Instructions for Consenting Participants Who Do Not Speak English but Are Literate

The below procedures are to be used to obtain signed consent from individuals who do not speak English but are literate:

1)Both an English version of the consent document and a version written in the language spoken by the potential study participants will need to be created and submitted to the IRB for review and approval.

2)The IRB will utilize a language consultant to confirm that both versions of the consent document say the same thing.

3)Upon approval, the consent document written in the language of the participants should be used to obtain participant consent.

  1. If the researcher does not speak the language of the potential participants, a translator should be utilized to respond to any questions posed by potential participants.

Short Form Consent Instructions: Oral Presentation of Consent to Participants Who Do Not Speak English and Are Illiterate

The below procedures are to be used to obtain signed consent from individuals who do not speak English and are illiterate:

1)Both an English version of the consent document and a version written in the language spoken by the potential study participants will need to be created and submitted to the IRB for review and approval.

  1. This document is referred to as the “summary.”

2)Both an English version of the short form consent document and a version written in the language spoken by the potential study participants will need to be created and submitted to the IRB for review and approval.

  1. The short form simply states that the elements of consent contained in the summary have been provided to participants.

3)The researcher, utilizing a translator if needed, should read or explain the information in the summary to participants.

4)The participant and a witness/the translatorshould sign the English version of the short form consent document.

  1. Participants not capable of signing may make their mark or provide a fingerprint.
  2. The translator can serve as the witness, but no one should serve as a witness if he or she is not fluent in the language of both the participant and the researcher.

5)The English version of the summary should be signed by the researcher and the witness and retained by the researcher.

6)The researcher will keep the signed English versions of the short form consent document and summary.

  1. We recommend that the researcher staple these documents together prior to utilizing them and having them signed.

7)The participant will be given a copy of the short form consent document and summary written in his or her language.

  1. We recommend that the researcher staple translated copies of the short form and the summary together prior to the consent procedures and provide both to the participant in a packet.
  2. It is not necessary to provide a photo copy of the signed versions; unsigned copies are fine.
  3. We understand that providing copies of written documents to illiterate participants seems odd, but the assumption is that even if the participant is illiterate, he or she may have current or future access to someone who is literate and capable of reading the form if questions or concerns arise once the study has concluded and the participant no longer has direct access to the researcher.

** If a researcher is concerned that cultural or safety concerns may inhibit the willingness of participants to sign, make their mark, or provide a fingerprint on consent documents, he or she should contact the IRB to discuss waiver options.