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 for a witness, 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
(i.e., a person who speaks both English and the participant's language and is not on the research team)
3) Translated HIPAA Authorization or justification for a waiver of authorization.
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.
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)
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.