Paperwork involved in clinical trials, such as consent forms, should be translated into other languages. Organizations that sponsor clinical trials usually pay the costs for this translation and to have those translations approved by the Institutional Review Board (IRB), to ensure that the translation is accurate. These forms as well as other documents in healthcare often undergo a sophisticated process called back translation, which gets to the root of the questions being asked instead of a word-for-word translation, Dr. Robbins says.
Sometimes translations are done by outside organizations, while other times they are done by the hospital. For example, at SUNY-Downstate, the study coordinator can translate consent forms into Mandarin Chinese, Dr. Ginzler says. Translations often have to take into account different variations of the same language that occur among speakers from different countries. “Our IRB has a translation service (as do the sponsors on occasion), and in nearly all cases, we are dealing with Spanish,” Dr. Wallace says.
However, in some situations, even with translations, the forms can still be difficult to read. “The forms read as horribly as they read in English,” says Dr. Onel, thinking about the high-level language often used in consent forms.
