A Little Study That Could: How One Group Met the Challenge of Conducting a Multi-Site Epidemiologic Study among Diverse Populations in the US and Canada

Epidemiologic research increasingly involves multi-center studies among populations with diverse cultural and linguistic backgrounds. Challenges to such studies include: (1) obtaining clearance from multiple institutional review boards (IRBs), (2) enrolling participants who do not speak English, (3) maintaining data quality, and (4) ensuring operational consistency among administratively diverse sites. To identify TB prevention opportunities for foreign-born persons in the U.S. and Canada, we interviewed and collected clinical data on 1,700 persons newly diagnosed with TB at 22 sites. Sites included health departments, universities, research institutions, and non-profit organizations overseen by more than 30 IRBs. Participants were from 50 countries and spoke 35 different languages. To meet these challenges, study researchers: (1) developed a simple process to designate a central IRB (a third of site IRBs ceded oversight), and required an identical consent form be approved by all IRBs; (2) translated questionnaires and consent forms into the 10 most common languages, arranged for fast translation of consent “short forms” into other languages as needed, and selected a single telephone interpretation service to work with all sites; (3) built a secure, internet-based remote data entry system with built-in quality assurance checks; and (4) developed site-specific implementation and quality assurance plans, remote training programs, and a Web-based communications and document system. In combination, these approaches allowed completion of the study expeditiously and within budget, and may be useful to other investigators facing these common challenges.