September 16 2025
Written by Jessica Salamacha, BS, CCRC, NRCMA; Sr. QualityAssurance Analyst, CommonSpirit Health Research Institute and Belinda Buehl, BS;Regulatory Specialist, University of Wisconsin Department of Human Oncology –Radiation Oncology
Who:
The short form consent process is utilized for participants who are not fluent in English, are unexpectedly encountered, and there are no available translations of the full informed consent document in the participant’s native language. Study sites should take proactive measures to identify the languages commonly spoken by potential participants in their region and ensure that the informed consent documents are appropriately translated in advance.
A site utilizing the Central Institutional Review Board (CIRB) may use translated short forms available in CTSU, provided their site has a current approved policy on short form consent reported to CIRB on either the Annual PI Worksheet or the Annual Signatory Institution Worksheet. Additionally, sites are permitted to utilize their own short forms if they have been approved by CIRB. When utilizing a short form consent and associated process it is imperative the site follow all regulations and their institutional SOPs.
What:
The short form consent document is a non-study specific document, translated into the potential participant’s native language, which outlines that the potential participant is being asked to participate in a study, and their participation is voluntary. It’s recommended the short form consent document include the basic elements of an informed consent document. Participants agreeing to sign consent must be given a signed copy of the documents and a written summary of the research. The entire process requires the use of an approved interpreter to review and facilitate the informed consent conversation. It is up to each institution who may serve as an approved interpreter, and in many cases, this may be a third party interpreter service specializing in certified medical interpretations. In addition, an individual the institution defines as an authorized/approved witness, must also be present for the conversation(s) and obtaining of signatures. Of note, some institutions may allow for the approved interpreter and witness to be the same individual.
When:
A short form consent may be utilized if the following criteria are met:
- There is not a fully translated consent available in the potential participant’s language.
- The protocol does not have eligibility criteria that prohibits participation based on language
- The Signatory Institution has submitted and been approved for the utilization of a short form consent.
- An IRB approved short form exists in the potential participant’s language
Where:
Sites will find the IRB approved short form consent documents from the CTSU website under Resources: https://www.ctsu.org/pet_main.aspx?nodeKey=9. Additionally, sites may also submit their own translated short forms for approval on either the Annual Signatory Institution Worksheet or the Annual PI Worksheet.
Why:
A short form consent is necessary to obtain informed consent from potential participants who are not fluent in the primary language of the research study consent documents. The process and associated documents provide participants, whose native language has not been anticipated, the ability to ensure they understand the research and their rights, while making an informed decision regarding their participation. The utilization of this process and documents allows for broader participation in clinical trials by allowing and encouraging participants with limited English proficiency the opportunity to participate.
How:
A site should review and follow their institutional policies and procedures for conducting a short form consent process. The general steps for utilizing the short form consent process are as follows;
- Ensure the short form consent has been IRB approved for your site and is available in the language of the potential participant or their legally authorized representative (LAR).
- Present the short form consent documents to the potential participant/LAR, ensuring adequate time for the potential participant to review and ask questions, as needed.
- Contact and utilize your site’s agreed upon individual(s) to serve as an approvedinterpreter and approved witness to assist with conversation and signing of the short form consent. These people must be willing to sign the informed consent document for their applicable role(s).
- Present all required documents orally, via the approved interpreter, to the participant/LAR, ensuring adequate time for review and questions, as needed. It is required that the short form consent documents are presented orally in a language understood by the participant/LAR. The English version of the IRB-approved Informed Consent Form (ICF) or other IRB-approved summary is to be read to the participant/LAR in a language understandable to the participant/LAR by an approved interpreter who is fluent in the participant’s language as well as English.
- The participant should review and sign the short form consent if willing to participate. The individual conducting the informed consent conversation must review and sign the English version of the IRB-approved ICF.
- When it comes to signatures, it is advised that each party only signs what they can read. The potential participant/ LAR, the approved interpreter, and the approved witness should sign the short form consent document. The individual obtaining consent, the approved witness, and the approved interpreter should sign the copy of the English version of the IRB-approved ICF or another IRB-approved summary. The investigator, or their designee, must give to the participant/LAR a signed copy of the Short Form and a copy of the English version of the IRB-approved ICF or another IRB-approved summary.
- Upon execution of the short form consent documents, sites should work as expeditiously as possible to provide the participant a fully translated version of the consent in the participant's native language.