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Introduction/Background

When enrolling a non-English speaking person into a study, the informed consent information needs to be presented in a language understandable to the subject and documented (DHHS: 45 CFR 46.116 and 45 CFR 46.117, FDA: 21 CFR 50.25 and 21 CFR 50.27).

The two (2) main options for written consent are:

  1. The entire written IRB-approved English informed consent form (ICF) may be translated into the language understandable to the subject; OR
  2. A “short form” may be used.*+

* If a study will enroll only a specific non-English speaking population, short forms may not be used. Translation of the entire IRB-approved English ICF is required.
+ If it is expected that more than five (5) persons of a specific non-English speaking population will be enrolled, the approved English ICF should be translated into the specific foreign language (please refer to the Translation of Study Documents Policy for document translation policy).

Use of a Translated Short Form

To ensure that non-English speaking persons are not excluded from participating in research a “short form” may be used. At Tufts MC/TUHS every study is eligible to use a short form ICF unless the IRB specifically determines to not permit the use of a short form as it relates to a particular study. Under certain circumstances, the IRB may determine to not allow the use of a short form ICF, for example based on the level of risk associated with the study (e.g., a gene transfer research study). Use of a short form is allowed unless specifically stated otherwise in the Tufts MC /TUHS minutes and Notice of IRB Approval letter.

A signed short form basically documents the oral presentation of the entire written IRB-approved English ICF in a language understandable to the subject. For industry sponsored research, Principal Investigators are advised to confer with the sponsor prior to the enrollment of a non-English speaking subject and obtain the sponsor’s support for such an enrollment.

The IRB has approved an English short form for use at Tufts MC and TUHS and has had the document translated to several languages and posted on the IRB website. Up to five (5) short forms in the same language may be used in a study in a twelve (12) month period.

As with consent of English speaking persons, the IRB will count every subject who has signed a short form as enrolled, whether or not that subject completes the study. That is to say, that each signed short form “counts” toward the five (5) that may be used in a study in a twelve (12) month period.

To help a non-English speaking subject get translation help to telephone the PI, if needed, the IRB has also created and translated a short page called “Directions for help to speak with a research study PI.” This page should be given to the enrolled subject in a language s/he understands.

When using a short form with a non-English speaking person, ALL of the following must be completed:

  1. Insert study specific information, including department name, title of study, principal investigator, and contact information into the short form document you plant to use. This information must be typed and the fields on all the pages of the short form document need to be completed
  2. The subject must be given a copy of the short form in the language understandable to him/her to read.
  3. A translator/interpreter who is fluent in the subject’s language and English must orally present the entire IRB-approved English ICF to the subject in the language understandable to the subject.

Note: A family member of the subject can act as a translator/interpreter. If a member of the research team is fluent in the language understandable to the subject and English s/he can act as the translator/interpreter and the Person Obtaining Consent; however, s/he may not also act as the witness.

If you need an interpreter or translator for your study, consider contacting Tufts Medical Center’s Interpreter Services for Research. Interpreter Services for research can provide face-to-face and telephone interpretation as well as document translation services for both Tufts Medical Center and Tufts University Health Sciences studies.

  1. The entire consent process must be witnessed by an individual who is fluent in both English and the language understandable to the subject.

Note: The witness may be staff, the translator/interpreter, a family member, or another person. A member of the study staff acting as translator/interpreter and Person Obtaining Consent is not to also serve as the witness. Before starting the consent process, the PI is to verify whether the translator/interpreter will also be able to serve as a witness. If not, another person will be needed to serve as the witness.

  1. The IRB-approved English ICF must be signed by the investigator authorized to obtain consent and the witness to the consent process.
  1. The short form in the language understandable to the subject must be signed by the subject and the witness to the consent process (see 2 above).
  1. The subject must be given signed copies of both the IRB-approved English ICF and the short form in the language understandable to the subject; AND
  1. The original signed English ICF and the original signed short form should be placed in the subject’s research record and a copy of both placed in his/her medical record, if appropriate.

During the consent process the translator/interpreter should briefly explain the consent process to the prospective subject. The prospective subject’s questions or concerns should be relayed by the translator/interpreter to the person obtaining consent, and the answers translated back to the prospective subject. Adequate time should be afforded the participant to make an informed decision regarding participation in the study.

A list of all IRB approved ‘Short Form’ consent documents and a Short Form Quick Reference Checklist for your reference are available here: Short Form Consent Documents and Translations into Commonly Encountered Languages.

Please refer to the following for more information about short form consent requirements and obtaining consent:

FDA: A Guide to Informed Consent

OHRP: Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English