
    1. Bilingual adult family members and significant others may serve as a translator
    2. If the study involves complex procedures, ensure the translator has an understanding of the technical information in the consent document
  3. ​Allow the translator to verbally present the information in the IRB-approved English version of the ICD to the potential subject in his/her language, translate any questions the individual may have for the investigator, and provide the potential subject with the investigator’s responses
  4. Provide the potential subject with time to read the Short Form
  5. Ensure that an individual over 18 years of age, fluent in both English and the subject’s language, is present to witness the entire consent process
    1.  The translator may also serve as the witness
    2. The witness must be unaffiliated with the study and fluent in both languages. Therefore, if the translator is the PI or a member of the study team, s/he may not also serve as the witness
    3. Bilingual family members and significant others may serve as witnesses
  6. If the potential subject indicates agreement to participate in the study, the consent documents are signedThe non-English speaking participant (or LAR) signs the translated Short Form; and attests that the information in the ICD was presented orally in a language understandable to him/her (or LAR) and s/he consents to participate in the study 
    1. The non-English speaking participant (or LAR) signs the translated Short Form; and attests that the information in the ICD was presented orally in a language understandable to him/her (or LAR) and s/he consents to participate in the study 
    2. The research team member signs the IRB-approved English version of the informed consent document 
    3. The witness signs both the Short Form and the IRB-approved English version of the informed consent document.  By signing the Short Form, the witness attests to the fact that s/he observed the consent process, the information was presented in a language understandable to the subject, and the subject had the opportunity to ask questions.  The English version of the consent document does not have a separate signature section for the witness, so s/he will sign and date below the Person Who Obtained Consent
    4. The translator signs the Short Form and affirms that s/he is fluent in both languages and orally presented the information in the English version of the consent document and answered any questions.  If the translator is also the witness, s/he signs both the witness and translator signature sections on the Short Form
       
  7. Provide the subject with copies of the IRB-approved English version of the consent form and the Short Form.  Store the original, signed forms in the research records.  Per IRB policy, the best practice is to store the signed ICDs (including Short Forms) separate from the subject data   
  8. The Principal Investigator must provide the subject with a translated version of the complete IRB-approved ICD within 30 days of enrollment if the study requires multiple visits or the subject’s participation will last more than 60 days
  9. Informed consent is an ongoing process.  Therefore, the research team must address issues related to the subject’s ability to communicate throughout the duration of the study.  The best practice is to have a person of the subject’s choosing, who is fluent in both languages accompany the subject to subsequent visits.  Alternately, the research team may arrange for a translator to be available at subsequent visits to ensure that subject has an opportunity to ask questions, understands the responses and receives relevant study information
 

 

Short Form Policy November 2013