Short Form Consent Document (Short Form) FAQ

 

  1. Where can I find the Use of the Short Form Consent Document with Non-English Speaking Subjects policy?
  2. What is a Short Form?
  3. When should I use a Short Form?
  4. Where do I find the Short Form and instructions?
  5. Where do I get a translated version of the Short Form?
  6. Do I need to submit a Short Form for IRB review and approval?
  7. Are there any resources to assist with translating the Short Form into additional languages?

 


Where can I find the Use of the Short Form Consent Document with Non-English Speaking Subjects policy?

Please access the UI Investigator's Guide for more information about the Use of the Short Form Consent Document with Non-English Speaking Subjects policy.

What is a Short Form?
A Short Form is a consent document written in a language understandable to a non-English speaking individual [or his/her legally authorized representative (LAR)].  It summarizes the required elements of informed consent outlined in the federal regulations but it does not contain specific study information.  Therefore, it is used in conjunction with an oral presentation of the IRB-approved English version of the Informed Consent Document (ICD), in a language understandable to the potential subject. 

When should I use a Short Form?
An investigator should use the Short Form when s/he unexpectedly encounters a non-English speaking, potential research participant but has not had the IRB-approved Informed Consent Document (ICD) translated into a language understandable to the individual. 

Where do I find the Short Form and instructions?
Click here to access the English version of the Short Form and Instructions for use of the Short Form Consent Document. Access the UI educational tool Short Form Consent and Process for information on how to use the Short Form Consent Document and Process.

Where do I get a translated version of the Short Form?
The Human Subjects Office (HSO) has had the Short Form translated into multiple languages and they are available here.  The Principal Investigator is responsible for having the IRB-approved English version of the Short Form translated into additional languages, when necessary.

Do I need to submit the Short Form for IRB review and approval?
No.  The IRB has approved the English version of the Short Form; and it was used as the template for the translated versions on the HSO website.  Therefore, investigators should use the English version as a template when having the Short Form translated into additional languages.

Are there any resources to assist with translating the Short Form into additional languages?
Yes.  The HSO has permission to share the names of these translators in the Iowa City/Coralville area, so investigators can contact them to discuss translation services.  The negotiation/contract for these services will be the investigator’s responsibility.