Short Form Consent Process

Overview

Investigators are strongly encouraged to recruit and include all segments of our community in research, including individuals whose primary language is not English. Participants who do not understand English should be presented with a consent document written in a language understandable to them. 

The Stanford IRB and Office for Human Research Protection (OHRP) encourage the use of a full consent form translated into the participant’s language whenever possible. However, with the prior approval of the IRB, federal regulations permit the use of a short form consent process when a non-English speaking participant is unexpectedly encountered (45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2)).

This webpage includes:

• What to Submit to the IRB for Approval
• The Role of Interpreters and Witnesses
• Signature Requirements During the Short Form Process
• Short Form Template Translations
• Requirement for Providing a Translated Consent Form After Using the Short Form Consent Process

What to Submit to the IRB for Approval

1) A description of the process to obtain the short form consent: This should be provided in the "Consent" section of the protocol application, where the investigator must agree to follow the procedures specified in the protocol application for use of the short form consent process. 

2) Summary Form (Modified English consent form): Modified to have a witness signature line and text added on the last page beneath the Person Obtaining Consent (POC) section. See Informed Consent Template.

3) If protected health information under the HIPAA Privacy Rule is involved, request an "Alteration of HIPAA Authorization" (or “Waiver of HIPAA Authorization” for VA studies): 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).

The Role of Interpreters and Witnesses

The short form consent process requires the assistance of an interpreter (who speaks the participant's language and English fluently) to assist with the consent process and the presence of a witness. The purpose of the witness is generally to attest that the participant’s consent is voluntary, and that the consent process is adequate by ensuring that the information was accurately conveyed and that the participant’s questions were answered.

Who should be the interpreter?

1. Preferably, a qualified hospital interpreter in any modality, whenever possible.
2. In certain situations, such as an emergency or when the participant has declined the use of a qualified interpreter, a family member of the participant can act as 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).

Who should be the witness?

• An adult (18 years and older); and
• An impartial witness, defined in ICH Good Clinical Practice as:
  • a person who is independent of the trial (can include patient advocates, interpreters, family members, but not staff involved in the research),
  • who cannot be unfairly influenced by people involved with the trial (free from coercion or undue influence),
  • who attends the informed consent process if the study or the subject’s legally acceptable representative cannot read, and
  • who reads the informed consent form and any other written information supplied to the subject.

A member of the study staff acting as interpreter and Person Obtaining Consent should not 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)

The participant should be given a signed and dated copy of both the translated Short Form and the Summary Form.

HIPAA Authorization - no signature needed. 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 it is embedded in the Summary Form).

Short Form Template Translations

The templates below 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.

Note that if the Stanford-provided translation of the short form documents are used, it is not necessary to submit them to the IRB for approval. If the investigator obtains a translation using the English version for a language not available below, the translated document should be included in the IRB protocol.

Requirement for Providing a Translated Consent Form After Using 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.

Page updated November, 2025