Short Form Consent

POLICY

The information that is given to the subject or the representative must be in language understandable to the participant or their legally authorized representative. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be effective.

UTHealth IRB expects Spanish consent forms for all clinical trials conducted in the Houston area as a default. Investigators may request for a waiver from this requirement with appropriate justification e.g. when the clinical trial involves validated questionnaires that are not available in Spanish.

If a non-English speaking subject is unexpectedly encountered, and a written translation of the consent document is not available, the preferred option is to translate the English consent forms into the required language and submit the translated document for IRB review and approval. However for some research studies, the enrollment time frame may not permit time for preparation of translated consent documents. In these cases, an IRB approved "short form" written consent document, in a language the subject understands, may be used to document that the elements of informed consent were presented orally.

Key Terms

Witness - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

PROCEDURE

Justification for Enrolling Subject without Translated Consent: If a non-English speaking subject is unexpected encountered, the investigator, must contact the IRB office at [email protected] with sufficient justification (e.g., due to a limited therapeutic window) for obtaining the subject’s consent without waiting for a translated long form to be reviewed and approved by the IRB prior to enrollment of the subject.

In making a decision to allow enrollment of a subject who does not understand English into a research protocol without waiting for a written translation of the long form, the investigator should consider whether the consent process, under this circumstance, will provide the subject with sufficient opportunity to understand the information being presented. If consent is sought and the investigator believes that the prospective subject has not understood the information presented, then the individual should not be enrolled in the research.

Consent Process: The person obtaining consent orally presents the information in the IRB approved English consent document. The interpreter translates this information in the language understandable to the participant. The participant is encouraged to ask questions and the interpreter translates these questions to the person obtaining consent.

There must be a witness to the oral presentation who must not be the person obtaining informed consent. The witness should be someone who is fluent in English and the translated language.  The witness should be present during the consent process and confirm that the process was conducted in full, and that the participant was given the opportunity to ask questions. The Interpreter may serve as the witness in a short form consent process.  

Documentation – The original English long form consent is to be signed by the person obtaining consent and the interpreter/witness. The short form consent is to be signed by the participant or legally authorized representative and the interpreter/witness.

After the consent process is complete, the original, signed English long form and the original, signed short form should be kept in the participant research file along with a documentation of the consent process. A copy of signed English long form and signed short form should be provided to the participant. 

FDA-regulated research: For FDA regulated research, the investigator must promptly obtain a translated copy of the IRB-approved English version of the long form, which served as the written summary. The investigator promptly submits it to the IRB for review and approval.

Once the translated long form/written summary is approved by the IRB, the investigator provides it to the subject 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. Many of the clinical investigations regulated by FDA involve ongoing interventions and may involve long-term follow-up. FDA believes that translation of the long form

is critically important as a means of providing subjects an ongoing source of information understandable to them.

Applicable Regulations:

1. 21 CFR 50.27(b)(2)
2. FDA Information Sheet - A Guide to Informed Consent. Guidance for Institutional Review Boards and Clinical Investigators. Final Jan 1998. Draft Jul 2014.

Reference to Other Policies:

1. Informed Consent

Attachments:

1. Short Form Consent Template

If you find errors in this document, contact [email protected]