UI researchers may use the Short Form Consent Document and Process when the research team unexpectedly identifies a potential subject who does not speak English and the IRB has not approved the Informed Consent Document into that language. The Short Form Consent Process allows the team to verbally translate the IRB-approved Informed Consent Document into the language the subject understands.

The Short Form Consent Process may be used to enroll a limited number of subjects into a study. To enroll any additional subjects, the team must use an IRB-approved, translated version of the full Informed Consent Document.

Prior to Enrollment

Before enrolling a subject who does not speak English, the research team should have a plan for

  • Obtaining the required signatures from the translator and a witness to the consent process who speaks both languages
  • Communicating with the subject or their Legally Authorized Representative throughout the study
  • Translating any other documents, instructions or survey instruments that are provided directly to subjects
  • Obtaining IRB approval for a full translation of the study Informed Consent Document, if required by the policy

About the Short Form Consent Document

The Short Form Consent Document is written in a language the non-English speaking subject or their Legally Authorized Representative can read and understand. It summarizes the information the investigator must tell the participant before consent, but it does not contain study-specific information. The Short Form Consent Document states that the consent process included a verbal translation of the IRB-approved English Informed Consent Document in a language understood by the subject or their Legally Authorized Representative (LAR).

Short Form Consent Document Policy and Guidance

For additional information about the Short Form Consent Document Policy, see the IRB Standard Operating Procedures & Researcher Guide (Section II, Part 11.B.iii.a) and the Short Form Consent Document and Process Educational Tool on the Human Subjects Office website.

Translators/Interpreters

The research team is responsible for finding someone qualified to provide a verbal translation of the consent document and consent process conducted by a member of the research team. The translator could be a native speaker or someone with appropriate education and training. It could be someone on the research team or someone employed by a translation service. The UI Health Care Interpretation and Translation Service is available for research purposes only under limited conditions. However, researchers may use the Cyracom interpreters by contacting the main hospital operator at 319-335-1616 and requesting to connect with the Cyracom service for the desired language. Additional information about Cyracom is available on the UIHC Interpretation and Translation Service website.

Other options to identify a translator include the UI Division of World Languages, Literatures and Cultures or the list of translators maintained by the UI IRB (not an endorsement). 

The research team must also have a witness to the consent process who speaks both languages. The witness could be a family member of the subject, but should not be the Legally Authorized Representative. But they should not be a member of the research team. According to the Federal Regulations (45 CFR 46.117(2)), the witness must sign the Short Form Consent Document. If the translator serves as the witness, they must sign the Short Form Consent Document.

Template Short Form Consent Documents

The IRB provides a template Short Form in English and translations in several other languages. UI researchers may translate the English version of the Short Form into other languages, as needed. Please email the translated Short Form and the translator credentials to the Human Subjects Office. Prior IRB approval is not required for use of a new translation of the Short Form.

Planned Enrollment of Non-English Speaking Subjects

If the research team expects to encounter and recruit non-English speaking subjects, they should indicate that in Section VI of the HawkIRB application and translate the Informed Consent Document into the necessary language(s) in advance. The IRB must approve all study documents in English and additional languages.