Individuals with limited English proficiency must receive informed consent information in a language understandable to them, using a consent process that allows for effective exchange of information between the potential participant and the research team, and (when applicable) documents the participant’s agreement to take part in a study. Study teams should follow the detailed, step-by-step guidance in HRP-090-SOP: Informed Consent Process for Research for conducting a consent process with individuals who have LEP and the guidance in HRP-091-SOP: Written Documentation of Consent when documenting informed consent.

Understandable consent information may be provided to participants with LEP using a written translation of the study-specific “long form” informed consent document, or a “short form” process to document informed consent. For studies with an approved waiver of documentation of consent, the IRB may approve an oral consent process in the participant’s language using a consent script.

Written Translation of Long Form Consent Documents

“Long form” consent refers to a study-specific, written informed consent document that includes all applicable regulatory elements (see HRP-314-WORKSHEET: Criteria for Approval).

The IRB requires written translation of the long form consent document into the relevant non-English language(s) when a study team:

  • Is recruiting participants likely to speak and read a non-English language and to have LEP.
  • Has conducted a short form consent process three times in the same language.

The IRB encourages written translation of the long form consent document when a study team:

  • Encounters an eligible participant with LEP and the enrollment window allows time to translate the long form and have it approved by the IRB before the consent process occurs.
  • Uses a short form consent process to obtain initial informed consent for a study with multiple visits. The long form consent may be translated into the participant’s preferred language and provided to the participant after enrollment.

For FDA regulated studies, FDA Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors advises fully translating the long form consent document, either before the consent process takes place, or after a short form consent process is used.

The IRB must approve translated long form consent documents prior to their use, via a change of protocol. See IRB approval required prior to enrolling individuals with limited English proficiency.

Short Form Consent Documentation

With “short form” consent documentation, a research team presents study-specific consent information to a potential participant orally through an interpreter and in the presence of a witness, basing the presentation on a written summary (usually the approved English long form consent document). The “short form” is a brief document in the participant’s language that outlines the elements of informed consent to be covered during the consent discussion; it is not study specific. The participant with LEP documents consent by signing the short form. See HRP-317-WORKSHEET: Short Form of Consent Documentation for details.

The IRB may approve a short form consent process if, when designing the study, the study team does not know if they will encounter potential participants with LEP, or cannot predict the languages needed, and the study team explains why it would not be feasible to translate the long form consent document if they encounter a potential participant with LEP.

Requirements and Resources for Short Form Consent Documents

The IRB must approve a study’s use of short form consent documentation prior to its use. If not approved at a study’s initial review, the study team can add a short form process via a change of protocol. (See IRB approval required prior to enrolling individuals with limited English proficiency.)

  • The short form consent process requires the presence of a witness and has specific signature requirements. For details, see HRP-317-WORKSHEET: Short Form of Consent Documentation, HRP-090-SOP: Informed Consent Process for Research, and HRP-091-SOP: Written Documentation of Consent. Also see “Addressing witness requirements” below.
  • Translated short form consent documents are posted in the UW IRB’s Toolkit Library. Studies approved by the IRB to use a short form consent process may use these translated documents without additional IRB approval; these short forms do not need to be uploaded in ARROW.
  • Studies approved by the IRB to use a short form process may also use translated short forms from WCG IRB and the University of Utah, which are available in a wide range of languages. These short forms need to be submitted for UW-Madison IRB approval only if they will be used with participants who lack consent capacity, in which case the signature lines need to be modified to accommodate an LAR signature. Translated short forms from a source not included above must be submitted for IRB approval prior to use.
  • For any translated short forms from a source other than UW IRB’s Toolkit Library, the English-language long-form consent provided to participants as a summary must include contact information for the study team and the HRPP’s confidential compliance phone line (see the UW’s English short form under “Who can I talk to?” for example language).
  • A study may use the short form process up to three times for the same language. Prior to conducting another consent discussion in that language, the study team should submit a change of protocol including the translated long form consent document and revising the consent process to describe using the translated consent form with speakers of that language. Once approved, the translated consent document should be provided to any active participants who speak that language, for their reference. The study team may continue using the short form process with participants who speak a different language.

Addressing Witness Requirements for the Short Form Consent Process

When a short form process is used, an impartial witness must be present during the entire consent discussion. See HRP-090-SOP: Informed Consent Process for Research for a definition of the witness’s role in the consent process.

Guidance from the Office of Human Research Protections (OHRP) and the FDA states that the witness should be fluent in English and in the LEP participant’s language and should be independent of the study team. An interpreter who interprets the consent process in person may also serve as the impartial witness.

Unless the IRB has approved a waiver of signed consent for the study, the witness signs the short form and the written summary (usually, the English long-form consent document). However, when an interpreter participates remotely by phone or video, the interpreter is unlikely to be able to sign the consent documents. In cases where an interpreter does not sign as the witness:

  • A bilingual family member or friend may serve as the impartial witness if the study is no more than minimal risk, does not involve a medical intervention, and does not involve sensitive information.
  • Another individual independent of the study team may witness the consent discussion. If this witness is not bilingual, the witness should confirm with the participant (through the interpreter) that their questions were answered.

HIPAA requirements and participants with limited English proficiency

See Authorization & Participants with Limited English Proficiency for guidance on obtaining HIPAA authorization.