Short Form Q & A

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 of the following conditions are met:

  • 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. For instructions on completing these Worksheets, go to Managing a Site.

What languages are available?

The translated Short Forms are available in the following languages:

  •     Arabic
  •     Creole (Haitian)
  •     French
  •     German
  •     Italian
  •     Korean
  •     Portuguese – Brazil
  •     Russian
  •     Spanish
  •     Tagalog
  •     Vietnamese

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.  The following key content should be addressed in the policy, at a minimum:

1.    Restrictions on Use

The Signatory Institution’s policy should address whether there are any restrictions on the use of short forms.  State and local laws should be taken into consideration, as well as any institutional restrictions, such as:

  • maximum number of uses of a short form per study;
  • maximum number of uses of a short form per language per study;
  • restrictions based on the study’s level of risk;
  • restrictions based on patient population (e.g. patients with impaired decision-making capacity who do not speak English).

2.    How to Obtain Short Forms

The policy should address whether the Signatory Institution will provide its own translated short forms, will use short forms approved by the CIRB and posted on the CTSU website, or a combination of the two.

3.    How to Use Short Forms

The policy should describe the procedure for obtaining consent when the short form is used, including:

  • The full CIRB-approved consent form is presented orally to the potential participant or their Legally Authorized Representative (LAR) in a language they understand.
  • The potential participant or their LAR can ask questions of the study team with the assistance of an interpreter.
  • A short form in a language understandable to the potential participant is provided to the potential participant or their LAR.
  • A copy of the CIRB-approved English language consent form is provided to the potential participant to serve as a written summary of the research.

4.    Provisions for Interpreters

The policy should address who may serve as an interpreter for obtaining consent using the short form.  For example, can a potential participant’s LAR or a family member may serve as an interpreter?  Similarly, the policy should address whether members of the study team may serve as an interpreter. 

5.    Witnesses

The policy should address who may serve as a witness.  For example:

  • An individual who has reached the age of majority within the jurisdiction and who is not otherwise excluded may serve as the witness.
  • An individual who is fluent in both English and a language understandable to the potential participant or their LAR may serve as the witness.
  • The interpreter may serve as the witness.
  • The study team member obtaining the consent may not also serve as the witness.

6.    Documentation

The policy should describe documentation requirements.  For example:

  • The potential participant or their LAR should sign and date the short form.
  • The witness should sign the short form and sign and date the written summary of the research.
  • The study team member obtaining informed consent should sign and date the written summary of the research.
  • The participant or their LAR should receive a copy of the signed and dated short form and the written summary of the research.
  •  If, in the future, the consent form is translated into the language of the participant or their LAR, an unsigned copy of the translated consent form will be provided, when possible, to the participant or their LAR as a courtesy.

 

Posted: April 25, 2018