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5.5 Use of the Short Form Consent Document

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for use of a short form written consent document for enrollment in clinical research.

2.0 Policy

  • 2.1. It is the policy of the Organization that use of a short form written consent document is permissible in accordance with HHS regulations at 45 CFR 46.117(b)(2) and FDA regulations at 21 CFR 50.27(b)(2) when:
    • 2.1.1. A subject/LAR who cannot understand English is unexpectedly encountered.
    • 2.1.2. There is not sufficient time to develop and obtain IRB approval for a complete ICF written in language understandable to the subject/LAR.
    • 2.1.3. The research presents the prospect of direct therapeutic benefit to the subject.
  • 2.2. The short form is not a substitute for a complete fully translated ICF when it is anticipated that a significant number of subjects will be non-English speaking. For research where it is reasonable to expect that a significant number of non-English speaking persons will participate, the IRB may require that a translated CF be prepared and used
  • 2.3. The short form is restricted to enrollment of no more than three subjects per language in a given protocol. In order to enroll more than three subjects, the PI is required to have the complete ICF translated into the appropriate language and reviewed and approved by the IRB.
  • 2.4. The enrollment of a minor under circumstances which satisfy the criteria specified above is permitted using the short form signed by the minor’s parent/guardian. There is no requirement that the minor be provided with a study information sheet. However, minors, age 13 and above, must sign the short form. Minors between the ages of 7-12 must be verbally assented with documentation in the research or medical record.
  • 2.5. It is the policy of the Organization that the use of a short form written consent document is permissible when an external IRB acts as the IRB of record for clinical trials conducted on the premises of the Organization provided the IRB of record approves the use of the short form written consent document.

3.0 Procedure

  • 3.1. The Short Form states that the elements of informed consent required by 45 CRFR 46.116 have been presented orally to the subject or the subject’s LAR
    • 3.1.1. Following the effective date of the Revised Rule the short form will also state that a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research (as required by rev 45 CFR 46.116(a)(5)(i)) was presented first to the subject, before other information, if any, was provided.
    • 3.1.2. IRB-approved short forms are available on the IRB website in the following languages: Arabic, Bosnian, Croatian, French, Hmong, Khmer, Laotian, Oromo, Russian, Somali, Spanish, and Vietnamese.
  • 3.2. Investigators must complete a Short Form Request (available on the IRB website for each subject, and submit to the ORA.
  • 3.3. If an IRB-approved short form is not available in a language understandable to the subject/LAR, the investigator may develop an appropriate short form based upon the IRB-approved English version of the short form (found on the IRB website. The completed Short Form Request and the translated Short Form must be submitted to ORA for expedited review and approval before use.
  • 3.4. The IRB Executive Chair/designee must approve each Short Form Request prior to use of the requested short form.
  • 3.5. The approved short form (IRB stamped) must be used within two weeks. The approval period can be extended by the Executive Chair/designee with adequate justification.
  • 3.6. The IRB number and title of the protocol (in English) and contact information must be typed in the appropriate spaces provided on the Short Form.
  • 3.7. An Official Interpreter who is fluent in both English and the language of the subject/LAR must be identified and can be any of the following in order of priority listing:
    • 3.7.1. A Nebraska Medicine, CH&MC or study site staff or contracted person who is a specifically trained interpreter/translator. This individual must be fluent in both languages and have a basic understanding of the medical or other scientific terminology related to the research.
    • 3.7.2. A commercial interpretation/translation service (such as CyraCom).
  • 3.8. If a prospective subject/LAR/parent wishes to designate his/her own interpreter:
    • 3.8.1. This must be documented in the medical/research record.
    • 3.8.2. The Official Interpreter that qualifies under 3.7 above must also be present to ensure the quality and accuracy of the interpretation and this must also be documented.
    • 3.8.3. A minor cannot be used as an interpreter.
  • 3.9. A witness who is fluent in both English and the language of the subject/LAR must be identified and can be any of the following in order of priority listing:
    • 3.9.1. An official Nebraska Medicine, CH&MC, or study site hospital interpreter/translator.
    • 3.9.2. A commercial interpretation/translation service (such as CyraCom).
    • 3.9.3. If the Official Interpreter qualifies under 3.7, then they may also serve as the witness (with the exception that study staff may not serve as witness).
  • 3.10. The interpreter must be involved in the process of consent as follows:
    • 3.10.1. The subject/LAR should be given a copy of the short form.
    • 3.10.2. The person obtaining consent, with the assistance of the interpreter, should explain the use of the short form.
    • 3.10.3. The person obtaining consent, with the assistance of the interpreter, must
      • 3.10.3.1. Provide a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research (as required by rev 45 CFR 46.116(a)(5)(i)) before other information about the research.
      • 3.10.3.2. Describe the research and the prospective subject’s rights (including elements of consent required by 45 CFR 46.116), using the IRB-approved English version of the complete ICF as a guide. As long as the above information is provided, the complete ICF need not be translated word-for-word.
    • 3.10.4. The complete ICF, which has been approved by the IRB, will serve as the summary required by 45 CFR 46.117(b)(2).
    • 3.10.5. The person obtaining consent, with the assistance of the interpreter, should obtain frequent feedback from the subject/LAR and ensure there is an acceptable level of understanding of the research and the rights of the subject.
    • 3.10.6. Interpreters should be provided with a copy of the short form and the IRB-approved English version of the ICF. Whenever possible, these forms should be provided in advance of initiating the consent process with the subject/LAR.
  • 3.11. Upon conclusion of the consent process the subject/LAR must sign and date the short form.
  • 3.12. The person obtaining consent must sign and date the English version of the complete ICF.
  • 3.13. A witness to the oral presentation of the ICF (per Section 3.9 above) must sign both the Short Form, as well as the English version of the complete ICF.
  • 3.14. A copy of the signed and dated short form and the English version of the complete ICF must be given to the subject/LAR.
  • 3.15. Depending on the nature and duration of the research, the IRB Executive Chair/designee may determine that the English version of the complete ICF must be translated into a language understandable to the subject with a copy given to the subject as soon as possible after enrollment in the research using the short form. In general, this may be required for studies which are significant risk and of long duration.
  • 3.16. The process of consent using the short form must be fully documented and maintained on file which includes the following:
    • 3.16.1. The time over which the process of consent was conducted.
    • 3.16.2. The name and contact information of the interpreter.
    • 3.16.3. The name and contact information of the witness.
  • 3.17. Both the investigator and interpreter must document the informed consent process utilizing the short form in the medical/research record.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 18, 2018

 INITIAL FEBRUARY 5, 2016

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