# INcreasing CLinical Trial OpportUnities anD Enrollment of Non-English Speaking Research Subjects: A Revised Research Pathway (INCLUDE)

> **NIH FDA U01** · MAINEHEALTH · 2024 · $249,994

## Abstract

The dramatic underrepresentation of Non-English speakers (NES) in clinical trials contributes to health
inequities and compromises the generalizability of research. Barriers to enrollment include factors associated
with patients (mistrust, competing demands, and challenges with follow-up), researchers (extra time and cost
required for translation, enrollment, communication, and regulatory burdens), and system-related factors
(inconsistent IRB interpretations of federal regulations, and interpreter availability and willingness to document
consent). Our recent research regarding local barriers is consistent with prior publications; the system-related
factors identified included staff familiarity with federal regulations, availability of interpreters, willingness of
interpreters to sign as witnesses, time for consent discussions, and translating short- and long-form consent
documents. Although an increasing number of publications have reported these barriers, few have proposed
solutions. Thus, identifying and testing solutions is a key focus area for research. This study uses a modified
Delphi method to reach consensus on best practice to overcome system and regulatory barriers. Stakeholders
involved in the Delphi process include Institutional Review Board (IRB) members, research compliance staff,
principal investigators, research coordinators, interpreters and community representatives from a local
organization serving immigrants and refugees. We will test the resulting process in the Hannaford Center for
Safety, Innovation & Simulation at MaineHealth for two different types of clinical trials: a trial with first-person
patient consent and a trial requiring consent from a legally authorized representative given the patient’s
incapacity at the time of initial enrollment. Simulated consent encounters will include principal investigators,
research staff, interpreters and standardized patients. Simulation participants, community members, IRB
members and compliance staff will evaluate the process through review of recorded simulations and debrief
meetings. The consent process will be varied in subsequent simulations in response to stakeholder
evaluations. A central premise of this study is that it is possible both to achieve the aim of protecting human
research subjects and the health equity aim of including NES in clinical trials. Thus, we seek to study the
development of a culturally appropriate and ethically exemplary informed consent process that is no less
efficient for IRB staff, researchers, and patients than is the pathway for English speaking patients.

## Key facts

- **NIH application ID:** 11046220
- **Project number:** 1U01FD008261-01
- **Recipient organization:** MAINEHEALTH
- **Principal Investigator:** Frank Chessa
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $249,994
- **Award type:** 1
- **Project period:** 2024-08-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11046220

## Citation

> US National Institutes of Health, RePORTER application 11046220, INcreasing CLinical Trial OpportUnities anD Enrollment of Non-English Speaking Research Subjects: A Revised Research Pathway (INCLUDE) (1U01FD008261-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11046220. Licensed CC0.

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