Short Form Consent Documents and Translations into Commonly Encountered Languages
When enrolling a non-English speaking person into a study, the two (2) main options for written consent are:
The entire written IRB-approved English informed consent form (ICF) may be translated into the language understandable to the subject; OR
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).
The translated short forms below have been approved by the Tufts MC/TUHS IRB and can be printed and used in a specific study without further IRB approval or used to enroll a specific subject, provided the use of a short form is allowed in the study (i.e., the Notice of IRB Approval letter does not specifically state that use of a short form is not approved and the sponsor allows use of a short form). Per the Tufts MC/TUHS IRB Short Form Policy, up to five (5) short forms in the same language may be used in a study in a twelve (12) month period.
Quick Guide on Using IRB approved ‘Short Form’ documents: When using a short form with a non-English speaking person, complete the following:
Insert study specific information, including department name, title of study, principal investigator, and contact information. This information must be typed and the fields on all the pages of the short form document need to be completed.
The subject must be given a copy of the short form in the language understandable to him/her to read;
A translator/interpreter must orally present the entire IRB-approved English ICF;
The consent process must be witnessed by an individual who is fluent in both English and the subject’s language;
The English ICF must be signed by the investigator and the witness;
The short form must be signed by the subject, and witness;
The subject must be given signed copies of the English ICF and short form; AND
The original signed English ICF and the original signed short form should be retained in the subject’s research record and medical record, if appropriate.
Tufts MC/TUHS IRB approved ‘Short Form’ consent documents for use: Please note that the IRB office is also working on providing approved short forms in Tagalog, and Slovenian. Translation of the Tufts MC/TUHS IRB English ‘short form’ into other languages must be done in accordance with the Tufts MC/TUHS IRB translation policy and must be submitted to the Tufts MC/TUHS IRB for review and approval prior to use. Refer to the Tufts MC / TUHS IRB Investigator Manual for information about translating documents.
Tufts Medical Center’s 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. Contact them directly for further details and cost information.
Please refer to the following for more information about short form consent requirements and obtaining consent: