A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encountered, there is not sufficient time to develop and obtain IRB approval for a complete ICF written in language understandable to the subject/LAR, AND the research presents the prospect of direct therapeutic benefit to the subject.
Use of the Short Form is limited to enrollment of no more than three subjects per language in a given protocol. In order to enroll more than three subjects, the PI is required to have the complete ICF translated into the appropriate language and reviewed and approved by the IRB.
The investigator must complete a Short Form Request (available in RSS) for each subject, and submit to the ORA. Each request must be approved before the Short Form may be used.
Depending on the nature and duration of the research, the IRB may determine that the English version of the complete ICF must be translated into a language understandable to the subject and a copy given to the subject as soon as possible after enrollment In general, this may be required for studies which are significant risk and of long duration.
Please refer to HRPP Policy 5.5 (Use of the Short Form Consent Document) for detailed instructions.
English translations of these short forms is included at the bottom of the page. Translated Short Forms generously supplied by Office of Human Subjects Research - Johns Hopkins Medicine and the University of Utah. (Key: * - Johns Hopkins University; # - The University of Utah)
Translated Short Forms generously supplied by Office of Human Subjects Research - Johns Hopkins Medicine and the University of Utah. (Key: * - Johns Hopkins University; # - The University of Utah)