Saint Louis University

Use of the short form consent process and short form documents require prior IRB approval.
For more information see Guideline For Studies Involving Non-English Speaking Subjects.


What to submit to the IRB for approval

1) Intention to use the short form consent process. This should be provided in the "consent" section of the eIRB application. The research team must agree to follow the stated procedures for consent specified in the protocol application consent section for use of the short form consent process.

2) Informed Consent Summary Form:
Modify the approved informed consent document to have a signature line and text added on the last page beneath the Person Obtaining Consent section (or add statement prior to the existing witness line), as follows:

The following witness line is to be signed only if the consent is provided as a summary form and accompanied by a short form foreign language consent.

______________________________   __________________
Signature of Witness                              Date

(e.g. staff, interpreter, family member, or other person who speaks both English and the participant's language and is not on the research team)


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?

• Preferably, a hospital interpreter whenever possible.
• A family member of the participant can act as interpreter only if the participant has declined the use of a hospital interpreter.
• 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 also 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), study staff, 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) Principal Investigator (required for FDA regulated research)


Summary Form (English) must be signed and dated by:
i) Person obtaining consent
ii) Witness (see above)
iii) Principal Investigator (required for FDA regulated research)


Templates

These templates include the basic required elements of informed consent.

These 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 of these forms is available below for use in translating into the target language. (A verification of translation must be submitted with the translated short form. See Guidelines for Studies Involving Non-English Speaking Subjects.

Bosnian
Chinese
English
Spanish

Verification of Translation for External Requests