# Implementation Science and Equity: Human Subjects & Regulatory (ETHICS) Core

> **NIH NIH P20** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2024 · $83,144

## Abstract

PROJECT SUMMARY/ABSTRACT: HUMAN SUBJECTS & REGULATORY (ETHICS) CORE
The purpose of the ETHICS Core is to provide COBRE members, and the broader KUMC community, targeted
support for conducting equity-focused implementation research with human subjects. Implementation science
is highly consistent with the goals of community-engaged, equity-focused research. The study designs and
methods used in implementation science, however, challenge the current training of investigators and IRB
committees. To meet the unique ethical challenges of conducting equity-minded implementation science, the
ETHICS core will assist Project Leads, pilot study, and other investigators with understanding and meeting the
ethical and regulatory requirements related to their specific implementation projects.
Aim 1. Establish the Implementation Research Ethics Consultation Service.
Core leadership will conduct Ethics Consultations with Project Leads and other KUMC implementation
researchers to: a) identify ethical and design-related challenges in their protocols; b) encourage Project Leads
to work with the CEO Core to get stakeholder input on research design and implementation; and c) develop an
Implementation Science and Equity in Human Subjects Plan for each study to address aspects of research that
involve vulnerable populations and novel research design. The Core will also establish the Ethics Navigation
service. The ETHICS Navigator, with expertise in regulatory practices and requirements, will assist Project
Leads and other investigators conducting implementation research to develop protocols/consent, interact with
the IRB, submit protocols, revise protocols, and remain up to date on all human subjects-related trainings and
deadlines.
Aim 2. Curate and provide trainings to support ethical research in Implementation Science and Equity.
The ETHICS Core will identify relevant internal and external trainings and link researchers with trainings as
appropriate. It also will enhance KUMC’s existing Responsible Conduct of Research and Good Clinical
Practice trainings to include examples of implementation and disparities research; incorporate evidence
regarding structural discrimination, and integrated exercises related to implicit bias. The Core will provide IRB
member training in these research approaches to build institutional capacity for appropriate review.
Aim 3. Collaborate with the Administrative Core to evaluate ETHICS performance.
The ETHICS Core will collect ongoing data required by the Administrative Core to evaluate Core services. In
addition, the ETHICS Core will conduct a detailed internal evaluation to address strengths, weaknesses, and
areas for improvement for Core services.

## Key facts

- **NIH application ID:** 10927191
- **Project number:** 5P20GM139733-02
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** Jason Edwin Glenn
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $83,144
- **Award type:** 5
- **Project period:** 2023-09-11 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10927191

## Citation

> US National Institutes of Health, RePORTER application 10927191, Implementation Science and Equity: Human Subjects & Regulatory (ETHICS) Core (5P20GM139733-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10927191. Licensed CC0.

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