Saint Louis University

The short form consent process may be used in studies that were not intending to enroll non-english speaking (NES) participants, but a potential NES participant presents and must be enrolled in a time window that does not allow for full translation of the English consent form and HIPAA Authorization form, if applicable. For more information see Guideline For Studies Involving Non-English Speaking Subjects.

Use of the short form consent process and short form documents require prior IRB approval. An amendment should be submitted as soon as the want to include an NES participant and use a short form consent process is known.


What to submit to the IRB for approval 

1) Intention to use the short form consent process and the translated Short Form. This should be provided in the "consent" section of the eIRB application. 

2) Informed Consent Summary Form:
Modify the approved informed consent document to have a signature line for a witness, as follows:

______________________________   __________________

Signature of Witness                                    Date


3) Translated HIPAA Authorization - this can be translated at time of short form consent process, or later along with translation of the full consent form


Interpreters and Witnesses - Who are they and what do they do?

The short form consent process requires the assistance of an interpreter (who speaks the participant's language and English fluently) and the presence of a witness.
 

• Who can be the interpreter?

• A hospital (qualified healthcare) interpreter whenever possible for studies involving complex diagnostic or medical procedures.
• A family member or other qualified persons for other studies.
• If a member of the study staff speaks the participant's language, the staff member can act as the interpreter and Person Obtaining Consent, but should not act as witness.

• Who can be the witness?

• A person who attests to the oral presentation and is conversant in both English and the participant's language.
• The witness may be the interpreter (including the hospital interpreter), a family member, or other person not on the research team.

Before starting the consent process, verify whether the interpreter will also be able to serve as a  witness - if not, you will need to identify another person to act as the witness.

Signature Requirements

If the participant agrees to take part in the study, the following signatures are required:

Short Form (translated) must be signed and dated by:
i) Participant, or the participant's legally authorized representative [LAR]
ii) Witness (see above)
iii) Person Obtaining Consent (research team member with consent duty)


Summary Form (English) must be signed and dated by:
i) Witness (see above)
ii) Person Obtaining Consent (research team member with consent duty)

HIPAA Authorization Form (English or translated) must be signed and dated by:
i) Participant, or the participant's LAR
ii) Person Obtaining Consent (research team member with consent duty)

Translated Versions Post-Enrollment

If the participant will continue in the study, the research team should have the full consent form and HIPAA Authorization (if applicable) translated into the participant's native language. The re-consent and re-authorization using translated forms should be completed in a reasonable time period following the initial consent process (e.g., 90 days). An amendment should be submitted to provide the IRB with translated versions prior to use.

Templates

These templates include the basic required elements of short form informed consent. The documents do not contain study specific information, but state what will be explained to the participant about the specific study by the interpreter (e.g. purpose, procedures, duration, risks, benefits, alternatives [if any] confidentiality of information, compensation [if any] for research-related injuries, and that participation is voluntary).

If a participant speaks a language other than what is provided below, the English version can be used to translate into the targeted language. (A verification of translation must be submitted with the translated short form).

Bosnian
Chinese
English
Spanish

Verification of Translation for External Requests