The Program for the Protection of Human Subjects (PPHS) recently announced the Short Form Consent process and policy to the research community during the monthly Research Forum (first Wednesday of the month, from 12 noon- 1 pm). The Short Form Consent process is intended to facilitate the enrollment of non-English speaking subjects under certain circumstances where a fully translated consent form has not been approved by the IRB. The PPHS will review a request to use the Short Form Consent process on a case-by-case basis for use with incidental, unanticipated non-English speaking potential subjects. A Short Form Consent process is approved for a one time use for a specific potential subject, for a specific research study only.
Limitations and Considerations:
This process cannot be used when enrollment of non-English speaking subjects of a particular language group are anticipated, when such a group is targeted for enrollment, or if a significant number of potential subjects come from a specific language group. The Short Form Consent process cannot be used for Spanish speaking subjects. Ad hoc translation of the English consent form is not allowed.
If you plan on requesting to use a Short Form Consent process, the first step is to review the resources available to pay for interpreter services to make sure that the costs associated with services needed to enroll the non-English speaker can be covered by the study budget. Keep in mind that all future communication with the subject will also need to occur in the subject’s preferred language.
If you are planning on enrolling a non-English speaking subject, you need to plan for all research related communication with subjects during all study visits, any phone calls you may receive from the subject, and how you will handle any research emergencies. In addition, if any study materials need to be provided to, or completed by, subjects, those materials will need to be translated into the language understood by the subject.
To Request to Use the Short Form Consent process:
Email Liz Carroll in the PPHS office with the following information: Study ID#, PI, language requested, and basic non-identifiable information about the potential subject/situation. If the Short Form consent is not immediately available from the library in the target language, arrangements for the translation of the Short Form consent will need to be made. The PPHS library currently includes over 20 languages.
Contact Adriana Cifuentes, the Language Assistance Program Coordinator in the Patient Service Center to obtain a dedicated access code. This dedicated access code will allow patient services to invoice you directly for services rendered for research purposes. You should add these fees to the study budget so the sponsor of the research will cover the cost of the interpreter service.
If the use of the Short Form Consent Process is not specifically described in the Consent Process section of your protocol template (#12 under “Non-English Speaking Subjects”), you must submit a modification to add it to your study. Review your protocol template section on the Consent Process to see if you included a section on Non-English Speaking Subjects. Be sure that you indicated that if you have a potential subject who does not speak English or Spanish, you will follow the Short Form Consent Process and comply with the policy. If this section indicates that all consent documents will be translated and approved by the IRB prior to use, submit a modification to the IRB to allow for the Short Form Consent Process. This modification should be submitted to the IRB as soon as possible. A requested Short Form will be released independently of the modification review process.
Please contact Liz Carroll, Assistant Director of Regulatory Affairs for the Program for the Protection of Human Subjects with any questions related to this policy or the procedures to be followed.