Short Form Consent

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. 

The IRB should be informed of the provisions in place for conducting the research activities with a non-English speaking participant. If the plan is to translate participant-facing study materials and submit these to the IRB at the time a non-English speaker is enrolled, this should be explained in the IRB application and/or Protocol. If all post-consent research activities (i.e. administration of questionnaires) will be conducted verbally with the assistance of a translator, this should be explained. 

The consent form may be translated by someone affiliated with the study OR by someone not affiliated with the study, provided the translation accuracy is verified through one of the following methods:

• Certified Translation: A qualified professional translator performs the translation. A qualified professional translator is an individual or certified translation service with formal credentials and demonstrable experience in translating research or medical documents. The process of becoming a certified translator typically involves passing an exam administered by a professional organization, such as the American Translators Association (ATA).  A translator certification form must be submitted to the IRB that confirms the translator’s credentials and attests to the accuracy of the document. A template certification form (named “Translator Declaration Statement”) can be found in the HRPP Short Form Library and may be utilized for this documentation.
• Back-Translation: A back-translation is the process of translating a previously translated document back into the original language by an individual who has not read the source document, used to assess the fidelity of the translation.  A back-translation conducted by a second qualified individual who has not read the original English-language document is permissible. This may be conducted by a study-affiliated translator. The individual performing the back-translation must sign an attestation confirming they had no prior knowledge of the original English version and attesting to the completeness and accuracy of the backtranslation. It is the Principal Investigator’s responsibility to review the original and back-translated versions and address any discrepancies.  
• Third-Part Review/Approval: A third-party reviewer is an individual unaffiliated with the study who is fluent in both the original and target languages and who conducts an impartial review of the translation. The reviewer must be provided with access to both the original and translated versions, and a written summary of their evaluation must be submitted to the IRB for review. 

When a child (or cog. Impaired adult) capable of assent does not read or understand English, the information should be presented to the child (or cog. impaired adult) in a language understandable to them, which may include the use of a translator. The study team should document the participant’s verbal assent in the research records (including the date verbal assent was obtained, any questions or concerns the participant expressed during the process, the resolution of those questions and concerns, and who obtained the verbal assent). If feasible, a written translation of the assent form can be performed utilized once approved by the IRB. 

The consent form should be presented orally to the participant, and the investigator should ensure there is sufficient time for questions to be asked and answered, both by the participant and by the person obtaining consent to ensure the participant comprehends the consent information. It is recommended that an impartial witness observe the consent process. If the participant verbally agrees to participate in the study, they should sign or “make their mark” on the consent form. The witness should also sign the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely. The investigator obtaining consent should also sign the consent form.