The Short Form

Recently, some colleagues and I had a discussion about the "short form" for documenting consent. As most of you know, the federal regulations allow the use of "A short form written consent document stating that the elements of informed consent required by [§46.116/>50.25] have been presented orally to the subject or the subject's legally authorized representative." [46.117(b)(2)/50.27(b)(2)] The short form may be used when the subject does not speak English or another language where there is a translated consent form. It may also be used when the subject is illiterate.

The short form is not used very much and many institutions don't use it all. This is probably because most people don't understand it and are afraid to use it. The problem is that there is not much guidance out there on the use of the short form. The only OHRP guidance on this is from 1995 (http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm) but I guess it still applies. It says that the short form should be in the subject's native language. It also says: "The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB."

I believe that IRBs should not be afraid to use the short form where it is appropriate since it is allowed in the regulations. The appropriate use is for subjects who speak an unanticipated language. If there is a reasonable expectation that there will be subjects recruited for the research who speak a certain language (most commonly, Spanish), then the consent form should be translated into that language. The short form should not be used in that case.

The problem is OHRP's guidance which requires IRB approval of the short form which should be in the subject's language. Although this can be done through expedited review, it can still be burdensome. This makes the use of the short form problematic for the situation where a subject shows up who speaks an unanticipated language. This, however, is guidance from OHRP and old guidance at that. I think an IRB could make a good case that the regulations do not require IRB approval of the short form or that the short form be in the subject's language. If a witness signs the short form indicating that the information in the English consent has been provided to the subject in his or her native language and that the subject consented to be in the research, that should be satisfactory documentation of informed.

I hope that OHRP comes up with new guidance on this topic and reconsiders the requirements of the old guidance. FDA guidance (http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#nonenglish) does not require IRB approval or that the short form be in the subject's language.