The University of Iowa
Human Subjects Office

Proactive Measures

Manuals

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The IRB allows the research team to use the Short Form with up to five (5) subjects in any one study.  Therefore, if the PI has used the Short Form five (5) times and anticipates enrolling additional non-English speaking subjects, the PI must inform the IRB using the following steps.
 
  1. Submit a HawkIRB modification:
    1. In Question VI.16, select ‘Yes’ and in Question VI.17 list the languages of the non-English subjects the PI anticipates encountering
    2. In Question VI.17a, provide the translator’s name, qualifications and activities the translator will complete (e.g., translate documents, explain the study to potential subjects and answer questions) 
    3. Review Section VII.D and edit any sections affected by the inclusion of non-English speaking individuals
      1. In Question VII.D.29, provide a detailed description of the consent process that will be used to otain consent from non-English speaking individuals using the translated document and addressing all the bullet points, including:
        1. Who will present the information and answer questions
        2. The measures the research team will use to minimize the possibility of coercion or undue influence during the consent process with non-English speaking persons
        3. How the research team will facilitate communication throughout the course of the study to ensure that ongoing information is presented in the subject’s language and how questions raised by the non-English speaking subject will be addressed
    4. Have the current IRB-approved Informed Consent Document (ICD) translated into the anticipated language(s) and include the following documents on the Attachment Tab:
      1. In the Consent & Assent Forms Category, attach an appropriately labeled, translated version of the ICD  
      2. In the Miscellaneous Category, attach an appropriately labeled document that provides the translator’s credentials
    5. If the PI plans to edit the IRB-approved English version of the ICD in any way, s/he is advised to await IRB approval of the modifications to the English version prior to translating the English version of the ICD into other languages, because any changes required by the IRB must be included in the translated version of the document.
      1. Once the IRB approves the modified English version of the ICD, the PI may enroll additional English speaking subjects using the newly revised consent document
      2. The research team must await IRB approval of the translated version to consent additional non-English speaking individuals
 
Short Form Policy November 2013