Short Form Consent

Welcome to the VUMC IRB Translation Library. Here you will find the VUMC IRB standard Short Form Consent Document translated into multiple languages. The Short Form is a method to document informed consent for participants who do not speak English when a fully translated version of the full consent document is not available in the participant’s language, or to obtain consent from a participant who cannot read (i.e. illiterate) and whose primary language is English. The Short Form Consent process is intended for use when few non-English speaking participants are expected, or when few participants who speak a particular language are expected (if at all). The short form consent is a document, translated into the participant's native language, that contains a description of the required elements of informed consent and notes that these elements, as they pertain to the study, will be presented orally to the participant or their legally authorized representative.

 

Short Form Translation Library

 

NEW SHORT FORM PROCESS INFORMATION:

What does this change mean for investigators?

The IRB will continue to review the proposed use of the short form consent process (as outlined by researchers in the “Consent” section of their IRB application). However, investigators do not need to attach the Standard VUMC Short Form document (from the Translation Library) to their IRB application if only the standard VUMC short forms from the Translation Library will be used. Once the IRB approves a short form consent process for a study, the standard VUMC short forms, available on this Translation Library website, may be used. The IRB will not approve/stamp the standard short form(s) on a study-by-study basis.

If an investigator wishes to use an alternative to the standard short form or translate their own version, it must be attached to the IRB application to be reviewed and approved/stamped by the IRB prior to use along with the translator declaration/certification.

If a study plans to continue to use previously approved study-specific short forms (e.g. old VUMC short form), these short forms must remain as approved/stamped study documents. This means they must be submitted at the time of annual continuing review for re-review/stamping.

If an ongoing study wishes to switch to using the new standard VUMC short forms and no longer intends to use the previously approved/stamped short forms, the old forms can be removed at the next continuing review or the next amendment. Investigators are not required to submit an amendment prior to use of the new standard short forms, so long as the IRB has approved a short form consent process for the study. 

 

When is this change effective?

This change is effective September 5th, 2025. Any current application requesting a short form consent process will not be required to attach short forms unless the investigator intends to use a non-standard VUMC Short form (i.e. not one found in the Translation Library). If a short form is not submitted, it is the expectation of the IRB that only standard VUMC short forms from the Translation Library will be used.

The Regulatory Determinations section of the IRB-issued approval letter (FAL) will now include a section that documents the planned use of the VUMC standard short forms.

 

FAQ:

  • As required by The Department of Health and Human Services (DHHS) regulations (45 CFR 46.116 and 45 CFR 46.117) and FDA regulations (21 CFR 50.25 and 21 CFR 50.27):
     

    Unless written consent has been waived as a requirement for the study, the participants who do not speak English must be provided with:

    • A written consent document in a language understandable to them AND
    • An interpreter fluent in both English and the participant's spoken language to aid in the consent process

  • Depending upon the research, the written consent document can be either:

    • A translation of the entire English version of the VUMC IRB approved consent document OR
    • A “short form” consent document stating that the elements of consent have been fully presented orally

  • A short form is a written document, in the participant’s language, stating that the elements of informed consent required by 45 CFR 46.116 have been presented to and are understood by the participant or the participant’s legally authorized representative.

  • A short form may be used when the majority of study participants are English speakers, but there may be an occasional person who will not be able to understand the consent form written in English. A short form, in the participant’s language, can be used in these instances to obtain consent ensuring equal access for potential participants.

  • For non-English speaking participants:

    • Oral presentation of informed consent information (from the full English informed consent document; referred to as the “written summary”) in the participant’s language, in conjunction with the translated short form document.
    • An impartial witness to the oral presentation is required. When the witness is not fluent in both English and the language of the participant, a translator (interpreter) may assist with the consent process and serve as the witness.

    Signatures:

    • The full English informed consent document (i.e. written summary) must be signed and dated by: 1) the impartial witness (or translator) and 2) person obtaining consent (KSP)
    • The translated short form must be signed and dated by: 1) the impartial witness (or translator) and 2) participant or the participant’s legally authorized representative.
    • The participant must be given copies of the short form informed consent document and the full English informed consent document (written summary).

    HELPFUL HINT: Each person should sign the consent forms they understand.  The non-English speaking participant signs the short form consent in their language.  The person obtaining consent signs the full English consent.  The witness understands both languages, so signs both.

     

    For English speaking participants (i.e. illiterate):

    • Oral presentation of informed consent information (from the full English informed consent document; referred to as the “written summary”), in conjunction with the English short form document.
    • An impartial witness to the oral presentation is required. The witness must be fluent in English.

    Signatures:

    • The full English informed consent document (i.e. written summary) must be signed and dated by: 1) the impartial witness and 2) person obtaining consent (KSP)
    • The English short form must be signed and dated by: 1) the impartial witness and 2) participant or the participant’s legally authorized representative. If the participant cognitively able to give consent but is not able to write their name, they can “make a mark” on the short form, such a thumb print, an X, or a mark they use to sign other legal documents. 
    • The participant must be given copies of the short form informed consent document and the full English informed consent document (written summary).

  • The witness is an impartial person not related to the research study who is brought in to observe the consent process with the consent document. They are not an LAR, not a parent, and are not signing for anyone else. They are someone completely independent of the research. An example of an impartial individual who can undertake this role is a nurse who is not part of the research team and has no other involvement with the investigator. In contrast, a study coordinator working on the same study, even if they are not directly responsible for obtaining consent, would not be considered impartial and thus not an appropriate witness.

  • If one of the standard VUMC IRB short forms in the Translation Library is used, the VUMC IRB does not have to approve the short form document itself for an individual study. However, the IRB does have to approve use of a short form process. Use of a short form process, whether it be for illiterate (i.e. cannot read) participants who speak English (use of English short form) or for participants who do not understand English (use of translated short form), must be described in the Consent section of the IRB application.
    If a non-standard VUMC IRB short form is used, the IRB must review and approve the short form for the individual study prior to its use. Its use must be described in the Consent section of the IRB application, and the short form must be attached to the IRB application along with a Translation Certificate.

  • If more than an occasional person speaking the same non-English language will be enrolled in a study, then a fully translated consent form should be utilized.

  • Yes. Investigators must submit a translated version of the VUMC IRB approved entire English informed consent document along with a Certificate of Translation.

  • The investigator may submit both the English version of the informed consent document and any translated informed consent documents needed for the study along with a Certificate of Translation. However, since any changes made by the VUMC IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators may consider having the translation completed and submitted via an amendment after VUMC IRB approval of the English version of the informed consent document.