Enrolling Participants with Limited English Proficiency (LEP) & Short Consent Form Translations
Limited English Proficiency (LEP) persons are individuals who do not speak English as their primary language and who have limited ability to read, speak, write, or understand English. LEP individuals should not be systematically excluded from research without a sound scientific or ethical rationale to ensure equitable participant selection. Investigators (particularly those conducting greater than minimal risk and clinical research) must prospectively review protocol requirements to ensure applicable provisions are in place to support the safety of a LEP individual to participate in the research. When LEP participants (or LARs) are incidentally encountered, a short consent form process is appropriate.
Short Consent Form Process
Federal regulations at 45 CFR 46.116(a)(3) and 21 CFR 50.20 require that informed consent be obtained in language that is understandable to the participant (or the participant’s legally authorized representative). In accordance with these regulations, informed consent discussions must include a reliable interpreter when the prospective participant does not understand the language of the person who is obtaining consent. Likewise, the written informed consent document should embody, in a language understandable to the participant, all the elements necessary for legally effective informed consent.
Process and Documentation Requirements
If investigators use a “short form” to document informed consent, they must also provide participants (or LAR) with ALL of the following listed below.
A written summary of the information that is presented orally. The written summary must contain the basic and additional elements of consent; in most cases this will be the full-length informed consent document in English
An interpreter who speaks English and the participant’s (or LAR’s) language, who can take part in the oral informed consent discussion (in-person or remotely) to provide the oral summary and to ensure participant’s understanding through facilitating exchange of information related to questions and/or concerns. For FDA-regulated research, the interpreter must be through a qualified translation service vendor. For additional details please review IRB SOPs
The investigator must also confirm there is a witness to the oral presentation. The witness must be a legal adult and fluent in both English and the language spoken by the research participant. It is preferred that the witness be impartial to both the study team and participant. However, if an impartial witness is not otherwise available, the witness may then be an adult family member/friend of the participant, or an adult staff member not otherwise involved with the study. The investigator obtaining consent may NOT be the witness to the consent process. For additional details on the role and requirements of the witness, review IRB SOPs.
The participant / LAR should be given copies of both the signed “short form” consent document and the written summary of the information that is presented orally. Below is guidance on who should sign which documents.
Short Consent Form
The “short form” consent document written in the participant’s (or LAR’s) language must be signed by the participant (or LAR) and the witness to the oral presentation. It is also recommended that the interpreter sign, when possible.
The written summary of the information that is presented orally (i.e., the full-length English consent document) must be signed by the person obtaining consent and the witness to the oral presentation. It is also recommended that the interpreter sign, when possible.
For studies requiring GCP compliance, the participant’s record should also include a note that documents the following:
- the elements of consent were presented orally, including study procedures, risks and benefits, time was given for questions and (if applicable) questions were answered,
- identify the interpreter, witness, and investigator obtaining consent,
- that the signed short form and summary (if not the IRB approved English consent form) was provided to the participant
On-going Consent or Re-consent
After enrolling a participant using a short form process, the investigator is encouraged (but not required) to pursue a complete translation of the full informed consent document, particularly for greater than minimal risk or FDA regulated research. For requirements and recommendations regarding on-going / re-consent of non-English speaking participants, please review the IRB SOPs.
Research Requiring HIPAA Authorization
For research requiring HIPAA authorization, when using a short form consent document to complete the primary consent process for a LEP participant, a fully translated standalone HIPAA authorization is also required.
When is Prospective IRB Approval NOT Required to Use a Short Form?
Prospective IRB approval to enroll a LEP individual with a short form is NOT required when all of the following conditions are met. In this case, the IRB will NOT stamp the short form consent document.
- The approved, English version of the informed consent document is used as the written summary. Signature lines may be adapted to permit applicable signatures without additional prospective IRB review/approval. No additional changes may be made without prospective IRB review;
- One of the generic “short form” consent documents available from the Penn or CHOP IRBs is utilized, AND
- A qualified interpreter service will be utilized throughout the course of the participant’s consent process and participation.
When is Prospective IRB Approval Required to Use a Short Form?
An exception request (prospective deviation) is required if ANY of the following conditions below are met. When formal exception requests are submitted, the IRB will stamp the short form consent document.
- The written summary is not the approved, stamped English version of the informed consent;
- A short form consent document translated into a language unavailable from the Penn or CHOP IRB is utilized. The IRB may accept short form translations from other AAHRPP accredited IRBs. The study team should consult with the IRB prior to utilization; OR
- An individual other than a qualified interpreter will be used for interpretation (e.g., a member of the study, another Penn employee, etc.)
Translated Short Informed Consent and HIPAA Forms
Currently the IRB provides translated Short forms in the following languages listed below. Versions with CT.gov in the file name contain clinicaltrials.gov language for studies that are required to register on CT.gov. They are based on the Penn IRB provided English Short Form template and were translated by Language Line Solutions. The translation certificate is also available in the Penn Box folder.
- Bassa (Nigerian Dialect) – Short IC template only
- Chinese (Traditional)
- Farsi – Short IC template only
- Haitian Creole
- Portuguese (Brazil)
- Spanish (US)
Other IRB’s Translations
NOTE: The Penn IRB will also allow use of non-Penn short forms from CHOP (for clinical trials) and the University of Utah (for non-clinical trials), when translations are not available for certain languages. English short forms from these institutions have been reviewed to confirm they align with Penn’s template.