# Community Engagement, Bioethics and Outreach Core

> **NIH NIH P20** · MAINEHEALTH · 2022 · $507,421

## Abstract

Abstract
The Community Engagement, Bioethics, and Outreach (CEBO) Core focuses on expanding the inclusion of
rural populations in acute care research projects requiring urgent initiation of therapy. In a rural state such as
Maine, urban regions concentrate academic medical resources into a few locations that may be many hours
from rural communities and regional hospitals. Patients outside these urban centers are at a significant
disadvantage regarding access to tertiary-level care and participation in medical research. Contributing factors
to this disparity include lack of awareness of ongoing research, geographic and transportation barriers, lower
numbers of eligible participants, and few clinician researchers. These challenges are pronounced for time-
pressured research for life-altering medical problems such as stroke, cardiac arrest, and neonatal
asphyxiation. Ensuring appropriate human subject protection and enhancing rural enrollment requires informed
and experienced researchers, but these essential resources are limited in our urban centers, and critically
lacking in our rural healthcare environment. Patients with these acute conditions are often not awake or
medically stable enough to provide informed consent, and it is often too late to enroll them hours later when
legally authorized representatives arrive at receiving tertiary care centers. To address these challenges, the
Department of Health and Human Services developed the Exception From Informed Consent (EFIC) pathway,
allowing research to proceed without consent under strict conditions, including robust community consultation
and public disclosure prior to initiating the study. Little research has addressed the implications of rurality on
EFIC - it is not known whether EFIC is as effective for rural communities as for urban settings, whether EFIC
increases recruitment from rural areas, and whether rural patients prefer EFIC or emerging options such as
remote teleconsent. The CEBO Core will address these issues to support the COBRE Project Leaders
pursuing acute care research in rural and urban settings across Maine. The core will: 1) Provide direct
assistance to COBRE Project Leaders in recruitment strategies, consent processes, and document preparation
for IRB submission; 2) Engage rural community members (patients, clinicians and other stakeholders) to better
understand their perspectives, preferences, and barriers to participation in research requiring urgent treatment,
and the ethical tradeoffs associated with different approaches to enrollment; and 3) Enhance research training,
regulatory compliance, and proper research conduct among COBRE Project Leaders, early career researchers
and mentors at Maine Medical Center, and emerging clinical researchers at rural sites engaged in these
COBRE projects by developing research networks and associated educational programs to support expanded
acute care clinical research.

## Key facts

- **NIH application ID:** 10348679
- **Project number:** 5P20GM139745-02
- **Recipient organization:** MAINEHEALTH
- **Principal Investigator:** Frank Chessa
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $507,421
- **Award type:** 5
- **Project period:** 2021-02-10 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10348679

## Citation

> US National Institutes of Health, RePORTER application 10348679, Community Engagement, Bioethics and Outreach Core (5P20GM139745-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10348679. Licensed CC0.

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