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Short Form Quick Reference Checklist
When using a short form with a non-English speaking potential subject, ALL of the following must be completed. Please refer to the Short Form Policy for additional details.
Click here for a printable version of this short form quick reference checklist.
1. Confirm use of the short form is permitted for the study.
If a study will enroll only a specific non-English speaking population, translation of the entire IRB-approved English ICF is required. Also, if it is expected that more than 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 short form is allowed unless specifically stated otherwise in the Tufts MC /TUHS minutes and Notice of IRB Approval letter and provided the study sponsor allows use of a short form.
2. Confirm not more than 5 short forms in the same language have been used in the study in a 12 month period.
3. Insert study specific information, including department name, title of study, Principal Investigator, and contact information (this text can be inserted in English) into the short form document and then print the document for use. This information must be typed and the fields on all the pages of the short form document need to be completed
4. The subject must be given a copy of the short form in the language understandable to him/her to read.
5. A translator/interpreter who is fluent in the subject’s language and English should briefly explain the consent process to the prospective subject 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.
6. 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.
7. 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 may not 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 the witness. If not, another person will be needed to serve as the witness. If telephone interpretation is being used, the translator/interpreter may not serve as the witness. The witness must be physically present for the entire consent discussion.
8. If the potential subject decides to participate, the IRB-approved English ICF must be signed by the investigator authorized to obtain consent and the witness to the consent process.
9. 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).
10. 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
11. 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.
Please click here for a printable version of this short form quick reference checklist.