Use of the short form consent process and short form documents requires prior IRB approval.
For more information see guidance.
What to submit to the IRB for approval
Interpreters and Witnesses – Who are they and what do they do?
Signature Requirements
Template translations in 30+ languages, with the Subject's Bill of Rights
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 protocol application, where the PD must agree to follow the procedures specified in the protocol application for use of the short form consent process.
Note: If the Stanford-provided translated short form documents are used (see links above), it is not necessary to submit them for IRB approval.
2) Summary Form (Modified English consent form):
Modified to have a signature line and text added on the last page beneath the Person Obtaining Consent (POC) section, 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)
3) If HIPAA applies: Request an "Alteration of HIPAA Authorization":
This should be provided in the "HIPAA" section of the protocol application. The alteration means that when using the Short Form Consent Process, neither the participant nor their LAR should sign the HIPAA Authorization (whether there is a separate HIPAA Authorization or one embedded in the Summary Form (the modified English consent form).
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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 (POC), but should not also act as 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.
- Before starting the consent process verify whether the interpreter will also be able to serve as a witness - if not, you will need to obtain another person to act as the witness.
Note: A member of the study staff acting as interpreter and Person Obtaining Consent cannot also act as witness.
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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 both:
i) Participant, or the participant's legally authorized representative [LAR], and
ii) Witness (see above)
Summary Form (English) must be signed and dated by both:
i) Person Obtaining Consent and
ii) Witness (see above)
-
The non-English speaking participant/LAR does not sign the English consent.
- If the participant or the LAR is non-English speaking, the POC must ensure:
1) the LAR's Description of Authority is completed, and
2) any questions or options presented by the consent form are documented and initialed by the POC on the Summary Form, per the participant's wishes, as they are understood during the consent process.
HIPAA - no signature: When using the Short Form Consent Process, neither the participant nor their LAR should sign the HIPAA Authorization (whether there is a separate HIPAA Authorization or one embedded in the Summary Form (the modified English consent form)).
Templates - Including the Experimental Subject's Bill of Rights
These templates include the basic required elements of informed consent and the Experimental Subject's Bill of Rights (California Law).
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 for use in translating into the target language.
See translating the consent document.
A certification of translation for these templates is available.
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Compliance Panels
Stem Cell Research Oversight (SCRO)
Laboratory Animal Care (APLAC)
Biosafety (EH&S)
APRS - Radiological Safety (EH&S)