Short Form Consent Process

Use of the short form consent process and documents requires prior IRB approval.
For more information see guidance.

• Templates - including the Experimental Subject's Bill of Rights
• What to submit to the IRB for approval
• Translators/interpreters and witnesses - who are they, and what do they do?
• Signature requirements

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 translator/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.

• Chinese
• Farsi
• Japanese
• Korean
• Russian
• Spanish
• Vietnamese

What to submit to the IRB for approval

1) Short Form consent document - foreign language version (and English version if the Stanford English Short Form Consent was not used as the template).
Short form consent templates and the Experimental Bill of Rights are available in several languages – see above.  The study title, Protocol Director (PD), his/her contact telephone number and approval and expiration dates in English must be inserted in the short form template.

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 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                                                  Date
 (e.g., staff, translator/interpreter, family member, etc.)

3) Description of how consent will be obtained using the short form process. This should be provided in the "consent background" of eProtocol. 

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Translators/interpreters and witnesses - who are they, and what do they do?

The assistance of a translator/interpreter and the presence of a witness are required for the short form consent process.

1. Translator/interpreter who speaks the participant's language and English fluently.
   Who can be the translator/interpreter?
   • Preferably, a hospital translator/interpreter should be used whenever possible.
   • A family member of the participant can act as a translator/interpreter only if the participant has declined the use of a hospital translator/interpreter.
   • If a member of the study staff speaks the participant's language, the staff member can act as the translator/interpreter and Person Obtaining Consent, but should not also act as witness.


2. Who can be the witness?
• The witness may be staff, the translator/interpreter, a family member,
  or other person.
• When the Person Obtaining Consent is assisted by a translator/interpreter, the translator/interpreter may act as the witness. [OHRP]
• Before starting the consent process, verify whether the translator/interpreter will also be able to serve as a witness - if not, you will need to obtain another person to act as the witness.
• A member of the study staff acting as translator/interpreter and Person Obtaining Consent should not also act as witness.

During the consent process:
The translator/interpreter should briefly explain the consent process to the participant.

The short form document in the participant's language should be given to the participant to read.

The translator/interpreter should translate the English consent section by section to the participant.
 
Questions or concerns the participant relays to the translator/interpreter should be addressed - it is recommended the Person Obtaining Consent document the questions and responses.

Adequate time should be afforded the participant, or their legally authorized representative, to make an informed decision regarding participation in the research.

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Signature Requirements
If the participant agress to take part in the study, the following signatures are required:

Short Form (translated):
i)  Participant, or the participant's legally authorized representative [LAR]
ii) Witness*

Summary Form (English):
i)  Person obtaining consent
ii) Witness*

*The translator/interpreter may act as the witness