Short Form Consent Instructions
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These instructions are for use by the research team and should not be shared with the subject.
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IRB approval is not necessary for use of the Short Form Consent Document (Short Form).
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If a translated version is not available in the appropriate language, the Principal Investigator must have the IRB-approved Short Form translated into that language.
- Present the attached Short Form to the potential research participant in a language s/he understands.
- The participant must sign and date the Short Form version appropriate for his/her language.
- Do not have individuals who cannot read English sign the English version of this form.
- Complete the following open fields in the document: the subject’s full name, IRB ID#, the Principal Investigator’s name and phone number on page 1, and the applicable language fields in the translator and witness signature sections on page 2 of the Short Form.
- A translator must read the IRB-approved English version of the full Informed Consent Document to the potential participant in his/her chosen language; the full Informed Consent Document serves as a written summary of the research.
- An individual who is fluent in both English and the potential participant’s language must witness the consent process.
- The witness must be unaffiliated with the study.
- The witness must sign and date the Short Form and the IRB-approved consent document.
- The English version of the consent document will not have a separate signature section for the witness, so s/he will sign below the Person Who Obtained Consent.
- The research staff must make an entry on the consent document or in the research records documenting the use of the short form.
- The translator may serve as a witness.
- If the medical or technical information in the consent document is complex, the translator must have an understanding of this information.
- If the translator is also the witness, the translator must complete the Witness and Translator signature sections on the Short Form.
- The Person Who Obtained Consent must sign and date the IRB-approved English consent document.
- The subject must receive a copy of the signed and dated Short Form and the IRB-approved English consent document as a written summary of the research.
- The Principal Investigator must provide the subject with a translated version of the complete IRB-approved Informed Consent Document within 30 days of enrollment, if the study requires multiple visits or lasts more than 60 days.
- The research team will file the original signed and dated IRB-approved English consent document, the original signed and dated Short Form and the translated version of the full Informed Consent Document, if applicable in the research records separate from the subject’s study data.
