Short Form Q & A
SOME OF YOUR FREQUENTLY ASKED QUESTIONS:
WHEN CAN I USE A TRANSLATED SHORT FORM TO OBTAIN CONSENT?
You may use a translated short form if all the following conditions are met:
- There is not a translated consent form available. For studies with a Spanish version of the consent approved and posted on CTSU, the Spanish version of the consent form should be used.
- When using the CIRB-approved Spanish version of the consent form, the institution must insert CIRB-approved translated boilerplate language so that the Spanish version reflects the same information as the English version for the site.
- There is no protocol eligibility restriction based on language that prohibits enrollment of the participant.
- The Signatory Institution’s policies permit the use of short form consents.
- These policies have been reported to the CIRB on either the Annual Signatory Institution Worksheet or the Annual PI Worksheet.
- A CIRB-approved short form exists in a language understandable to the potential participant.
WHERE CAN I GET A TRANSLATED SHORT FORM?
Sites who use the CTSU can obtain the CIRB-approved translated short forms from the Resources section of the CTSU website. The English short form is provided for reference and should not be used to consent participants, given the availability of consent forms in English.
You may also submit your own translated short forms for approval on either the Annual Signatory Institution Worksheet or the Study-Specific Worksheet.
WHEN CAN I USE THE UPDATED SHORT FORM FOR STUDIES INITIALLY APPROVED AFTER 1/21/2019 TO OBTAIN CONSENT?
- The Short Forms translations were updated to be compliant with the 2018 Common Rule which became effective 01/21/2019.
- Studies initially approved after 01/21/2019 may use the 2018 Common Rule Short Forms.
- Studies initially approved prior to 01/21/2019 may use the Short Forms approved by the CIRB version date 11/09/95.
- Sites may utilize the 2018 Common Rule Short Forms for studies approved prior to 01/21/2019 per their local policy if local policy allows the 2018 Common Rule to be applied to studies approved before 01/21/2019.
WHAT LANGUAGES ARE AVAILABLE?
The translated Short Forms for the 2018 Common Rule are available in the following 43 languages:
The translated Short Forms for the pre-2018 Common Rule are available in the following 11 languages (version 11/09/95):
- Creole (Haitian)
- Portuguese – Brazil
WHAT IF MY INSTITUTION DOES NOT HAVE A POLICY FOR USE OF A SHORT FORM?
For Signatory Institutions that do not already have a policy in place for the use of short form consents, we recommend that one be developed. Please refer to the OHRP guidance regarding Informed Consent of Subjects Who Do Not Speak English.