Obtaining an informed consent forms (ICF) poses several challenges such as language barriers, if the research participants are non-English speaker, which would require translating the ICF as well as other study documents. Even with translation and back-translation of the ICF, comprehension is still not guaranteed. This study looked into IRBs’ opinions regarding research integrity, communications with principal investigators and IRB decision-making process in regards to translation of Informed consent forms.
The author interviewed members of 34 different geographically located US IRBs (amounting to 57% response rate), which the National Institute of Health NIH ranked among its top 240 funding. The sample included 28 chairs/co-chairs, 1 director, 10 administrators and 7 members who were telephone interviewed for almost 2 hours each. The authors obtained Informed Consent (IC) from all participants and IRB approval from the Columbia University Department of Psychiatry.
Applying the grounded theory, the author identified ‘thick description’ by comparing similarities and differences of the data text.
The data showed it is mandatory to translate study documents that investigate matters among non-English speaking populations, however, many challenges arise regarding the degree to which these documents are correctly translated. Researchers have to take into consideration the literal translation of scientific terms as well as their suitability to the traditional conceptions. In addition, other problems emerged for example; the high cost of translating study documents vs. maintaining the principle of justice by including non-English speakers in the studies even if they make up a minimal fraction of the sample.
Moreover, the process of translation itself is challengeable as some terms/words maybe understood in different ways in some cultures, which may later foster broader cultural misunderstandings. It is advisable to seek assistance of local communities during the translation process.
During the review process, IRBs may consider the translation as a minor problem when compared to other important issues such as the study design. So the researcher might be granted the approval for the protocol with a promise of pursuing funds for translating the study documents.
Many limitations still exist in this study since the reported results are from interviews of members and not direct observation of IRB meetings or examination of the archives, which, nonetheless, are hard to gather.
Future studies are recommended to better assess the need for translation, while, still respecting practicality and logistics of the research process. One solution proposed is the drafting of uniform ICF models in multiple languages and their distribution to researchers and IRBs.
Language, culture and communication have a great impact on the success of clinical research, and in providing accurate scientific data. They do not only affect the IC process, but they significantly jeopardize patient compliance, data accuracy and reporting adverse events. Therefore, language issues must be properly addressed in preparatory phases of clinical research in order to maximize the benefits of international clinical trials. Although this study did not report the actual magnitude of the problem, (as the author did not measure the number of translation problems encountered by the studied IRBs) nonetheless, it shed light on the ongoing discussion and how it can impact the progress of clinical research.
To read the article please visit: How US institutional review boards decide when researchers need to translate studies
Klitzman R. J Med Ethics Published Online First: [please include Day Month Year] doi:10.1136/ medethics-2012-101174