Examining the Factors Affecting the Inclusion of Non-English Speaking Individuals in Clinical Research
Creators: name: Johnson, Ann Rebecca
Publisher: name: University of Utah
Year: 2019

description: The purpose of this project was to examine the factors that pertain to the inclusion of non-English speaking (NES) individuals in clinical research and recommend strategies for improving their inclusion. Factors were considered from the perspective of academic medical centers as well as clinical researchers and research staff. Strategies were recommended based upon the assessment of these factors. A case study was used to evaluate the comprehensive policies and procedures of 12 academic medical centers in order to describe their current translation and interpretation policies. Case institutions were selected based upon (a) their level of federal funding, (b) their geographic location in a state with higher proportions of the population that do not speak English, and (c) the comprehensive nature of their policies. After collecting all of the relevant written policies and procedures for each institution, qualitative analysis was performed in order to identify common themes. Five major themes were identified, including translation process, use of the short form consent process, representation of the Belmont Report principles, representation in the Institutional Review Board (IRB) application, and use of interpreters. Four minor themes were also identified. A study was also conducted to evaluate the perceptions of researchers and research staff toward the inclusion of non-English speaking patients in research. A behavioral framework was used to identify relevant constructs and subsequently design an online survey and conduct in-depth interviews. Most survey respondents (97.7%) indicate that they have some knowledge of the issues concerning inclusion of non- English speaking patients and 62.6% indicated that they probably or definitely intend to use language services in a future research project to facilitate inclusion of non-English speaking patients. Three primary themes were identified based on the in-depth interviews: (a) researchers had a developed awareness of the NES patient and research cultures, acknowledging that research validity, research participant justice, and the institutional expectations for conducting research must be taken into account; (b) researchers engaged in the process of weighing the costs and benefits of including NES patients in research; (c) researcher's connected the availability of resources and their own preparation to their feelings of self-efficacy. Recommended strategies for improving the inclusion of non-English speaking individuals in research were presented in detail. These strategies focus on increasing researcher preparation and reducing barriers perceived by the researchers. Strategies for increasing preparation include bringing up the topic of including NES individuals during the planning stages of a study, knowing the local population and those served by the institution, and establishing clear expectations and guidelines for how to appropriately enroll NES individuals. Strategies for reducing barriers include increasing availability of language translation and interpretation services, as well as improvements and flexibility for informed consent documentation and processes.