Stanford
Research Compliance Office

Short Form Consent Process

A fully translated consent form in the participant’s language must be provided after the use of a short form for certain studies involving investigational biologics, drugs, and/or devices.  For more information, see the below updated guidance link.

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

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 below), 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)

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, i.e., the modified English 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 should be the interpreter?
    1. Preferably, a hospital interpreter whenever possible.
    2. A family member of the participant can act as interpreter only if the participant has declined the use of a hospital interpreter.
    3. 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.
  • Who should be the witness?
    • An adult (18 years and older); and
    • An impartial party not otherwise connected with the study (e.g., staff not involved in the research, a patient advocate, an interpreter, or other person) should serve as the witness; and
    • An individual who is fluent in both English and the language of the participant.

Note: A member of the study staff acting as interpreter and Person Obtaining Consent cannot also act as witness.

  • 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.

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:

  1. Participant, or the participant's legally authorized representative [LAR] (if two parent signatures are required, each parent/LAR should sign a short form), and 
  2. Witness (see above)

Summary Form (English) must be signed and dated by both:

  1. Person Obtaining Consent (POC), including completion of:
    • The LAR's Description of Authority (if applicable), and
    • 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.
  2. Witness (see above)

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, i.e., 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. key information, purpose of the research, expected duration, procedures, risks, benefits, alternatives [if any], confidentiality of information, compensation [if any] for research-related injuries, whom to contact for questions about the research and research subjects' rights, that participation is voluntary, future use of the participants' information or biological specimens, and whether information about the research will be submitted for inclusion in a clinical trial registry).

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:

When is a translated consent form required after the use of the short form consent process?

Stanford [aligning with FDA’s Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors] requires that a fully translated consent form in the participant’s language must be provided to the participant or LAR promptly after the short form is used for certain studies involving investigational biologics, drugs, and/or devices.

  • Which studies are affected by this FDA guidance and Stanford policy? 
    Currently, all new FDA-regulated studies conducted under an IND or IDE require a translated consent form after use of the short form.  There may be certain studies for which this requirement may not apply. 
  • What are acceptable translation tools/services?
    The Protocol Director is responsible for confirming the accuracy of all documents submitted to the IRB. For more information on translations, see the Translating the Consent Document section on the  Consent Process webpage.
  • Should participants be re-consented with the translated version of the consent form?
    Once the translated long form/written summary is approved by the IRB, the investigator must provide it to the subject or LAR and should do so as soon as possible.  FDA considers this step essential to the requirement that informed consent be documented by the use of a written consent document and that the subject be provided a copy (21 CFR 50.27). Many of the clinical investigations regulated by FDA involve ongoing interventions and may involve long-term follow-up. For this reason, translation of the long form is critically important as a means of providing subjects or their LAR an ongoing source of information understandable to them.

    Generally, re-consent using the translated consent form is required; however, if the Protocol Director decides that re-consent is not appropriate, this should be specified in the modification (along with a reason explaining why) when the translated document is submitted to the IRB for review.
  • What is the expectation for “promptly”?
    Once the translated long form/written summary is approved by the IRB, the investigator must provide it to the subject or LAR and should do so as soon as possible.  If the study team anticipates significant delays, contact the Panel Manager.
  • What is the process for submitting translated documents in eProtocol?
    1. English versions of study documents are approved by the IRB.
    2. Approved English versions are then translated into the participant’s language.
    3. A modification is submitted to the IRB with translated documents attached.
    4. Once the modification is approved, the documents can be disseminated, as needed.
    5. Any subsequent document revisions should follow the same steps noted above. Outdated documents should be replaced by the newer versions in eProtocol.